s-1743 and Esophagitis--Peptic

Proton-pump inhibitors (PPIs) and vonoprazan are recommended as first-line therapies for erosive esophagitis (EE). However, it is uncertain how the magnitude of efficacy and safety of first-line therapy, the choice of individual PPIs or vonoprazan in the treatment of EE remains controversial. This study aimed to evaluate the efficacy and safety of vonoprazan and PPIs in healing esophageal mucosal injury in patients with EE.. Relevant databases were searched to collect randomized controlled trials of proton pump inhibitors and vonoprazan in the treatment of reflux esophagitis up to December 2021. Studies on standard-dose PPIs or vonoprazan that were published in Chinese or English and assessed healing effects in EE were included in the analysis. Stata16.0 was used to conduct a network Meta-analysis to evaluate the efficacy and safety of the treatment.. A total of 41 literatures were included with 11,592 enrolled patients. For the endoscopic cure rate, all the PPIs and vonoprazan significantly improve compared to Placebo; Based on the surface under the cumulative ranking curve, Ilaprazole ranked first, followed by esomeprazole, vonoprazan, pantoprazole, lansoprazole, omeprazole, rabeprazole and placebo therapy ranked the last. For the rate of adverse events, there was no significant difference among all the PPIs, vonoprazan, and placebo.. Ilaprazole, esomeprazole and vonoprazan have more advantages in mucosal erosion healing, there was no significant difference in the comparative safety among all interventions.

Topics: Abdominal Injuries; Esomeprazole; Esophagitis, Peptic; Humans; Network Meta-Analysis; Peptic Ulcer; Proton Pump Inhibitors; Rabeprazole

This study compared the effectiveness and acceptability of all Food and Drug Administration (FDA)-recommended dose proton pump inhibitors (PPIs) in erosive esophagitis (EE): Dexlansoprazole 60 mg, Esomeprazole 40 mg, Esomeprazole 20 mg, Pantoprazole 40 mg, Lansoprazole 30 mg, Rabeprazole 20 mg, Omeprazole 20 mg.. A systematic literature search was performed using PubMed, Embase, and Cochrane Library. Totally, 25 randomized controlled trials (RCTs) met study selection criteria and were incorporated in this network meta-analysis (NMA) study.. For the NMA, eligible RCTs of adults with EE verified by endoscopic examination were randomly assigned to the licensed PPIs at least 4 weeks of continuous therapy. The primary efficacy outcome was the endoscopic healing rates at 4 and 8 weeks. Heartburn relief rates were a secondary efficacy outcome. The rates of withdrawal were analyzed as a safety outcome. In comparison to the common comparator omeprazole 20 mg, esomeprazole 40 mg provided significantly healing rates at 4 weeks [odds ratio (OR), 1.46 (95% confidence interval, 95% CI, 1.24-1.71)] and 8 weeks [1.58 (1.29-1.92)], and improved the heartburn relief rates [1.29 (1.07-1.56)]. In comparison to lansoprazole 30 mg, esomeprazole 40 mg provided significantly healing rates at 4 weeks [1.30 (1.10-1.53)] and 8 weeks [1.37 (1.13-1.67)], and improved the heartburn relief rates [1.29 (1.03-1.62)]. In terms of acceptability, only dexlansoprazole 60 mg had significantly more all-cause discontinuation than omeprazole 20 mg [1.54 (1.03-2.29)], pantoprazole 40 mg [1.68 (1.08-2.63)], and lansoprazole 30 mg [1.38 (1.02-1.88)].. The standard-dose esomeprazole 40 mg had more superiority in mucosal erosion healing and heartburn relief. Esomeprazole 40 mg, pantoprazole 40 mg, esomeprazole 20 mg, and lansoprazole 30 mg showed more benefits in effectiveness and acceptability than other interventions.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adult; Comparative Effectiveness Research; Dexlansoprazole; Esomeprazole; Esophagitis, Peptic; Female; Heartburn; Humans; Lansoprazole; Male; Middle Aged; Network Meta-Analysis; Omeprazole; Pantoprazole; Proton Pump Inhibitors; Rabeprazole; Treatment Outcome; United States; United States Food and Drug Administration

No randomized controlled trial has compared all the licensed standard dose proton pump inhibitors in the healing of reflux oesophagitis.. To compare the effectiveness of esomeprazole with licensed standard dose proton pump inhibitors for healing of reflux oesophagitis (i.e. lansoprazole 30 mg, omeprazole 20 mg, pantoprazole 40 mg and rabeprazole 20 mg).. Systematic review of CENTRAL, BIOSIS, EMBASE and MEDLINE for randomized controlled trials in patients with reflux oesophagitis. Searching was completed in February 2005. Data on endoscopic healing rates at 4 and 8 weeks were extracted and re-analysed if not analysed by intention-to-treat. Meta-analysis was conducted using a fixed effects model.. Of 133 papers identified in the literature search, six were of sufficient quality to be included in the analysis. No studies were identified comparing rabeprazole with esomeprazole. A meta-analysis of healing rates of esomeprazole 40 mg compared with standard dose proton pump inhibitors gave the following results: at 4 weeks [relative risk (RR) 0.92; 95% CI: 0.90, 0.94; P < 0.00001], and 8 weeks (RR 0.95; 95% CI: 0.94, 0.97; P < 0.00001). Publication bias did not have a significant impact on the results. The results were robust to changes in the inclusion/exclusion criteria and using a random effects model.. Esomeprazole consistently demonstrates higher healing rates when compared with standard dose proton pump inhibitors.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Clinical Trials as Topic; Enzyme Inhibitors; Esomeprazole; Esophagitis, Peptic; Humans; Lansoprazole; Omeprazole; Pantoprazole; Proton Pump Inhibitors; Rabeprazole; Treatment Outcome

There are limited data comparing the effectiveness of available proton pump inhibitors (PPIs) in erosive esophagitis (EE). We performed a meta-analysis to calculate the pooled effect of esomeprazole on healing rates, symptom relief, and adverse events versus competing PPIs in EE.. We performed a structured electronic search of MEDLINE and EMBASE and reviewed published abstracts to identify English-language, randomized clinical trials from 1995-2005, comparing rates of endoscopic healing, symptom relief, and adverse events with esomeprazole versus alternative PPIs in the treatment of gastroesophageal reflux disease (GERD)/EE. We then performed meta-analysis to compare the relative risk (RR) of EE healing, symptom relief, and adverse events between study arms and calculated the absolute risk reduction and number needed to treat (NNT) for each outcome.. Meta-analysis was performed on 10 studies (n=15,316). At 8 weeks, there was a 5% (RR, 1.05; 95% confidence interval, 1.02-1.08) relative increase in the probability of healing of EE with esomeprazole, yielding an absolute risk reduction of 4% and NNT of 25. The calculated NNTs by Los Angeles grade of EE (grades A-D) were 50, 33, 14, and 8, respectively. Last, esomeprazole conferred an 8% (RR, 1.08; 95% confidence interval, 1.05-1.11) relative increase in the probability of GERD symptom relief at 4 weeks.. As compared with other PPIs, esomeprazole confers a statistically significant improvement, yet, clinically, only a modest overall benefit in 8-week healing and symptom relief in all-comers with EE. The clinical benefit of esomeprazole appears negligible in less severe erosive disease but might be important in more severe disease.

Topics: Enzyme Inhibitors; Esomeprazole; Esophagitis, Peptic; Humans; Proton Pump Inhibitors; Randomized Controlled Trials as Topic; Treatment Outcome

Esomeprazole (Nexium, AstraZeneca) is the (S)-isomer of omeprazole and the first proton pump inhibitor to be developed as an optical isomer. Esomeprazole has an improved pharmacokinetic profile, resulting in increased systemic exposure and less interindividual variability compared with omeprazole, and more effective suppression of gastric acid production compared with other proton pump inhibitors. In several large, double-blind, randomised trials, significantly higher rates of endoscopically-confirmed healing of erosive oesophagitis and resolution of heartburn have been achieved in patients with gastro-oesophageal reflux disease receiving 8 weeks of esomeprazole 40 mg o.d. compared with those receiving omeprazole 20 mg o.d. or lansoprazole 30 mg o.d. In the maintenance of healed erosive oesophagitis, esomeprazole 10, 20 or 40 mg o.d. was significantly more effective than placebo in two 6-month, randomised, double-blind trials. Additionally, esomeprazole 20 mg o.d. was more effective than lansoprazole 15 mg in the maintenance of healed erosive oesophagitis in another 6-month, randomised, double-blind trial. Healing of oesophagitis was also effectively maintained by esomeprazole 40 mg o.d. in a 12-month non-comparative trial. Esomeprazole 20 or 40 mg o.d. effectively relieved heartburn in patients with gastro-oesophageal reflux disease without oesophagitis in two 4-week, placebo-controlled trials. Clinical trials have shown that triple therapy with esomeprazole 40 mg o.d. in combination with amoxicillin and clarithromycin produced Helicobacter pylori eradication rates similar to those obtained using triple therapy involving twice-daily dosing with other proton pump inhibitors. Esomeprazole is well-tolerated, with a spectrum and incidence of adverse events similar to those associated with omeprazole.

Topics: Anti-Ulcer Agents; Dose-Response Relationship, Drug; Esomeprazole; Esophagitis, Peptic; Gastric Acid; Gastroesophageal Reflux; Helicobacter Infections; Helicobacter pylori; Humans; Omeprazole; Proton Pump Inhibitors; Randomized Controlled Trials as Topic

The use of proton pump inhibitors (PPIs) for the treatment of erosive esophagitis has had a major impact on the prescribing budgets of primary care organizations in the United Kingdom. Assessments of the clinical and economic effectiveness of PPIs would provide useful tools for decision-making.. The goal of this study was to review the available preclinical and clinical studies comparing esomeprazole with lansoprazole in the healing and maintenance of erosive esophagitis, and to compare the budgeting impact of the 2 strategies. Comparative tolerability was also reviewed.. MEDLINE (1966-September 2002) and EMBASE (1980-September 2002) were searched for abstracts and articles reporting comparative studies of esomeprazole and lansoprazole. The search terms used were gastroesophageal reflux disease, reflux esophagitis, and proton pump inhibitor; all comparisons of esomeprazole and lansoprazole at any dose were considered. The database search was supplemented based on the authors' familiarity with the literature.. The comparative studies that were identified fell into 4 categories: (1) intragastric acid suppression studies; (2) randomized controlled trials in the healing of erosive esophagitis; (3) randomized controlled trials in the maintenance of erosive esophagitis; and (4) health economic analyses. Based on these studies, when healing doses (esomeprazole 40 mg once daily, lansoprazole 30 mg once daily) and low doses (20 and 15 mg once daily, respectively) were compared, esomeprazole was more efficacious than lansoprazole in suppressing acid in the intragastric compartment (both comparisons, P < 0.05). More patients with erosive esophagitis experienced healing at 4 and 8 weeks with esomeprazole 40 mg once daily than with lansoprazole 30 mg once daily (P < 0.001 at 4 and 8 weeks). At 6 months, remission was maintained in more patients receiving esomeprazole 20 mg once daily than in those receiving lansoprazole 15 mg once daily (P < 0.001). No significant differences in tolerability were noted in clinical trials that directly compared the 2 PPIs. When the cost-effectiveness of esomeprazole treatment was compared with that of lansoprazole treatment in the healing and maintenance of erosive esophagitis, the greater efficacy of esomeprazole translated into potential cost savings and better outcomes.. The currently available comparative data for esomeprazole and lansoprazole indicate clinical and cost-effectiveness advantages for esomeprazole in the healing and maintenance of erosive esophagitis compared with lansoprazole.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Clinical Trials as Topic; Cost-Benefit Analysis; Enzyme Inhibitors; Esomeprazole; Esophagitis, Peptic; Humans; Lansoprazole; Proton Pump Inhibitors

The pharmacology, pharmacodynamics, pharmacokinetics, clinical efficacy, and adverse effects of esomeprazole are reviewed. Esomeprazole, a proton-pump inhibitor (PPI), is the S-isomer of omeprazole. Esomeprazole has FDA-approved labeling for use in the treatment of symptomatic gastroesophageal reflux disease (GERD), including healing and maintenance of healing of erosive esophagitis and as part of a triple-drug regimen for Helicobocter pylori infection. Esomeprazole is structurally similar to other PPIs but is the first PPI to include only the active isomer, which may lead to improved pharmacokinetic and pharmacodynamic characteristics. Esomeprazole maintains intragastric pH at a higher level and above 4 for a longer period than other PPIs. Clinical studies have shown that esomeprazole is at least equivalent in safety and efficacy to other drugs in the class. Esomeprazole has demonstrated efficacy in the treatment of erosive esophagitis, the maintenance of healing of erosive esophagitis, and the treatment of signs and symptoms of GERD. Effective dosages are 20 or 40 mg orally every day or as needed. Esomeprazole magnesium 40 mg once daily in combination with amoxicillin and clarithromycin is effective in eradicating H. pylori infection. The potential for interacting with other drugs is limited and is similar to that of omeprazole. The most common adverse effects are headache, respiratory infection, and abdominal symptoms. Esomeprazole has pharmacokinetic properties that may make it more effective than omeprazole in some patients.

Topics: Clinical Trials as Topic; Drug Interactions; Drug Therapy, Combination; Enzyme Inhibitors; Esomeprazole; Esophagitis, Peptic; Helicobacter Infections; Humans; Omeprazole; Stereoisomerism

To review the pharmacology, pharmacokinetics, clinical efficacy, and safety of esomeprazole, a new proton-pump inhibitor (PPI).. A MEDLINE search (1966-March 2001) was conducted for relevant literature using the terms esomeprazole, Nexium, and H199/18. Abstracts from the XXXII Nordic Meeting of Gastroenterology and journal articles provided by AstraZeneca were reviewed.. All available studies on the pharmacology, pharmacokinetics, clinical efficacy, and safety of esomeprazole were reviewed.. Esomeprazole is a new PPI and is the S-isomer of racemic omeprazole. Esomeprazole has demonstrated acid control comparable to that of the other PPIs currently available. Esomeprazole undergoes less hepatic metabolism compared with omeprazole, and thus may result in less interpatient variability among slow and fast metabolizers of CYP2C19. The oral bioavailability of esomeprazole is approximately 89% with a dose of 40 mg, and the half-life is approximately 1.5 hours. Esomeprazole is effective in the healing of erosive esophagitis, with a rate of healing at week 8 of 93.7% (p < 0.001). In maintenance therapy of healed erosive esophagitis, esomeprazole maintained healing rates >90% (6-mo trial). Esomeprazole is comparable with omeprazole (both in combination with appropriate antibiotics) in the eradication of Helicobacter pylori, with eradication rates of 89.7% and 87.8%, respectively. The drug is well tolerated. The few adverse effects associated with esomeprazole are diarrhea, headache, nausea, abdominal pain, respiratory infection, and sinusitis.. Esomeprazole is a safe and effective PPI. It is effective in the treatment of peptic ulcer disease and gastroesophageal reflux disease.

