s-1743 and Esophagitis

Proton pump inhibitors (PPIs) are widely used for the treatment of acid-related diseases such as gastroesophageal reflux disease (GERD). They are recommended by the American College of Gastroenterology for healing erosive esophagitis (EO) and as long-term treatment in patients with healed EO. The available PPIs differ somewhat in their pharmacokinetics and clinical properties, but whether these differences are of clinical relevance is a matter of debate. Some safety concerns have been raised with the use of PPIs, mostly an increased incidence of infectious diseases such as community-acquired pneumonia or Clostridium difficile diarrhea.. This article explores the results of clinical studies on the pharmacokinetics and pharmacodynamics of esomeprazole , as well as on its clinical efficacy to manage patients with GERD.. GERD is a public health concern as its worldwide incidence and associated complications are increasing alongside the exponentially increasing problem of obesity. PPIs are the first pharmacological option because of their efficacy and overall positive risk-to-benefit ratio. Improved efficacy with the use of stereospecific isomers of PPIs, such as esomeprazole, has not yet been convincingly demonstrated. Nevertheless, because of individual experience with former treatment, some patients may report better symptom control when treated with a specific PPI rather than with others.

Topics: Esomeprazole; Esophagitis; Gastroesophageal Reflux; Humans; Incidence; Proton Pump Inhibitors; Stereoisomerism

The results of clinical trials with proton pump inhibitors (PPIs) are usually based on the Hetzel-Dent (HD), Savary-Miller (SM), or Los Angeles (LA) classifications to describe the severity and assess the healing of erosive oesophagitis. However, it is not known whether these classifications are comparable. The aim of this study was to review systematically the literature to compare the healing rates of erosive oesophagitis with PPIs in clinical trials assessed by the HD, SM, or LA classifications.. A recursive, English language literature search in PubMed and Cochrane databases to December 2006 was performed. Double-blind randomized control trials comparing a PPI with another PPI, an H2-RA or placebo using endoscopic assessment of the healing of oesophagitis by the HD, SM or LA, or their modified classifications at 4 or 8 weeks, were included in the study. The healing rates on treatment with the same PPI(s), and same endoscopic grade(s) were pooled and compared between different classifications using Fisher's exact test or chi2 test where appropriate.. Forty-seven studies from 965 potential citations met inclusion criteria. Seventy-eight PPI arms were identified, with 27 using HD, 29 using SM, and 22 using LA for five marketed PPIs. There was insufficient data for rabeprazole and esomeprazole (week 4 only) to compare because they were evaluated by only one classification. When data from all PPIs were pooled, regardless of baseline oesophagitis grades, the LA healing rate was significantly higher than SM and HD at both 4 and 8 weeks (74, 71, and 68% at 4 weeks and 89, 84, and 83% at 8 weeks, respectively). The distribution of different grades in study population was available only for pantoprazole where it was not significantly different between LA and SM subgroups. When analyzing data for PPI and dose, the LA classification showed a higher healing rate for omeprazole 20 mg/day and pantoprazole 40 mg/day (significant at 8 weeks), whereas healing by SM classification was significantly higher for omeprazole 40 mg/day (no data for LA) and lansoprazole 30 mg/day at 4 and 8 weeks. The healing rate by individual oesophagitis grade was not always available or robust enough for meaningful analysis. However, a difference between classifications remained.. There is a significant, but not always consistent, difference in oesophagitis healing rates with the same PPI(s) reported by the LA, SM, or HD classifications. The possible difference between grading classifications should be considered when interpreting or comparing healing rates for oesophagitis from different studies.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Databases, Factual; Endoscopy, Gastrointestinal; Esomeprazole; Esophagitis; Humans; Lansoprazole; Omeprazole; Pantoprazole; Proton Pump Inhibitors; Rabeprazole; Randomized Controlled Trials as Topic; Registries; Wound Healing

No randomized controlled trial (RCT) has compared all European-licensed standard- and double-dose PPIs for the healing of severe erosive oesophagitis.. To compare the effectiveness of licensed doses of PPIs for healing severe erosive oesophagitis (i.e. esomeprazole 40 mg, lansoprazole 30 mg, omeprazole 20 mg and 40 mg, pantoprazole 40 mg and rabeprazole 20 mg).. Systematic review of CENTRAL, EMBASE and MEDLINE for RCTs in patients with erosive oesophagitis (completed October 2008). Endoscopically verified healing rates at 4 and 8 weeks were extracted and re-calculated if not analysed by intention-to-treat. A mixed treatment comparison was used to combine direct treatment comparisons with indirect trial evidence while maintaining randomization. Odds ratios (OR) are reported compared to omeprazole 20 mg.. A total of 3021 papers were identified in the literature search; 12 were of sufficient quality to be included in the analysis. Insufficient data were available to included rabeprazole. Esomeprazole 40 mg was found to provide significantly higher healing rates at 4 weeks [OR 1.84, 95% Credible Interval (95% CrI): 1.50 to 2.22] and 8 weeks (OR 1.91, 95% CrI: 1.13 to 2.88). No other PPI investigated had significantly higher healing rates than omeprazole 20 mg.. Esomeprazole 40 mg consistently demonstrates higher healing rates compared with licensed standard- and double-dose PPIs.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Anti-Ulcer Agents; Dose-Response Relationship, Drug; Esomeprazole; Esophagitis; Humans; Lansoprazole; Omeprazole; Proton Pump Inhibitors; Rabeprazole; Randomized Controlled Trials as Topic; Treatment Outcome

