s-1743 and Heartburn

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

The use of non-steroidal anti-inflammatory drugs (NSAIDs) is often associated with upper gastrointestinal symptoms such as heartburn and acid regurgitation.. To assess the efficacy of esomeprazole 20 and 40 mg for resolution of heartburn and acid regurgitation in continuous NSAIDs.. A post hoc analysis of five clinical trials was performed. Two identically designed, placebo-controlled, 4-week studies (NASA1, SPACE1) enrolled non-ulcer, NSAIDs-treated patients with upper abdominal pain, discomfort or burning. PLUTO and VENUS were identically designed, placebo-controlled, 6-month studies that enrolled patients at risk of NSAIDs-induced ulcers. Study 285 was an 8-week comparative study with ranitidine (300 mg/day) in patients with NSAIDs-induced gastric ulcers. Resolution of investigator-assessed heartburn and acid regurgitation was defined as symptom severity of 'none' in the last 7 days.. In NASA1/SPACE1, heartburn resolved in 61% and 62% of patients taking esomeprazole 20 and 40 mg, respectively (vs. 36% on placebo, P < 0.001), and acid regurgitation resolved in 65% and 67% (vs. 48%, P < 0.001). Resolution of both symptoms was greater with esomeprazole than with placebo in PLUTO/VENUS (P

Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer Agents; Esomeprazole; Female; Gastroesophageal Reflux; Heartburn; Humans; Middle Aged; Multicenter Studies as Topic; Randomized Controlled Trials as Topic; Treatment Outcome

Efficacy of proton pump inhibitors is limited in patients with nonerosive reflux disease (NERD). The aim of this study was to comparatively evaluate the efficacy and safety of esomeprazole with sodium bicarbonate and esomeprazole alone.. This was a multicenter, randomized, double-blind, active-controlled, noninferiority comparative study. A total of 379 patients with NERD were randomly allocated to receive either Esoduo. A total of 355 patients completed the study (180 in the Esoduo. Esoduo

Topics: Double-Blind Method; Esomeprazole; Gastroesophageal Reflux; Heartburn; Humans; Proton Pump Inhibitors; Sodium Bicarbonate; Treatment Outcome

Proton-pump inhibitors (PPIs) are cornerstone treatments for gastro-esophageal reflux disease (GERD); however, evidence suggests that most patients exhibit partial response to PPIs, suggesting the need for novel therapies that can provide an improved and sustained increase in gastric pH.. This study aimed to determine the effect of vonoprazan, a novel, orally active small-molecule potassium-competitive acid blocker, versus esomeprazole, a PPI, in preventing heartburn symptoms over a 4-week treatment period in patients with GERD and a partial response to esomeprazole treatment.. This randomized, double-blind, proof-of-concept, phase 2 clinical trial was conducted between 2016 and 2018 at 39 sites across Europe and designed to evaluate the efficacy and safety of vonoprazan 20 mg once daily (q.d.) and 40 mg q.d. versus esomeprazole 40 mg q.d. after 1:1:1 randomization of symptomatic patients with GERD and a partial response to a healing dose of esomeprazole.. No statistically significant difference in efficacy and safety was observed among treatment groups, and vonoprazan was well tolerated. The trial is registered with the National Board of Health (EudraCT: 2015-001154-14) database.

Topics: Double-Blind Method; Esomeprazole; Female; Gastroesophageal Reflux; Heartburn; Humans; Middle Aged; Proton Pump Inhibitors; Treatment Outcome

A two-week course of therapy with an over-the-counter proton-pump inhibitor (PPI) is recommended for frequent heartburn. Limited research has been conducted on the sustained efficacy of short-term PPI therapy after treatment cessation. Esomeprazole 20 mg was evaluated in the seven-day follow-up period after the two-week treatment period using pooled data from two identical randomized, double-blind, placebo-controlled studies.. Adults without confirmed diagnoses of gastroesophageal reflux disease experiencing heartburn at least two days/week in the past four weeks were eligible. Subjects received treatment with esomeprazole 20 mg or placebo once daily for 14 days. Heartburn episodes were documented using daily diaries. Missing data during the two-week treatment period were assumed to be days with heartburn. The proportion of subjects with heartburn resolution while on treatment and during the seven days of follow-up was assessed. Predictors of resolution during this post-treatment period were evaluated using a stepwise logistic regression model.. All subjects in the pooled analysis set who reported diary data for at least three follow-up days were analyzed (N = 584). This cut-off was used to ensure that sufficient data were collected for these analyses. Greater run-in heartburn frequency was a significant negative predictor of heartburn resolution during follow-up (P < 0.001). Among the on-treatment efficacy variables, the best predictor of resolution during follow-up was resolution during the last seven days of treatment (odds ratio: 3.81 [95% confidence interval: 2.40, 6.05; P < 0.0001]).. Lower baseline heartburn frequency and heartburn resolution during the last seven days of treatment were associated with a greater likelihood of heartburn resolution during the seven-day follow-up.. Registered at ClinicalTrials.gov June 11, 2011: NCT01370525 ; NCT01370538 .

Topics: Adult; Double-Blind Method; Drug Administration Schedule; Esomeprazole; Female; Follow-Up Studies; Heartburn; Humans; Male; Middle Aged; Nonprescription Drugs; Proton Pump Inhibitors; Treatment Outcome

Reflux symptoms are frequently associated with esophageal acid exposure. However, other potential causes unrelated to acid secretion are possible, and the relationship between acid control and symptomatic improvement remains unclear. This study investigated the correlation between individual intragastric pH control and heartburn relief among subjects with frequent heartburn who are likely to self-treat with over-the-counter (OTC) medications. We hypothesized that improved acid control would provide greater symptomatic improvement among individuals representative of an OTC population.. This phase 4, single-center, randomized, double-blind, placebo-controlled study was conducted in subjects without diagnosed gastroesophageal reflux disease or other gastrointestinal conditions who were experiencing frequent heartburn (≥ 3 episodes/week; ≥ 2 nighttime episodes/week over past 30 days) that was responsive to treatment. Subjects entered a 7-day run-in phase, received placebo BID (before breakfast and dinner), and completed symptom diaries. During the treatment phase, subjects received esomeprazole 20 mg BID, esomeprazole 20 mg then placebo, or placebo BID. Subjects underwent 24-h intragastric pH monitoring at baseline and day 14 and completed daily symptom diaries.. In the per-protocol population (n = 39), mean (SD) change from baseline in percentage of time with intragastric pH > 4 was 58.7% (± 26.4%) versus 41.0% (± 30.4%) for those who did and did not achieve 24-h heartburn relief. Significant correlations were observed between change in percentage of time with intragastric pH > 4 and 24-h heartburn relief (OR 1.028; 95% CI 1.001, 1.055; P = 0.0442) and complete resolution (OR 1.034; 95% CI 1.003, 1.065; P = 0.0301).. Individuals with greater improvements in duration of intragastric acid suppression had an increased likelihood of achieving heartburn relief and resolution. These results indicate that individuals not adequately controlling their intragastric pH may require an escalation in dose of their acid-suppressive therapy, assessment with 24-h pH monitoring, or a change in treatment regimen to address non-reflux-related etiologies of their heartburn.. ClinicalTrials.gov identifier: NCT02708355.. Pfizer Consumer Healthcare, Madison, NJ, USA. Plain language summary available for this article.

Topics: Adult; Double-Blind Method; Drug Administration Schedule; Drug Monitoring; Esomeprazole; Female; Gastric Acidity Determination; Gastroesophageal Reflux; Heartburn; Humans; Male; Middle Aged; Nonprescription Drugs; Proton Pump Inhibitors; 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

Sleep disturbances related to reflux symptoms have a significant impact on the daily lives of affected individuals. These analyses identified clinical factors related to resolution of reflux-related sleep disturbance in subjects treated with esomeprazole 20 mg for 14 days.. Data from the first 14 days of 2 similar randomized, double-blind studies were pooled for subjects experiencing frequent heartburn and related sleep disturbances receiving esomeprazole 20 mg (n = 357) or placebo (n = 346). A stepwise logistic regression analysis was performed with pooled and individual study data to evaluate relationships between clinical factors [treatment (esomeprazole vs. placebo), run-in sleep disturbance frequency, occurrence (yes/no) of 24-h, daytime, and nighttime heartburn (yes: ≥1 episode in 14-day treatment period)] and complete sleep disturbance resolution (no disturbances for 7 consecutive days).. Absence of daytime (p = 0.0018) or nighttime (p < 0.0001) heartburn during treatment was a significant predictor of complete sleep disturbance resolution at 14 days for the total population, while higher run-in sleep disturbance frequency (p < 0.0001) was associated with a lower likelihood of resolution. Esomeprazole treatment was an independent significant predictor of improvement across all endpoints (p < 0.0001). A significant treatment by run-in sleep disturbance interaction was observed for complete resolution (p = 0.0231), indicating greater therapeutic benefit with esomeprazole in subgroups with higher run-in symptom frequency.. Lower run-in sleep disturbance frequency, no occurrence of daytime or nighttime heartburn during therapy, and esomeprazole treatment predicted complete reflux-related sleep disturbance resolution. The magnitude of therapeutic benefit for esomeprazole 20 mg over placebo increased with increasing baseline sleep disturbance.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Double-Blind Method; Endpoint Determination; Esomeprazole; Female; Gastroesophageal Reflux; Heartburn; Humans; Male; Middle Aged; Prognosis; Proton Pump Inhibitors; Sleep Wake Disorders; Treatment Outcome; Young Adult