Topics: Absorption; Anti-Ulcer Agents; Clinical Trials as Topic; Esomeprazole; Esophagitis, Peptic; Humans; MEDLINE; Omeprazole; Treatment Outcome

Esomeprazole is a new proton pump inhibitor, which has been compared to omeprazole for the treatment of reflux oesophagitis in clinical trials.. To compare the effectiveness of esomeprazole with the recommended dose of proton pump inhibitors in the healing of reflux oesophagitis, using omeprazole as a common comparator.. Systematic review of randomized controlled trials. Extraction and re-analysis of data to provide 'intention-to-treat' results. Meta-analysis using a Fixed Effects model.. A meta-analysis of healing rates of esomeprazole 40 mg compared to omeprazole 20 mg gave the following results: at 4 weeks (relative risk 1.14; 95% CI: 1.10, 1.18) and 8 weeks (RR 1.08; 95%CI: 1.05, 1.10). Other proton pump inhibitors compared to omeprazole 20 mg are as follows: lansoprazole 30 mg at 4 weeks (RR 1.02; 95%CI: 0.97, 1.08) and 8 weeks (RR 1.01; 95%CI: 0.97, 1.06); pantoprazole 40 mg at 4 weeks (RR 0.99; 95%CI: 0.91, 1.07) and 8 weeks (RR 0.98; 95%CI: 0.93, 1.04); rabeprazole 20 mg at 4 weeks (RR 1.00; 95%CI: 0.87, 1.14) and 8 weeks (RR 0.98; 95%CI: 0.91, 1.05).. Esomeprazole has demonstrated higher healing rates than omeprazole at 4 and 8 weeks. Other proton pump inhibitors (lansoprazole, pantoprazole and rabeprazole) have not shown higher healing rates when compared with omeprazole.

Topics: Administration, Oral; Dose-Response Relationship, Drug; Enzyme Inhibitors; Esomeprazole; Esophagitis, Peptic; Humans; Omeprazole; Proton Pump Inhibitors; Randomized Controlled Trials as Topic; Treatment Outcome

Esomeprazole, the S-isomer of omeprazole, is the first proton pump inhibitor synthesised as an optical isomer to become available for clinical use. Esomeprazole is optically stable in humans with negligible inversion to the R-isomer. Esomeprazole has significantly higher oral bioavailability than omeprazole, resulting in greater acid suppression. In clinical studies, 4 weeks' treatment with 40 mg esomeprazole demonstrated greater healing of all grades of erosive oesophagitis, compared with 20 mg omeprazole (76-82% versus 69-71%) and higher rates of symptom resolution (65-68% versus 58-61%) Furthermore, esomeprazole maintained healing rates of up to 90% over 6 months in erosive oesophagitis. Comparisons with other proton pump inhibitors in oesophagitis are, as yet, unavailable. In patients with endoscopy-negative gastro-oesophageal reflux disease (GERD), on-demand therapy with esomeprazole 20 mg has been shown to be very efficacious compared with placebo, and is well tolerated; however, comparisons with other proton pump inhibitors have not been performed. Long-term use of esomeprazole for up to 12 months in patients with GERD have not raised any significant safety concerns with respect to the development of atrophic gastritis or clinically relevant changes in enterochromaffin-like cells.

Topics: Adult; Aged; Anti-Ulcer Agents; Area Under Curve; Biological Availability; Esomeprazole; Esophagitis, Peptic; Female; Half-Life; Humans; Male; Middle Aged; Omeprazole; Proton Pump Inhibitors; Treatment Outcome

Reflux esophagitis (RE) is a common digestive disorder, and its frequent recurrences cause significant physical pain and are financially burdensome to patients. However, studies on the natural history of treated RE are few. Although proton pump inhibitors (PPIs) as the first-line treatment provide notable symptomatic relief, disordered gut microbiota has been observed among PPI users. Probiotics are commonly administered to patients to regulate the disordered intestinal flora.. To evaluate the therapeutic effects in RE patients treated with a combination of esomeprazole and probiotics [. One hundred and thirty-four RE patients were randomized into two groups of 67 subjects each. The probiotics group was administered with esomeprazole 20 mg. Sixty-six patients in the probiotics group and 64 patients in the placebo group completed the 8-wk treatment. The healing rate and RDQ score had no significant difference between the two groups (. Esomeprazole combined with probiotics (

Topics: Adolescent; Adult; Aged; Bacillus subtilis; Body Mass Index; Dietary Supplements; Endoscopy; Enterococcus faecium; Esomeprazole; Esophagitis, Peptic; Female; Gastrointestinal Microbiome; Humans; Male; Middle Aged; Probiotics; Proportional Hazards Models; Proton Pump Inhibitors; Recurrence; Severity of Illness Index; Surveys and Questionnaires; Treatment Outcome; Young Adult

Proton pump inhibitors (PPIs) are the main drugs for the treatment of reflux esophagitis. Phase II clinical trials showed that, compared with Esomeprazole, the new PPI Ilaparazole is great in terms of efficacy for reflux symptoms relief and curling for esophagitis. The aim of this study was to confirm suitable dose of Ilaparazole in the treatment of reflux esophagitis.. This study used a randomized, double-blind, parallel positive drug control, multi-center design. A total of 537patients diagnosed as reflux esophagitis by gastroscopy were randomly divided into Ilaparazole group (n = 322, Ilaparazole 10 mg QD) and esomeprazole group (n = 215, Esomeprazole 40 mg QD). The patients in the two groups were treated for 8 weeks. Heartburn and reflux symptoms prior to treatment, and 2, 4 and 8 weeks after the treatment were assessed. Gastroscopy was performed after 4 weeks of treatment. Unhealed patients within 4 weeks underwent gastroscopy again at the end of 8 weeks.. A total of 471 cases completed the treatment. In Esomeprazole and Ilaparazole groups. After 8 weeks treatment, the healing rate in Esomeprazole group and Ilaparazole group were 82.79% (94.94%) and 83.54% (92.50%), respectively. The corresponding rate difference [Ilaparazole-esomeprazole] was 0.75% (-2.44%) and the two-sided 95% CI was -5.72 to 7.22 (-6.90 to 2.01). The symptom disappearance rates for FAS (PPS) were 75.81% (82.02%) and 76.71% (80.36%) P = 0.8223 (0.7742). Adverse reactions related to the drugs were: 10.70% and 11.80%, (P = 0.7817).. The efficacy and safety of Ilaparazole (10 mg/day) in treating reflux esophagitis was similar to esomeprazole (40 mg/day). Ilaparazole (10 mg/day) can be used in the treatment of esophagitis. The clinical trial registration number of the study is NCT 02860624.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adult; Double-Blind Method; Drug Monitoring; Esomeprazole; Esophagitis, Peptic; Female; Gastroscopy; Humans; Male; Middle Aged; Proton Pump Inhibitors; Symptom Assessment; Treatment Outcome

These secondary analyses used data from 2 similarly designed studies in subjects experiencing frequent heartburn to evaluate the efficacy of esomeprazole 20 mg once daily for 2 weeks, which reflects the approved over-the-counter dosage and duration.. Subjects without endoscopically identified erosive esophagitis who were experiencing heartburn for ≥6 months and ≥4 of 7 days prior to baseline (study 1, N = 368; study 2, N = 349) were randomly assigned to receive double-blind treatment with esomeprazole 40 or 20 mg (administered as esomeprazole magnesium trihydrate 44.5 and 22.3 mg, respectively) or placebo once daily for 4 weeks. Subjects recorded the severity of heartburn in a daily diary, and investigators assessed subjects at each study visit. Two-week assessments were the primary end points of interest in these analyses and included the percentage of subjects with complete heartburn resolution (no episodes during 7 consecutive days), time to sustained complete heartburn resolution (the first of 7 consecutive episode-free days), and heartburn relief (no episodes other than ≤1 mild episode during 7 consecutive days).. At week 2, the percentages of subjects who experienced complete heartburn resolution were significantly greater with esomeprazole 40 mg (study 1, 26.1%; study 2, 35.3%) and 20 mg (study 1, 25.2%; study 2, 35.7%) compared with placebo (study 1, 9.0%; study 2, 3.4%) (all, P ≤ 0.001). Beginning on day 1, the percentages of subjects who experienced sustained heartburn resolution was significantly greater in the groups treated with esomeprazole 40 mg (study 1, 19%; study 2, 19%; P < 0.0001) and 20 mg (study 1, 10%; study 2, 15%; P < 0.05) compared with the group that received placebo (study 1, 2%; study 2, 1%). Additionally, at week 2, the percentages of subjects experiencing heartburn relief were significantly greater with esomeprazole 40 mg (study 1, 35.3%; study 2, 40.5%) and 20 mg (study 1, 34.5%; study 2, 46.4%) compared with placebo (study 1, 16.5%; study 2, 8.6%) (all, P ≤ 0.001).. The results of this study demonstrate that once-daily treatment with esomeprazole 20 mg for 2 weeks effectively resolved subjects׳ heartburn compared with placebo, beginning on day 1. Studies precede FDA Act 801 clinical trial registration and results submission requirements.

Topics: Adult; Double-Blind Method; Drug Administration Schedule; Esomeprazole; Esophagitis, Peptic; Female; Heartburn; Humans; Male; Middle Aged; Proton Pump Inhibitors; Treatment Outcome

To compare the one-week clinical effects of single doses of dexlansoprazole and esomeprazole on grades A and B erosive esophagitis.. We enrolled 175 adult patients with gastroesophageal reflux disease (GERD). The patients were randomized in a 1:1 ratio into two sequence groups to define the order in which they received single doses of dexlansoprazole (. Thirteen patients were lost to follow-up, resulting in 81 patients in each group for the per-protocol analysis. The CSRs for both groups were similar at days 1, 3 and 7. In the subgroup analysis, the female patients achieved higher CSRs in the dexlansoprazole group than in the esomeprazole group at day 3 (38.3%. The overall CSR for GERD patients was similar at days 1-7 for both the dexlansoprazole and esomeprazole groups, although a higher incidence of CSR was observed on day 3 in female patients who received a single dose of dexlansoprazole.

Topics: Adult; Dexlansoprazole; Esomeprazole; Esophagitis, Peptic; Feeding Behavior; Female; Gastroesophageal Reflux; Humans; Intention to Treat Analysis; Male; Middle Aged; Pilot Projects; Proton Pump Inhibitors; Sex Factors; Treatment Outcome

Most patients with gastroesophageal reflux disease experience symptomatic relapse after stopping acid-suppressive medication. The aim of this study was to compare willingness to continue treatment with esomeprazole on-demand versus continuous maintenance therapy for symptom control in patients with non-erosive reflux disease (NERD) after 6 months.. This multicenter, open-label, randomized, parallel-group study enrolled adults with NERD who were heartburn-free after 4 weeks' treatment with esomeprazole 20 mg daily. Patients received esomeprazole 20 mg daily continuously or on-demand for 6 months. The primary variable was discontinuation due to unsatisfactory treatment. On-demand treatment was considered non-inferior if the upper limit of the one-sided 95 % confidence interval (CI) for the difference between treatments was <10 %.. Of 877 patients enrolled, 598 were randomized to maintenance treatment (continuous: n = 297; on-demand: n = 301). Discontinuation due to unsatisfactory treatment was 6.3 % for on-demand and 9.8 % for continuous treatment (difference -3.5 % [90 % CI: -7.1 %, 0.2 %]). In total, 82.1 and 86.2 % of patients taking on-demand and continuous therapy, respectively, were satisfied with the treatment of heartburn and regurgitation symptoms, a secondary variable (P = NS). Mean study drug consumption was 0.41 and 0.91 tablets/day, respectively. Overall, 5 % of the on-demand group developed reflux esophagitis versus none in the continuous group (P < 0.0001). The Gastrointestinal Symptom Rating Scale Reflux dimension was also improved for continuous versus on-demand treatment. Esomeprazole was well tolerated.. In terms of willingness to continue treatment, on-demand treatment with esomeprazole 20 mg was non-inferior to continuous maintenance treatment and reduced medication usage in patients with NERD who had achieved symptom control with initial esomeprazole treatment.. ClinicalTrials.gov identifier (NCT number): NCT02670642 ; Date of registration: December 2015.

Topics: Adult; Drug Administration Schedule; Esomeprazole; Esophagitis, Peptic; Female; Gastroesophageal Reflux; Heartburn; Humans; Maintenance Chemotherapy; Male; Middle Aged; Patient Satisfaction; Proton Pump Inhibitors; Treatment Outcome

To investigate the effects of esomeprazole and rebamipide combination therapy on symptomatic improvement in patients with reflux esophagitis.. A total of 501 patients with reflux esophagitis were randomized into one of the following two treatment regimens: 40 mg esomeprazole plus 300 mg rebamipide daily (combination therapy group) or 40 mg esomeprazole daily (monotherapy group). We used a symptom questionnaire that evaluated heartburn, acid regurgitation, and four upper gastrointestinal symptoms. The primary efficacy end point was the mean decrease in the total symptom score.. The mean decreases in the total symptom score at 4 weeks were estimated to be -18.1±13.8 in the combination therapy group and -15.1±11.9 in the monotherapy group (p=0.011). Changes in reflux symptoms from baseline after 4 weeks of treatment were -8.4±6.6 in the combination therapy group and -6.8±5.9 in the monotherapy group (p=0.009).. Over a 4-week treatment course, esomeprazole and rebamipide combination therapy was more effective in decreasing the symptoms of reflux esophagitis than esomeprazole monotherapy.