To compare the efficacy of esomeprazole, 20 mg once daily, vs. lansoprazole, 15 mg once daily, for the maintenance treatment of patients with healed reflux oesophagitis.. During the initial open healing phase, 1391 patients with endoscopically verified reflux oesophagitis and a history of heartburn, with or without acid regurgitation, received esomeprazole 40 mg for 4-8 weeks. Patients who were healed (identified by endoscopy at 4 or 8 weeks) and symptom free were then randomized to receive 6 months of treatment with esomeprazole, 20 mg once daily, or lansoprazole, 15 mg once daily.. Esomeprazole, 20 mg once daily, maintained a significantly higher proportion of patients in remission than lansoprazole, 15 mg once daily, over 6 months [83% (95% CI, 80-86%) of esomeprazole recipients compared with 74% (95% CI, 70-78%) of lansoprazole recipients; P < 0.0001; life table estimates]. When data were analysed according to baseline Los Angeles grade classification, esomeprazole, 20 mg once daily, achieved consistently higher remission rates across all grades of disease severity, whereas the efficacy of lansoprazole decreased to a greater extent with increasing severity of reflux oesophagitis.. Esomeprazole, 20 mg once daily, is more effective than lansoprazole, 15 mg once daily, in maintaining remission in patients with healed reflux oesophagitis.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adult; Aged; Anti-Ulcer Agents; Dose-Response Relationship, Drug; Double-Blind Method; Esomeprazole; Esophagitis; Female; Gastroesophageal Reflux; Humans; Lansoprazole; Male; Middle Aged; Proton Pump Inhibitors; Recurrence; Survival Analysis; Treatment Outcome

The primary therapeutic endpoint for patients with gastroesophageal reflux disease is complete relief of symptoms and improvement in quality of life. The withdrawal of cisapride has created a vacuum in the prokinetic market, with few promising drugs in the pipeline. Reflux inhibitors are being considered for clinical trials, but as of yet are unavailable. Proton pump inhibitors (PPIs) continue to be the backbone of therapy for acid suppression, providing excellent relief of symptoms and healing of erosive esophagitis. Isomeric technology with esomeprazole as the prototype represents an advance in PPI pharmacology. Antireflux surgery is now more patient-friendly, with shorter hospitalization and less major morbidity compared to open fundoplication, but surgery is at best equal to medical therapy when optimal doses of antisecretory therapy are used. Two endoscopic procedures were recently approved by the U.S. Food and Drug Administration for treatment of gastroesophageal reflux disease: radiofrequency energy delivery to the gastroesophageal junction, and transoral flexible endoscopic suturing. These techniques should be used selectively until we have more data and until results are compared to the safe and highly effective medical therapies.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Anti-Ulcer Agents; Endoscopy, Gastrointestinal; Esomeprazole; Esophagitis; Gastroesophageal Reflux; Humans; Lansoprazole; Length of Stay; Proton Pump Inhibitors; Treatment Outcome

The U.S. Food and Drug Administration's Nonprescription Drugs Advisory Committee and Gastroenterological Drugs Advisory Committee recommended approval of omeprazole as an over-the-counter treatment of heartburn in patients who have at least two episodes of heartburn each week. The consumer studies that have been conducted indicate that the majority of patients understand the proposed labeling and could use the proposed label to determine if the omeprazole therapy was appropriate for them. Esomeprazole is an effective agent in the treatment of gastroesophageal reflux disease (GERD) and erosive esophagitis. Newer studies continue to support its efficacy and safety in the treatment of these conditions. Several of the most recent studies have included comparisons with other proton pump inhibitors. The results of these studies indicate that all the proton pump inhibitors are effective in treating GERD and erosive esophagitis and that some patients would benefit from esomeprazole therapy.

Topics: Anti-Ulcer Agents; Clinical Trials as Topic; Drug Labeling; Enzyme Inhibitors; Esomeprazole; Esophagitis; Gastroesophageal Reflux; Humans; Omeprazole; Proton Pump Inhibitors

The burden of gastroesophageal reflux disease (GERD) results from its widespread prevalence and the unfavorable impact of its symptoms on well-being and quality of life. Whereas abnormalities of the antireflux barrier (lower esophageal sphincter) are important in the pathophysiology of GERD, pharmacologic therapy for GERD is based on suppression of acid, which is responsible for the majority of the symptoms and for epithelial damage. Proton pump inhibitors (PPIs) are the agents of choice for achieving the goals of medical therapy in GERD, which include symptom relief, improvement in quality of life, and healing and prevention of mucosal injury. As a class, these drugs are extremely safe. The newest PPI, esomeprazole, brings a statistically significant increase in healing of mucosal injury and symptom relief in patients with erosive esophagitis, compared with omeprazole and lansoprazole. This article reviews the role of medical therapy in the short- and long-term management of symptomatic patients with or without erosive esophagitis, including extraesophageal presentations, GERD during pregnancy, and Barrett's esophagus. Management of refractory patients is addressed.

Topics: Barrett Esophagus; Esomeprazole; Esophagitis; Female; Gastroesophageal Reflux; Humans; Omeprazole; Pregnancy; Pregnancy Complications; Proton Pump Inhibitors; Treatment Outcome

Esomeprazole, the S-isomer of omeprazole, is a new proton pump inhibitor. Esomeprazole provides better control of intragastric pH than omeprazole. It is more effective in treating erosive esophagitis in patients with GERD than omeprazole. Esomeprazole can maintain the healing of erosive esophagitis when used daily or on demand. It is also effective for the eradication of Helicobacter pylori infections. The incidence and type of adverse events associated with esomeprazole therapy are infrequent and likely to be similar to omeprazole.

Topics: Anti-Ulcer Agents; Esomeprazole; Esophagitis; Gastroesophageal Reflux; Helicobacter Infections; Humans; Omeprazole; Treatment Outcome

The recent introduction of proton pump inhibitors has extraordinarily improved the therapeutic approach to gastro-oesophageal reflux disease. The concept of decreasing gastric acid secretion and increasing the pH in the lower oesophagus has been demonstrated to be therapeutically effective and the higher the level of pH achieved, the better the results. In spite of the evident efficacy of these molecules, there are still many patients who will continue to have symptoms despite medical treatment. Proton pump inhibitors suppress gastric acidity, but this effect shows a remarkable interindividual variation depending on different reasons. Thus, it is still possible to optimise medical therapy for gastro-oesophageal reflux disease. Esomeprazole, the S-isomer of omeprazole, has an advantageous metabolism and this particular feature translates into superior clinical efficacy. Clinical trials for initial and long-term treatment across the gastro-oesophageal reflux disease spectrum, have clearly demonstrated the superiority of esomeprazole over omeprazole, even if tolerability and safety are very similar.