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

Esomeprazole 20 mg once daily has been shown to be effective for treating frequent heartburn over 14 days in subjects who are likely to self-treat with over-the-counter medications. These analyses were conducted to assess durability of effects and symptomatic rebound after cessation of treatment, treatment satisfaction, and rescue antacid use with esomeprazole 20 mg once daily for 14 days.. Adults with frequent heartburn (≥ two days/week in the past four weeks) were randomly assigned to 14 days of double-blind treatment with esomeprazole 20 mg or placebo in two identical multicenter studies. All subjects entered a 1-week single-blind placebo follow-up period after treatment. The results of the primary efficacy endpoints were reported previously. The percentage of heartburn-free days during the 1-week follow-up, use of rescue antacids, and treatment satisfaction, measured with the Global Assessment Questions instrument, are described.. The percentage of heartburn-free days was maintained during the 1-week follow-up period; the proportion was 43% among esomeprazole subjects in these studies, suggesting no evidence of symptomatic rebound. Rescue antacid use generally decreased compared with the run-in period in the 14-day treatment and 1-week follow-up periods. Significantly more subjects taking esomeprazole were "very satisfied" or "satisfied" with treatment versus placebo (Study 1: 78% vs. 63%, respectively, P = 0.0038; Study 2: 81% vs. 60%, respectively, P = 0.0002).. Subjects who are likely to self-treat their frequent heartburn with over-the-counter medications reported satisfaction with esomeprazole 20 mg. Esomeprazole's treatment effect was maintained for ≥ one week after treatment ended, with no sign of symptomatic rebound. These trials were registered at ClinicalTrials.gov: NCT01370525; NCT01370538.

Topics: Adult; Antacids; Double-Blind Method; Drug Administration Schedule; Esomeprazole; Female; Heartburn; Humans; Male; Middle Aged; Patient Satisfaction; Proton Pump Inhibitors; Quality of Life; Recurrence; Single-Blind Method

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

To investigate the resolution of heartburn and gastroesophageal reflux disease (GERD)-related sleep disturbances during the first 14 days of treatment with esomeprazole 20 mg compared to placebo in subjects with frequent nighttime heartburn and GERD-related sleep disturbances.. This was a post hoc analysis of 2 week data from two previously published, similarly designed randomized, placebo-controlled trials of 4 weeks' duration comparing esomeprazole 20 mg, 40 mg (one study), and placebo. Inclusion and exclusion criteria for both trials were the same.. NCT00628342; NCT00660660.. The main outcome measures for this analysis were the resolution and/or relief of GERD-related sleep disturbances during 2 weeks of treatment with esomeprazole 20 mg or placebo. Resolution and/or relief of heartburn symptoms were also measured.. In trial 1, 455 subjects were randomized, with 225 and 229 receiving esomeprazole 20 mg and placebo, respectively. In trial 2, 276 subjects were randomized, with 142 and 132 receiving esomeprazole and placebo, respectively. After 2 weeks, significantly more subjects who received esomeprazole 20 mg (50.5% [95% confidence interval: 43.8%-57.1%] and 39.4% [31.2%-47.6%] in trials 1 and 2, respectively) had resolution of sleep disturbances compared to placebo (19.9% [14.6%-25.2%] and 16.0% [9.6%-22.4%], respectively; p < 0.0001 for both trials). The median time to resolution of sleep disturbances with esomeprazole 20 mg was 1 day in both trials. After 2 weeks, significantly more subjects receiving esomeprazole 20 mg (32.3% [26.1%-38.5%] and 26.3% [18.9%-33.6%] in trials 1 and 2, respectively) had resolution of nighttime heartburn symptoms compared to placebo (5.4% [2.4%-8.4%] and 4.8% [1.1%-8.5%], respectively; p < 0.0001 for both trials).. Esomeprazole 20 mg significantly and effectively reduced nighttime heartburn and GERD-related sleep disturbances in the first 2 weeks of treatment compared to placebo, with rapid resolution of sleep disturbances in the first days of treatment.

Topics: Adult; Double-Blind Method; Esomeprazole; Female; Gastroesophageal Reflux; Heartburn; Humans; Male; Middle Aged; Proton Pump Inhibitors; Sleep Wake Disorders; Treatment Outcome

To determine the efficacy of a 14-day regimen of esomeprazole 20 mg for the treatment of frequent heartburn in subjects who are likely to self-treat with over-the-counter medications without consulting a health care provider.. Adults with frequent heartburn ≥ 2 days per week in the past 4 weeks were randomly assigned to 14-day double-blind treatment with esomeprazole 20 mg once daily or placebo in 2 identical multicenter studies (ClinicalTrials.gov identifiers: NCT01370525, NCT01370538). The primary efficacy outcome was percentage of heartburn-free 24-hour days across 14 days. Secondary efficacy outcomes included heartburn resolution, defined as heartburn ≤ 2 days over 14 days, and percentages of subjects reporting ≤ 1 day with heartburn in the first and final weeks of treatment. Subjects recorded data in daily self-assessment diaries.. The percentage of heartburn-free 24-hour days over 14 days was significantly higher (P < 0.0001) in subjects receiving esomeprazole 20 mg compared with placebo in study 1 (N = 331; 46.13% vs. 33.07%, respectively) and study 2 (N = 320; 48.00% vs 32.75%, respectively). Significantly more subjects treated with esomeprazole 20 mg had heartburn resolution over 14 days and in the first and final weeks compared with placebo. Within the first 4 days, the proportion of subjects with heartburn-free days was significantly greater with esomeprazole 20 mg versus placebo. Treatment was generally well tolerated, with a safety pattern consistent with the known profile for esomeprazole.. A 14-day regimen of esomeprazole 20 mg once daily was effective for treating frequent heartburn in subjects who are likely to self-treat with over-the-counter medications.

Topics: Adult; Double-Blind Method; Esomeprazole; Female; Heartburn; Humans; Male; Middle Aged; Nonprescription Drugs; Proton Pump Inhibitors; Self Medication; Treatment Outcome

High-quality data regarding the efficacy of acid-suppressive treatment for unexplained chest pain are lacking. The aim of this study was to evaluate the efficacy of esomeprazole in primary-care treatment of patients with unexplained chest pain stratified for frequency of reflux/regurgitation symptoms.. Patients with a ≥ 2-week history of unexplained chest pain (unrelated to gastroesophageal reflux) who had at least moderate pain on ≥ 2 of the last 7 days were stratified by heartburn/regurgitation frequency (≤ 1 day/week (stratum 1) vs. ≥ 2 days/week (stratum 2)) and randomized to 4 weeks of double-blind treatment with twice-daily esomeprazole 40 mg or placebo. Chest pain relief during the last 7 days of treatment (≤ 1 day with minimal symptoms assessed daily using a 7-point scale) was analyzed by stratum in keeping with the predetermined analysis plan.. Overall, 599 patients (esomeprazole: 297, placebo: 302) were randomized. In stratum 1, more esomeprazole than placebo recipients achieved chest pain relief (38.7% vs. 25.5%; P=0.018); no between-treatment difference was observed in stratum 2 (27.2% vs. 24.2%; P=0.54). However, esomeprazole was superior to placebo in a post-hoc analysis of the whole study population (combined strata; 33.1% vs. 24.9%; P=0.035).. A 4-week course of high-dose esomeprazole provided statistically significant relief of unexplained chest pain in primary-care patients who experienced infrequent or no heartburn/regurgitation, but there was no such significant reduction in patients with more frequent reflux symptoms.