Topics: Adult; Alanine; Drug Administration Schedule; Drug Therapy, Combination; Esomeprazole; Esophagitis, Peptic; Female; Humans; Male; Middle Aged; Prospective Studies; Proton Pump Inhibitors; Quinolones; Severity of Illness Index; Treatment Outcome

Proton pump inhibitors (PPIs) are the main drugs for the treatment of reflux esophagitis. Previous studies have indicated ilaprazole to be safer and more effective in treating duodenal ulcers as compared with omeprazole. Being a novel PPI, ilaprazole may be used in the treatment of reflux esophagitis. The purpose of this study was to evaluate the safety and efficacy of ilaprazole tablets in the treatment of reflux esophagitis.. This study used a randomized, double-blind, multi-center, active-comparison design. The patients were randomly divided into an ilaprazole group (10 mg once daily and 15 mg once daily) and an esomeprazole group (40 mg once daily). Both the groups were treated for 8 weeks. Heartburn and reflux symptoms prior to treatment, and 4 and 8 weeks after the treatment were assessed. Gastroscopy was performed after 4 and 8 weeks. The healing rate after 4 weeks treatment was compared. If esophagitis was healed at the end of 4 weeks, patients did not undergo gastroscopy at the end of 8 weeks.. Three hundred and twenty-five patients were enrolled in this study. The 4-week full analysis set (per-protocol set) healing rates in the esomeprazole 40-mg group, the ilaprazole 10-mg group, and the ilaprazole 15-mg group were: 71.43 % (78.89 %), 81.31 % (86.73 %), and 71.70 % (81.40 %), respectively, p = 0.1595 (0.4122); the 8-week healing rates were 84.76 % (93.33 %), 88.79 % (94.90 %), and 85.85 % (97.67 %), respectively, p = 0.6689 (0.4049). Drug-related adverse events rate were 10.48 %, 14.02 %, and 15.09 %, respectively, in the three groups (p = 0.6114).. The efficacy and safety of ilaprazole (10 mg/day, 15 mg/day) in treating reflux esophagitis was similar to esomeprazole (40 mg/day). Ilaprazole (10 mg/day) has a smaller dosage, hence it should be considered more in clinical uses.. ClinicalTrials.gov NCT01107938.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adult; Double-Blind Method; Esomeprazole; Esophagitis, Peptic; Female; Heartburn; Humans; Male; Middle Aged; Proton Pump Inhibitors

Proton pump inhibitors (PPIs) are the treatment of choice for reflux esophagitis (RE). The effectiveness of PPIs throughout RE management, from healing to maintenance, has not been fully studied.. To compare esomeprazole with lansoprazole or pantoprazole for RE management using a management model.. Data from six studies comparing esomeprazole with lansoprazole or pantoprazole for healing (4-8 weeks) or maintenance of healing (6 months) of RE were incorporated into hypothetical management models to determine the proportion of patients in endoscopic remission after sequential healing and maintenance therapy, assuming that patients received the same PPI throughout. The number needed to treat (NNT) to achieve one more patient in remission with esomeprazole vs. other PPIs was estimated. The hypothetical model was validated using results from the EXPO study, which compared esomeprazole with pantoprazole for RE healing and maintenance.. Overall, esomeprazole 40 mg produced higher rates of healing (life-table estimates) than lansoprazole 30 mg (82.4-92.6% vs. 77.5-88.8%; p < 0.01) or pantoprazole 40 mg (95.5% vs. 92.0%; p < 0.001) and higher rates of endoscopic and symptomatic remission at 6 months than lansoprazole (83.0-84.8% vs. 74.0-75.9%; p < 0.001; life-table estimates) or pantoprazole (70.9% vs. 59.6%; p < 0.0001; observed rates). In the hypothetical management model, the NNT for esomeprazole was 9 vs. lansoprazole and 8 vs. pantoprazole. The actual NNT for esomeprazole vs. pantoprazole in the EXPO study was 9 (95% confidence interval: 6; 16).. In this management model, esomeprazole was more effective than either lansoprazole or pantoprazole for maintaining remission after sequential healing and 6 months' maintenance therapy for RE.

Topics: Administration, Oral; Dose-Response Relationship, Drug; Double-Blind Method; Drug Therapy, Combination; Endoscopy, Gastrointestinal; Esomeprazole; Esophagitis, Peptic; Follow-Up Studies; Humans; Lansoprazole; Proton Pump Inhibitors; Time Factors; Treatment Outcome

Helicobacter pylori (H. pylori) frequently colonizes the stomach. Gastroesophageal reflux disease (GERD) is a common and costly disease. But the relationship of H. pylori and GERD is still unclear. This study aimed to explore the effect of H. pylori and its eradication on reflux esophagitis therapy.. Patients diagnosed with reflux esophagitis by endoscopy were enrolled; based on rapid urease test and Warth-Starry stain, they were divided into H. pylori positive and negative groups. H. pylori positive patients were randomly given H. pylori eradication treatment for 10 days, then esomeprazole 20 mg bid for 46 days. The other patients received esomeprazole 20 mg bid therapy for 8 weeks. After treatment, three patient groups were obtained: H. pylori positive eradicated, H. pylori positive uneradicated, and H. pylori negative. Before and after therapy, reflux symptoms were scored and compared. Healing rates were compared among groups. The χ2 test and t-test were used, respectively, for enumeration and measurement data.. There were 176 H. pylori positive (with 92 eradication cases) and 180 negative cases. Healing rates in the H. pylori positive eradicated and H. pylori positive uneradicated groups reached 80.4% and 79.8% (P = 0.911), with reflux symptom scores of 0.22 and 0.14 (P = 0.588). Healing rates of esophagitis in the H. pylori positive uneradicated and H. pylori negative groups were, respectively, 79.8% and 82.2% (P = 0.848); reflux symptom scores were 0.14 and 0.21 (P = 0.546).. Based on esomeprazole therapy, H. pylori infection and eradication have no significant effect on reflux esophagitis therapy.

Topics: Adolescent; Adult; Aged; Amoxicillin; Esomeprazole; Esophagitis, Peptic; Female; Gastroesophageal Reflux; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Tinidazole; Young Adult

Topics: Adult; Dose-Response Relationship, Drug; Esomeprazole; Esophagitis, Peptic; Esophagoscopy; Humans; Long-Term Care; Proton Pump Inhibitors; Recurrence

Acid suppression with a proton pump inhibitor is standard treatment for gastroesophageal reflux disease and erosive esophagitis in adults and increasingly is becoming first-line therapy for children aged 1-17 years. We evaluated endoscopic healing of erosive esophagitis with esomeprazole in young children with gastroesophageal reflux disease and described esophageal histology.. Children aged 1-11 years with endoscopically or histologically confirmed gastroesophageal reflux disease were randomized to esomeprazole 5 or 10 mg daily (< 20 kg) or 10 or 20 mg daily (≥ 20 kg) for 8 weeks. Patients with erosive esophagitis underwent an endoscopy after 8 weeks to assess healing of erosions.. Of 109 patients, 49% had erosive esophagitis and 51% had histologic evidence of reflux esophagitis without erosive esophagitis. Of the 45 patients who had erosive esophagitis and underwent follow-up endoscopy, 89% experienced erosion resolution. Dilation of intercellular space was reported in 24% of patients with histologic examination.. Esomeprazole (0.2-1.0 mg/kg) effectively heals macroscopic and microscopic erosive esophagitis in this pediatric population with gastroesophageal reflux disease. Dilation of intercellular space may be an important histologic marker of erosive esophagitis in children.

Topics: Child; Child, Preschool; Double-Blind Method; Esomeprazole; Esophagitis, Peptic; Female; Gastroesophageal Reflux; Humans; Infant; Male; Proton Pump Inhibitors; Treatment Outcome; Wound Healing

The aim of the study was to evaluate erosive esophagitis healing and symptom improvement with once-daily esomeprazole in children ages 12 to 36 months with endoscopically or histologically proven gastroesophageal reflux disease (GERD).. Data from children ages 12 to 36 months were included in a post-hoc analysis of an 8-week, multicenter, randomized, and double-blind by dose strata study of patients ages 1 to 11 years with endoscopically or histologically confirmed GERD. Children were randomized to receive esomeprazole 5 or 10 mg once daily. Patients underwent endoscopy and, if required, mucosal biopsy at baseline. Patients who had erosive esophagitis (graded using the Los Angeles classification system) at baseline underwent a follow-up endoscopy at final study visit to assess healing of erosive esophagitis. Investigators scored severity of GERD symptoms at baseline and every 2 weeks using the Physician Global Assessment.. Thirty-one of 109 primary study patients ages 12 to 36 months were included in the post hoc analysis. At baseline, 15 patients (48.4%) had erosive esophagitis, underwent follow-up endoscopy, and were healed after 8 weeks of esomeprazole treatment. Of the 19 patients with moderate-to-severe baseline Physician Global Assessment symptom scores, 84.2% had lower scores by the final visit. Following esomeprazole treatment, GERD symptoms were significantly improved from baseline to final visit (P ≤ 0.0018).. Esomeprazole 5 or 10 mg may be used to successfully treat erosive esophagitis and symptoms of GERD in children as young as 1 year. Moreover, although not yet validated in pediatric patients, the Los Angeles classification system was useful in grading erosive esophagitis in children ages 12 to 36 months.

Topics: Child, Preschool; Double-Blind Method; Esomeprazole; Esophagitis, Peptic; Female; Gastroesophageal Reflux; Humans; Infant; Male; Proton Pump Inhibitors; Treatment Outcome; Wound Healing

Acid suppression with a proton pump inhibitor is standard treatment for gastroesophageal reflux disease and erosive esophagitis in adults and increasingly is becoming first-line therapy for children aged 1-17 years. We evaluated endoscopic healing of erosive esophagitis with esomeprazole in young children with gastroesophageal reflux disease and described esophageal histology.. Children aged 1-11 years with endoscopically or histologically confirmed gastroesophageal reflux disease were randomized to esomeprazole 5 or 10 mg daily (<20 kg) or 10 or 20 mg daily (≥ 20 kg) for 8 weeks. Patients with erosive esophagitis underwent an endoscopy after 8 weeks to assess healing of erosions.. Of 109 patients, 49% had erosive esophagitis and 51% had histologic evidence of reflux esophagitis without erosive esophagitis. Of the 45 patients who had erosive esophagitis and underwent follow-up endoscopy, 89% experienced erosion resolution. Dilation of intercellular space was reported in 24% of patients with histologic examination.. Esomeprazole (0.2-1.0 mg/kg) effectively heals macroscopic and microscopic erosive esophagitis in this pediatric population with gastroesophageal reflux disease. Dilation of intercellular space may be an important histologic marker of erosive esophagitis in children.

Topics: Anti-Ulcer Agents; Child; Child, Preschool; Double-Blind Method; Esomeprazole; Esophagitis, Peptic; Female; Gastroesophageal Reflux; Humans; Infant; Male; Pediatrics; Peptic Ulcer; Proton Pump Inhibitors; Treatment Outcome; Wound Healing

The aim of the study was to evaluate erosive esophagitis healing and symptom improvement with once-daily esomeprazole in children ages 12 to 36 months with endoscopically or histologically proven gastroesophageal reflux disease (GERD).. Data from children ages 12 to 36 months were included in a post-hoc analysis of an 8-week, multicenter, randomized, and double-blind by dose strata study of patients ages 1 to 11 years with endoscopically or histologically confirmed GERD. Children were randomized to receive esomeprazole 5 or 10 mg once daily. Patients underwent endoscopy and, if required, mucosal biopsy at baseline. Patients who had erosive esophagitis (graded using the Los Angeles classification system) at baseline underwent a follow-up endoscopy at final study visit to assess healing of erosive esophagitis. Investigators scored severity of GERD symptoms at baseline and every 2 weeks using the Physician Global Assessment.. Thirty-one of 109 primary study patients ages 12 to 36 months were included in the post hoc analysis. At baseline, 15 patients (48.4%) had erosive esophagitis, underwent follow-up endoscopy, and were healed after 8 weeks of esomeprazole treatment. Of the 19 patients with moderate-to-severe baseline Physician Global Assessment symptom scores, 84.2% had lower scores by the final visit. Following esomeprazole treatment, GERD symptoms were significantly improved from baseline to final visit (P ≤ 0.0018).. Esomeprazole 5 or 10 mg may be used to successfully treat erosive esophagitis and symptoms of GERD in children as young as 1 year.Moreover, although not yet validated in pediatric patients, the Los Angeles classification system was useful in grading erosive esophagitis in children ages 12 to 36 months.

Topics: Anti-Ulcer Agents; Child, Preschool; Double-Blind Method; Esomeprazole; Esophagitis, Peptic; Female; Gastroesophageal Reflux; Humans; Infant; Male; Pediatrics; Peptic Ulcer; Proton Pump Inhibitors; Treatment Outcome; Wound Healing

Little is known regarding patient characteristics that influence the speed of reflux oesophagitis (RO) healing.. To investigate patient characteristics that may influence RO healing rates.. A post hoc analysis of clinical trial data for potent acid suppression treatment of RO (esomeprazole or AZD0865) was conducted. Group A underwent endoscopy at baseline, week 2 and 4, and group B at baseline, week 4 and 8. Group A patients were sub-grouped as 'rapid' (healed at 2 weeks) or unhealed at 2 weeks. Group B patients were sub-grouped as 'slow' (healed at 8 weeks, not at 4 weeks) or 'refractory' (not healed at 8 weeks). Logistic regression analysis was performed only for comparisons within group A.. At 2, 4 and 8 weeks, RO had healed in 68%, 65% and 61% of patients unhealed at previous endoscopy, respectively. Low-grade [vs. high-grade (C or D)] RO was the only independent predictor of rapid healing in group A after logistic regression analysis. Significantly more rapid healers had low grade RO (A or B) at baseline than patients with refractory RO (84% vs. 49%; P < 0.001), and significantly more refractory patients had frequent regurgitation at baseline than slow healers (80% vs. 63%; P = 0.039).. Low- (vs. high-) grade RO determines the most rapid benefit from acid suppression. Roughly two-thirds of patients healed with each time increment of potent acid suppression therapy. This suggests that some unhealed patients may still heal with continued therapy and that truly refractory RO is rare. (ClinicalTrials.gov: NCT00206245).

Topics: Adult; Double-Blind Method; Drug Resistance; Endoscopy; Esomeprazole; Esophagitis, Peptic; Female; Humans; Imidazoles; Male; Middle Aged; Proton Pump Inhibitors; Pyridines; Wound Healing

A multicenter, randomized, double-blind study comparing the efficacy and safety of esomeprazole 20mg/day (E20) and 10mg/day (E10) with omeprazole 10mg/day (O10) for maintenance of remission in patients with healed reflux esophagitis (RE). For RE, at week 24, the estimated Kaplan-Meier recurrence-free rates were 92.0%, 87.5%, and 82.7% in the E20, E10, and O10 groups, respectively. There was a statistically significant difference between the E20 and O10 groups (p=0.007). Drug-related adverse events tended to be mild but were reported at rates of 9.0%, 8.0%, and 5.3% in the E20, E10, and O10 groups, respectively. Compared with omeprazole, maintenance therapy with 20mg esomeprazole was generally well tolerated and effective for RE.

Topics: Aged; Double-Blind Method; Esomeprazole; Esophagitis, Peptic; Female; Humans; Male; Middle Aged; Omeprazole; Proton Pump Inhibitors

Efficacy of esomeprazole 40mg/day (E40) and 20mg/day (E20) as initial treatment for reflux esophagitis (RE) was compared with omeprazole 20mg/day (O20) in this multicenter, prospective, randomized, double-blind study. Healing rates at week 8 (primary endpoint) were 90.0% (171/190), 87.3% (165/189), and 87.4% (166/190) for the E40, E20, and O20 groups, respectively, confirming the non-inferiority of E40 and E20 to O20. Drug-related adverse events were reported in 4.2%, 7.9%, and 8.4% of patients in the E40, E20 and O20 groups, respectively, but none of these events were serious. Initial treatment of esomeprazole for RE was generally well tolerated, confirming the non-inferiority effect with omeprazole.