Topics: Anti-Ulcer Agents; Biological Availability; Esomeprazole; Esophagitis; Gastric Mucosa; Gastroesophageal Reflux; Humans; Hydrogen-Ion Concentration; Isomerism; Omeprazole; Proton Pump Inhibitors; Treatment Outcome

Tegoprazan is a novel potassium-competitive acid blocker that has a fast onset of action and can control gastric pH for a prolonged period, which could offer clinical benefit in acid-related disorders.. To confirm the non-inferiority of tegoprazan to esomeprazole in patients with erosive oesophagitis (EE).. In this multicentre, randomised, double-blind, parallel-group comparison study, 302 Korean patients with endoscopically confirmed EE (Los Angeles Classification Grades A-D) were randomly allocated to either tegoprazan (50 or 100 mg) or esomeprazole (40 mg) treatment groups for 4 or 8 weeks. The primary endpoint was the cumulative proportion of patients with healed EE confirmed by endoscopy up to 8 weeks from treatment initiation. Symptoms, safety and tolerability were also assessed.. The cumulative healing rates at week 8 were 98.9% (91/92), 98.9% (90/91) and 98.9% (87/88) for tegoprazan 50 mg, tegoprazan 100 mg and esomeprazole 40 mg, respectively. Both doses of tegoprazan were non-inferior to esomeprazole 40 mg. The incidence of adverse events was comparable among the groups, and tegoprazan was well-tolerated.. Once daily administration of tegoprazan 50 or 100 mg showed non-inferior efficacy in healing EE and tolerability to that of esomeprazole 40 mg.

Topics: Adult; Aged; Anti-Ulcer Agents; Benzene Derivatives; Double-Blind Method; Esomeprazole; Esophagitis; Female; Humans; Imidazoles; Male; Middle Aged; Potassium; Proton Pump Inhibitors; Treatment Outcome; Wound Healing; Young Adult

There is disagreement over the ideal duration of initial proton pump inhibitor (PPI) therapy for gastroesophageal reflux disease, and whether prolonged therapy increases healing of the esophagitis and prevents symptom relapse. We performed a multicenter, prospective, randomized, controlled study to compare the efficacies of 4 weeks vs 8 weeks of PPI therapy in reducing reflux symptoms and preventing symptom relapse in patients with Los Angeles grade A or B erosive esophagitis.. Consecutive patients with symptomatic Los Angeles grade A or B erosive esophagitis were assigned randomly to groups given daily esomeprazole (40 mg) for 4 weeks (n = 207) or 8 weeks (n = 201) as their initial treatment. Patients with complete symptom resolution were switched to on-demand therapy until the end of week 20. All patients underwent follow-up endoscopy at the end of week 20. Symptom relapse was defined as 2 or more episodes of troublesome reflux symptoms per week or ingestion of PPI for more than 7 days within 4 weeks, owing to reflux symptoms.. The 4-week and 8-week groups had comparable rates of complete symptom resolution (77.9% vs 82.1%). However, the cumulative 12-week incidence of symptom relapse was higher for the 4-week group than for the 8-week group (62.5% vs 47.8%; difference, 14.7%; 95% confidence interval, 3.7%-25.7%; P = .009). No significant difference was observed between groups in the proportions of patients with sustained healing at the end of week 20 (49.6% vs 40.9%; P = .160).. Prolonging PPI therapy from 4 weeks to 8 weeks does not appear to increase the rate of complete symptom resolution in patients with mild erosive esophagitis. However, 8 weeks of PPI therapy reduces symptom relapse, compared with 4 weeks, in patients with Los Angeles grade A or B erosive esophagitis. ClinicalTrials.gov number: NCT01874535.

Topics: Adult; Aged; Aged, 80 and over; Drug Therapy; Esomeprazole; Esophagitis; Female; Humans; Male; Middle Aged; Prospective Studies; Proton Pump Inhibitors; Recurrence; Time Factors; Treatment Outcome; Young Adult

Pantoprazole magnesium (pantoprazole-Mg) may display extended inhibition of the proton pump with the potential for improved clinical efficacy in gastro-oesophageal reflux disease (GERD).. To compare the efficacy of pantoprazole-Mg and esomeprazole in GERD.. Gastro-oesophageal reflux disease (Los Angeles grades A-D) patients were randomised to 4 weeks of treatment with pantoprazole-Mg (n = 290) or esomeprazole (n = 288), both 40 mg once daily, in this multicentre (14 Brazilian sites in 9 cities), double-blind study, with an additional 4 weeks' treatment in nonresponding patients. Severity of oesophagitis (at endoscopy) and GERD-related symptoms (ReQuest-GI) were assessed. The primary end point was the proportion of patients in complete remission (ReQuest-GI score <1.73 plus endoscopic healing) at week 4.. Complete remission occurred in 61% of patients in each treatment group at 4 weeks (primary endpoint) and in 81% and 79% of patients in the pantoprazole-Mg and esomeprazole groups at 8 weeks, with no significant differences. Mucosal healing rates were high and not significantly different. At 8 weeks, symptom relief with pantoprazole-Mg was significantly greater than that with esomeprazole (91.6% vs. 86.0%, P = 0.0370) because of continued improvement in symptoms with pantoprazole-Mg from week 4 to week 8 (P = 0.0206).. Pantoprazole-Mg 40 mg was at least as effective as esomeprazole 40 mg for complete remission and the mucosal healing rate was high. Symptom relief with pantoprazole-Mg continued to improve from 4 to 8 weeks and was greater than that with esomeprazole at week 8, suggesting an extended period of treatment effect (ClinicalTrials.gov identifier: NCT01132638).

