INTRODUCTIONHelicobacter pylori infection is recognized as a causative factor for development of duodenal ulcers. H. pylori eradication results in ulcer healing, prevention of ulcer recurrence, and decreased overall use of health care SUMMARY Background: Studies assessing the ef®cacy of triple therapy containing clarithromycin and amoxicillin for the eradication of Helicobacter pylori infection and healing of duodenal ulcers in Asian and African countries are limited. Aim: To determine the ef®cacy and safety of 1-week triple therapy with omeprazole, amoxicillin and clarithromycin for eradicating H. pylori infection in patients with active duodenal ulcer living in Asian and African regions.
Methods:This was an open-label, multicentre study in 11 centres in Asia and Africa. Patients with endoscopyproven duodenal ulcer and who were H. pylori-positive were treated with clarithromycin 500 mg, omeprazole 20 mg, and amoxicillin 1000 mg, all given twice daily
The proton pump inhibitor pantoprazole has linear pharmacokinetics and a high and constant bioavailability of 80% which results in powerful acid inhibition, making it useful for the treatment of gastro-oesophageal re¯ux disease (GERD). 1±3 Dose-®nding studies and comparative trials have demonstrated that pantoprazole, 40 mg, is the optimal dose for the treatment of moderate to severe re¯ux oesophagitis and 20 mg for mild disease. 4±6 Our aim was to compare a once-daily dose of pantoprazole, 20 mg, with omeprazole, 20 mg, in the treatment of grade I re¯ux oesophagitis as de®ned by Savary and Miller. 7 Because omeprazole, 10 mg, does not consistently provide adequate control of acid secretion and re¯ux symptoms, a comparative dosage of 20 mg was chosen. 8±11 An even higher dose of 40 mg omeprazole offers only marginal bene®t over 20 mg, and hence 20 mg omeprazole has previously been recommended as the standard dose for the treatment of symptomatic re¯ux oesophagitis. 12 In this study, patients received pantoprazole and omeprazole at the optimal dose or standard dose, respectively.
Background/Aim: Gastroesophageal reflux disease (GERD) is a prevalent disease associated with a high symptom burden and a reduced quality of life. This multicenter, randomized, double-blind study compared relief from key GERD symptoms (heartburn, acid eructation, and pain on swallowing) and from other gastrointestinal symptoms (epigastric pain, vomiting, nausea, flatulence, retching, and retrosternal feeling of tightness) and safety profiles of the proton pump inhibitor pantoprazole and the H2 antagonist ranitidine in patients suffering from symptomatic GERD. Methods: The patients [338 intention-to-treat (ITT) population; 284 per-protocol (PP) population] received 20 mg pantoprazole (once daily in the morning) plus ranitidine placebo (once daily in the evening; ITT n = 167, PP n = 136) or pantoprazole placebo (once daily in the morning) plus 300 mg ranitidine (once daily in the evening; ITT n = 171, PP n = 148) for 28 days. The primary efficacy criterion (ITT and PP populations) was relief from key GERD symptoms (heartburn, acid eructation, and pain on swallowing) after 28 days of treatment. Secondary criteria (PP) included relief from key GERD symptoms on day 14, relief from all gastrointestinal symptoms on days 14 and 28, and relief from key GERD symptoms on days 14 and 28. Safety evaluations included adverse events and laboratory assessments. Results: Significantly more pantoprazole-treated patients were free from key GERD symptoms at day 28 (68.3%, n = 114) as compared with ranitidine-treated patients (43.3%, n = 74; 95% confidence interval for odds ratio 1.84–4.51). Pantoprazole was also significantly more efficacious in controlling all gastrointestinal symptoms of GERD. By day 28, 51.5% (n = 70) of the pantoprazole-treated patients were completely symptom free versus 31.1% (n = 46) of the ranitidine-treated patients (95% confidence interval for odds ratio1.45–3.83). Both treatments were well tolerated. Conclusion: Pantoprazole is significantly superior to ranitidine in the treatment of key and associated gastrointestinal symptoms of GERD and is well tolerated.
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