Healing of gastric ulcers with esomeprazole versus ranitidine in patients who continued to receive NSAID therapy: a randomized trial.

Abstract

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. 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. 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. 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.