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adolescent; Adult; Aged; Anti-Ulcer Agents; Double-Blind Method; Endoscopy; Esomeprazole; Esophagitis; Female; Gastroesophageal Reflux; Humans; Male; Middle Aged; Pantoprazole; Proton Pump Inhibitors; Remission Induction; 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

Both gastroesophageal reflux disease and allergy/atopy have been implicated in the pathogenesis of eosinophilic esophagitis (EoE). There are no prospective studies comparing treatment of EoE with acid suppression versus topical corticosteroids.. To determine the outcome of adult eosinophilic esophagitis patients treated with esomeprazole versus topical fluticasone.. Prospective randomized controlled trial.. Academic medical center.. Adults (18-80) diagnosed with EoE by symptoms of dysphagia and esophageal biopsies with >or=15 eosinophils/hpf.. Subjects were randomized to esomeprazole (40 mg by mouth every morning) or aerosolized, swallowed fluticasone (440 mcg by mouth twice a day) for 8 weeks.. Improvement in dysphagia (8-point scale), esophageal eosinophil infiltration before and after treatment, prevalence of GERD measured by validated questionnaire and baseline pH study.. About 56% (14/25) had acid reflux by pH study. There was no difference between treatment groups in improvement in dysphagia scores [3/12 (25%) of the esomeprazole group versus 6/12 (50%) in the fluticasone group, P = 0.40]. Eosinophil infiltration decreased with treatment in both groups, and there was no difference in the amount of decrease between groups (P = 0.70).. Small sample size, unexpectedly high drop-out rate.. Gastroesophageal reflux disease is common in adult eosinophilic esophagitis patients. Dysphagia improves and esophageal eosinophilic infiltration decreases with either treatment. There was no difference in degree of improvement in dysphagia or eosinophil infiltration in patients treated with either topical fluticasone or oral esomeprazole. GERD may be important in the pathogenesis of adult EoE.

Topics: Administration, Oral; Adolescent; Adult; Aerosols; Aged; Androstadienes; Anti-Inflammatory Agents; Anti-Ulcer Agents; Eosinophilia; Esomeprazole; Esophagitis; Female; Fluticasone; Humans; Male; Middle Aged; Prospective Studies; Statistics, Nonparametric; Treatment Outcome

Reducing mucosal cyclo-oxygenase-2 and prostaglandin E(2) production and suppressing intraoesophageal acid may be effective chemopreventive strategies in patients with Barrett's oesophagus.. To compare the effects of aspirin and rofecoxib when administered with esomeprazole on prostaglandin E(2) production, cyclo-oxygenase-2 expression and proliferating cell nuclear antigen expression in patients with Barrett's oesophagus.. This exploratory, multicentre, randomized, open-label, four-way crossover study in 45 patients with Barrett's oesophagus evaluated prostaglandin E(2) content, proliferating cell nuclear antigen expression, and cyclo-oxygenase-2 expression after 10 days of sequential treatments with: esomeprazole 40 mg twice daily plus aspirin 325 mg once daily (E40 b.d. + A325); E40 b.d. plus rofecoxib 25 mg once daily (E40 b.d. + R25); E40 b.d.; and rofecoxib 25 mg once daily (R25).. Prostaglandin E(2) content reduction in Barrett's oesophagus tissue was significantly greater with E40 b.d. + A325 compared with E40 b.d. + R25, E40 b.d. or R25 (P < 0.05). All treatments containing E40 b.d. significantly decreased proliferating cell nuclear antigen expression from baseline (P < 0.05). None of the treatments significantly reduced cyclo-oxygenase-2 expression.. The combined treatment of esomeprazole 40 mg b.d. and aspirin 325 mg significantly decreased mucosal prostaglandin E(2) content and all treatments containing esomeprazole significantly reduced proliferating cell nuclear antigen expression in patients with Barrett's oesophagus.

Topics: Adult; Aged; Aspirin; Barrett Esophagus; Cross-Over Studies; Cyclooxygenase 2; Cyclooxygenase 2 Inhibitors; Cyclooxygenase Inhibitors; Dinoprostone; Drug Therapy, Combination; Enzyme Inhibitors; Esomeprazole; Esophagitis; Esophagus; Female; Humans; Lactones; Male; Middle Aged; Proliferating Cell Nuclear Antigen; Prospective Studies; Sulfones

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

On-demand therapy with esomeprazole is effective for long-term treatment of non-erosive gastro-oesophageal reflux disease, but it has not been evaluated in erosive gastro-oesophageal reflux disease.. To compare endoscopic and symptomatic remission over a 6-month period when patients with healed erosive gastro-oesophageal reflux disease are treated with esomeprazole 20 mg, either once daily or on-demand.. Patients with verified erosive reflux oesophagitis of Los Angeles grades A-D were enrolled. Following 4-8 weeks treatment with esomeprazole 40 mg daily, those who were endoscopically healed and had symptom control during the last week were randomized to maintenance therapy for 6 months with esomeprazole 20 mg, taken either once daily or on-demand.. Of 539 enrolled patients, 494 (91%) were healed at 8 weeks and 477 were randomized to maintenance therapy with esomeprazole 20 mg, 243 once daily and 234 on-demand. After once daily treatment, 81% of patients were still in remission at 6 months, compared with only 58% who took on-demand treatment (P < 0.0001). A difference in remission was found irrespective of baseline grade of oesophagitis, but it was more pronounced for the more severe grades. There was no difference in overall symptomatic remission between the two treatments, although heartburn was significantly more prevalent in the on-demand group.. Once daily esomeprazole 20 mg was better than that taken on-demand for maintaining healed erosive oesophagitis, regardless of baseline Los Angeles grade.

