New data on healing of nonsteroidal anti-inflammatory drug-associated ulcers and erosions. Omeprazole NSAID Steering Committee.

A total of 1,456 patients were available for the All Patients Treated analysis of two large, randomized, double-blind, multicenter, controlled studies (Acid Suppression Trial: Ranitidine versus Omeprazole for NSAID-Associated Ulcer Treatment [ASTRONAUT] and Omeprazole versus Misoprostol for NSAID-Induced Ulcer Management [OMNIUM]). These studies examined the efficacies of omeprazole, 20 and 40 mg once daily (both studies), ranitidine, 150 mg twice daily (ASTRONAUT), and misoprostol, 200 microg four times daily (OMNIUM), for the healing of gastric ulcer, duodenal ulcer, or erosions, and the relief of dyspeptic symptoms. At entry, patients were receiving, and continued to receive, nonsteroidal anti-inflammatory drugs (NSAIDs), and had a gastric or duodenal ulcer, and/or >10 erosions in the stomach or duodenum at initial endoscopy. Patients were randomized to blinded treatment for 4/8 weeks until treatment success, which was defined as the healing of ulcer(s), <5 erosions at any site, and not more than mild dyspeptic symptoms. The proportions of patients reaching treatment success by 8 weeks were 77% with both doses of omeprazole, 63% with ranitidine, and 71% with misoprostol. In patients who initially had a gastric ulcer, more ulcers were healed at 8 weeks with omeprazole, 20 (83%) and 40 mg once daily (82%), than with ranitidine (64%) or misoprostol (74%). In patients who initially had a duodenal ulcer, 93% were healed at 8 weeks with omeprazole, 20 mg once daily, compared with 88% for omeprazole, 40 mg once daily, 79% for ranitidine, and 79% for misoprostol. Erosions healed slightly faster at 4 weeks with misoprostol, compared with the other regimens, but by 8 weeks most patients had <5 erosions per gastroduodenal region in each treatment group. Diarrhea and abdominal pain were more common in patients taking misoprostol, as were adverse events leading to withdrawal. Patients with duodenal ulcer or erosions at entry and the presence of Helicobacter pylori were good prognostic factors for overall treatment success. Using a model that included only patients with ulcers, those with smaller ulcers also had a higher likelihood of achieving treatment success. Against the background of these new data, omeprazole is the treatment of choice for healing NSAID-associated ulcers, on the basis of its efficacy and tolerability, and the optimal dose appears to be 20 mg once daily.

RCT Entities:   Population Interventions Outcomes