Topics: Aged; Double-Blind Method; Esomeprazole; Esophagitis, Peptic; Female; Humans; Male; Middle Aged; Omeprazole; Prospective Studies; Proton Pump Inhibitors

Gastroesophageal reflux disease (GERD)-associated changes in esophageal histology have been reported mainly after short-term medical antireflux therapy, and few individual lesions have been examined. We report detailed histological findings from the LOTUS study, at baseline and at 1 and 3 years after laparoscopic antireflux surgery (LARS) or esomeprazole treatment in patients with chronic GERD.. LOTUS is a long-term, open, parallel-group, multicenter, randomized, controlled trial conducted in 11 European countries that compared LARS (n=248) with esomeprazole 20-40 mg daily (n=266). Biopsies from the distal esophagus 2 cm above the Z-line and at the Z-line were taken at baseline, and 1 and 3 years. The following lesions were assessed: basal cell hyperplasia (BCH), papillary elongation (PE), intercellular space dilatations (ISDs), intraepithelial eosinophils (EOSs), neutrophils, and necrosis/erosion. A severity score (SS, range 0-2) was calculated by taking the average score of all assessable lesions.. All lesions were more severe on Z-line biopsies than at 2 cm, and almost all improved significantly from baseline to 1 and 3 years. The average SS (from 2 cm to Z-line) changed from 0.95 to 0.57 (1 year) and to 0.49 (3 years) on esomeprazole, and from 0.91 to 0.56 (1 year) and to 0.52 (3 years) after LARS (P<0.001 for both treatments at 1 and 3 years, with no significant difference between treatments). The proportions of patients with severe histological changes decreased from approximately 50% at baseline to 11% at 3 years.. Both continuous esomeprazole treatment and laparoscopic fundoplication are associated with significant and similar overall improvement in microscopic esophagitis after 1 year that is maintained at 3 years.

Topics: Adult; Age Distribution; Biopsy, Needle; Chronic Disease; Esomeprazole; Esophageal pH Monitoring; Esophagitis, Peptic; Esophagoscopy; Female; Follow-Up Studies; Fundoplication; Gastroesophageal Reflux; Humans; Immunohistochemistry; Incidence; Kaplan-Meier Estimate; Male; Middle Aged; Probability; Risk Assessment; Severity of Illness Index; Sex Distribution; Statistics, Nonparametric; Time Factors; Treatment Outcome

In patients with Los Angeles (LA) grade C or D oesophagitis, a positive relationship has been established between the duration of intragastric acid suppression and healing.. To determine whether there is an apparent optimal time of intragastric acid suppression for maximal healing of reflux oesophagitis.. Post hoc analysis of data from a proof-of-concept, double-blind, randomized study of 134 adult patients treated with esomeprazole (10 or 40 mg od for 4 weeks) for LA grade C or D oesophagitis. A curve was fitted to pooled 24-h intragastric pH (day 5) and endoscopically assessed healing (4 weeks) data using piecewise quadratic logistic regression.. Maximal reflux oesophagitis healing rates were achieved when intragastric pH >4 was achieved for approximately 50-70% (12-17 h) of the 24-h period. Acid suppression above this threshold did not yield further increases in healing rates.. After 4 weeks' acid-suppressive therapy for LA grade C or D oesophagitis, successful healing appears to reach a threshold above which improvements are unlikely to be achieved despite an increase in number of hours with intragastric pH >4.

Topics: Adult; Aged; Dose-Response Relationship, Drug; Double-Blind Method; Esomeprazole; Esophageal pH Monitoring; Esophagitis, Peptic; Female; Humans; Hydrogen-Ion Concentration; Los Angeles; Male; Middle Aged; Wound Healing; Young Adult

Acid suppression with a proton pump inhibitor is standard treatment for gastroesophageal reflux disease and erosive esophagitis in adults and increasingly is becoming first-line therapy for children aged 1-17 years. We evaluated endoscopic healing of erosive esophagitis with esomeprazole in young children with gastroesophageal reflux disease and described esophageal histology.. Children aged 1-11 years with endoscopically or histologically confirmed gastroesophageal reflux disease were randomized to esomeprazole 5 or 10 mg daily (< 20 kg) or 10 or 20 mg daily (> or = 20 kg) for 8 weeks. Patients with erosive esophagitis underwent an endoscopy after 8 weeks to assess healing of erosions.. Of 109 patients, 49% had erosive esophagitis and 51% had histologic evidence of reflux esophagitis without erosive esophagitis. Of the 45 patients who had erosive esophagitis and underwent follow-up endoscopy, 89% experienced erosion resolution. Dilation of intercellular space was reported in 24% of patients with histologic examination.. Esomeprazole (0.2-1.0 mg/kg) effectively heals macroscopic and microscopic erosive esophagitis in this pediatric population with gastroesophageal reflux disease. Dilation of intercellular space may be an important histologic marker of erosive esophagitis in children.. D9614C00097; ClinicalTrials.gov identifier NCT00228527.

Topics: Anti-Ulcer Agents; Child; Child, Preschool; Double-Blind Method; Esomeprazole; Esophagitis, Peptic; Esophagoscopy; Female; Humans; Infant; Male; Proton Pump Inhibitors

The aim of the study was to evaluate erosive esophagitis healing and symptom improvement with once-daily esomeprazole in children ages 12 to 36 months with endoscopically or histologically proven gastroesophageal reflux disease (GERD).. Data from children ages 12 to 36 months were included in a post-hoc analysis of an 8-week, multicenter, randomized, and double-blind by dose strata study of patients ages 1 to 11 years with endoscopically or histologically confirmed GERD. Children were randomized to receive esomeprazole 5 or 10 mg once daily. Patients underwent endoscopy and, if required, mucosal biopsy at baseline. Patients who had erosive esophagitis (graded using the Los Angeles classification system) at baseline underwent a follow-up endoscopy at final study visit to assess healing of erosive esophagitis. Investigators scored severity of GERD symptoms at baseline and every 2 weeks using the Physician Global Assessment.. Thirty-one of 109 primary study patients ages 12 to 36 months were included in the post hoc analysis. At baseline, 15 patients (48.4%) had erosive esophagitis, underwent follow-up endoscopy, and were healed after 8 weeks of esomeprazole treatment. Of the 19 patients with moderate-to-severe baseline Physician Global Assessment symptom scores, 84.2% had lower scores by the final visit. Following esomeprazole treatment, GERD symptoms were significantly improved from baseline to final visit (P ≤ 0.0018).. Esomeprazole 5 or 10 mg may be used to successfully treat erosive esophagitis and symptoms of GERD in children as young as 1 year. Moreover, although not yet validated in pediatric patients, the Los Angeles classification system was useful in grading erosive esophagitis in children ages 12 to 36 months.

Topics: Anti-Ulcer Agents; Child, Preschool; Double-Blind Method; Esomeprazole; Esophagitis, Peptic; Female; Gastroesophageal Reflux; Humans; Infant; Male; Treatment Outcome

The ability to predict symptom response to reflux oesophagitis-healing therapy may optimize treatment decisions.. To identify factors associated with heartburn resolution in patients receiving acid-suppressive therapy for reflux oesophagitis.. In this multicentre, randomized, double-blind trial (EXPO; AstraZeneca study code: SH-NEG-0008), patients with endoscopically confirmed reflux oesophagitis and reflux symptoms received once-daily proton pump inhibitor therapy [esomeprazole 40 mg (n = 1562) or pantoprazole 40 mg (n = 1589)] for >or=4 weeks. Factors associated with heartburn resolution after 4 weeks were identified by multiple logistic regression analysis.. Esomeprazole therapy, positive Helicobacter pylori status and greater age were associated with an increased likelihood of heartburn resolution [odds ratio (95% confidence interval): 1.31 (1.12, 1.54), 1.44 (1.19, 1.74) and 1.013 (1.007, 1.019) per year, respectively; all P < 0.001]. Men and patients with no acid regurgitation or epigastric pain pre-treatment were also more likely to achieve heartburn resolution (all P < 0.05).. The use of esomeprazole rather than pantoprazole increases the probability of achieving resolution of heartburn during reflux oesophagitis-healing therapy. Other factors, including H. pylori status, age, gender and symptom profile may be helpful in determining the likelihood of heartburn resolution in such patients.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adolescent; Adult; Age Factors; Aged; Aged, 80 and over; Anti-Ulcer Agents; Double-Blind Method; Esomeprazole; Esophagitis, Peptic; Female; Heartburn; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Pantoprazole; Proton Pump Inhibitors; Treatment Outcome; Young Adult

Ability to predict freedom from heartburn relapse during maintenance therapy for healed reflux oesophagitis may facilitate optimal treatment choices for individual patients.. To determine factors predicting freedom from heartburn relapse during maintenance proton pump inhibitor therapy in patients with healed reflux oesophagitis.. This post-hoc analysis used data from the maintenance phase of the EXPO study (AstraZeneca study code: SH-NEG-0008); 2766 patients with healed reflux oesophagitis and resolved heartburn received once-daily esomeprazole 20 mg or pantoprazole 20 mg for 6 months. Multiple logistic regression analysis determined factors associated with freedom from heartburn relapse.. Heartburn relapse rates were lower with esomeprazole than pantoprazole in all subgroups analysed. Esomeprazole treatment was the factor most strongly associated with freedom from heartburn relapse (odds ratio 2.08; P < 0.0001). Other factors significantly associated with freedom from heartburn relapse were Helicobacter pylori infection, greater age, non-obesity, absence of epigastric pain at baseline, pre-treatment nonsevere heartburn and GERD symptom duration < or =5 years.. Several factors predict freedom from heartburn relapse during maintenance proton pump inhibitor therapy for healed reflux oesophagitis, the strongest being choice of proton pump inhibitor. These findings outline the importance of optimizing acid control and identifying predictors of relapse for effective long-term symptom management in reflux oesophagitis patients.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adult; Aged; Aged, 80 and over; Anti-Ulcer Agents; Dose-Response Relationship, Drug; Double-Blind Method; Esomeprazole; Esophagitis, Peptic; Female; Heartburn; Humans; Male; Middle Aged; Pantoprazole; Proton Pump Inhibitors; Regression Analysis; Secondary Prevention; Time Factors; Treatment Outcome; Young Adult

This study aimed to determine whether Helicobacter pylori eradication limits the progression of precancerous changes, manifested as intestinal metaplasia (IM), in patients with reflux esophagitis using long-term esomeprazole.. Three hundred twenty-five reflux esophagitis patients were enrolled and randomly assigned to (i) the H. pylori-positive eradication group receiving 1-week triple therapy (n=105); (ii) H. pylori-positive non-eradication controls (n=105); and (iii) H. pylori-negative controls (n=115). All the patients received continuous esomeprazole until sustained symptomatic response, and when possible, shifted to on-demand therapy (ODT) thereafter. Serial gastroscopy was scheduled on enrollment and at the end of the first and second years to assess the prevalence and progression or regression of gastric atrophy (AT) and IM.. There were 93 patients in the H. pylori-eradication group, 83 in the non-eradication controls, and 100 in the negative controls to complete the study. The negative controls had no progression of AT and IM during follow-up. For the H. pylori-positive eradication group, there was significant regression of AT and IM during follow-up (P<0.05). In the H. pylori-positive non-treated controls, the prevalence rates of AT and IM were significantly greater on the second year than on enrollment (P<0.05). During the second-year follow-up, the patients in the eradication group achieved more regression and less development of AT and IM than did the non-eradication controls (P<0.001).. In patients using long-term esomeprazole for reflux esophagitis, screening for and eradicating H. pylori infection are necessary in order to limit the progression or cause the regression of gastric precancerous changes.

Topics: Adult; Analysis of Variance; Anti-Ulcer Agents; Biopsy, Needle; Confidence Intervals; Disease Progression; Dose-Response Relationship, Drug; Drug Administration Schedule; Esomeprazole; Esophagitis, Peptic; Esophagoscopy; Female; Follow-Up Studies; Gastroscopy; Helicobacter Infections; Helicobacter pylori; Humans; Immunohistochemistry; Intestinal Neoplasms; Long-Term Care; Male; Metaplasia; Middle Aged; Odds Ratio; Precancerous Conditions; Probability; Stomach; Stomach Neoplasms; Treatment Outcome

The primary objective was to assess gastroesophageal reflux disease (GERD) symptom resolution rates with esomeprazole by erosive esophagitis (EE) status, and the secondary objective was to evaluate potential predictors of the presence of EE and heartburn resolution.. Patients with GERD who have EE have higher reported symptom resolution rates than those with nonerosive reflux disease (NERD) when treated with proton pump inhibitors (PPIs).. This open-label multicenter study included adults with GERD symptoms. Patients were stratified by EE status after endoscopy and received once-daily esomeprazole 40 mg for 4 weeks. Questionnaires determined symptom response rates, and baseline predictors of EE or heartburn resolution were evaluated. Potential predictors, including years with GERD, history of EE, and time to relief with antacids, were examined.. Heartburn resolution rates at 4 weeks were higher for patients with EE than NERD (69% [124/179] vs. 48% [85/177]; p < 0.0001). Multivariate models had moderate predictive ability for EE (c-index, 0.76) and poor predictive ability (c-index, 0.57) for heartburn resolution. However, faster heartburn relief with antacid use, particularly within 15 min, was predictive of EE and heartburn resolution.. Patients with EE have higher heartburn resolution rates than patients with NERD after treatment, although recall bias may be possible. Fast relief with antacid use is predictive of EE and heartburn resolution with a PPI and suggests that a history of antacid relief may provide corroborative evidence to empiric PPI therapy in determining whether patients with heartburn have acid reflux disease. ClinicalTrials.Gov IDENTIFIER: NCT00242736.