Topics: Administration, Oral; Adolescent; Adult; Aged; Antacids; Chest Pain; Double-Blind Method; Drug Administration Schedule; Esomeprazole; Female; Gastroesophageal Reflux; Heartburn; Humans; Intention to Treat Analysis; Male; Middle Aged; Pain Measurement; Primary Health Care; Treatment Outcome; Young Adult

Current PPIs may not achieve desired outcomes in some GERD patients due to limited duration of acid inhibition.. To evaluate a novel rabeprazole extended release (ER), which provides longer duration of drug exposure and acid suppression, in healing and symptomatic resolution of moderate-severe erosive oesophagitis.. Patients with LA grade C or D oesophagitis were randomised to rabeprazole-ER 50 mg or esomeprazole 40 mg once daily in two identical 8-week double-blind trials (N = 2130). Two primary endpoints were tested sequentially: (1) healing by 8 weeks [hypothesis: rabeprazole-ER non-inferior to esomeprazole (non-inferiority margin = 8%)], (2) healing by 4 weeks [hypothesis: rabeprazole-ER superior to esomeprazole (P < 0.05)]. The secondary endpoint was sustained heartburn resolution at 4 weeks.. Rabeprazole-ER was non-inferior to esomeprazole in week-8 healing (80.0% vs. 75.0%; 77.5% vs. 78.4%). Week-4 healing (54.8% vs. 50.3%; 50.9% vs. 50.7%) and sustained heartburn resolution (48.3% vs. 48.2%; 53.2% vs. 52.5%) were not significantly different. Post hoc combined results for grade D revealed rabeprazole-ER vs. esomeprazole differences in week-8 healing = 10.4% (95% CI: -1.4%, 22.2%) and week-4 healing = 12.0% (P = 0.048).. Rabeprazole-ER is as effective as esomeprazole in healing moderate-severe oesophagitis and achieves similar rates of heartburn resolution. Subgroup analysis suggests the possibility of benefit in severe oesophagitis, but this requires further evaluation (ClinicalTrials.gov: NCT00658528 and NCT00658775).

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adolescent; Adult; Aged; Double-Blind Method; Esomeprazole; Esophagitis; Female; Heartburn; Humans; Male; Middle Aged; Proton Pump Inhibitors; Rabeprazole; Severity of Illness Index; Statistics as Topic; Time Factors; Treatment Outcome; Young Adult

Despite the high prevalence of gastro-oesophageal reflux disease (GORD) and the documented impact of GORD symptoms on individual health-related quality of life (HR-QOL) and on socioeconomic factors, structured management of GORD has had a low priority in Swedish routine primary health care.. The primary objective of this study (IMPROVE) was to evaluate the effects of a structured follow-up and management regimen for primary-care GORD patients with symptomatic breakthrough despite standard proton pump inhibitor (PPI) treatment. Patients received either an increased dose of current PPI treatment or were switched to the more effective acid inhibitor esomeprazole.. GORD patients with symptomatic breakthrough despite standard PPI treatment were identified through medical records and by a postal survey using the GERD Impact Scale (GIS) questionnaire. Patients rated the severity and frequency of GORD symptoms, general health status (EuroQol Group 5-Dimension Self-Report Questionnaire) and the impact of GORD symptoms on work productivity (Work Productivity and Activity Impairment) before and 4 weeks following randomization to open-label treatment with either increased acid suppressive therapy or an adjusted, higher dosage of the PPI previously used. The patients' valuation, in monetary terms, of the treatment they received pre-study versus the treatment given during the study was documented through willingness-to-pay (WTP) questions.. Following more effective acid suppression, 66.3% of the study population experienced complete relief of heartburn, with no difference between the groups; HR-QOL was restored to a level comparable to that of a normal Swedish population and ability to work efficiently was significantly improved. Access to a better acid suppressive treatment was highly valuable to the patients in terms of WTP.. An improved GORD management strategy including structured follow-up of treatment given and initiation of more effective acid inhibitor therapy when symptoms persist will be of great benefit to GORD patients. [ClinicalTrials.gov Identifier: NCT00272701].

Topics: Adolescent; Adult; Aged; Anti-Ulcer Agents; Dose-Response Relationship, Drug; Efficiency; Esomeprazole; Female; Follow-Up Studies; Gastroesophageal Reflux; Heartburn; Humans; Male; Middle Aged; Primary Health Care; Proton Pump Inhibitors; Quality of Life; Surveys and Questionnaires; Sweden; Young Adult

BACKGROUND. Non-steroidal anti-inflammatory drugs are associated with poor upper gastrointestinal (UGI) tolerability and increased ulcer risk, but patient adherence to gastroprotective co-therapy is frequently inadequate. A fixed-dose combination of enteric-coated naproxen 500 mg and immediate-release esomeprazole magnesium 20 mg was evaluated: efficacy is reported by Hochberg et al. (Curr Med Res Opin 2011;27:1243-53); tolerability findings are reported here. PATIENTS AND METHODS. In two 12-week double-blind, placebo-controlled, multicenter, phase III studies (PN400-307 and PN400-309), patients aged ≥ 50 years with symptomatic knee osteoarthritis randomly (2:2:1) received naproxen/esomeprazole magnesium BID, celecoxib 200 mg QD, or placebo. Tolerability end-points included: modified Severity of Dyspepsia Assessment (mSODA); heartburn severity; and UGI adverse events (AEs). RESULTS. Overall, 619 (PN400-307) and 615 (PN400-309) patients were randomized; mSODA scores improved (baseline to week 12) in each group, with no significant treatment differences between naproxen/esomeprazole magnesium and celecoxib (95% CIs: PN400-307: -0.4, 1.9; PN400-309: -1.8, 0.6). Naproxen/esomeprazole magnesium-treated patients reported significantly more heartburn-free days versus celecoxib (95% CIs: PN400-307: 2.1, 12.7; PN400-309: 2.5, 13.4). UGI AE incidence (PN400-307: 17.3%; PN400-309: 20.3%) was similar between treatment groups. UGI AEs resulted in few discontinuations (< 4%, either study). CONCLUSIONS. Naproxen/esomeprazole magnesium has comparable UGI tolerability to celecoxib in patients with osteoarthritis.

Topics: Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer Agents; Celecoxib; Cyclooxygenase 2 Inhibitors; Double-Blind Method; Drug Combinations; Dyspepsia; Esomeprazole; Female; Gastrointestinal Tract; Heartburn; Humans; Male; Middle Aged; Naproxen; Osteoarthritis, Knee; Pyrazoles; Sulfonamides; Tablets, Enteric-Coated; Treatment Outcome

To determine whether strategies to counsel and empower patients with heartburn-predominant dyspepsia could improve health-related quality of life.. Using a cluster randomized, parallel group, multicentre design, nine centres were assigned to provide either basic or comprehensive counselling to patients (age range 18 to 50 years) presenting with heartburn-predominant upper gastrointestinal symptoms, who would be considered for drug therapy without further investigation. Patients were treated for four weeks with esomeprazole 40 mg once daily, followed by six months of treatment that was at the physician's discretion. The primary end point was the baseline change in Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire score.. A total of 135 patients from nine centres were included in the intention-to-treat analysis. There was a statistically significant baseline improvement in all domains of the QOLRAD questionnaire in both study arms at four and seven months (P<0.0001). After four months, the overall mean change in QOLRAD score appeared greater in the comprehensive counselling group than in the basic counselling group (1.77 versus 1.47, respectively); however, this difference was not statistically significant (P=0.07). After seven months, the overall mean baseline change in QOLRAD score between the comprehensive and basic counselling groups was not statistically significant (1.69 versus 1.56, respectively; P=0.63).. A standardized, comprehensive counselling intervention showed a positive initial trend in improving quality of life in patients with heartburn-predominant uninvestigated dyspepsia. Further investigation is needed to confirm the potential benefits of providing patients with comprehensive counselling regarding disease management.

Topics: Adolescent; Adult; Anti-Ulcer Agents; Cluster Analysis; Counseling; Directive Counseling; Dyspepsia; Esomeprazole; Female; Follow-Up Studies; Heartburn; Humans; Male; Middle Aged; Patient Advocacy; Patient Education as Topic; Physicians, Family; Practice Patterns, Physicians'; Primary Health Care; Quality of Life; Surveys and Questionnaires; Young Adult

Nighttime heartburn, common among patients with gastro-oesophageal reflux disease (GERD), is associated with substantial clinical effects. GERD-related sleep disturbances are underappreciated and undertreated.. To evaluate the efficacy of esomeprazole on GERD-related nighttime heartburn and associated sleep disturbances.. In this multicentre, randomized, double-blind, placebo-controlled study, patients with moderate-to-severe nighttime heartburn and GERD-related sleep disturbances (endoscopies not required) received esomeprazole 20 mg or placebo each morning for 4 weeks. Heartburn symptoms and GERD-related sleep disturbances were evaluated using the validated Pittsburgh Sleep Quality Index and validated Work Productivity and Activity Impairment Questionnaire.. The analysis included 262 patients (esomeprazole, n = 137; placebo, n = 125). Significantly more patients receiving esomeprazole achieved nighttime heartburn relief (primary end point) than those receiving placebo (34.3% vs. 10.4%; P < 0.0001). Secondary end points such as relief of GERD-related sleep disturbances (P = 0.006), days without GERD-related sleep disturbances (P = 0.0003) and complete resolution of sleep disturbances (P < 0.0001) favoured esomeprazole over placebo. Sleep quality, work productivity and regular daily activities also improved significantly with esomeprazole vs. placebo.. Esomeprazole 20 mg is effective for patients with moderate-to-severe nighttime heartburn and GERD-related sleep disturbances, improving heartburn symptoms, sleep quality, work productivity and functionality.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anti-Ulcer Agents; Double-Blind Method; Esomeprazole; Female; Gastroesophageal Reflux; Heartburn; Humans; Male; Middle Aged; Prospective Studies; Sleep Wake Disorders; Surveys and Questionnaires; Treatment Outcome; Young Adult

