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.

Abstract

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.

• Authors: Kentaro Sugano, Yasushi Matsumoto, Tsukasa Itabashi, Sumihisa Abe, Nobuhiro Sakaki, Kiyoshi Ashida, Yuji Mizokami, Tsutomu Chiba, Shigeyuki Matsui, Tatsuya Kanto, Kazuyuki Shimada, Shinichiro Uchiyama, Naomi Uemura, Naoki Hiramatsu
• Journal: Journal of gastroenterology (J Gastroenterol) Vol. 46 Issue 6 Pg. 724-35 (Jun 2011) ISSN: 1435-5922 [Electronic] Japan
• PMID: 21499703 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• 2-Pyridinylmethylsulfinylbenzimidazoles
• Anti-Ulcer Agents
• Platelet Aggregation Inhibitors
• Lansoprazole
• Gefarnate
• Aspirin

Topics

• 2-Pyridinylmethylsulfinylbenzimidazoles (therapeutic use)
• Aged
• Anti-Ulcer Agents (therapeutic use)
• Aspirin (adverse effects, therapeutic use)
• Double-Blind Method
• Duodenal Ulcer (chemically induced, prevention & control)
• Female
• Follow-Up Studies
• Gefarnate (therapeutic use)
• Humans
• Incidence
• Japan
• Kaplan-Meier Estimate
• Lansoprazole
• Male
• Middle Aged
• Platelet Aggregation Inhibitors (adverse effects, therapeutic use)
• Prospective Studies
• Secondary Prevention
• Stomach Ulcer (chemically induced, prevention & control)