Topics: Adult; Aged; Antacids; Anti-Ulcer Agents; Esomeprazole; Esophagitis, Peptic; Female; Gastroesophageal Reflux; Heartburn; Humans; Male; Middle Aged; Models, Biological; Prognosis; Risk Factors; Young Adult

The aim of this study was to assess the efficacy and safety of esomeprazole 40 mg once daily (q.d.) in healing reflux oesophagitis at 4 and 8 weeks, and the efficacy of esomeprazole 20 mg q.d. for 12 weeks in the maintenance of remission.. A total of 235 patients with endoscopically proven reflux oesophagitis were enrolled in this study, which consisted of two phases (healing and maintenance therapy). Patients who showed complete endoscopic and symptomatic healing at the end of 4 or 8 weeks were switched to maintenance treatment with esomeprazole 20 mg q.d. for 12 weeks. The primary efficacy endpoint was healing of reflux oesophagitis at week 8. Secondary assessments included the proportion of patients with symptomatic relapse in the maintenance phase.. At the end of week 8, 88% (95% life-table confidence intervals [CI]: 84%, 92%) of patients were healed endoscopically and 90.6% of the patients were asymptomatic. Patient age, gender and Helicobacter pylori status had no effect on the efficacy of treatment. During the 12-week maintenance treatment phase, symptomatic relapse ratios were 0.5%, 2.2%, and 0%, for the first, second, and third 4-week periods, respectively. The proportions of patients satisfied with treatment were 95% and 99.4% at the end of acute and maintenance treatment, respectively. The most common adverse effects were headache, upper respiratory tract infection and abdominal pain.. Esomeprazole is effective in the healing of reflux oesophagitis, the resolution of heartburn, and in maintaining symptomatic remission. The effectiveness of esomeprazole in patients with gastroesophageal reflux disease is not affected by the presence of H. pylori.

Topics: Adolescent; Adult; Aged; Anti-Ulcer Agents; Drug Administration Schedule; Endoscopy, Digestive System; Esomeprazole; Esophagitis, Peptic; Female; Humans; Male; Middle Aged; Patient Satisfaction; Prospective Studies; Young Adult

To assess the relationship between the percentage of time intragastric pH >4.0 and healing of erosive oesophagitis.. In this proof-of-concept study, adults with endoscopically verified Los Angeles grade C or grade D erosive oesophagitis were randomly assigned to oral esomeprazole 10 or 40 mg once daily for 4 weeks. On day 5, patients underwent 24-h pH monitoring. At 4 weeks, erosive oesophagitis healing status was endoscopically assessed. Investigators scored gastro-oesophageal reflux disease symptoms on a 4-point scale [none to severe (0-3)] before and 4 weeks after treatment. The percentage of time intragastric pH was >4.0 and healing status were correlated and tested for significance using a Spearman rank correlation (r).. 103 patients had evaluable data (mean age, 48.7 years; 65% men). Mean percentages of time with intragastric pH >4.0 on day 5 in patients with healed and unhealed erosive oesophagitis were 61% and 42%, respectively (P = 0.0002), indicating that erosive oesophagitis healing rates were positively related to the percentage of time intragastric pH was >4.0. Greater intragastric acid control correlated with lower final daytime and night-time heartburn and acid regurgitation symptom scores (r = -0.029, -0.029 and -0.021; P = 0.003, 0.003 and 0.032, respectively).. A positive relationship between intragastric acid control and erosive oesophagitis healing was demonstrated.

Topics: Adolescent; Adult; Aged; Anti-Ulcer Agents; Double-Blind Method; Esomeprazole; Esophagitis, Peptic; Female; Gastric Acid; Gastric Acidity Determination; Gastroesophageal Reflux; Humans; Male; Middle Aged

AZD0865 belongs to a new class of acid-suppressing agents with rapid onset of action and potent acid inhibition. We evaluated its effectiveness for healing reflux esophagitis.. One thousand five hundred twenty-one patients with Los Angeles A-D esophagitis and heartburn of moderate or severe intensity for > or = 4 days/week were randomized to AZD0865 25, 50, or 75 mg or esomeprazole 40 mg once daily for 4-8 weeks. The primary end point was esophagitis healing by AZD0865 at 4 weeks. Healing and control of heartburn were also assessed at 2, 4, and 8 weeks for AZD0865 and esomeprazole.. After 4 weeks of treatment, healing rates were similar among AZD0865 doses (76.9%; confidence interval [CI], 72.4%-81.1%); 78.2% (CI, 73.7%-82.3%), and 81.1% (CI, 76.7%-84.9%) for 25, 50, and 75 mg, respectively). The healing rate with esomeprazole at 4 weeks was similar (81.9%; CI, 77.6%-88.7%), and healing rates also were comparable among all treatments at 2 and 8 weeks. There were no significant differences in heartburn control among treatments. AZD0865 and esomeprazole were well-tolerated, although reversible increases in transaminases occurred in a small number of patients receiving AZD0865, especially at the 75-mg dose.. AZD0865 25, 50, and 75 mg provided similar efficacy to esomeprazole 40 mg in terms of esophagitis healing and heartburn control. These findings suggest that increasing the degree of acid inhibition beyond that already achieved by esomeprazole 40 mg (or AZD0865 25 mg) does not translate into increased clinical efficacy in esophagitis patients.

Topics: Administration, Oral; Adolescent; Adult; Aged; Dose-Response Relationship, Drug; Double-Blind Method; Enzyme Inhibitors; Esomeprazole; Esophagitis, Peptic; Female; Follow-Up Studies; Gastric Acidity Determination; Humans; Hydrogen-Ion Concentration; Imidazoles; Male; Middle Aged; Patient Satisfaction; Pyridines; Retrospective Studies; Treatment Outcome

Acid suppression is the mainstay of therapy in gastro-oesophageal reflux disease. Esomeprazole 40 mg is more effective than lansoprazole 30 mg in healing mucosal lesions in severe erosive reflux oesophagitis. However, data comparing esomeprazole with lansoprazole in patients with complications of gastro-oesophageal reflux disease, such as ulcerative reflux oesophagitis and Barrett's oesophagus, are lacking.. To compare the efficacy of esomeprazole and lansoprazole at their standard dosages in suppressing oesophageal acid exposure in complicated gastro-oesophageal reflux disease.. Thirty patients with complicated gastro-oesophageal reflux disease (7 with ulcerative reflux oesophagitis and 23 with Barrett's oesophagus), randomly assigned to receive 40 mg esomeprazole (n=16) or 30 mg lansoprazole (n=14) once daily, underwent oesophageal 24-h pH monitoring while on therapy. Total, upright diurnal and supine nocturnal percentage acid reflux time were assessed.. Esomeprazole was significantly more effective than lansoprazole in decreasing oesophageal acid exposure. Normalisation of both total and supine nocturnal percentage acid reflux time was obtained in 12 of 16 (75%) patients treated with esomeprazole but only in 4 of 14 (28%) cases treated with lansoprazole (p=0.026).. Normalisation of oesophageal acid exposure can be achieved in the majority of complicated gastro-oesophageal reflux disease cases with esomeprazole 40 mg once daily.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Anti-Ulcer Agents; Barrett Esophagus; Esomeprazole; Esophagitis, Peptic; Esophagus; Female; Gastric Acid; Gastroesophageal Reflux; Humans; Hydrogen-Ion Concentration; Lansoprazole; Male; Manometry; Middle Aged; Prospective Studies; Proton Pump Inhibitors

Proton pump inhibitor therapy has been reported to reduce proliferative changes of the oesophagus significantly in gastro-oesophageal reflux disease (GERD).. To assess the histological effects of esomeprazole treatment on the oesophagus.. Data were derived from a subgroup of patients participating in the proGERD study, who had either erosive reflux disease (n = 720) or non-erosive reflux disease (n = 35) and who had biopsy data from two sites [(i) 2 cm above the z-line and (ii) at the z-line], obtained at baseline and following treatment with esomeprazole. Proliferative changes of the squamous epithelium were assessed histologically by measuring thickness of the basal cell layer and elongation of the papillae as a percentage of the whole epithelial thickness.. In erosive reflux disease patients, the thickness of the basal cell layer and length of the papillae pretreatment were associated with the severity of oesophagitis (P < 0.05), at both biopsy sites. After esomeprazole treatment, baseline thickness and length of papillae were significantly reduced (P < 0.05) at both biopsy sites in non-erosive reflux disease and erosive reflux disease patients (particularly those with Los Angeles grades C and D).. This demonstrates a strong correlation between severity of GERD and histological parameters. Esomeprazole therapy resulted in clear reversal of proliferative changes observed prior to treatment in the squamous epithelium at both biopsy locations.

Topics: Adult; Biopsy; Cell Division; Enzyme Inhibitors; Epithelial Cells; Epithelium; Esomeprazole; Esophagitis, Peptic; Esophagoscopy; Esophagus; Female; Gastroesophageal Reflux; Humans; Male; Prospective Studies; Treatment Outcome

To compare esomeprazole with omeprazole for healing erosive esophagitis (EE), 1148 patients with endoscopically confirmed EE were randomized to once-daily esomeprazole, 40 mg, or omeprazole, 20 mg, for 8 weeks in this multicenter, double-blind, parallel-group trial. The primary outcome was the proportion of patients with healed EE at week 8. Secondary outcomes included diary and investigator assessments of heartburn symptoms. At week 8, estimated healing rates were 92.2% (95% CI, 89.9%-94.5%) with esomeprazole and 89.8% (95% CI, 87.2%-92.4%) with omeprazole. Healing rates with esomeprazole were significantly higher than those with omeprazole at weeks 8 (88.4% vs 77.5%; P = 0.007) and 4 (60.8% vs 47.9%; P = 0.02) in patients with moderate to severe (Los Angeles grade C or D) EE at baseline but were not significantly different for patients with mild (Los Angeles grade A or B) EE. Both treatments were comparable for other secondary measures and had similar tolerability profiles.

Topics: Adolescent; Adult; Aged; Anti-Ulcer Agents; Dose-Response Relationship, Drug; Double-Blind Method; Esomeprazole; Esophagitis, Peptic; Female; Gastroesophageal Reflux; Humans; Male; Middle Aged; Omeprazole

The aim was to compare esomeprazole with lansoprazole for the maintenance of healed erosive esophagitis and resolution of gastroesophageal reflux disease-related symptoms in a United States population.. Patients who entered this double-blind, randomized, parallel-group, multicenter, maintenance trial had been treated and healed (no endoscopic evidence of erosive esophagitis) with esomeprazole 40 mg or lansoprazole 30 mg once daily (patients with Los Angeles grades C and D erosive esophagitis at baseline) or esomeprazole 40 mg (patients with Los Angeles grades A and B erosive esophagitis at baseline) and had no heartburn or acid regurgitation symptoms during the previous week. Patients were randomized to maintenance once-daily therapy with esomeprazole 20 mg (n = 512) or lansoprazole 15 mg (n = 514) for up to 6 months. Esophago-gastroduodenoscopies were done at months 3 and 6, and investigators assessed symptom severity at months 1, 3, and 6. Endoscopic/symptomatic remission was defined as no erosive esophagitis and no study withdrawal as a result of reflux symptoms.. The estimated endoscopic/symptomatic remission rate during a period of 6 months was significantly higher (P = .0007) for patients who received esomeprazole 20 mg once daily (84.8%) compared with those who received lansoprazole 15 mg (75.9%). Most patients had no heartburn (383/462 and 369/466) or acid regurgitation (401/462 and 400/466) symptoms at 6 months, and there were no significant differences between treatments. Both treatments were well-tolerated.. Esomeprazole 20 mg is more effective than lansoprazole 15 mg in maintaining endoscopic/symptomatic remission in patients with healed erosive esophagitis.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adolescent; Adult; Aged; Anti-Ulcer Agents; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Endoscopy, Digestive System; Esomeprazole; Esophagitis, Peptic; Female; Gastroesophageal Reflux; Humans; Lansoprazole; Male; Middle Aged; Treatment Outcome

The objective of this trial was to compare the efficacy of esomeprazole, 20 mg, with that of omeprazole, 20 mg, in patients with erosive esophagitis (EE). In this multicenter, double-blind, parallel-group trial, 1176 patients with EE confirmed by endoscopy (Helicobacter pylori-negative by serology) were randomized to once-daily treatment with 20 mg esomeprazole or 20 mg omeprazole for 8 weeks. The primary outcome was the proportion of patients with healed EE through week 8. Secondary outcomes included diary and investigator assessments of heartburn symptoms. Cumulative life-table healing rates at week 8 were similarly high for 20 mg esomeprazole (90.6%; 95% confidence interval, 88.1%-93%) and 20 mg omeprazole (88.3%; 95% confidence interval, 85.5%-91.0%). The two treatments were comparable for other secondary measures and had similar tolerability profiles.

Topics: Adolescent; Adult; Aged; Anti-Ulcer Agents; Dose-Response Relationship, Drug; Double-Blind Method; Esomeprazole; Esophagitis, Peptic; Female; Gastroesophageal Reflux; Humans; Male; Middle Aged; Omeprazole

Secondary analyses from previous studies indicated that esomeprazole was more effective than lansoprazole and omeprazole in healing moderate or severe (Los Angeles grades C or D) erosive oesophagitis (EE).. To compare prospectively healing rates with esomeprazole vs. lansoprazole in patients with moderate to severe EE.. In this multicentre, randomized, double-blind, parallel-group trial, adult patients with endoscopically confirmed moderate or severe EE received esomeprazole 40 mg (n = 498) or lansoprazole 30 mg (n = 501) once daily for up to 8 weeks. The primary end point was EE healing through week 8. Secondary assessments included investigator-assessed resolution of symptoms and safety and tolerability.. Time to healing was significantly different (P = 0.007), favouring esomeprazole. Estimated healing rates at week 8 were 82.4% with esomeprazole 40 mg and 77.5% with lansoprazole 30 mg. Heartburn resolved at week 4 in 72% and 64% of patients who received esomeprazole and lansoprazole, respectively (P = 0.005). Control of other GERD symptoms was similar between treatments. Both treatments were well tolerated.. With 8 weeks' treatment, esomeprazole 40 mg once daily heals moderate to severe EE faster and in more patients, and resolves heartburn in more patients after 4 weeks of treatment, than lansoprazole 30 mg once daily.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adult; Aged; Anti-Ulcer Agents; Double-Blind Method; Esomeprazole; Esophagitis, Peptic; Female; Heartburn; Humans; Lansoprazole; Male; Middle Aged; Prospective Studies; Proton Pump Inhibitors; Treatment Outcome; Wound Healing

Esomeprazole, an oral S-form of omeprazole, has been a greater acid inhibitor over omeprazole in treating acid-related diseases. Only less published data is available to confirm its efficacy for Asian people. Therefore, a perspective, double-blind, randomized comparison of esomeprazole tablets 40 mg (Nexium) vs omeprazole capsules 20 mg (Losec) in treating Chinese subjects with erosive/ulcerative reflux esophagitis (EE) was conducted.. A total of 48 EE patients were enrolled and randomized into two treatment groups under 8-wk therapy: 25 receiving esomeprazole, while another 23 receiving omeprazole treatment. Finally, 44 completed the whole 8-wk therapy.. The difference in healing EE between two groups was 22.7% (72.7% vs 50.0%), not reaching significant value (P = 0.204). The median of the first time needed in relieving heartburn sensation was 1 d for both groups and the remission rates for heartburn on the 1st d after treatment were 77.3% and 65%, respectively (NS). The scores of various reflux relieving symptoms evaluated either by patients or by investigators were not different. Regarding drug safety, 28% of esomeprazole group and 26.1% of omeprazole group reported at least one episode of adverse effects, while constipation and skin dryness were the common side effects in both groups (NS).. Esomeprazole 40 mg is an effective and safe drug at least comparable to omeprazole in treating Chinese EE patients.