A trial of empirical PPI therapy is usual practice for most patients with symptoms of gastro-oesophageal reflux disease (GERD) in primary care.. To determine if the 4-week efficacy of rabeprazole 20 mg for resolving heartburn and regurgitation symptoms is non-inferior to esomeprazole 40 mg or 20 mg.. In all, 1392 patients were randomized to rabeprazole 20 mg, esomeprazole 20 mg or 40 mg once daily. Patients, doctors and assessors were blinded. Symptom resolution data were collected on days 0-7 and day-28 using the Patient Assessment of Upper Gastrointestinal Disorders Symptom Severity Index with a shortened version used on days 8-27.. Rabeprazole 20 mg was non-inferior to esomeprazole 40 mg for complete resolution of regurgitation and satisfactory resolution of heartburn and regurgitation. For complete heartburn resolution, the efficacy of rabeprazole 20 mg and esomeprazole 40 mg was statistically indistinguishable, although the non-inferiority test was inconclusive. Rabeprazole 20 mg was non-inferior to esomeprazole 20 mg for all outcomes.. In uninvestigated GERD patients, rabeprazole 20 mg was non-inferior to esomeprazole 40 mg for complete and satisfactory relief of regurgitation and satisfactory relief of heartburn, and not different for complete resolution of heartburn.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Ulcer Agents; Dose-Response Relationship, Drug; Double-Blind Method; Esomeprazole; Female; Gastroesophageal Reflux; Heartburn; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Primary Health Care; Rabeprazole; Time Factors; Treatment Outcome; Young Adult

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

To clarify whether there is any difference in the symptom relief in patients with reflux esophagitis following the administration of four Proton pump inhibitors (PPIs).. Two hundred and seventy-four patients with erosive reflux esophagitis were randomized to receive 8 wk of 20 mg omeprazole (n = 68), 30 mg of lansoprazole (n = 69), 40 mg of pantoprazole (n = 69), 40 mg of esomeprazole (n = 68) once a day in the morning. Daily changes in heartburn and acid reflux symptoms in the first 7 d of administration were assessed using a six-point scale (0: none; 1: mild; 2: mild-moderate; 3: moderate; 4: moderate-severe; 5: severe).. The mean heartburn score in patients treated with esomeprazole more rapidly decreased than those receiving other PPI. Complete resolution of heartburn was also more rapid in patients treated with esomeprazole for 5 d compared with omeprazole (P = 0.0018, P = 0.0098, P = 0.0027, P = 0.0137, P = 0.0069, respectively), lansoprazole (P = 0.0020, P = 0.0046, P = 0.0037, P = 0.0016, P = 0.0076, respectively), and pantoprazole (P = 0.0006, P = 0.0005, P = 0.0009, P = 0.0031, P = 0.0119, respectively). There were no significant differences between the four groups in the rate of endoscopic healing of reflux esophagitis at week 8.. Esomeprazole may be more effective than omeprazole, lansoprazole, and pantoprazole for the rapid relief of heartburn symptoms and acid reflux symptoms in patients with reflux esophagitis.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adult; Aged; Anti-Ulcer Agents; Esomeprazole; Female; Gastroesophageal Reflux; Heartburn; Humans; Lansoprazole; Male; Middle Aged; Omeprazole; Pantoprazole; Patient Selection

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

Rebound acid hypersecretion (RAHS) has been demonstrated after 8 weeks of treatment with a proton-pump inhibitor (PPI). If RAHS induces acid-related symptoms, this might lead to PPI dependency and thus have important implications.. A randomized, double-blind, placebo-controlled trial with 120 healthy volunteers was conducted. Participants were randomized to 12 weeks of placebo or 8 weeks of esomeprazole 40 mg/d followed by 4 weeks with placebo. The Gastrointestinal Symptom Rating Scale (GSRS) was filled out weekly. A score of >2 on 1 of the questions regarding heartburn, acid regurgitation, or dyspepsia was defined as a clinically relevant acid-related symptom.. There were no significant differences between groups in GSRS scores at baseline. GSRS scores for acid-related symptoms were significantly higher in the PPI group at week 10 (1.4 +/- 1.4 vs 1.2 +/- 0.9; P = .023), week 11 (1.4 +/- 1.4 vs 1.2 +/- 0.9; P = .009), and week 12 (1.3 +/- 1.2 vs 1.0 +/- 0.3; P = .001). Forty-four percent (26/59) of those randomized to PPI reported > or = 1 relevant, acid-related symptom in weeks 9-12 compared with 15% (9/59; P < .001) in the placebo group. The proportion reporting dyspepsia, heartburn, or acid regurgitation in the PPI group was 13 of 59 (22%) at week 10, 13 of 59 (22%) at week 11, and 12 of 58 (21%) at week 12. Corresponding figures in the placebo group were 7% at week 10 (P = .034), 5% at week 11 (P = .013), and 2% at week 12 (P = .001).. PPI therapy for 8 weeks induces acid-related symptoms in healthy volunteers after withdrawal. This study indicates unrecognized aspects of PPI withdrawal and supports the hypothesis that RAHS has clinical implications.

Topics: Adolescent; Adult; Double-Blind Method; Drug Administration Schedule; Dyspepsia; Esomeprazole; Female; Gastric Acid; Gastric Mucosa; Gastroesophageal Reflux; Heartburn; Humans; Male; Middle Aged; Proton Pump Inhibitors; Reference Values; Severity of Illness Index; Time Factors; Treatment Outcome; Young Adult

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

Some patients with gastro-oesophageal reflux disease (GORD) remain symptomatic despite proton pump inhibitor (PPI) treatment. There is a need to determine the most appropriate management of these patients.. To assess the effectiveness of esomeprazole 40 mg in GORD symptoms persisting in patients receiving a full daily dose PPI.. In this multi-centre open label study patients who had received full daily dose PPI for 8 weeks, but were still experiencing persistent GORD symptoms, were treated with esomeprazole 40 mg for 8 weeks (n = 99). The primary outcome variable was the change in the frequency of heartburn. Patient-reported outcomes were also assessed using the Reflux Disease Questionnaire (RDQ) and the GORD Impact Scale (GIS).. The mean frequency of heartburn was reduced by 78% from 4.4 days a week to 1 day a week at the end of the 8-week treatment period (p < 0.0001). Other GORD symptoms were also significantly reduced following of treatment with esomeprazole (all p < 0.0001). All RDQ dimensions and the level of symptom control as measured by the GIS also showed significant improvement at 8 weeks.. In patients with persistent GORD symptoms despite full dose daily PPI therapy, esomeprazole 40 mg significantly improved the frequency and severity of all GORD symptoms.

Topics: Anti-Ulcer Agents; Chronic Disease; Esomeprazole; Female; Gastroesophageal Reflux; Heartburn; Humans; Male; Middle Aged; Proton Pump Inhibitors; Secondary Prevention; Treatment Outcome

AZD0865 is a gastric acid-suppressing agent that has a rapid onset of action and long duration of effect. This double-blind, randomized, multicenter study investigated the efficacy and safety of AZD0865 in the treatment of patients with nonerosive reflux disease (NERD).. Patients with troublesome heartburn for at least 6 months and no evidence of erosions at endoscopy were randomized to receive AZD0865 (25, 50, or 75 mg/day) or esomeprazole 20 mg/day, for 4 wk. Throughout the treatment period, patients reported the presence and intensity of heartburn and other NERD symptoms twice daily using an electronic diary. Twenty-four-hour ambulatory intraesophageal/intragastric pH monitoring was performed in a subset of patients on day 14.. A total of 1,469 patients were randomized. The median time to sustained absence of heartburn (for 7 consecutive days) was approximately 12 days for all treatment groups and did not differ significantly for any of the AZD0865 doses or compared with esomeprazole. There were no significant differences among treatment groups in the cumulative incidence of sustained absence of heartburn during 4 wk treatment (i.e., 65-70%). The percentage of time for which intragastric pH was greater than 4 was significantly greater for AZD0865 75 mg/day compared with esomeprazole 20 mg (75% vs 60%, P < 0.05). AZD0865 was generally well tolerated although reversible elevations of liver transaminases occurred in some patients receiving the agent.. AZD0865 did not provide clinical benefit over esomeprazole 20 mg in the management of patients with NERD.

