Comparable clinical efficacy and tolerability of 20 mg pantoprazole and 20 mg omeprazole in patients with grade I reflux oesophagitis
Date
2001
Authors
Bardhan K.D.
Van Rensburg C.
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Abstract
Background: Several clinical trials have shown that pantoprazole (40 mg) and omeprazole (40 or 20 mg) have similar efficacy and safety in the treatment of grade II-IV reflux oesophagitis (Savary-Miller classification). Aim: To compare the efficacy and safety of once-daily doses of pantoprazole (20 rog) and omeprazole (20 mg) with respect to symptom relief and healing of patients with grade I reflux oesophagitis. Methods: Patients with endoscopically established grade I reflux oesophagitis (non-confluent, patchy red lesions with/without white fibrin coating) were enrolled into this randomized, open, parallel-group, multicentre study. A total of 328 patients (n = 166 in the pantoprazole group, n = 162 in the omeprazole group) were recruited in 23 centres. Patients received 4 weeks of treatment. If the reflux oesophagitis was not completely healed, the treatment was extended to 8 weeks. Results: After 2 and 4 weeks of treatment with either pantoprazole or omeprazole, the rate of symptom relief was similar (70% vs. 79% and 77% vs, 84%, respectively). High healing rates were observed after 4 and 8 weeks (pantoprazole: 84% and 90%, respectively; omeprazole: 89% and 95%, respectively). Both treatments were well tolerated. The most frequently reported adverse events on pantoprazole and omeprazole, respectively, were nausea (8% vs. 7%), diarrhoea (5% vs. 6%) and headache (6% vs. 3%). Conclusions: After 4 and 8 weeks of treatment with pantoprazole (20 mg) or omeprazole (20 mg), patients with mild gastro-oesophageal reflux disease (grade I) showed comparably high rates of symptom relief and healing. Both treatments were safe and well tolerated.
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Keywords
omeprazole, pantoprazole, adult, article, clinical trial, comparative study, controlled clinical trial, controlled study, diarrhea, drug efficacy, drug safety, drug tolerability, female, headache, healing, human, major clinical study, male, multicenter study, nausea, priority journal, randomized controlled trial, reflux esophagitis, symptomatology, 2-Pyridinylmethylsulfinylbenzimidazoles, Adult, Anti-Ulcer Agents, Benzimidazoles, Esophagitis, Peptic, Female, Humans, Male, Middle Aged, Omeprazole, Sulfoxides, Treatment Outcome
Citation
Alimentary Pharmacology and Therapeutics
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