Double-blind comparison of lansoprazole 15 mg, lansoprazole 30 mg, and placebo in the maintenance of healed gastric ulcer.
Our purpose was to compare the safety and efficacy of lansoprazole 15 mg and 30 mg with placebo in preventing recurrence in 49 patients with a history of gastric ulcer. Within one month, 40% of patients receiving placebo experienced ulcer recurrence compared to 0% and 7% of patients receiving lansoprazole 15 mg and 30 mg, respectively. All placebo patients became symptomatic, experienced ulcer recurrence or withdrew from the study by month 9. As compared to placebo, a significantly (P < 0.001) higher percentage of patients treated with lansoprazole 15 mg (83%) and lansoprazole 30 mg (93%) with healed gastric ulcer disease remained healed at month 12. Of patients asymptomatic at baseline, 100% and 59% of those treated with lansoprazole 15 mg and 30 mg, respectively, remained asymptomatic at month 12. The incidence of adverse events was comparable among the treatment groups. Lansoprazole safely and effectively reduces ulcer recurrence in patients with a history of gastric ulcer disease.
Kovacs
T O
TO
Center for Ulcer Research and Education, VA Medical Center West Los Angeles, California 90073, USA.
Campbell
D
D
Haber
M
M
Rose
P
P
Jennings
D E
DE
Richter
J
J
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D001706:Biopsy; D002452:Cell Count; D004311:Double-Blind Method; D019861:Enterochromaffin-like Cells / Q000166:cytology; D005260:Female; D005500:Follow-Up Studies; D005753:Gastric Mucosa / Q000473:pathology; D005755:Gastrins / Q000097:blood*; D006801:Humans; D064747:Lansoprazole; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D054328:Proton Pump Inhibitors; D012008:Recurrence; D013276:Stomach Ulcer / Q000188:drug therapy* / Q000517:prevention & control; D013997:Time Factors
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents; D005755:Gastrins; D054328:Proton Pump Inhibitors; D064747:Lansoprazole; D009853:Omeprazole