Topics: Administration, Oral; Adolescent; Adult; Aged; Dose-Response Relationship, Drug; Double-Blind Method; Endoscopy, Gastrointestinal; Enzyme Inhibitors; Esomeprazole; Esophagus; Female; Follow-Up Studies; Gastric Acidity Determination; Gastroesophageal Reflux; Heartburn; Humans; Hydrogen-Ion Concentration; Imidazoles; Male; Middle Aged; Pyridines; Retrospective Studies; Severity of Illness Index; Surveys and Questionnaires; Treatment Outcome

The reflux disease questionnaire (RDQ) is a short, patient-completed instrument.. To investigate the psychometric characteristics of the RDQ in patients with heartburn-predominant (HB) and non-heartburn predominant (NHB) dyspepsia.. HB (n = 388) and NHB (n = 733) patients were randomized to esomeprazole 40 mg daily or twice daily for 1 week, followed by 3 weeks of esomeprazole 40 mg daily.. High factor loadings (0.78-0.86) supported the 'regurgitation' dimension of the RDQ. Overlapping factor loadings in the 'heartburn' and 'dyspepsia' dimensions suggested symptom overlap. All dimensions demonstrated high internal consistency (Cronbach's alpha: 0.79-0.90). Intra-class correlation coefficients over 4 weeks were good (0.66-0.85). The RDQ showed good responsiveness over 4 weeks of treatment, with high effect sizes (> or =0.80). Moderate or large symptom improvements were reported by 90% and 77% of HB and NHB patients, respectively, following treatment. Patients who responded to acid suppression also experienced symptom benefits in all RDQ dimensions.. The RDQ is reliable, valid and responsive to change in HB and NHB patients. The symptom overlap is important but need not play a major role in determining treatment strategy as both patient groups benefited from proton pump inhibitor treatment.

Topics: Adult; Anti-Ulcer Agents; Canada; Dyspepsia; Esomeprazole; Gastric Acid; Gastroesophageal Reflux; Heartburn; Humans; Male; Psychometrics; Surveys and Questionnaires

To evaluate the potential role of tegaserod in the management of functional dyspepsia (FD) and gastroesophageal reflux disease (GERD) in patients with chronic constipation and to determine the possible efficacy of tegaserod on solid-phase gastric emptying and gastric hypersensitivity.. This was an exploratory open-label trial of tegaserod therapy for dyspepsia and reflux symptoms in patients with chronic constipation. The study cohort consisted of 90 patients randomized to three treatment groups for a study period of 4 weeks (tegaserod 6 mg, twice daily; esomeprazole 40 mg, once daily; tegaserod 6 mg, twice daily plus esomeprazole 40 mg, once daily). Twenty healthy volunteers provided control values. Clinical symptoms were evaluated by one of the investigators using a Gastrointestinal Symptom Rating Scale (GSRS). Solid-phase gastric emptying and colonic transit were measured by the radiopaque barium marker method, and the water load test (WLT) was used to evaluate gastric sensation and the function of proximal stomach. The proportions of patients with complete relief of epigastric pain /discomfort, epigastric fullness, early satiety and heartburn in the tegaserod group and the tegaserod plus esomeprazole group were compared with the esomeprazole group, respectively.. The mean global gastrointestinal (GI) scores of all three treatment groups reported using the GSRS showed the same trend, with decreasing scores over the 4-week study period indicating a reported decreasing severity of symptoms that was significantly different from baseline values. Patients in the tegaserod plus esomeprazole group reported the lowest global GI scores after 4 weeks, as expected. Solid-phase gastric emptying (GER) and colonic transit (CTT) increased significantly in the tegaserod 6 mg twice daily group compared with baseline. These parameters did not change in the esomeprazole group at week 4 compared with baseline. In terms of gastric sensation, in the tegaserod group, the proportions of patients with hypersensitivity of the first perception threshold did not change at week 2 or week 4 compared with baseline; however, in this group and in the tegaserod plus esomeprazole group, the proportions of patients with hypersensitivity of discomfort threshold decreased significantly at week 4 compared with baseline. In the esomeprazole group, there were no changes in the proportions of patients with hypersensitivity of the first perception threshold and discomfort threshold at week 2 or 4 compared with baseline. No severe adverse events were recorded, and the medications were in general well-tolerated.. Tegaserod is effective and safe at improving dyspepsia and reflux symptoms in patients with chronic constipation, and tegaserod plus esomeprazole is superior to esomeprazole alone in the resolution of epigastric pain/discomfort and heartburn.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Analysis of Variance; Anti-Ulcer Agents; Chronic Disease; Cohort Studies; Constipation; Drug Therapy, Combination; Dyspepsia; Esomeprazole; Female; Gastric Emptying; Gastroesophageal Reflux; Gastrointestinal Transit; Heartburn; Humans; Indoles; Male; Middle Aged; Serotonin 5-HT4 Receptor Agonists; Treatment Outcome

We studied spontaneous gastroesophageal reflux (GER)-induced esophageal distension using ultrasound imaging and its role in the genesis of esophageal symptoms before and during esomeprazole therapy. Ten controls and 10 GER disease (GERD) patients were studied by combined impedance, esophageal pH, manometry, and ultrasonography before and during esomeprazole therapy. Physiological data and symptoms were recorded for 2 h following a standardized meal. From ultrasound images, the esophageal cross-sectional area (CSA) at the peak of GER-induced distension was determined and compared between controls vs. patients, symptomatic vs. asymptomatic GER episodes, and before vs. during esomeprazole in GERD patients. The mean lumen CSA is greater in the patients than controls (271 +/- 71 mm(2) vs. 163 +/- 56 mm(2), P = 0.001) but not different among asymptomatic reflux episodes, and those associated with regurgitation (290 +/- 110 mm(2)) or heartburn (271 +/- 67 mm(2)). Eight chest pain episodes associated with reflux revealed a tendency toward larger mean esophageal distension (459 +/- 40 mm(2)) compared with asymptomatic reflux (268 +/- 70 mm(2), P = 0.058). Following esomeprazole treatment, most GER episodes were nonacidic and asymptomatic except in two patients in whom cyclical reflux was associated with large esophageal distensions. Esomeprazole did not alter the lumen CSA during GER. Esophageal distension is greater in the GERD subjects compared with controls; however, it is unlikely that the GER-induced distension of the esophagus plays a significant role in the genesis of heartburn sensation. Esomeprazole therapy does not alter the GER-induced distension of the esophagus.

Topics: Adult; Anti-Ulcer Agents; Case-Control Studies; Dilatation, Pathologic; Electric Impedance; Endosonography; Enzyme Inhibitors; Esomeprazole; Esophageal pH Monitoring; Esophagus; Female; Gastroesophageal Reflux; H(+)-K(+)-Exchanging ATPase; Heartburn; Humans; Hydrogen-Ion Concentration; Male; Manometry; Middle Aged; Pressure; Proton Pump Inhibitors; Treatment Outcome

While empiric acid-suppressive therapy for uninvestigated dyspepsia patients with symptoms of epigastric pain or burning is standard practice, it is unknown whether an early response to therapy predicts outcome.. To evaluate whether a 1-w acid suppression trial is effective for predicting 8-w response in such patients.. Helicobacter pylori-negative patients (aged 18-50 years) in primary care with uninvestigated epigastric pain or burning were randomized to esomeprazole 40 mg q.d.s. or b.d. for 1w, followed by esomeprazole 40 mg q.d.s. or placebo for 7w. Each day, patients rated the severity of their symptoms.. Based on the last 3d, 1-w response rates were 39% (231 of 588) and 43% (258 of 596) with esomeprazole 40 mg q.d.s. and b.d., respectively. Based on the last 7d, response rates at 4w were 38% (283 of 738) and 25% (93 of 380) for esomeprazole and placebo, respectively, and 47% (339 of 716) and 34% (124 of 368), respectively, at 8w (both P < 0.001 vs. placebo). The sensitivity and specificity of esomeprazole treatment were 58% and 70%, respectively, at 8w.. A 1-w acid suppression trial is of limited clinical value for predicting 8-w response in patients with symptoms of epigastric pain or burning. Esomeprazole provides greater symptom control than placebo at 4w and 8w.

Topics: Administration, Oral; Adolescent; Adult; Anti-Ulcer Agents; Dose-Response Relationship, Drug; Dyspepsia; Esomeprazole; Female; Heartburn; Humans; Male; Middle Aged; Placebos; Quality of Life; Treatment Outcome

Early identification of true responders to acid suppression in functional dyspepsia patients with symptoms of epigastric pain or burning may enable clinicians to optimally tailor treatment.. To evaluate whether a 1-w acid suppression trial is useful for identifying true responders in this population.. Patients (18-70 years) were randomized to either esomeprazole 40 mg q.d.s., b.d. or placebo for 1w, and then esomeprazole 40 mg q.d.s. or placebo for 7w. Epigastric pain and/or burning were recorded on a 4-point scale (0 = none, 3 = severe). Trial-week response was defined as symptom score sum < or = 1 on last 3d of therapy; response at 8w was symptom score sum < or = 1 over preceding 7d.. 1-w response rates were 33% (199 of 597), 29% (188 of 629) and 23% (71 of 315) with esomeprazole q.d.s., esomeprazole b.d. and placebo, respectively (P = 0.002 for esomeprazole groups vs. placebo). At 8w, trial week sensitivity and specificity were 46% and 80%, respectively, for esomeprazole (40 or 80 mg), and 33% and 87%, respectively, for placebo. The positive and negative predictive values for esomeprazole were 60% and 69%.. Response to a 1-w acid suppression trial is of limited use for predicting symptom response at 8w in patients with unexplained epigastric pain or burning.