Topics: Administration, Oral; Adult; Aged; Anti-Ulcer Agents; Capsules; Double-Blind Method; Esomeprazole; Esophagitis, Peptic; Female; Heartburn; Humans; Male; Middle Aged; Omeprazole; Prospective Studies; Tablets

Following initial healing of erosive oesophagitis, most patients require maintenance therapy to prevent relapse.. To compare endoscopic and symptomatic remission rates over 6 months' maintenance therapy with esomeprazole or pantoprazole (both 20 mg once daily) in patients with healed erosive oesophagitis.. Patients with symptoms of gastro-oesophageal reflux disease and endoscopically confirmed erosive oesophagitis at baseline were randomized to receive esomeprazole 40 mg or pantoprazole 40 mg for up to 8 weeks. Patients with healed erosive oesophagitis and free of moderate/severe heartburn and acid regurgitation at 4 weeks or, if necessary, 8 weeks entered the 6-month maintenance therapy phase of the study.. A total of 2766 patients (63% men; mean age 50 years) received esomeprazole 20 mg (n = 1377) or pantoprazole 20 mg (n = 1389) and comprised the intention-to-treat population. Following 6 months of treatment, the proportion of patients in endoscopic and symptomatic remission was significantly greater for those receiving esomeprazole 20 mg (87.0%) than pantoprazole 20 mg (74.9%, log-rank test P < 0.0001). Esomeprazole 20 mg produced a higher proportion of patients free of moderate to severe gastro-oesophageal reflux disease symptoms and fewer discontinuations because of symptoms than pantoprazole 20 mg (92.2% vs. 88.5%, P < 0.001).. Esomeprazole 20 mg is more effective than pantoprazole 20 mg for maintenance therapy following initial healing of erosive oesophagitis and relief of gastro-oesophageal reflux disease symptoms.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Anti-Ulcer Agents; Benzimidazoles; Double-Blind Method; Drug Tolerance; Enzyme Inhibitors; Esomeprazole; Esophagitis, Peptic; Esophagoscopy; Female; Gastroesophageal Reflux; Humans; Male; Middle Aged; Pantoprazole; Proton Pump Inhibitors; Secondary Prevention; Sulfoxides; Treatment Outcome

Intravenous esomeprazole may be beneficial for patients who cannot take oral medications.. To compare intravenous esomeprazole with oral esomeprazole for effects on maximal acid output during pentagastrin stimulation in patients with gastro-oesophageal reflux disease symptoms.. In four separate open-label, randomized, two-way crossover studies, adult patients were administered esomeprazole 20 or 40 mg once daily either orally or intravenously (by 15-min infusion or 3-min injection) for 10 days and switched to the other formulation with no washout period. Basal acid output and maximal acid output were measured on days 11, 13 and 21.. In the four studies (total of 183 patients), least-squares mean maximal acid output ranged from 3.0 to 4.1 mmol/h after intravenous esomeprazole 40 or 20 mg and from 2.2 to 3.3 mmol/h after oral esomeprazole 20 or 40 mg. Differences between formulations were small and not statistically significant but did not meet the prospectively defined criterion for non-inferiority of the intravenous formulation. Median basal acid output values ranged from 0.04 to 0.27 mmol/h after intravenous administration and from 0.05 to 0.25 mmol/h after oral esomeprazole.. Intravenous esomeprazole is an acceptable alternative to the oral formulation for treatment of up to 10 days of duration.

Topics: Administration, Oral; Adolescent; Adult; Aged; Cross-Over Studies; Enzyme Inhibitors; Esomeprazole; Esophagitis, Peptic; Female; Gastric Acid; Gastroesophageal Reflux; Humans; Infusions, Intravenous; Male; Middle Aged; Proton Pump Inhibitors; Sex Factors; Treatment Outcome

Treatment of gastroesophageal reflux disease (GERD) with proton pump inhibitors was investigated in three controlled prospective, randomized open studies. Lansoprazole, omeprazole MUPS and esomeprazole were compared under doctor's office conditions. The outcomes of interest were the rapidity of pain relief achieved with a single dose, effectiveness and patient satisfaction with on demand therapy. In the first study, 180 patients with chronic and prolonged episodes of reflux were investigated. Time to pain relief following a single dose was 1.1 +/- 0.8 hours with 30 mg lansoprazole, 3.0 +/- 2.5 hours with 20 mgomeprazole MUPS and 2.1 +/- 1.2 hours with 40 mg esomeprazole. Studies 2 and 3 were designed as cross-over studies intended to investigate drug consumption. In study 2, the amount of lansoprazole consumed was approximately 50% less than that of omeprazole, and this translated to 81% patient satisfaction with lansoprazole compared with only 9.5% for omeprazole. In study 3 comparing lansoprazole and esomeprazole, consumption of the former was 85% that of the latter. 58% of the patients opted to continuetreatment with lansoprazole, compared with only 25% in the case of esomeprazole. The appreciably greater patient satisfaction with lansoprazole was due tothe faster pain relief achieved with this drug.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adult; Aged; Anti-Ulcer Agents; Cross-Over Studies; Dose-Response Relationship, Drug; Drug Administration Schedule; Esomeprazole; Esophagitis, Peptic; Family Practice; Female; Germany; Heartburn; Humans; Lansoprazole; Male; Middle Aged; Omeprazole; Pain Measurement; Patient Satisfaction; Prospective Studies; Proton Pump Inhibitors; Recurrence

Proton pump inhibitors are the most effective agents for treating erosive oesophagitis, but their relative efficacies have not been well characterized in large clinical trials.. To compare standard doses of esomeprazole and lansoprazole in healing oesophagitis and resolving accompanying symptoms.. This was a US, multicentre, randomized, double-blind trial and included 5241 adult patients (intention-to-treat) with endoscopically documented erosive oesophagitis. Patients were randomized to esomeprazole, 40 mg once daily, or lansoprazole, 30 mg once daily, for up to 8 weeks. The primary end-point, endoscopic healing at Week 8, was assessed using life-table analysis and a log-rank test. Secondary endpoints included healing at Week 4, healing according to baseline severity of oesophagitis, control of heartburn and side-effects.. Healing rates were 92.6% with esomeprazole and 88.8% with lansoprazole at Week 8 (P = 0.0001, log-rank test). A significant difference was also observed at Week 4. Sustained resolution of heartburn occurred faster and in a larger proportion of patients treated with esomeprazole. Both agents were well tolerated.. Esomeprazole produced significantly higher oesophagitis healing rates than lansoprazole over all grades of oesophagitis. Esomeprazole also provided better control of heartburn and was associated with a greater proportion of patients with sustained resolution of symptoms.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adult; Double-Blind Method; Esomeprazole; Esophagitis, Peptic; Humans; Lansoprazole; Proton Pump Inhibitors; Treatment Outcome

Esomeprazole, the first proton pump inhibitor to be developed as an optical isomer, has demonstrated more effective healing vs. omeprazole and lansoprazole in patients with reflux oesophagitis (RO). However, RO recurs in a high proportion (approximately 80%) of these patients within 12 months of initial therapy, highlighting the importance of maintenance treatment. Previous studies have shown esomeprazole to be effective as maintenance therapy in healed RO patients.. This study was conducted to compare esomeprazole 20 mg once daily (o.d.) with lansoprazole 15 mg o.d. for the prevention of recurrence of RO.. 1391 patients with endoscopically verified RO (LA classification) were enrolled in this randomized, double-blind, parallel-group, multicentre trial. During the initial healing phase of the study, all patients received 4-8 weeks' open treatment with esomeprazole 40 mg: 1236 healed (identified by endoscopy at 4 and 8 weeks) and symptom-free (i.e. no heartburn or acid regurgitation) patients were randomized to 6 months' maintenance treatment with esomeprazole 20 mg o.d. or lansoprazole 15 mg o.d. Time to relapse (relapse of RO and/or discontinuation due to symptom recurrence) was analysed using a log-rank test.. Esomeprazole maintained a significantly higher proportion of patients in remission than lansoprazole over the 6-month course of treatment (P < 0.0001, intention-to-treat analysis). After 6 months' treatment, 83% of esomeprazole recipients were in remission compared with 74% of lansoprazole recipients (life-table estimates). Esomeprazole gave a longer time to relapse than lansoprazole irrespective of baseline LA Grade, significantly so for baseline LA Grades B, C and D (P < 0.05 for each comparison). Significantly more patients were free from heartburn in the esomeprazole group compared with the lansoprazole group at 1, 3 and 6 months (P < 0.05). Significant differences at 6 months between esomeprazole 20 mg o.d. and lansoprazole 15 mg o.d. were also observed for control of epigastric pain and acid regurgitation (P < 0.05 and P < 0.001, respectively). Both treatment regimens were well tolerated.. Esomeprazole 20 mg o.d. is a more effective maintenance treatment than lansoprazole 15 mg o.d. for symptom-free patients with healed RO.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Anti-Ulcer Agents; Dose-Response Relationship, Drug; Double-Blind Method; Esomeprazole; Esophagitis, Peptic; Humans; Lansoprazole

Reflux esophagitis of Los Angeles grade A or B is more common than grades C and D disease among Taiwanese. This study compared the efficacy of esomeprazole 40 mg and omeprazole 20 mg for starting on-demand therapy for grade A and B reflux esophagitis.. 100 patients with grade A and B reflux esophagitis were randomized to receive either esomeprazole 40 mg once daily (n = 50) or omeprazole 20 mg once daily (n = 50) for the first 4 weeks. Sustained symptomatic response (SSR) was defined as freedom from symptoms for the last 7 days of the 4-week treatment duration. On-demand therapy was used for the next 4 weeks in patients with SSR; patients without SSR continued with the same proton pump inhibitor regimen. Patients were asked to record their daily severity of acid regurgitation (AR) and heartburn (HB). Medication usage during on-demand therapy was recorded.. Forty six patients in the esomeprazole group and 45 patients in the omeprazole group completed the study protocol. The rate of SSR was higher in the esomeprazole group than in the omeprazole group (per-protocol: 73.9% vs 51.1%, p < 0.05; intent-to-treat: 68% vs 46%, p < 0.05). The symptomatic scores for AR and HB were similar between patients taking medication continuously and those taking medication on-demand with both esomeprazole and omeprazole. For patients starting on-demand therapy, the total number of tablets used during 4 weeks was lower in the esomeprazole group than in the omeprazole group (13.5 vs 18.5, p < 0.05).. In patients with grade A and B reflux esophagitis, esomeprazole 40 mg was more effective than omeprazole 20 mg for the initiation of on-demand therapy.

Topics: Anti-Ulcer Agents; Drug Administration Schedule; Esomeprazole; Esophagitis, Peptic; Female; Humans; Male; Middle Aged; Omeprazole; Treatment Outcome

The proton pump inhibitors have consistently been shown to be far more effective than the others are in gastro-oesophageal reflux disease (GERD) as proton pump inhibitors (PPIs) block the final and rate-limiting step of parietal acid production. The primary objective of the study was to assess the efficacy and tolerability of esomeprazole 40 mg given once a day for 4 weeks in patients with reflux oesophagitis. An open, non-comparative study was done with 103 patients in 4 centres with endoscopic erosive oesophagitis. Symptoms of reflux oesophagitis such as heartburn/retrosternal pain and regurgitation recorded on a 4-point scale, dysphagia being marked as present or absent. Oesophagitis was graded as 5-point scale. There was a significant decrease in mean score of heartburn (60.8% and 86%), retrosternal pain (60.84% and 86.75%), mean score of regurgitation (65% and 90%) at second and fourth week respectively. Global assessment of overall symptoms by patients showed complete resolution of symptoms in 86.4% patients at week 4. At the end of treatment 93 out of 103 patients showed complete healing, 13.6% of total cases had side effects. Esomeprazole was found effective and safe in the treatment of GERD.

Topics: Adolescent; Adult; Anti-Ulcer Agents; Enzyme Inhibitors; Esomeprazole; Esophagitis, Peptic; Evaluation Studies as Topic; Female; Humans; India; Male; Middle Aged; Severity of Illness Index; Treatment Outcome

Esomeprazole, the S isomer of omeprazole, has been shown to have higher healing rates of erosive esophagitis than omeprazole. This study compared esomeprazole with lansoprazole for the healing of erosive esophagitis and resolution of heartburn.. This United States multicenter, randomized, double blind, parallel group trial was performed in 5241 adult patients (intent-to-treat population) with endoscopically documented erosive esophagitis, which was graded by severity at baseline (Los Angeles classification). Patients received 40 mg of esomeprazole (n = 2624) or 30 mg of lansoprazole (n = 2617) once daily before breakfast for up to 8 wk. The primary efficacy endpoint was healing of erosive esophagitis at week 8. Secondary assessments included proportion of patients healed at week 4, resolution of investigator-recorded heartburn, time to first and time to sustained resolution of patient diary-recorded heartburn, and proportion of heartburn-free days and nights.. Esomeprazole (40 mg) demonstrated significantly higher healing rates (92.6%, 95% CI = 91.5-93.6%) than lansoprazole (30 mg) (88.8%, 95% CI = 87.5-90.0%) at week 8 (p = 0.0001, life-table estimates, intent-to-treat analysis). A significant difference in healing rates favoring esomeprazole was also observed at week 4. The difference in healing rates between esomeprazole and lansoprazole increased as baseline severity of erosive esophagitis increased. Sustained resolution of heartburn occurred faster and in more patients treated with esomeprazole. Sustained resolution of nocturnal heartburn also occurred faster with esomeprazole. Both treatments were well tolerated.. Esomeprazole (40 mg) is more effective than lansoprazole (30 mg) in healing erosive esophagitis and resolving heartburn. Healing rates are consistently high with esomeprazole, irrespective of baseline disease severity.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adolescent; Adult; Aged; Anti-Ulcer Agents; Double-Blind Method; Endoscopy, Digestive System; Esomeprazole; Esophagitis, Peptic; Female; Heartburn; Humans; Lansoprazole; Male; Middle Aged; Severity of Illness Index; Wound Healing

Esomeprazole, the S-isomer of omeprazole, is the first proton pump inhibitor to be developed as an optical isomer. In patients with erosive oesophagitis, esomeprazole has produced significantly greater healing rates and improved symptom resolution vs. omeprazole.. This study assesses the efficacy of esomeprazole for preventing relapse in patients with healed oesophagitis.. In this 6-month US multicentre randomized double-blind placebo-controlled trial, 375 Helicobacter pylori-negative patients with endoscopically healed oesophagitis received esomeprazole 40 mg, 20 mg, 10 mg, or placebo once daily. The primary efficacy end-point was maintenance of healing at 6 months. Secondary end-points assessed changes in symptoms, and long-term safety and tolerability.. Significantly (P < 0.001) more patients remained healed with esomeprazole 40 mg (87.9%), 20 mg (78.7%), or 10 mg (54.2%), than with placebo (29.1%). Relapse, when it occurred, was later with esomeprazole. Sustained resolution of heartburn was observed in the 40 mg and 20 mg groups; there was a high correlation between absence of heartburn and maintenance of healing. Adverse effects were mild, infrequent and not significantly different between groups.. Esomeprazole is effective and well-tolerated in the maintenance of healing of erosive oesophagitis. Esomeprazole 40 mg and 20 mg offer significant clinical benefit to patients.

