Double-blind comparison of lansoprazole 15 mg, lansoprazole 30 mg and placebo as maintenance therapy in patients with healed duodenal ulcers resistant to H2-receptor antagonists.
BACKGROUND
Maintenance antisecretory therapy is often used to prevent duodenal ulcer recurrence and control symptoms. This study compared the efficacy and safety of lansoprazole 15 mg and 30 mg daily with placebo in preventing ulcer recurrence in patients with a recent history of duodenal ulcer disease.


METHODS
Fifty-six patients were treated with either lansoprazole 15 mg, 30 mg or placebo o.m.


RESULTS
Within 1 month of study initiation, 27% (four out of 15) of placebo-treated patients experienced ulcer recurrence as compared to 13% (two out of 15) and 6% (one out of 18) of lansoprazole 15 mg and 30 mg treated patients, respectively. Median time to first ulcer recurrence was > 12 months in lansoprazole patients. At Month 12, significantly (P < 0.001) more lansoprazole 15 mg patients (70%) and lansoprazole 30 mg patients (85%) remained healed. Eighty-two per cent of lansoprazole 15 mg and 76% of lansoprazole 30 mg patients remained asymptomatic during the entire study period. All placebo patients became symptomatic, experienced ulcer recurrence, or withdrew from the study by month six. The incidence of adverse events was comparable among the three treatment groups.


CONCLUSIONS
Lansoprazole safely and effectively reduces duodenal ulcer recurrence and ulcer-related symptoms.
Kovacs
T O
TO
Center for Ulcer Research and Education, VA Medical Center West Los Angeles, CA, USA.
Campbell
D
D
Richter
J
J
Haber
M
M
Jennings
D E
DE
Rose
P
P
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000328:Adult; D000368:Aged; D000897:Anti-Ulcer Agents / Q000008:administration & dosage*; D004311:Double-Blind Method; D004351:Drug Resistance; D004381:Duodenal Ulcer / Q000378:metabolism* / Q000517:prevention & control*; D005260:Female; D005753:Gastric Mucosa / Q000378:metabolism; D005755:Gastrins / Q000097:blood; D006635:Histamine H2 Antagonists / Q000494:pharmacology*; D006801:Humans; D064747:Lansoprazole; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage / Q000031:analogs & derivatives*; D054328:Proton Pump Inhibitors; D012008:Recurrence; D016896:Treatment Outcome; D014481:United States
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents; D005755:Gastrins; D006635:Histamine H2 Antagonists; D054328:Proton Pump Inhibitors; D064747:Lansoprazole; D009853:Omeprazole