Topics: Adolescent; Adult; Aged; Anti-Ulcer Agents; Dose-Response Relationship, Drug; Dyspepsia; Esomeprazole; Female; Follow-Up Studies; Gastroesophageal Reflux; Heartburn; Humans; Male; Middle Aged; Placebos; Quality of Life; Sensitivity and Specificity; Treatment Outcome

The primary objective was to assess the safety of esomeprazole 20 or 40 mg once daily in adolescents with clinically diagnosed gastroesophageal reflux disease (GERD). A secondary aim was to assess changes in GERD symptoms after esomeprazole therapy.. In this multicenter, randomized, double-blind study, adolescents ages 12 to 17 years inclusive received esomeprazole 20 or 40 mg once daily for 8 weeks. Adverse events and changes in clinical parameters (eg, physical examination, laboratory measurements) were evaluated to assess safety. Patients or their parents or guardians scored symptom severity daily, and investigators scored overall GERD symptom severity every 2 weeks using a 4-point scale.. In the 148 adolescents with safety data, treatment-related and non-treatment-related adverse events were reported by 75% and 78% of patients in the esomeprazole 20- and 40-mg groups, respectively. Twenty-two patients (14.9%) experienced adverse events that were considered related to treatment; the most common were headache (8%, 12/148), abdominal pain (3%, 4/148), nausea (2%, 3/148), and diarrhea (2%, 3/148). No serious adverse events or clinically important findings in other safety assessments were observed. At baseline, 68% (100/147) had heartburn, 63% (93/147) had epigastric pain, 57% (84/147) had acid regurgitation, and 15% (22/147) had vomiting symptoms. Symptom scores decreased significantly in both the esomeprazole 20-mg and 40-mg groups by the final study week (P < 0.0001). Investigators rated 63.1% (94/149) of the patients as having moderate or severe symptoms at baseline; at the final visit, this percentage decreased significantly to 9.3% (13/140; P < .0001).. In adolescent patients with GERD, esomeprazole 20 or 40 mg daily for 8 weeks was well tolerated, and GERD-related symptoms were significantly reduced from baseline values in both groups.

Topics: Abdominal Pain; Adolescent; Anti-Ulcer Agents; Child; Diarrhea; Dose-Response Relationship, Drug; Double-Blind Method; Esomeprazole; Female; Gastroesophageal Reflux; Headache; Heartburn; Humans; Male; Nausea; Severity of Illness Index; Treatment Outcome; Vomiting

Common treatment practices in patients who continue to be symptomatic on proton pump inhibitor once-daily treatment include either increasing the dosage or the use of supplemental medication. This trial's purpose was to compare 2 therapeutic strategies, increasing the proton pump inhibitor dosage to twice daily versus switching to another proton pump inhibitor, in patients with persistent heartburn while receiving standard-dose proton pump inhibitor therapy.. This multicenter, randomized, double-blind, double-dummy trial included patients with persistent heartburn symptoms while receiving therapy with lansoprazole 30 mg once daily. Patients were randomly assigned to treatment for 8 weeks with either single-dose esomeprazole (40 mg once daily) (n = 138) or lansoprazole 30 mg twice daily (n = 144). The primary efficacy variable was the percentage of heartburn-free days from day 8 to the end of treatment.. Single-dose esomeprazole was at least as effective as twice-daily lansoprazole for the primary end point of percentage of heartburn-free days during the study period (54.4% and 57.5%, respectively). Symptom scores improved from baseline in similar numbers of patients for heartburn (83.3% of patients in each group), acid regurgitation (76.8% vs 72.9%, P = .58), and epigastric pain (67.4% vs 61.1%, P = .32), and rescue antacid use was also similar (0.4 tablets/day vs 0.5 tablets/day, P = .50).. Switching patients with persistent heartburn on a standard-dose proton pump inhibitor to a different proton pump inhibitor was as effective as increasing the proton pump inhibitor dosage to twice daily for controlling heartburn symptoms.

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

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

To assess the efficacy of the 8-week therapy with esomeprazole 40 mg vs. pantoprazole 40 mg for healing erosive oesophagitis (EE) as part of a management study.. Patients had a history of gastro-oesophageal reflux disease symptoms (> or =6 months) and had suffered heartburn on at least 4 of the 7 days preceding enrollment. Endoscopies were performed to grade EE severity using the Los Angeles (LA) classification system at baseline, 4 and 8 weeks (if unhealed at 4 weeks). Heartburn severity was recorded by patients on diary cards. The primary end point was healing of EE by week 8 of treatment.. Of 3170 patients randomized, the intent-to-treat population consisted of 3151 patients (63% male, mean age: 50.6 years, 27% Helicobacter pylori-positive). Esomeprazole 40 mg healed a significantly greater proportion of EE patients than pantoprazole 40 mg at both 4 weeks (life table estimates: esomeprazole 81%, pantoprazole 75%, P < 0.001) and 8 weeks (life table estimates: esomeprazole 96%, pantoprazole 92%, P < 0.001). The median time to reach sustained heartburn resolution was 6 days in patients receiving esomeprazole and 8 days with pantoprazole (P < 0.001).. Esomeprazole 40 mg is more effective than pantoprazole 40 mg for healing EE and providing resolution of associated heartburn.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adult; Anti-Ulcer Agents; Benzimidazoles; Double-Blind Method; Esomeprazole; Esophagitis; Female; Gastroesophageal Reflux; Heartburn; Humans; Male; Middle Aged; Pantoprazole; Sulfoxides; Treatment Outcome

The real-life clinical setting has been known to provide, sometimes, results different from controlled study outcomes. IPEP (InPractice Evaluation Program) was designed to evaluate the efficacy of esomeprazole in providing symptom relief in patients with reflux disease who present to primary care physicians for heartburn and symptoms that are poorly controlled by other drugs, thus testing the efficacy of the drug in day-to-day practice.. 119 primary care physicians and 22 internal medicine specialists, widely distributed geographically, participated in the program. The frequency and severity of three symptoms (heartburn, acid regurgitation and upper abdominal pain) were assessed before and at the end of one month treatment with esomeprazole 40 mg once daily.. Follow-up data from 747 patients enrolled in IPEP was available to evaluate the efficacy of the intervention. Over 80% of the enrolled patients reported a decrease in the frequency of symptoms to less than one episode per week for all the three major symptoms (heartburn, acid regurgitation and upper abdominal pain). Regarding the severity of symptoms, 50-60% of the patients reported total relief, while 30-40% reported persistence of symptoms, but admitted them to be milder and with lower frequency. At the end of treatment, no patient reported severe or extremely severe symptoms.. The results of this routine clinical practice program are consistent with data reported in controlled trials indicating the efficacy of esomeprazole even in patients with upper gastrointestinal symptoms "refractory" to treatments prescribed by primary care practitioners.

Topics: Administration, Oral; Adult; Enzyme Inhibitors; Esomeprazole; Gastroesophageal Reflux; Heartburn; Humans; Male; Middle Aged; Primary Health Care; Severity of Illness Index; Treatment Outcome

Upper gastrointestinal (GI) symptoms are common in patients using non-steroidal antiinflammatory drugs (NSAIDs) including selective cyclooxygenase (COX)-2 inhibitors and may be acid related. We therefore assessed esomeprazole treatment for upper GI symptoms in these patients.. A total of 794 and 848 continuous NSAID users, free of gastroduodenal ulcers, erosive esophagitis, and Helicobacter pylori, were enrolled into two identical, multinational, multicenter double-blind studies (NASA1, SPACE1). Moreover, 608 and 556 patients were randomized to receive 4 wk esomeprazole 20 mg, or 40 mg, or placebo once daily. The primary variable was the patient-reported change in the upper GI symptom (pain, discomfort, or burning in the upper abdomen) score on a 7-graded severity scale (0-6) from the 7 days prior to treatment to the last 7 days in the study.. Esomeprazole was associated with highly significant symptom improvement compared to placebo. Symptom improvements were 2.30 mean [SD 1.63] on esomeprazole 20 mg and 2.03 [1.56] on esomeprazole 40 mg versus 1.64 [1.57] on placebo in NASA1 and 2.17 [1.34] and 2.12 [1.48]versus 1.56 [1.26], respectively, in SPACE1 (all placebo comparisons at least p < 0.001). Esomeprazole-improved symptoms in patients taking selective COX-2 inhibitors, with changes of 2.21 [1.46] and 1.92 [1.38]versus 1.64 [1.46] in NASA1 and 2.20 [1.26] and 2.24 [1.62]versus 1.58 [1.37] in SPACE1 (all placebo comparisons at least p < 0.05), as well as those on non-selective NSAIDs. Esomeprazole was well tolerated and associated with significant improvements in HRQL.. Esomeprazole 20 mg and 40 mg improve upper GI symptoms associated with continuous, daily NSAID therapy, including selective COX-2 inhibitors.