Topics: Administration, Oral; Adolescent; Adult; Aged; Aged, 80 and over; Dose-Response Relationship, Drug; Double-Blind Method; Esomeprazole; Esophagitis, Peptic; Female; Gastroesophageal Reflux; Heartburn; Humans; Isomerism; Male; Middle Aged; Placebos; Proton Pump Inhibitors; Recurrence; Treatment Outcome

The pharmacologic profile of the new proton pump inhibitor esomeprazole has demonstrated advantages over omeprazole that suggest clinical benefits for patients with acid-related disease.. 1960 patients with endoscopy-confirmed reflux oesophagitis (RO) were randomized to once daily esomeprazole 40 mg (n=654) or 20 mg (n=656), or omeprazole 20 mg (n=650), the standard recommended dose for RO, for up to 8 weeks in a US, multicentre, double-blind trial. The primary efficacy variable was the proportion of patients healed at week 8. Secondary variables included healing and heartburn resolution at week 4, time to first resolution and sustained resolution of heartburn, and per cent of heartburn-free days and nights. Safety and tolerability were also evaluated.. Significantly more patients were healed at week 8 with esomeprazole 40 mg (94.1%) and 20 mg (89.9%) vs. omeprazole 20 mg (86.9%), using cumulative life table estimates, ITT analysis (each P < 0.05). Esomeprazole 40 mg was also significantly more effective than omeprazole for healing at week 4 and for all secondary variables evaluating heartburn resolution. The most common adverse events in all treatment groups were headache, abdominal pain and diarrhoea.. Esomeprazole was more effective than omeprazole in healing and symptom resolution in GERD patients with reflux oesophagitis, and had a tolerability profile comparable to that of omeprazole.

Topics: Adult; Aged; Anti-Ulcer Agents; Double-Blind Method; Esomeprazole; Esophagitis, Peptic; Female; Heartburn; Humans; Male; Middle Aged; Omeprazole

Topics: Adult; Drug Substitution; Esomeprazole; Esophagitis, Peptic; Hallucinations; Hernia, Hiatal; Humans; Male; Omeprazole; Proton Pump Inhibitors

The real size of the gastro-oesophageal reflux disease (GERD) population not responding to proton pump inhibitor (PPI) therapy has still not been fully elucidated. Causes of PPI refractoriness include incorrect diagnosis and lack of adherence to therapy, in terms of incorrect dosage and timing.. To evaluate the prevalence of refractoriness to optimal PPI therapy and the contribution of non-erosive reflux disease (NERD), reflux hypersensitivity, and functional heartburn, to PPI refractoriness. The association of functional GI symptoms in non-responders was evaluated.. Frequency and severity of GERD symptoms (heartburn, regurgitation, chest pain), dysphagia, belching, epigastric pain, postprandial distress, irritable bowel syndrome (IBS), globus, and ear nose and throat (ENT) symptoms were evaluated in patients previously classified as non-responders. Patients with at least one of the oesophageal symptoms with a frequency ≥3 /week were treated with esomeprazole 40 mg once daily for 8 weeks and then re-evaluated. Non-responders (patients with oesophageal symptoms ≥3 times per week) underwent 24 hour multichannel intraluminal impedance-pH monitoring.. Of 573 consecutive patients, 92 with oesophageal symptoms and classified as PPI-refractory underwent the esomeprazole trial; 60 did not respond. IBS, epigastric pain, and post-prandial distress episodes were associated with a poor response on multivariate analysis. NERD, reflux hypersensitivity, and functional heartburn patients constituted 32%, 42%, and 26%, respectively of the PPI-refractory group.. True refractoriness in patients with GERD symptoms attending a secondary care setting is lower than previously reported. Following a careful history and optimal PPI dosing, the rate of refractoriness was 20%. True NERD constitutes only a third of the PPI-refractory group.

Topics: Adult; Aged; Deglutition Disorders; Drug Resistance; Eructation; Esomeprazole; Esophagitis, Peptic; Female; Gastroesophageal Reflux; Heartburn; Humans; Irritable Bowel Syndrome; Middle Aged; Prevalence; Prospective Studies; Proton Pump Inhibitors

Topics: Esomeprazole; Esophagitis; Esophagitis, Peptic; Gastroesophageal Reflux; Humans; Intra-Abdominal Fat; Proton Pump Inhibitors

Interleukin (IL)-1β is a potent inhibitor of gastric acid secretion and its genetic polymorphism is linked to the severity of reflux esophagitis. Proton-pump inhibitor (PPI) metabolized by P450 2C19 (CYP2C19) is the chief medication in reflux esophagitis treatment. The CYP2C19 genotype may influence the therapeutic effect of PPI for reflux esophagitis. From November 2009 to June 2012, 184 patients were enrolled in this study with endoscopy examination, 8 weeks of esomeprazole treatment, and 20 weeks of follow-up with questionnaire. These patients also received endoscopy examination after 20 weeks. Blood was collected for genetic polymorphism analysis with polymerase chain reaction. After 8 weeks of treatment with esomeprazole, all of these 184 patients had achieved complete symptom relief. However, in the following 12 weeks, 58.70% (108/184) complained of symptom relapse, 45.65% (84/184) patients had persistent esophageal erosion verified by endoscopy, and in total, 76.09% (140/184) patients had treatment failure at the end of 20 weeks. There were no influences between the genetic polymorphisms of CYP2C19 and IL1B to treatment failure (p = 0.896). Therefore, prolonging PPI treatment and further lifestyle modification might be warranted for symptomatic mild esophagitis. There were no relationships between IL-1β and CYP2C19 in the treatment effect in mild reflux esophagitis.

Topics: Cytochrome P-450 CYP2C19; Esomeprazole; Esophagitis, Peptic; Humans; Interleukin-1beta; Polymorphism, Genetic; Proton Pump Inhibitors; Surveys and Questionnaires; Treatment Outcome

Limited data exist on the impact of regurgitation on health-related quality of life (HRQOL) in gastro-oesophageal reflux disease (GORD). We assessed the relationship between regurgitation frequency and HRQOL before and after acid suppression therapy in GORD.. We used data from two randomised trials of AZD0865 25-75 mg/day versus esomeprazole 20 or 40 mg/day in non-erosive reflux disease (NERD) (n=1415) or reflux oesophagitis (RO) (n=1460). The Reflux Disease Questionnaire was used to select patients with frequent and intense heartburn for inclusion and to assess treatment response. The Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire was used to assess HRQOL.. At baseline, 93% of patients in both the NERD and RO groups experienced regurgitation. Mean QOLRAD scores were similar for NERD and RO at baseline and at week 4 and disclosed decremental HRQOL with increasing frequency of regurgitation; a clinically relevant difference of >0.5 in mean QOLRAD scores was seen with regurgitation ≥4 days/week versus <4 days/week. The prevalence of frequent, persistent regurgitation (≥4 days/week) at week 4 among heartburn responders (≤1 day/week of mild heartburn) was 28% in NERD and 23% in RO. QOLRAD scores were higher among heartburn responders. There was a similar pattern of impact related to regurgitation frequency in heartburn responders compared with the group as a whole.. Frequent regurgitation was associated with a clinically relevant, incremental decline in HRQOL beyond that associated with heartburn before and after potent acid suppression in both NERD and RO.. NCT00206284 and NCT00206245.

Topics: Antacids; Drug Administration Schedule; Esomeprazole; Esophagitis, Peptic; Follow-Up Studies; Gastroesophageal Reflux; Heartburn; Humans; Imidazoles; Proton Pump Inhibitors; Pyridines; Quality of Life; Randomized Controlled Trials as Topic; Retrospective Studies; Surveys and Questionnaires; Treatment Outcome

Topics: Esomeprazole; Esophagitis, Peptic; Female; Humans; Imidazoles; Male; Proton Pump Inhibitors; Pyridines

Topics: Esomeprazole; Esophagitis, Peptic; Female; Humans; Imidazoles; Male; Proton Pump Inhibitors; Pyridines

The Reflux Disease Questionnaire (RDQ) contains six symptom items for diagnosing and gauging gastroesophageal reflux disease (GERD) severity. However, clinical trials have generally focused only on the "substernal burning" item and limited data exist on the effect of concomitant items on the treatment response of "substernal burning".. Data from two large randomized trials of AZD0865 25-75 mg/day vs. esomeprazole 20 or 40 mg/day in patients with GERD defined by moderate to severe (≥ 4 days per week) "substernal burning" (non-erosive reflux disease (NERD), N = 1,460; reflux esophagitis (RE), N = 1,514) were re-analyzed. As no differences were found between drugs or doses in treatment response of "substernal burning", pooled data were used to determine the impact of additional RDQ items on the response of "substernal burning" to acid suppression.. At baseline, patients reported an average of four RDQ items. "Substernal burning" was the most responsive to therapy in the 3.3% of individuals with this as their only baseline RDQ symptom. The report of any other RDQ item was associated with a reduction in the responsiveness of "substernal burning" to acid suppression (e.g., RE patients with high severity "dyspepsia-pain" had an odds ratio of 0.20 for an improvement in "substernal burning" to treatment).. Other concomitant RDQ items, particularly "substernal pain" or "dyspepsia-pain", were associated with a reduced treatment effect of acid suppression on "substernal burning". These findings support the use of a more comprehensive assessment of disease state and treatment response in GERD trials and clinical practice.

Topics: Adult; Anti-Ulcer Agents; Esomeprazole; Esophagitis, Peptic; Gastroesophageal Reflux; Heartburn; Humans; Retrospective Studies; Surveys and Questionnaires; Treatment Outcome

Although most patients with gastro-oesophageal reflux disease (GERD) benefit from proton pump inhibitor (PPI) therapy, some experience only partial symptom relief.. To determine the prevalence of partial heartburn response to PPIs and its impact on health-related quality of life.. Four randomised, double-blind studies in adults with reflux disease compared esomeprazole 40 mg/day or 20 mg/day with omeprazole 20 mg/day, or esomeprazole 40 mg/day with pantoprazole 40 mg/day. Patients with heartburn on ≥4 days during the 1-week recall period at baseline were included. Partial response was defined as heartburn on ≥3 days during the last treatment week and reduced heartburn frequency after 4 weeks of treatment compared with baseline.. The analysis included 2645 patients with non-erosive reflux disease (mean age: 48.8 years; 54.4% women) and 3151 patients with reflux oesophagitis (mean age: 50.6 years; 37.1% women). At baseline, most patients reported heartburn on 5-7 days (non-erosive reflux disease: 82.2%; reflux oesophagitis: 86.8%). Partial heartburn response occurred in 19.9% of patients with non-erosive reflux disease and 14.0% with reflux oesophagitis. Defining partial response as heartburn on ≥2 days increased these rates to 26.2% and 19.3%, respectively; defining partial response as heartburn of moderate or severe intensity on ≥3 days decreased these rates to 6.4% and 5.3%, respectively. Nonresponse to PPIs was rare (non-erosive reflux disease: 2.4%; reflux oesophagitis: 1.4%).. Using our conservative definition, partial heartburn response to proton pump inhibitor therapy occurred in 14-20% of gastro-oesophageal reflux disease patients, more commonly in non-erosive reflux disease than in reflux oesophagitis.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adult; Esomeprazole; Esophagitis, Peptic; Female; Gastroesophageal Reflux; Humans; Male; Middle Aged; Omeprazole; Pantoprazole; Proton Pump Inhibitors; Quality of Life; Randomized Controlled Trials as Topic; Severity of Illness Index; Time Factors; Treatment Outcome

The predictors for treatment failure of on-demand proton pump inhibitor (PPI) therapy in gastro-esophageal reflux disease (GERD) patients are unclear. We studied the efficacy and predictors for treatment failure of step-down on-demand PPI therapy in patients with non-erosive reflux disease (NERD) and those with low grade erosive esophagitis.. Consecutive symptomatic GERD patients who had positive esophageal pH studies and complete symptom resolution with initial treatment of esomeprazole were given step-down on-demand esomeprazole for 26 weeks. Patients with esophagitis of Los Angeles (LA) grade C or above and recent use of PPI were excluded. Treatment failure was defined as an inadequate relief of reflux symptoms using global symptom assessment. Potential predictors of treatment failure were determined using multivariate analysis.. One hundred and sixty three NERD and 102 esophagitis patients were studied. The 26-week probability of treatment failure was 36.2% (95% CI: 23.9-46.5%) in NERD group and 20.1% (95% CI: 10.9-28.3%) in esophagitis group, respectively (P = 0.021). Irritable bowel syndrome (adjusted HR: 2.1, 95% CI: 1.5-3.8, P = 0.01), in addition to daily reflux symptom (adjusted hazard ratio: 2.7, 95% CI: 1.9-4.2, P = 0.001) and concomitant dyspepsia (adjusted hazard ratio: 1.7, 95% CI: 1.1-2.8, P = 0.04), were independent predictors for treatment failure.. Compared to patients with esophagitis, NERD patients have higher failure rate of on-demand PPI therapy. Concomitant irritable bowel syndrome, in addition to daily reflux symptom and dyspepsia, is associated with the failure of on-demand PPI in these patients.

Topics: Adult; Cohort Studies; Comorbidity; Esomeprazole; Esophagitis, Peptic; Female; Gastroesophageal Reflux; Humans; Hydrogen-Ion Concentration; Irritable Bowel Syndrome; Longitudinal Studies; Male; Manometry; Middle Aged; Multivariate Analysis; Predictive Value of Tests; Prospective Studies; Proton Pump Inhibitors; Retrospective Studies; Treatment Failure

We assessed whether the esophageal mucosa index of hemoglobin (IHb) could assist the Los Angeles (LA) classification in defining the severity of erosive reflux esophagitis (RE) and predicting the treatment response by esomeprazole.. Five hundred twenty-four subjects (424 RE and 100 controls) with normal body mass index and hemoglobin had undergone endoscopy to confirm the RE grade by LA classification and to check the series of IHb values at every centimeter of the esophageal mucosa while withdrawing the endoscope to above the esophageal-gastric junction (EGJ). The RE cases had received esomeprazole for 8 weeks (40 mg/day) to assess the cumulative proportions of sustained symptomatic response (SSR).. The IHb value at the EGJ was higher in RE patients than in controls (P < 0.001). Selecting 70 as the cutoff IHb value at the EGJ, the efficacy to define RE achieved 95.8% (406/424) sensitivity and 94% (94/100) specificity. For the patients with same the LA grade, the length of IHb value >70 above the EGJ (L-IHb70) that is greater than 4 cm correlated with a poor cumulative rate of SSR (P < 0.01).. The IHb value >70 at the EGJ is a reliable indicator of RE. The L-IHb70 can serve as a supplementary indicator to predict the response to esomeprazole index within the same LA grade.

