Superiority of lansoprazole vs ranitidine in healing nonsteroidal anti-inflammatory drug-associated gastric ulcers - Results of a double-blind, randomized, multicenter study

Background: The usefulness of nonsteroidal antiinflammatory drugs (NSAIDs) is limited by adverse gastrointestinal tract events. Objective; To identify the optimal antisecretory therapy for healing of gas tric ulcer in patients using NSAIDs and the impact of concurrent Helicobact er pylori infection on ulcer healing. Design: Prospective, double-blind, multicenter, parallel-group study. Setting: Gastroenterology practices in ambulatory and referral center setti ngs. Patients: Three hundred fifty-three patients with an active, nonmalignant g astric ulcer at least 5 mm in diameter confirmed by Endoscopy and biopsy an d who continued to receive stable doses of NSAIDs. Intervention: Patients were randomized to receive ranitidine hydrochloride, 150 mg twice daily, or lansoprazole, 15 mg or 30 mg once daily, for 8 week s. Measurements: Healing was assessed by endoscopy at 4 and 8 weeks in an inte nt-to-treat population. Helicobacter pylori status was assessed by histolog ical examination. Results: After 8 weeks of treatment, healing was observed in 61 (53%) of 115, 81 (69%) of 118, and 85 (73%) of 117 patients receivin g ranitidine lansoprazole, 15 mg, and lansoprazole, 30 mg, respectively (P< .05 for ranitidine vs both lansoprazole doses; 95% confidence interval, 3.2 -28.0 for ranitidine vs lansoprazole, 15 mg, and 7.4-31.8 for ranitidine vs lansoprazole, 30 mg). The gastric ulcer healing rates were similar between H pylori-infected and -noninfected patients, with a statistically signific ant increase with the use of lansoprazole vs ranitidine. Conclusions: In patients who require continuous treatment with NSAIDs, lans oprazole is superior to ranitidine for healing of NSAID-associated gastric ulcers. Healing is not delayed by the presence of H pylori infection.