Topics: Aged; Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer Agents; Cyclooxygenase 2; Cyclooxygenase 2 Inhibitors; Cyclooxygenase Inhibitors; Double-Blind Method; Esomeprazole; Female; Follow-Up Studies; Gastroesophageal Reflux; Heartburn; Humans; Isoenzymes; Male; Membrane Proteins; Middle Aged; Nausea; Pain; Peroxidases; Placebos; Prostaglandin-Endoperoxide Synthases; Quality of Life; Treatment Outcome; Upper Gastrointestinal Tract

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

Sleep disturbances are common in patients with gastroesophageal reflux disease (GERD). This study examined the effects of esomeprazole on nighttime heartburn, GERD-related sleep disturbances, sleep quality, work productivity, and regular activities.. This multicenter, randomized, double-blind, placebo-controlled trial included adults with GERD-associated sleep disturbances and moderate-to-severe nighttime heartburn (recorded by patient diary during screening). Patients received oral esomeprazole 40 mg (n = 220) or 20 mg (n = 226) or placebo (n = 229) once daily for 4 wk. The primary outcome was relief of nighttime heartburn. Secondary outcomes included resolution of sleep disturbances, sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire, and work productivity measured by the Work Productivity and Activity Impairment Questionnaire.. Nighttime heartburn was relieved in 53.1% (111/209), 50.5% (111/220), and 12.7% (28/221) of patients who received esomeprazole 40 mg, esomeprazole 20 mg, and placebo, respectively. Differences (95% CI) versus placebo were 40.5% (32.4%, 48.5%) and 37.8% (29.9%, 45.7%) and were highly significant (p < 0.0001). GERD-related sleep disturbances resolved in significantly more (p < 0.0001) patients who received esomeprazole 40 (73.7%) or 20 mg (73.2%) than in those who received placebo (41.2%). Both esomeprazole groups had greater PSQI global score changes from baseline (p < 0.0001 vs placebo) and more (p < 0.0001 vs placebo) work hours saved per week per patient compared with baseline (esomeprazole 40 mg, 11.6 h; esomeprazole 20 mg, 12.3 h; placebo, 6.2 h).. Esomeprazole reduced nighttime heartburn and GERD-related sleep disturbances and improved sleep quality and work productivity.

Topics: Administration, Oral; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Ulcer Agents; Double-Blind Method; Efficiency; Esomeprazole; Female; Gastroesophageal Reflux; Heartburn; Humans; Male; Middle Aged; Sleep; Surveys and Questionnaires; 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

To assess symptom relief in patients with heartburn following treatment with esomeprazole 40 mg daily.. Patients with heartburn (for > or = 6 months) were assessed in this double-blind, multicenter study. After a 3-day single-blind placebo run-in, 440 patients were randomized to esomeprazole 40 mg o.d., esomeprazole 20 mg b.i.d. or placebo for 14 days. Heartburn symptoms were recorded daily; as insufficient patients had data available from days 13 and 14, analyses included data up to day 12. Gastroesophageal reflux disease (GERD) was diagnosed by upper GI endoscopy and 24-h pH-monitoring. The primary end-point was total heartburn relief defined as no heartburn symptoms during the preceding 24-h period.. 240 patients had erosive esophagitis (EO) and 114 patients had GERD defined by pH-monitoring. Proportions of patients with total heartburn relief increased during the first days of treatment and stabilized after Day 4. Total heartburn relief occurred in 67%-73%, 62%-70%, and 21%-32% of patients in the esomeprazole 40 mg o.d., esomeprazole 20 mg b.i.d., and placebo groups, respectively, between days 6 and 12. Proportions of patients with total heartburn relief were higher in patients with EO (71%-80% of patients from Day 4 onwards) compared to those without EO (52%-67% of patients from Day 4 onwards). Figures for patients diagnosed by pH-monitoring were 65%-73% of those with a positive diagnosis and 51%-58% with a negative diagnosis.. Esomeprazole 40 mg o.d. treatment produces total heartburn relief in a high proportion of patients with GERD. Once-daily esomeprazole 40 mg dosing is recommended as no advantage was gained by splitting the dose.

Topics: Adult; Aged; Anti-Ulcer Agents; Double-Blind Method; Endoscopy, Gastrointestinal; Esomeprazole; Female; Gastric Acidity Determination; Gastroesophageal Reflux; Heartburn; Humans; Hydrogen-Ion Concentration; Male; Middle Aged; Prospective Studies; Treatment Outcome

Patients with chronic heartburn but with no endoscopic evidence of erosive oesophagitis require gastric acid suppression to relieve symptoms.. To assess the efficacy and safety of esomeprazole in patients with frequent heartburn for >or = 6 months and no evidence of erosive oesophagitis on endoscopy.. Two randomized, double-blind, 4-week, multi-centre trials with identical methodology compared once-daily esomeprazole, 40 mg (n = 241) or 20 mg (n = 234), with placebo (n = 242) for the rigorous end-point of complete resolution of heartburn. Secondary end-points included the percentage of heartburn-free days and the time to first and sustained resolution of heartburn.. Patients treated with either dose of esomeprazole were two to three times more likely to achieve complete resolution of heartburn than patients treated with placebo (P < 0.001). The percentage of heartburn-free days was significantly higher with esomeprazole 40 mg (63%, 66%) or 20 mg (63%, 68%) than with placebo (46%, 36%; P < or = 0.001) in each of the two studies. Esomeprazole was associated with a significantly shorter mean time to first (6-7 days) and sustained (12-17 days) resolution of heartburn compared with placebo (first, 10-12 days; sustained, 21-22 days; P < or = 0.008). The spectrum and frequency of adverse events with esomeprazole were similar to those with placebo.. Esomeprazole, at daily doses of 40 mg or 20 mg, is effective and safe for the treatment of chronic heartburn in patients without erosive oesophagitis.

Topics: Adult; Aged; Anti-Ulcer Agents; Chronic Disease; Double-Blind Method; Esomeprazole; Esophagitis; Female; Heartburn; Humans; Male; Middle Aged; 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

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

A 68-year-old man with no symptoms presented to Hokkaido University Hospital for esophagogastroduodenoscopy screening. He had a history of Helicobacter pylori eradication. Initial esophagogastroduodenoscopy showed no gastric cobblestone-like mucosa or gastric cracked mucosa. After 1 year, he received esomeprazole (20 mg) once daily for heartburn at another hospital. Esophagogastroduodenoscopy was performed after 2 years of esomeprazole administration. Endoscopic findings showed that after H. pylori eradication, according to the Kyoto classification, gastric cobblestone-like mucosa presented in the gastric body area. Dilation of the oval crypt opening and intervening part in the gastric cobblestone-like mucosa was detected by endoscopy with narrow band imaging. Endoscopic ultrasonography revealed a thick gastric second layer and sporadic small a-echoic lesions in the low-echoic thickened second layer in the gastric cobblestone-like mucosa. The gastric cobblestone-like mucosa biopsy specimen showed parietal cell protrusions and oxyntic gland dilatations. Recently, we reported that gastric mucosal changes such as gastric cracked mucosa and gastric cobblestone-like mucosa were caused by proton-pump inhibitors; however, the gastric cobblestone-like mucosa was not examined by endoscopic ultrasonography. In this case, endoscopic ultrasonography findings suggested that oxyntic gland dilatations caused the elevated gastric mucosa, such as gastric cobblestone-like mucosa, from the use of proton-pump inhibitors.

Topics: Aged; Endosonography; Esomeprazole; Gastric Mucosa; Heartburn; Humans; Male; Proton Pump Inhibitors

Up to half of gastroesophageal reflux disease (GERD) patients report having heartburn that awakens them from sleep during the night. Recumbent-awake and conscious awakenings from sleep during the night are commonly associated with acid reflux events. The aim of the study was to assess the effect of esomeprazole 40 mg once daily on nighttime acid reflux, frequency of conscious awakenings associated with acid reflux and the recumbent-awake period.. Patients with heartburn and/or regurgitation at least three times a week were eligible for this study. All patients underwent upper endoscopy and were evaluated by demographic, Epworth Sleepiness scale, Berlin and GERD symptom checklist questionnaires. Subjects then underwent esophageal pH testing concomitantly with an actigraphy. All subjects were given esomeprazole 40 mg once daily for 7 days and completed a daily symptom record diary. On day 7, subjects repeated the pH test with actigraphy.. Twenty patients (mean age of 48.95 ± 18.69, age range 20-81 years) were enrolled. Esophageal acid exposure parameters, during recumbent-awake, recumbent-asleep, and conscious awakenings were significantly improved on last day of treatment as compared to baseline (p < 0.05). However, the frequency and duration of conscious awakenings and duration of recumbent-awake period did not improve as compared to baseline (p > 0.05).. While esomeprazole significantly reduced esophageal acid exposure during conscious awakenings and recumbent-awake and asleep periods, it did not decrease the number and duration of conscious awakening or duration of recumbent-awake period.

