title: 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).
  
  
  CONCLUSIONS
  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.affiliation: Division of Gastroenterology, Department of Internal Medicine, Jichi Medical University, 3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, Japan. sugano@jichi.ac.jp
authors.forename: Kentaro
authors.initials: K
authors.lastname: Sugano
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Matsumoto
authors.forename: Tsukasa
authors.initials: T
authors.lastname: Itabashi
authors.forename: Sumihisa
authors.initials: S
authors.lastname: Abe
authors.forename: Nobuhiro
authors.initials: N
authors.lastname: Sakaki
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Ashida
authors.forename: Yuji
authors.initials: Y
authors.lastname: Mizokami
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Chiba
authors.forename: Shigeyuki
authors.initials: S
authors.lastname: Matsui
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Kanto
authors.forename: Kazuyuki
authors.initials: K
authors.lastname: Shimada
authors.forename: Shinichiro
authors.initials: S
authors.lastname: Uchiyama
authors.forename: Naomi
authors.initials: N
authors.lastname: Uemura
authors.forename: Naoki
authors.initials: N
authors.lastname: Hiramatsu
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000627:therapeutic use*; D000368:Aged; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D001241:Aspirin / Q000009:adverse effects* / Q000627:therapeutic use; D004311:Double-Blind Method; D004381:Duodenal Ulcer / Q000139:chemically induced / Q000517:prevention & control; D005260:Female; D005500:Follow-Up Studies; D005778:Gefarnate / Q000627:therapeutic use; D006801:Humans; D015994:Incidence; D007564:Japan; D053208:Kaplan-Meier Estimate; D064747:Lansoprazole; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D011446:Prospective Studies; D055502:Secondary Prevention; D013276:Stomach Ulcer / Q000139:chemically induced / Q000517:prevention & control
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents; D010975:Platelet Aggregation Inhibitors; D064747:Lansoprazole; D005778:Gefarnate; D001241:Aspirin