Lansoprazole for secondary prevention of gastric or duodenal ulcers associated with long-term low-dose aspirin therapy: results of a prospective, multicenter, double-blind, randomized, double-dummy, active-controlled trial

• Published in: Journal of gastroenterology Vol. 46; no. 6; pp. 724 - 735
• Main Authors: Sugano, Kentaro, Matsumoto, Yasushi, Itabashi, Tsukasa, Abe, Sumihisa, Sakaki, Nobuhiro, Ashida, Kiyoshi, Mizokami, Yuji, Chiba, Tsutomu, Matsui, Shigeyuki, Kanto, Tatsuya, Shimada, Kazuyuki, Uchiyama, Shinichiro, Uemura, Naomi, Hiramatsu, Naoki
• Format: Journal Article
• Language: English
• Published: Japan Springer Japan 01.06.2011; Springer; Springer Nature B.V
• Subjects: 2-Pyridinylmethylsulfinylbenzimidazoles - therapeutic use; Abdominal Surgery; Aged; Anti-Ulcer Agents - therapeutic use; Aspirin; Aspirin - adverse effects; Aspirin - therapeutic use; Clinical trials; Colorectal Surgery; Diseases; Dosage and administration; Double-Blind Method; Duodenal Ulcer - chemically induced; Duodenal Ulcer - prevention & control; Female; Follow-Up Studies; Gastroenterology; Gefarnate - therapeutic use; Hepatology; Humans; Incidence; Japan; Kaplan-Meier Estimate; Lansoprazole; Male; Medical colleges; Medicine; Medicine & Public Health; Middle Aged; Original Article—Alimentary Tract; Original —Alimentary Tract; Platelet Aggregation Inhibitors - adverse effects; Platelet Aggregation Inhibitors - therapeutic use; Prevention; Prospective Studies; Rankings; Relapse; Secondary Prevention; Stomach Ulcer - chemically induced; Stomach Ulcer - prevention & control; Surgical Oncology; Ulcers; Japan; Low-dose aspirin; Gastric or duodenal ulcers; Cardiovascular diseases; Cerebrovascular diseases; Lansoprazole
• ISSN: 0944-1174; 1435-5922
• DOI: 10.1007/s00535-011-0397-7

Background The efficacy of low-dose lansoprazole has not been established for the prevention of recurrent gastric or duodenal ulcers in those receiving long-term low-dose aspirin (LDA) for cardiovascular and cerebrovascular protection. This study sought to examine the efficacy of low-dose lansoprazole (15 mg once daily) for the secondary prevention of LDA-associated gastric or duodenal ulcers. Methods Patients were randomized to receive lansoprazole 15 mg daily ( n  = 226) or gefarnate 50 mg twice daily ( n  = 235) for 12 months or longer in a prospective, multicenter, double-blind, randomized active-controlled trial, followed by a 6-month follow-up study with open-label lansoprazole treatment. The study utilized 94 sites in Japan and 461 Japanese patients with a history of gastric or duodenal ulcers who required long-term LDA therapy for cardiovascular and cerebrovascular disease. Results The primary endpoint was the development of gastric or duodenal ulcers. The cumulative incidence of gastric or duodenal ulcers on days 91, 181, and 361 from the start of the study was calculated by the Kaplan–Meier method as 1.5, 2.1, and 3.7%, respectively, in the lansoprazole group versus 15.2, 24.0, and 31.7%, respectively, in the gefarnate group. The risk of ulcer development was significantly (log-rank test, P  < 0.001) lower in the lansoprazole group than in the gefarnate group, with the hazard ratio being 0.099 (95% confidence interval [CI] 0.042–0.230). Conclusion Lansoprazole was superior to gefarnate in reducing the risk of gastric or duodenal ulcer recurrence in patients with a definite history of gastric or duodenal ulcers who required long-term LDA therapy.