Topics: Adult; Aged; Aged, 80 and over; Esomeprazole; Esophageal pH Monitoring; Female; Gastroesophageal Reflux; Heartburn; Humans; Male; Middle Aged; Proton Pump Inhibitors; Sleep Initiation and Maintenance Disorders; Young Adult

Topics: Esomeprazole; Gastroesophageal Reflux; Heartburn; Humans; Proton Pump Inhibitors; Severity of Illness Index

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

Recently, it has been suggested that low esophageal basal impedance may reflect impaired mucosal integrity and increased acid sensitivity. We aimed to compare baseline impedance levels in patients with heartburn and pathophysiological characteristics related to functional heartburn (FH) divided into two groups on the basis of symptom relief after proton pump inhibitors (PPIs).. Patients with heartburn and negative endoscopy were treated with esomeprazole or pantoprazole 40 mg daily for 8 weeks. According to MII-pH (off therapy) analysis, patients with normal acid exposure time (AET), normal reflux number, and lack of association between symptoms and refluxes were selected; of whom 30 patients with a symptom relief higher than 50% after PPIs composed Group A, and 30 patients, matched for sex and age, without symptom relief composed Group B. A group of 20 healthy volunteers (HVs) was enrolled. For each patient and HV, we evaluated the baseline impedance levels at channel 3, during the overnight rest, at three different times.. Group A (vs Group B) showed an increase in the following parameters: mean AET (1.4 ± 0.8% vs 0.5 ± 0.6%), mean reflux number (30.4 ± 8.7 vs 24 ± 6.9), proximal reflux number (11.1 ± 5.2 vs 8.2 ± 3.6), acid reflux number (17.9 ± 6.1 vs 10.7 ± 6.9). Baseline impedance levels were lower in Group A than in Group B and in HVs (p < 0.001).. Evaluating baseline impedance levels in patients with heartburn and normal AET could achieve a better understanding of pathophysiology in reflux disease patients, and could improve the distinction between FH and hypersensitive esophagus.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Electric Impedance; Esomeprazole; Esophageal pH Monitoring; Esophagus; Female; Gastroesophageal Reflux; Heartburn; Humans; Male; Middle Aged; Pantoprazole; Proton Pump Inhibitors

Although most patients with gastroesophageal reflux disease (GERD) achieve substantial symptom relief with acid suppression, many have some residual symptoms. We evaluated the responsiveness of regurgitation, characterized by the reflux disease questionnaire (RDQ) to potent acid suppression.. We analyzed data from 2 randomized controlled trials of AZD0865 (a potassium-competitive acid blocker) 25-75 mg/day vs esomeprazole 20-40 mg/day for the treatment of nonerosive reflux disease (NERD, n = 1460) or reflux esophagitis (RE, n = 1514). Inclusion criteria for both studies were high-severity substernal burning (≥4 days per week of at least moderate intensity) during the week before enrollment. Pooled data from all treatment arms were used to ascertain the response of the reflux disease questionnaire regurgitation items to potent acid suppression during the fourth week of treatment.. When the study began, 93% of patients with NERD or RE had either "acid taste in the mouth" (regurgitation-taste) or "unpleasant movement of material upwards from the stomach" (regurgitation-movement). Either or both symptoms were present and severe in 53% of NERD (n = 717) and 54% of RE patients (n = 751) for the main study outcome. During week 4 of therapy, patients with severe "regurgitation-taste" and "regurgitation-movement" responded significantly less well than patients with NERD and high severity "substernal burning" (34% and 26% vs 49%) or those with RE (44% and 33% vs 55%). There were no differences in symptom response between patients with healed and nonhealed RE.. Regurgitation was less responsive to acid suppression than heartburn in patients with gastroesophageal reflux disease, indicating that persistent regurgitation is a common cause of incomplete treatment response.

Topics: Anti-Ulcer Agents; Esomeprazole; Gastroesophageal Reflux; Heartburn; Humans; Imidazoles; Laryngopharyngeal Reflux; Pyridines; Randomized Controlled Trials as Topic; Treatment Outcome

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

Symptom diaries are potentially attractive but, because of concerns about patient compliance, they have had limited use in clinical trials. We assessed the validity and responsiveness of a symptom diary for patients with gastro-oesophageal reflux disease.. We included 215 patients with gastro-oesophageal reflux disease after starting treatment for 4 weeks with 40 mg esomeprazole once daily. Patients recorded whether they experienced night-time heartburn (yes/no), the severity of daytime heartburn on a scale from 1 (no heartburn) to 4 (severe heartburn) and their antacid use. Patients also completed a number of disease-specific and preference-based Health-related Quality of Life questionnaires at baseline and follow-up.. Consistent with a priori predictions, daytime heartburn showed moderate to strong correlations with the Quality of Life in Reflux and Dyspepsia questionnaire (0.36-0.67) and four scales of symptom severity (0.36-0.70) for baseline, follow-up and change scores, but low correlations with the Standard Gamble. Responsiveness of the daytime heartburn item was excellent with a mean change from baseline to follow-up of -1.3 (95% CI -1.4 to -1.1) and a standardized response mean of 1.33 while responsiveness of the daily antacid use item was moderate (mean change scores -1.8 tablets taken, 95% CI -2.3 to -1.3 and standardized response mean of 0.64).. The excellent psychometric properties of this simple gastro-oesophageal reflux disease diary make it an attractive measure for future trials.

Topics: Antacids; Anti-Ulcer Agents; Cross-Sectional Studies; Esomeprazole; Female; Gastroesophageal Reflux; Heartburn; Humans; Longitudinal Studies; Male; Medical Records; Middle Aged; Quality of Life; Severity of Illness Index; Treatment Outcome

The correlation between treatment satisfaction and demographic characteristics, symptoms, or health-related quality of life (HRQL) in patients with gastroesophageal reflux disease (GERD) is unknown. The objective of this study was to assess correlates of treatment satisfaction in patients with GERD receiving a proton pump inhibitor, esomeprazole.. Adult GERD patients (n = 217) completed demography, symptom, HRQL, and treatment satisfaction questionnaires at baseline and/or after treatment with esomeprazole 40 mg once daily for 4 weeks. We used multiple linear regressions with treatment satisfaction as the dependent variable and demographic characteristics, baseline symptoms, baseline HRQL, and change scores in HRQL as independent variables.. Among the demographic variables only Caucasian ethnicity was positively associated with treatment satisfaction. Greater vitality assessed by the Quality of Life in Reflux and Dyspepsia (QOLRAD) and worse heartburn assessed by a four-symptom scale at baseline, were associated with greater treatment satisfaction. The greater the improvement on the QOLRAD vitality (change score), the more likely the patient is to be satisfied with the treatment.. Ethnicity, baseline vitality, baseline heartburn severity, and change in QOLRAD vitality correlate with treatment satisfaction in patients with GERD.

Topics: Adult; Aged; Aged, 80 and over; Canada; Demography; Enzyme Inhibitors; Esomeprazole; Female; Gastroesophageal Reflux; Heartburn; Humans; Linear Models; Male; Middle Aged; Patient Satisfaction; Quality of Life; Surveys and Questionnaires; Treatment Outcome

Adequacy of acid suppression is a critical factor influencing healing in gastro-oesophageal reflux disease (GORD). The European prospective study ProGORD was set up to determine the endoscopic and symptomatic progression of GORD over five years under routine care, after initial acid suppression with esomeprazole. We report on factors influencing endoscopic healing and symptom resolution during the acute treatment phase.. Patients with symptoms suggestive of GORD underwent endoscopy and biopsies were obtained from the oesophagus for diagnosis of abnormalities, including Barrett's oesophagus (BO). Data from 6215 patients were included in the "intention to treat" analysis, 3245 diagnosed as having erosive reflux disease (ERD) and 2970 non-erosive reflux disease (NERD). ERD patients were treated with esomeprazole 40 mg for 4-8 weeks for endoscopic healing while NERD patients received 20 mg for 2-4 weeks for resolution of heartburn symptoms.. Endoscopic healing occurred overall in 87.7% of ERD patients although healing was significantly lower in those with more severe oesophagitis (76.9%) and in those with BO (72.4%), particularly in Helicobacter pylori negative BO patients (70.1%). Age, sex, and body mass index appeared to have no significant impact on healing. Complete heartburn resolution was reported by 70.4% of ERD patients and by 64.8% of NERD patients at the last visit. Only H pylori infection had a significant influence on complete heartburn resolution in the NERD group (68.1% and 63.7% for H pylori positive and H pylori negative, respectively; p = 0.03).. The presence of Barrett's mucosa, as well as severe mucosal damage, exerts a negative impact on healing. H pylori infection had a positive influence on healing in ERD patients with coexistent BO but no influence on those without BO.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Antacids; Anti-Ulcer Agents; Barrett Esophagus; Biopsy; Cohort Studies; Endoscopy, Gastrointestinal; Esomeprazole; Esophagitis; Female; Gastroesophageal Reflux; Heartburn; Helicobacter Infections; Helicobacter pylori; Humans; Male; Middle Aged; Prognosis; Prospective Studies; Treatment Outcome