Author(s): Goldstein JL, Johanson JF, Suchower LJ, Brown KA
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Abstract OBJECTIVE: To compare orally administered esomeprazole 40 mg once daily and 20 mg once daily with ranitidine 150 mg twice daily for the healing of gastric ulcers (GUs) during 8 wks in patients who continued to receive daily nonsteroidal anti-inflammatory drug (NSAID) therapy. METHODS: This multicenter, randomized, double-blind, parallel-group trial included patients who were receiving nonselective or cyclo-oxygenase-2 (COX-2)-selective NSAIDs and had at least one GU >or=5 mm but no gastric or duodenal ulcer >25 mm in diameter at the baseline esophagogastroduodenoscopy (EGD). After 4 and 8 wks of treatment, ulcer-healing status was confirmed by EGD. The primary outcome was the percentage of patients in each treatment group who had no GUs (GU healing rate) at week 8. RESULTS: A total of 406 patients were randomized to treatment. At week 8, GU healing rates with esomeprazole 40 and 20 mg were 91.5\% (118/129; 95\% CI, 86.7-96.3\%) and 88.4\% (122/138; 95\% CI, 83.1-93.7\%), respectively, and were significantly higher than the 74.2\% rate (98/132; 95\% CI, 66.8-81.7\%) with ranitidine (p<0.01 for both comparisons). GU healing rates at 4 wks (78.3\%[101/129] and 79.0\%[109/138] in the esomeprazole 40- and 20-mg groups, respectively) were also significantly higher (p<0.05) than in the ranitidine group (66.7\%[88/132]). All treatments were well tolerated. CONCLUSIONS: Esomeprazole 40 and 20 mg once daily are effective and well-tolerated therapies compared with ranitidine 150 mg twice daily for healing GUs in patients who need to continue NSAID therapy.
This article was published in Am J Gastroenterol
and referenced in Journal of Gastrointestinal & Digestive System