Topics: Adult; Aged; Aged, 80 and over; Anti-Ulcer Agents; Drug Administration Schedule; Esomeprazole; Esophagitis; Esophagoscopy; Female; Humans; Male; Middle Aged; Remission Induction; Secondary Prevention; Severity of Illness Index; Treatment Outcome

An intravenous formulation of esomeprazole has been developed for use in patients where oral administration is not appropriate. This study evaluated safety after 1 and 4 weeks, and efficacy after 4 weeks' esomeprazole 40 mg once daily treatment, administered via an intravenous injection, intravenous infusion or orally, in patients with erosive esophagitis.. In this double-blind, multi-centre study, patients with endoscopically confirmed erosive esophagitis (Los Angeles grade A-D) were randomized to receive 1 week's treatment of esomeprazole 40 mg once daily, via a 3-min injection, a 30-min infusion or orally, followed by 3 weeks of open treatment with oral esomeprazole 40 mg once daily. Safety variables were evaluated following 1 and 4 weeks' esomeprazole treatment. Healing rates at 4 weeks were estimated.. Intravenous and oral esomeprazole were equally well tolerated during the first week, and after 4 weeks' treatment. The 3 treatment groups showed similar levels of healing following 4 weeks' treatment with esomeprazole (injection + oral: 79.7%; infusion + oral: 80.2%; oral alone: 82.6%).. Esomeprazole 40 mg administered via an intravenous injection, intravenous infusion or orally administered for 1 week, followed by 3 weeks of oral dosing, is well tolerated and provides effective healing of erosive esophagitis.

Topics: Administration, Oral; Adult; Aged; Anti-Ulcer Agents; Dose-Response Relationship, Drug; Esomeprazole; Esophagitis; Female; Humans; Infusions, Intravenous; Injections, Intravenous; Male; Middle Aged; Treatment Outcome

To compare the efficacy of esomeprazole, 20 mg once daily, vs. lansoprazole, 15 mg once daily, for the maintenance treatment of patients with healed reflux oesophagitis.. During the initial open healing phase, 1391 patients with endoscopically verified reflux oesophagitis and a history of heartburn, with or without acid regurgitation, received esomeprazole 40 mg for 4-8 weeks. Patients who were healed (identified by endoscopy at 4 or 8 weeks) and symptom free were then randomized to receive 6 months of treatment with esomeprazole, 20 mg once daily, or lansoprazole, 15 mg once daily.. Esomeprazole, 20 mg once daily, maintained a significantly higher proportion of patients in remission than lansoprazole, 15 mg once daily, over 6 months [83% (95% CI, 80-86%) of esomeprazole recipients compared with 74% (95% CI, 70-78%) of lansoprazole recipients; P < 0.0001; life table estimates]. When data were analysed according to baseline Los Angeles grade classification, esomeprazole, 20 mg once daily, achieved consistently higher remission rates across all grades of disease severity, whereas the efficacy of lansoprazole decreased to a greater extent with increasing severity of reflux oesophagitis.. Esomeprazole, 20 mg once daily, is more effective than lansoprazole, 15 mg once daily, in maintaining remission in patients with healed reflux oesophagitis.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adult; Aged; Anti-Ulcer Agents; Dose-Response Relationship, Drug; Double-Blind Method; Esomeprazole; Esophagitis; Female; Gastroesophageal Reflux; Humans; Lansoprazole; Male; Middle Aged; Proton Pump Inhibitors; Recurrence; Survival Analysis; Treatment Outcome

The aim of this study was to determine the effect of 6-12 months of treatment with esomeprazole on the histopathology of the gastric mucosa.. Two identically designed, randomized, placebo-controlled trials of esomeprazole 40, 20, or 10 mg daily for up to 6 months, as well as a noncomparative, multicenter trial of esomeprazole 40 mg daily for up to 12 months, were conducted in 1326 patients with healed erosive esophagitis (1294 negative for Helicobacter pylori [H. pylori]). Gastric biopsy samples were obtained before treatment and on completion of (or discontinuation from) the trials. Samples were evaluated for the presence of H. pylori, characteristics of acute gastritis or atrophic gastritis, and enterochromaffin-like cell pathology.. During treatment with esomeprazole, the number of patients with an improvement in gastric histological scores was typically greater than or equal to the number who worsened. Gastric histological scores worsened for each corporal or antral characteristic of gastritis in <6.2% of patients. Histological scores with esomeprazole and placebo were similar throughout the 6-month trials. Only one among 1326 patients treated with esomeprazole (H. pylori negative) had evidence of treatment-emergent atrophic gastritis. On final biopsy, 5-12% of patients had abnormal enterochromaffin-like cell scores (simple, linear, or micronodular hyperplasia). There were no instances of enterochromaffin-like cell dysplasia, carcinoids, or neoplasia.. Patients with healed erosive esophagitis receiving esomeprazole for up to 12 months had minor fluctuations in gastric histological scores, similar to those experienced in untreated populations. Use of esomeprazole did not raise any safety concerns with respect to the development of atrophic gastritis, or cause clinically significant changes in enterochromaffin-like cells.

Topics: Adult; Anti-Ulcer Agents; Enterochromaffin-like Cells; Esomeprazole; Esophagitis; Gastric Mucosa; Gastrins; Gastritis, Atrophic; Helicobacter Infections; Helicobacter pylori; Humans; Metaplasia

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, achieves a significantly greater healing rate and symptom resolution of erosive esophagitis than that achieved by omeprazole. The objective of this study is to assess the efficacy of the new proton pump inhibitor esomeprazole in preventing relapse over a prolonged period in patients with healed erosive esophagitis.. A total of 318 gastroesophageal reflux patients whose erosive esophagitis was healed in a comparative study of esomeprazole 40 mg, 20 mg, or omeprazole 20 mg, were randomized to maintenance therapy with once daily esomeprazole 40 mg, 20 mg, or 10 mg, or placebo in a U.S., double-blind multicenter trial.. After 6 months, healing was maintained (cumulative life table rates) in 93.6% (95% CI 87.4-99.7) of patients treated with esomeprazole 40 mg, 93.2% (95% CI 87.4-99.0) treated with esomeprazole 20 mg, and 57.1% (95% CI 45.2-69) treated with esomeprazole 10 mg; p < 0.001 vs placebo (29.1%; 95% CI 17.7-40.3). Of patients relapsing, mean time to first recurrence of esophagitis increased with dose, from 34 days (placebo) to 78 days (10 mg), 115 days (20 mg), and 163 days (40 mg). Patients treated with esomeprazole had less frequent and less severe heartburn than those treated with placebo. At month 6, more than 70% of patients being treated with esomeprazole remained symptom-free.. Esomeprazole is effective and well tolerated in the maintenance of a healing erosive esophagitis. Esomeprazole 40 mg and 20 mg maintain healing in over 90% of patients while providing effective control of heartburn symptoms.

Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Biopsy, Needle; Confidence Intervals; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Enzyme Inhibitors; Esomeprazole; Esophagitis; Female; Follow-Up Studies; Gastric Mucosa; Gastroesophageal Reflux; Humans; Male; Middle Aged; Omeprazole; Probability; Reference Values; Secondary Prevention; Treatment Outcome

In patients with gastroesophageal reflux disease (GERD), esomeprazole, the S-isomer of omeprazole, has demonstrated pharmacological and clinical benefits beyond those seen with the racemic parent compound. This study was designed to further evaluate the efficacy and tolerability of esomeprazole relative to that of omeprazole in healing erosive esophagitis and resolving accompanying symptoms of GERD.. Esomeprazole 40 mg was compared with omeprazole 20 mg once daily in 2425 patients with erosive esophagitis (Helicobacter pylori negative by serology) in an 8-wk, multicenter, randomized, double-blind, parallel-group study conducted in 163 centers throughout the US. The primary efficacy endpoint was the proportion of patients with healed esophagitis at wk 8. Secondary endpoints were the proportion of patients healed at wk 4, resolution of heartburn at wk 4, time to first resolution and sustained resolution of heartburn, and proportion of heartburn-free days and nights. Safety and tolerability were also assessed.. Significantly more patients were healed with esomeprazole versus omeprazole at wk 8 (93.7% vs 84.2%, p < 0.001; life table estimates, intention-to-treat analysis). Healing rates at wk 4 were 81.7% and 68.7%, respectively. Esomeprazole was superior to omeprazole for all secondary measures and had a similar safety profile. The most common adverse events in both treatment groups were headache, diarrhea, and nausea.. Esomeprazole demonstrates significantly greater efficacy than omeprazole in the treatment of GERD patients with erosive esophagitis. The tolerability and safety of esomeprazole are comparable to that of omeprazole. (Am

Topics: Adult; Aged; Double-Blind Method; Enzyme Inhibitors; Esomeprazole; Esophagitis; Female; Gastroesophageal Reflux; Humans; Isomerism; Male; Middle Aged; Omeprazole; Safety; Treatment Outcome

To evaluate the safety and tolerability of long term treatment with esomeprazole in patients with healed erosive oesophagitis, and to describe its efficacy in the maintenance of healing.. US multicentre, noncomparative, nonblind study.. 807 patients with endoscopically confirmed healed erosive oesophagitis.. Patients received esomeprazole 40 mg once daily for up to 12 months. Adverse events and clinical laboratory tests were assessed over the study period. Endoscopy was performed at the final visit of the antecedent healing trials and at months 6 and 12 of the current safety trial; gastric biopsies were obtained at the initial visit of the healing trials and at the end of the safety trial.. 80.9% of patients completed 6 months of treatment; 76.6% completed 12 months of treatment. There were no serious drug-related adverse events. Diarrhoea, abdominal pain, flatulence, and headache were the only treatment-related adverse events reported by >3% of patients. Mean changes in laboratory measures were generally small and not clinically meaningful. Plasma gastrin levels increased, as expected, and reached a plateau after 3 months. No changes in gastric histological scores were noted in the majority of patients. Evaluation of gastric biopsies revealed an overall decline in chronic inflammation and atrophy. Intestinal metaplasia findings remained essentially unchanged. Life table estimates of maintenance of healing were 93.7% [95% confidence interval (CI) 92.0 to 95.5%] at 6 months and 89.4% (95% CI 87.0 to 91.7%) at 12 months.. Daily treatment with esomeprazole 40 mg for up to 1 year in patients with healed erosive oesophagitis was generally well tolerated and effective. No safety concerns arose.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anti-Ulcer Agents; Biopsy; Esomeprazole; Esophagitis; Humans; Male; Middle Aged; Treatment Outcome

Topics: Administration, Oral; Aged; Doxycycline; Endoscopy, Digestive System; Esomeprazole; Esophagitis; Humans; Male; Tablets; Treatment Outcome

Topics: Acyclovir; Aged; Antiviral Agents; Esomeprazole; Esophagitis; Esophagus; Female; Gastroscopy; Herpes Simplex; Humans; Severity of Illness Index; Treatment Outcome

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

Topics: Anti-Ulcer Agents; Anticoagulants; Drug Interactions; Drug Resistance; Esomeprazole; Esophagitis; Gastroesophageal Reflux; Humans; International Normalized Ratio; Male; Middle Aged; Phenindione; Venous Thrombosis

Histological Barrett's esophagus, defined as specialized intestinal metaplasia (SIM+) at the cardia without endoscopic suspicion of columnar epithelium, is found frequently in biopsies at the gastro-esophageal junction although its clinical relevance is unknown. The authors aim was to evaluate prospectively the progression of SIM+ to macroscopically evident Barrett's esophagus (BE/SIM+), and to identify risk factors for this progression.. Data were obtained from a sub-group of patients (no visible BE at presentation, but SIM+) included in the ProGERD study, a prospective evaluation of the clinical course of GERD under routine clinical care. They had esomeprazole 20-40 mg/day for 2-8 weeks. Symptom assessment was performed annually, and endoscopy with biopsy was planned at baseline, after healing treatment and after 2 and/or 5 years.. 128 of 171 (74.8%) patients with unequivocal SIM at the z-line after healing were biopsied again after 2 and/or 5 years. At follow-up, 33 (25.8%) of these patients showed progression to BE/SIM+. Factors significantly associated with progression were smoking, a long history of GERD and severe esophagitis at baseline. Patients who had progressed to BE/SIM+ already at 2 years showed consistent findings at 5 years.. More than 20% of GERD patients with SIM+ in this study were found to have BE/SIM+ within 2-5 years. This finding supports the hypothesis that SIM+ at the cardia could be the missing link explaining increased cancer risk in GERD patients without overt BE and merits further investigation in a prospective study.