Topics: Adult; Anti-Ulcer Agents; Esomeprazole; Esophagitis, Peptic; Esophagoscopy; Female; Gastric Mucosa; Hemoglobins; Humans; Male; Predictive Value of Tests; Prospective Studies; Severity of Illness Index

Erosive oesophagitis appears to be more common in white vs. nonwhite patients with gastro-oesophageal reflux disease (GERD).. To evaluate the association between race and erosive oesophagitis healing in patients with GERD treated with once-daily proton pump inhibitors (PPIs).. Data from five double-blind trials of once-daily treatment with esomeprazole 40mg vs. omeprazole 20mg or lansoprazole 30mg for erosive oesophagitis healing (evaluated at weeks 4 and 8 by endoscopy) were pooled and stratified by baseline race and Los Angeles (LA) severity grade. Multiple logistic regression models were fit with erosive oesophagitis healing (dependent variable) and race (independent variable), with adjustments for treatment, study, baseline LA grade, age, gender, BMI, Helicobacter pylori status, hiatal hernia and interactions of these factors with race.. Of 11,027 patients, 91% were white. Nonwhite (n=978) and black (n=613) patients were less likely to have severe baseline erosive oesophagitis (LA grade C or D) than white patients [adjusted OR: 0.69 (95% CI, 0.61-0.79) and 0.67 (0.57-0.78), respectively; P<0.0001]. At week 8, nonwhite and black patients had lower healing rates than white patients [OR: 0.75 (0.63-0.89) and 0.67 (0.54-0.83), respectively; P≤0.001]. Greater odds of healing were associated with less severe baseline LA grade, increasing age, hiatal hernia, esomeprazole treatment (vs. lansoprazole or omeprazole) and lansoprazole treatment (vs. omeprazole) (all P≤0.0009); no factor interacted significantly with race.. Nonwhite patients with GERD had less severe baseline erosive oesophagitis, but were less likely than white patients to have erosive oesophagitis healing after 8-week PPI therapy.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adolescent; Adult; Aged; Aged, 80 and over; Esomeprazole; Esophagitis, Peptic; Faith Healing; Female; Gastroesophageal Reflux; Humans; Lansoprazole; Logistic Models; Los Angeles; Male; Middle Aged; Omeprazole; Proton Pump Inhibitors; Racial Groups; Randomized Controlled Trials as Topic; Retrospective Studies; Treatment Outcome; Young Adult

A 56-year-old white woman developed a distinctive skin eruption over her mammary, lumbosacral, and pubic areas 2 weeks after the start of esomeprazole therapy for dyspeptic symptoms. Skin biopsy disclosed a spongiotic dermatitis with predominantly lymphocytic dermal infiltrate. Treatment with a tapering dose of corticosteroid and withdrawal of the suspected drug led to a rapid resolution of the eruption without residual dyschromia. Patch testing with esomeprazole 2% in petrolatum was negative at 48 and 72 hours but became positive on day 6. Oral-controlled provocation test induced the reappearance of the lesions over the mammary areas, confirming the putative involvement of this drug. Therefore, the patient was diagnosed as having a nonpigmented fixed drug eruption associated with esomeprazole. This compound is a proton-pump inhibitor developed as the S-isomer of omeprazole to improve its pharmacokinetic properties. Reports of cutaneous reactions to proton-pump inhibitors are quite common, but reports of such reactions to esomeprazole are rare, which demonstrates the need for higher clinical awareness and knowledge of reactions to these drugs.

Topics: Drug Eruptions; Esomeprazole; Esophagitis, Peptic; Female; Humans; Middle Aged; Omeprazole; Proton Pump Inhibitors; Skin Pigmentation; Treatment Outcome

Topics: Anti-Ulcer Agents; Body Mass Index; Esomeprazole; Esophagitis, Peptic; Humans; Risk Reduction Behavior; Weight Loss

Topics: Adolescent; Anti-Ulcer Agents; Child; Esomeprazole; Esophagitis, Peptic; Female; Gastric Acid; Humans; Male

This study assessed the endoscopic healing rates of reflux esophagitis with Los Angeles grades C and D (RE-CD) using a 6-month esomeprazole and the demographic factors or genotypes of S-mephenytoin 4'-hydroxylase (CYP2C19) that correlated with the healing of RE-CD.. One hundred thirteen patients with RE-CD received esomeprazole 40 mg daily for 6 months and completed serial follow-ups regarding healing by endoscopies at the 1st month and the 6th month, respectively. In each patient, demographic factors, including body mass index (BMI), and the CYP2C19 genotypes were checked.. The endoscopic healing rates of RE-CD were similar among patients with different genotypes of CYP2C19 at the 1st month and the 6th month, respectively (P > 0.05). A lower healing rate of RE-CD at the 1st month was independently related to a higher BMI > 25 kg/m(2), coffee drinking, and the presence of hiatus hernia (P < 0.05), but not with the CYP2C19 genotypes. A higher BMI > 25 kg/m(2) independently had a 2.32-fold decrease of the healing of RE-CD (P < 0.001), but a net decrease of BMI > 1.5 kg/m(2) independently had a 3.65-fold increase of the healing of RE-CD at the 6th month (P= 0.014).. Esomeprazole 40 mg daily can be effective for RE-CD patients with different CYP2C19 genotypes. BMI > 25 kg/m(2) is an independent risk factor to determine the healing of RE-CD by esomeprazole. Reducing BMI > 1.5 kg/m(2), especially for those with an initial BMI > 25 kg/m(2), could be promising to improve the healing of RE-CD by esomeprazole.

Topics: Analysis of Variance; Anti-Ulcer Agents; Aryl Hydrocarbon Hydroxylases; Body Mass Index; Chi-Square Distribution; Cytochrome P-450 CYP2C9; Dose-Response Relationship, Drug; Esomeprazole; Esophagitis, Peptic; Esophagoscopy; Female; Genotype; Humans; Male; Middle Aged; Prospective Studies; Risk Factors; Severity of Illness Index; Treatment Outcome

Patients with Los Angeles grade A or B reflux esophagitis (RE-AB) can potentially be switched from active-phase therapy to on-demand esomeprazole as maintenance therapy. Body mass index (BMI) correlates significantly with reflux symptoms. We investigated whether BMI affects the efficacy of esomeprazole in active-phase or subsequent on-demand therapy.. Three hundred fifty patients with RE-AB were prospectively enrolled to receive an 8-wk course of esomeprazole (40 mg/day) as active-phase therapy. Based on the daily severity of acid regurgitation and heartburn, the cumulative proportions of patients with sustained symptomatic response (SSR), defined as free from symptoms for the last 7 days, were compared among different BMI groups (control: BMI <25 kg/m2, overweight: BMI 25-30 kg/m2, obese: BMI >30 kg/m2). In patients who had achieved SSR by week 8, on-demand therapy for 2 months was started. The number of 40-mg esomeprazole tablets used per 4-wk period was recorded.. SSR rates were lower in both the overweight and obese groups than in the control group (P < 0.001). During on-demand therapy, the mean number of tablets used per 4-wk period was lower in the control group than in either the overweight or the obese group (13.2 vs 15.3 or 16.2, P < 0.05). The failure rate of on-demand therapy increased with increasing BMI-2.4%, 5.3%, and 14.2%, respectively, for the control, overweight, and obese groups (P= 0.002).. For RE-AB, a higher BMI decreases the rate of SSR after 8-wk of esomeprazole therapy, and increases the need for medication and the failure rate of on-demand therapy.

Topics: Adult; Analysis of Variance; Anti-Ulcer Agents; Body Mass Index; Dose-Response Relationship, Drug; Esomeprazole; Esophagitis, Peptic; Female; Humans; Logistic Models; Male; Middle Aged; Prospective Studies; Severity of Illness Index; Statistics, Nonparametric; Treatment Outcome

Patients with gastro-oesophageal reflux disease may complain of epigastric pain, bloating, early satiety, epigastric fullness, epigastric burning, nausea and vomiting.. To evaluate the symptoms in response to gastric distension and its relationship to a therapeutic course in patients with gastro-oesophageal reflux disease using the water load test, compared to healthy controls.. Thirty gastro-oesophageal reflux disease patients with grade A oesophagitis (studied before and after 4 weeks of therapy with esomeprazole, 40 mg per day) and 15 patients with reflux-related symptoms demonstrated at wireless pH monitoring (non-erosive reflux disease) were compared to 30 healthy volunteers.. Patients with grade A oesophagitis and with reflux-related symptoms ingested significantly lower water volumes than did controls, before onset of fullness, without statistically significant difference between erosive or non-erosive gastro-oesophageal reflux disease; this variable improved in patients after treatment. Nausea scores were higher basally in patients, pre- and post-therapy, and improved after therapy. Thirty-minute fullness and bloating scores improved after therapy in all gastro-oesophageal reflux disease patients compared to controls and pre-therapy. In all pre-treatment patients, a significant correlation was found only with epigastric fullness; after treatment, there was no significant relationship between the water load and the symptom scores.. In patients with reflux-related symptoms, with or without grade A oesophagitis, the water load test is frequently abnormal, suggesting an altered gastric function. This could explain the incomplete resolution of symptoms after treatment in some patients, and should lead to additional studies aimed at exploring gastric function in gastro-oesophageal reflux disease patients.

Topics: Adult; Drinking; Dyspepsia; Enzyme Inhibitors; Esomeprazole; Esophagitis, Peptic; Female; Gastroesophageal Reflux; Humans; Male; Middle Aged; Treatment Outcome; Water

Patients with gastroesophageal reflux disease (GERD) may suffer from a large variety of symptoms in the upper aerodigestive tract such as globus sensation, chronic cough, hoarseness and many others. Diagnosis and causal therapy may sometimes be difficult with gastroenterologic evaluation sometimes revealing no pathologic result. The objective of this study was to determine the impact of 24-hour intraesophageal pH monitoring with 2 channels (gastric and laryngeal) in the diagnosis of reflux-induced otolaryngologic disorders.. This study included 22 patients presenting to the Department of Otolaryngology with symptoms like chronic cough (n = 3), globus sensation and dysphagia (n = 11), heartburn (n = 2), hoarseness and dysphonia (n = 2) or burning sensation of the tongue (n = 1). Three patients had a pathologic formation in the glottic area (leukoplakia, granuloma, polyp). All patients underwent a otolaryngological examination, a gastroenterological investigation and a 24-hour intraesophageal pH monitoring with 2 channels.. All 22 patients showed laryngeal mucosal lesions (posterior laryngitis). The gastroenterological evaluation with esophagogastroduodenoscopy was normal in 4 cases. 13 patients showed a hiatal hernia, 4 patients were suffering from a reflux-esophagitis grade I and 2 patients from grade II. One patient had an erythema and 5 patients showed erosions of the gastric mucosa. Seven patients had more than one of the above mentioned diagnoses. Intraesophageal pH-monitoring with 2 channels over 24 hours revealed a gastroesophageal reflux of all 22 patients and a high reflux to the laryngeal level of 21 patients, probably causing laryngopharyngeal symptoms. Therapy of the patients consisted of medical antireflux treatment with proton pump inhibitor esomeprazol (Nexium, 40 mg, 1-0-0). Within 4 weeks 15 of 22 patients had no more laryngopharyngeal symptoms or at least a significant reduction.. Patients with laryngopharyngeal symptoms such as hoarseness, globus sensation or dysphagia can suffer from GERD, even if typical symptoms such as heartburn or retrosternal pain do not exist and gastroesophageal intervention reveals a normal result. The best diagnostic instrument for the diagnosis of reflux-induced otolaryngologic disorders is a 24-hour intraesophageal pH-monitoring with 2 channels (measure-points at the distal esophagus and laryngeal level). Medical antireflux treatment should consist of proton pump inhibitors (e. g. Nexium) in a dose of 40 mg per day over at least 4 weeks.

Topics: Adult; Aged; Anti-Ulcer Agents; Esomeprazole; Esophagitis, Peptic; Female; Gastric Acidity Determination; Gastroesophageal Reflux; Humans; Male; Middle Aged; Monitoring, Ambulatory; Otorhinolaryngologic Diseases; Proton Pump Inhibitors; Reproducibility of Results; Signal Processing, Computer-Assisted; Treatment Outcome

Clinical studies have demonstrated that esomeprazole is superior to omeprazole for the acute treatment of reflux oesophagitis.. To compare the cost effectiveness of esomeprazole 40mg once daily with omeprazole 20mg once daily in patients with reflux oesophagitis.. Pooled data were used from three 8-week clinical trials comparing the efficacy and safety of esomeprazole 40mg once daily and omeprazole 20mg once daily for the acute treatment of reflux oesophagitis. A simple decision analysis model, using UK direct medical costs, compared the cost effectiveness of the two treatments. Healing probabilities derived from the clinical studies using the Life Table method were used to estimate the effectiveness and cost of treating 100 patients with reflux oesophagitis. Patient management assumptions were based on a clinical management survey involving 25 UK physicians.. UK National Health Service.. After 4 weeks' therapy, the Life Table estimated the oesophageal healing rate to be 77.7% in esomeprazole 40mg once-daily recipients (n = 2446), compared with 67.6% in omeprazole 20mg once-daily recipients (n = 2431; p < 0.001). The corresponding values after 8 weeks' treatment were 93.4% and 86.2%, respectively (p < 0.001). The model predicted that when considering healing probabilities over 8 weeks, esomeprazole 40mg once daily produced total direct cost savings of pound1290 (14%) when compared with omeprazole 20mg once daily. When considering the cost of treating patients who had failed treatment (defined as patient not healed as assessed by endoscopy) after 8 weeks, the cost advantage for esomeprazole was even greater.. Esomeprazole 40mg once daily is cost effective compared with omeprazole 20mg once daily in the acute treatment of patients with reflux oesophagitis; esomeprazole provides greater effectiveness at a lower cost.

Topics: Anti-Ulcer Agents; Cost-Benefit Analysis; Decision Support Techniques; Esomeprazole; Esophagitis, Peptic; Female; Humans; Male; Middle Aged; Omeprazole; United Kingdom