title: Lansoprazole for secondary prevention of gastric or duodenal ulcers associated with long-term non-steroidal anti-inflammatory drug (NSAID) therapy: results of a prospective, multicenter, double-blind, randomized, double-dummy, active-controlled trial.
abstract: BACKGROUND
  Low-dose lansoprazole has not been intensively evaluated for its efficacy in the prevention of recurrent gastric or duodenal ulcers in patients receiving long-term non-steroidal anti-inflammatory drug (NSAID) therapy for pain relief in such diseases as rheumatoid arthritis, osteoarthritis, and low back pain.
  
  
  METHODS
  This multi-center, prospective, double-blind, randomized, active-controlled study involving 99 sites in Japan was designed to compare the efficacy of lansoprazole (15 mg daily) with gefarnate (50 mg twice daily). Patients with a history of gastric or duodenal ulcers who required long-term NSAID therapy were randomized to receive lansoprazole 15 mg daily (n = 185) or gefarnate 50 mg twice daily (n = 181) and followed up for 12 months or longer prospectively.
  
  
  RESULTS
  The cumulative incidence of gastric or duodenal ulcer at days 91, 181, and 361 from the start of the study was calculated by the Kaplan-Meier method as 3.3, 5.9, and 12.7%, respectively, in the lansoprazole group versus 18.7, 28.5, and 36.9%, respectively, in the gefarnate group. The risk for ulcer development was significantly (log-rank test, P < 0.0001) lower in the lansoprazole group than in the gefarnate group, with the hazard ratio being 0.2510 (95% CI 0.1400-0.4499). A long-term follow-up study showed an acceptable safety profile for low-dose lansoprazole therapy, with diarrhea as the most frequent adverse event.
  
  
  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 NSAID therapy.
authors.affiliation: Division of Gastroenterology, Department of 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: Teiji
authors.initials: T
authors.lastname: Kontani
authors.forename: Shinichi
authors.initials: S
authors.lastname: Katsuo
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Takei
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: Masahiro
authors.initials: M
authors.lastname: Asaka
authors.forename: Shigeyuki
authors.initials: S
authors.lastname: Matsui
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Kanto
authors.forename: Satoshi
authors.initials: S
authors.lastname: Soen
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Takeuchi
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Hiraishi
authors.forename: Naoki
authors.initials: N
authors.lastname: Hiramatsu
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects* / Q000627:therapeutic use; D000897:Anti-Ulcer Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001168:Arthritis / Q000188:drug therapy; D004311:Double-Blind Method; D004381:Duodenal Ulcer / Q000139:chemically induced / Q000517:prevention & control*; D005260:Female; D005778:Gefarnate / Q000627:therapeutic use; D006801:Humans; D053208:Kaplan-Meier Estimate; D064747:Lansoprazole; D017116:Low Back Pain / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D055502:Secondary Prevention; D013276:Stomach Ulcer / Q000139:chemically induced / Q000517:prevention & control*; D016896:Treatment Outcome
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000894:Anti-Inflammatory Agents, Non-Steroidal; D000897:Anti-Ulcer Agents; D064747:Lansoprazole; D005778:Gefarnate