Abstract | BACKGROUND: OBJECTIVE: METHODS: This post hoc subanalysis was based on a previous multicenter, prospective, randomized, double-blind, placebo-controlled, 12-week study in patients who had a history of gastric ulcer, were Helicobacter pylori negative, required chronic NSAID therapy, and were free of gastric or duodenal ulcer on baseline endoscopy. The study treatments were misoprostol 200 microg QID or lansoprazole 15 or 30 mg OD. The subanalysis included data from patients in the intent-to-treat cohort who took aspirin at an amount <or=325 mg/d. The end point was the cumulative rate of gastric ulcers, as assessed by serial endoscopy at 4, 8, and 12 weeks. RESULTS: Of 535 intent-to-treat patients from the primary study, 70 (40 men, 30 women; mean [SD] age, 64.7 [10.0] years; age range, 40-83 years) met the criteria for inclusion in the subanalysis. The proportions of patients who were free of gastric ulcers at the end of 12 weeks were 96% in the misoprostol group, 93% in the lansoprazole 15-mg group, 100% in the lansoprazole 30-mg group, and 35% in the placebo group (P <or= 0.008, each active treatment vs placebo). Adverse events considered possibly or probably related to treatment occurred in 5 (20.0%) misoprostol recipients (4 episodes of diarrhea, 1 episode of abdominal pain), 1 (14.3%) recipient of lansoprazole 30 mg (1 episode of pharyngitis), and 3 (13.6%) placebo recipients (1 episode each of abdominal pain, palpitations, and dyspepsia). CONCLUSIONS:
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Authors | Jay L Goldstein, Bidan Huang, Fouad Amer, Nikos G Christopoulos |
Journal | Clinical therapeutics
(Clin Ther)
Vol. 26
Issue 10
Pg. 1637-43
(Oct 2004)
ISSN: 0149-2918 [Print] United States |
PMID | 15598480
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- 2-Pyridinylmethylsulfinylbenzimidazoles
- Anti-Inflammatory Agents, Non-Steroidal
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Misoprostol
- Lansoprazole
- Omeprazole
- Aspirin
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Topics |
- 2-Pyridinylmethylsulfinylbenzimidazoles
- Adult
- Aged
- Aged, 80 and over
- Anti-Inflammatory Agents, Non-Steroidal
(administration & dosage, adverse effects)
- Anti-Ulcer Agents
(therapeutic use)
- Aspirin
(administration & dosage, adverse effects)
- Dose-Response Relationship, Drug
- Double-Blind Method
- Drug Therapy, Combination
- Duodenal Ulcer
(complications, prevention & control)
- Female
- Humans
- Lansoprazole
- Male
- Middle Aged
- Misoprostol
(therapeutic use)
- Omeprazole
(analogs & derivatives, therapeutic use)
- Peptic Ulcer Hemorrhage
(chemically induced, prevention & control)
- Prospective Studies
- Proton Pump Inhibitors
- Risk Factors
- Secondary Prevention
- Stomach Ulcer
(complications, prevention & control)
- Treatment Outcome
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