Topics: Adult; Aged; Barrett Esophagus; Biopsy; Cardia; Confidence Intervals; Endoscopy, Gastrointestinal; Esomeprazole; Esophagitis; Esophagogastric Junction; Female; Follow-Up Studies; Gastroesophageal Reflux; Humans; Male; Metaplasia; Middle Aged; Odds Ratio; Prospective Studies; Proton Pump Inhibitors; Smoking; Time Factors

Previous studies suggested that Chinese have a milder spectrum of gastro-oesophageal reflux disease and a lower dose of proton pump inhibitors (PPI) is sufficient for the control of symptoms as compared with the Western population.. To determine if 8 weeks of esomeprazole 20 mg daily would be adequate for both symptom resolution and oesophagitis healing in Chinese patients and the predictive factors for the response.. 66 patients with oesophagitis were included. Oesophagitis severity was graded by Los Angeles (LA) classification. 61 patients underwent 24-hour ambulatory pH study at baseline. All were given esomeprazole 20 mg daily for 8 weeks. Symptom response and healing of oesophagitis was assessed at the end of the treatment period.. 75.8% of the patients had complete reflux symptom resolution but only 48% had complete healing of the oesophagitis at endoscopy after 8 weeks of treatment. LA classification grading at baseline endoscopy (p < 0.0001) and total number acid reflux episodes on 24-hour pH monitoring prior to treatment (p = 0.007) were both good predictors of oesophagitis healing but not for symptom resolution.. Our results suggested that 8 weeks of lower dose PPI is not sufficient for oesophagitis healing. Symptom resolution with PPI does not predict oesophagitis healing in Chinese.

Topics: Anti-Ulcer Agents; Chi-Square Distribution; China; Esomeprazole; Esophagitis; Esophagoscopy; Female; Gastric Acidity Determination; Humans; Hydrogen-Ion Concentration; Logistic Models; Male; Manometry; Middle Aged; Risk Factors; Severity of Illness Index; Surveys and Questionnaires; Treatment Outcome

There is a controversy as to whether gastroesophageal reflux disease (GERD) exists as a spectrum of disease severity or as a categorial disease in three distinct groups: nonerosive (NERD) and erosive reflux disease (ERD) and Barrett's esophagus (BE). Aim of the study was to assess progression or regression of GERD over 2 yr in a large cohort of patients (N = 3,894) under routine clinical care in Germany, Austria, and Switzerland (ProGERD study).. Patients with predominant heartburn, with or without esophagitis, were recruited and classified according to endoscopic status at baseline, i.e., NERD, erosive reflux disease-Los Angeles (ERD-LA) grade A/B and ERD-LA grade C/D, and BE. After an initial treatment with esomeprazole, they were followed, regardless of their response. Medical therapy or endoscopy was initiated at the discretion of their primary care physician, in line with routine care. At 2 yr, endoscopy with biopsy was performed according to the protocol.. After 2 yr, 25% of patients who had NERD at baseline progressed to LA A/B and 0.6% to LA C/D; 1.6% of patients who had LA A/B progressed to LA C/D and 61% regressed to NERD; 42% of patients who had LA C/D regressed to LA A/B and 50% regressed to NERD (all figures exclude patients with confirmed BE at baseline). At 2 yr, 22% of patients had been off medication for at least 3 months. Patients with ERD-LA grade C/D were at greatest risk of developing BE: 5.8% compared with 1.4% for ERD-LA grade A/B and 0.5% for NERD.. GERD does not seem to be a categorial disease. Progression and regression between grades was observed in this large cohort of patients under routine clinical care.

Topics: Barrett Esophagus; Disease Progression; Esomeprazole; Esophageal Neoplasms; Esophagitis; Esophagoscopy; Female; Follow-Up Studies; Gastroesophageal Reflux; Humans; Male; Middle Aged; Prospective Studies

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

Esomeprazole, the pure S isomer form of omeprazole, is indicated for the treatment of peptic esophagitis. We report here a major episode of cytolytic hepatitis following a single administration.. A 41-year-old woman with infiltrating ductal carcinoma of the breast was undergoing chemotherapy with paclitaxel and trastuzumab. On the fourth day of the second course, she took 1 tablet of esomeprazole 20 mg for epigastric pain. Liver pain and asthenia followed, and liver function tests showed substantial cytolysis. These tests returned to normal levels despite continuation of the chemotherapy.. This cytolytic hepatitis is very probably imputable to esomeprazole, but a synergistic hepatic toxicity of the chemotherapy with esomeprazole cannot be ruled out.

Topics: Adult; Anti-Ulcer Agents; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Protocols; Breast Neoplasms; Carcinoma, Ductal, Breast; Chemical and Drug Induced Liver Injury; Esomeprazole; Esophagitis; Female; Humans; Paclitaxel; Trastuzumab

The aim of this article is to determine the severity of esophagitis and the response to treatment with proton-pump inhibitors in patients with and without evidence of Helicobacter pylori infection.. This retrospective analysis evaluated data collected in a randomized, double-blind clinical trial that assessed the efficacy and safety of once-daily esomeprazole 40 mg (n = 2,624) versus lansoprazole 30 mg (n = 2,617) for up to 8 wk in the treatment of reflux-associated erosive esophagitis. At baseline, erosive esophagitis was graded using the Los Angeles (LA) classification; serologic testing for H. pylori was performed using a FlexSure HP serum test.. There were 14.7% of patients who were seropositive for H. pylori. The percentages of seropositive and seronegative patients with each grade of esophagitis were: LA grade A, 38%, 36%; LA grade B, 41%, 39%; LA grade C, 16%, 19%; and LA grade D, 5%, 6%, respectively. Severe heartburn was present at baseline in 42% of H. pylori-positive and 42% of H. pylori-negative patients. Life-table healing rates with esomeprazole were not influenced by H. pylori status (seropositive 92.6% (95% confidence interval: 89.8-95.4); seronegative 92.6% (95% confidence interval: 91.4-93.7)). The rates with esomeprazole were significantly higher than those with lansoprazole (seropositive 90.5% (95% confidence interval: 87.5-93.5); seronegative 88.5% (95% confidence interval: 87.1-89.8)) after adjusting for baseline H. pylori status (p = 0.001).. The severity of erosive esophagitis at baseline was similar regardless of H. pylori seropositivity. Healing rates were not influenced by H. pylori status.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Adult; Aged; Enzyme Inhibitors; Esomeprazole; Esophagitis; Female; Helicobacter Infections; Helicobacter pylori; Humans; Lansoprazole; Male; Middle Aged; Proton Pump Inhibitors; Randomized Controlled Trials as Topic; Serologic Tests

More than half the patients with gastroesophageal reflux disease (GERD) show no endoscopic abnormality or minimal change esophagitis (non-erosive reflux disease, NERD). We investigated the value of endoscopic and histological markers for the prediction of NERD before and after treatment with 20 mg esomeprazole.. Between July and October 2002, consecutive patients presenting for upper endoscopy were stratified into GERD and non-reflux patients (control group) with the help of a questionnaire. The endoscopist was blind to the presence of reflux symptoms. Using magnifying endoscopes minimal change esophagitis was defined by the presence of vascular injection or vascular spots above the Z-line, villous mucosal surface and islands of squamous cell epithelium below the Z-line. Targeted and random biopsies were taken below and above the Z-line. Patients with endoscopically visible classical signs of esophagitis (Los Angeles A-D) or histologically proven Barrett's esophagus were not further investigated in the study (drop out). The esophageal specimens were histologically evaluated for erosions, infiltration with leukocytes, hyperplasia of basal cells and length of papillae. Patients with NERD were treated with 20 mg esomeprazole/day for 4 weeks and reevaluated by endoscopy as described before.. 39 patients with heartburn and 39 patients without reflux symptoms (controls) were finally included in the analysis (per protocol). Patients with NERD significantly (p = 0.005) more often showed endoscopic signs of minimal change esophagitis (27/39) than the control group (8/39). An increased length of papillae (14/39 versus 2/39; p = 0.005) and basal cell hyperplasia (17/39 versus 4/39; p = 0.009) were significantly more common in the heartburn group. After treatment with esomeprazole, no significant endoscopic or histological differences between the NERD and control group could be observed.. Minimal change esophagitis can be seen with high resolution magnifying endoscopy. By combining endoscopic and histological markers NERD can be predicted with a sensitivity of 62% and a specificity of 74%. Treatment with esomeprazole for 4 weeks reverses the slight alterations to normal.

Topics: Anti-Ulcer Agents; Biopsy; Case-Control Studies; Enzyme Inhibitors; Esomeprazole; Esophagitis; Esophagoscopy; Female; Humans; Male; Middle Aged; Predictive Value of Tests; Prospective Studies; Proton Pump Inhibitors; Sensitivity and Specificity

To evaluate the cost effectiveness of on-demand treatment with esomeprazole 20mg compared with two alternative omeprazole treatment strategies for the long-term management of patients with gastro-oesophageal reflux disease (GORD) without oesophagitis.. A simple Markov model was designed to compare the cost effectiveness of on-demand esomeprazole 20mg therapy for 6 months with a strategy consisting of intermittent 4-week acute treatment courses of omeprazole 20mg once daily or a strategy consisting of continuous omeprazole treatment (20mg once daily) following acute treatment of first relapse while on no drug treatment (a commonly used conventional care strategy). Relapse probabilities were based on pooled results from two 6-month placebo-controlled clinical studies of on-demand esomeprazole 20mg treatment in patients with GORD without oesophagitis and on results from a GORD study with a 6-month untreated follow-up. The expected number of relapses per patient was used as the effectiveness measure. SETTING AND PERSPECTIVE: Patient management assumptions were based on a UK physician survey. The cost-effectiveness analysis considered UK direct medical costs from the perspective of the National Health Service.. The pooled analysis showed that after 6 months treatment, 90% of patients could control symptoms effectively with on-demand esomeprazole 20mg. The expected number of relapses per patient was estimated at 0.10 for on-demand esomeprazole, 0.57 to 1.12 for intermittent omeprazole and 0.47 to 0.75 for conventional omeprazole treatment. The esomeprazole strategy incurred considerably lower direct medical costs (16 to 61%) than either omeprazole strategy.. On-demand treatment with esomeprazole 20mg is cost effective compared with two alternative omeprazole treatment strategies in patients with GORD without oesophagitis.

Topics: Adult; Cost-Benefit Analysis; Enzyme Inhibitors; Esomeprazole; Esophagitis; Female; Gastroesophageal Reflux; Humans; Male; Markov Chains; Middle Aged; Models, Economic; Omeprazole; Proton Pump Inhibitors; United Kingdom

Topics: Biological Availability; Controlled Clinical Trials as Topic; Delayed-Action Preparations; Double-Blind Method; Enzyme Inhibitors; Esomeprazole; Esophagitis; Gastroesophageal Reflux; Humans; Proton Pump Inhibitors