PREVENTION OF NSAID-INDUCED GASTRIC ULCER WITH MISOPROSTOL: MULTICENTRE, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL

A double-blind, placebo-controlled study was carried out to see whether the synthetic E prostaglandin, misoprostol, would prevent gastric ulcer induced by non-steroidal anti-inflammatory drugs (NSAIDs). 420 patients with osteoarthritis and NSAID-associated abdominal pain were studied; they were rece...

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Veröffentlicht in:The Lancet (British edition) 1988-12, Vol.332 (8623), p.1277-1280
Hauptverfasser: Graham, DavidY, Agrawal, NaurangM, Roth, SanfordH
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container_title The Lancet (British edition)
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creator Graham, DavidY
Agrawal, NaurangM
Roth, SanfordH
description A double-blind, placebo-controlled study was carried out to see whether the synthetic E prostaglandin, misoprostol, would prevent gastric ulcer induced by non-steroidal anti-inflammatory drugs (NSAIDs). 420 patients with osteoarthritis and NSAID-associated abdominal pain were studied; they were receiving ibuprofen, piroxicam, or naproxen. Endoscopy was done at entry and after 1, 2, and 3 months of continuous treatment with 100 μg or 200 μg misoprostol or placebo, given four times daily with meals and at bedtime, concurrently with the NSAID. Abdominal pain was rated independently by patients and physicians. A treatment failure was defined as development of a gastric ulcer. Gastric ulcers (0·3 cm in diameter or greater) occurred less frequently (p
doi_str_mv 10.1016/S0140-6736(88)92892-9
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Endoscopy was done at entry and after 1, 2, and 3 months of continuous treatment with 100 μg or 200 μg misoprostol or placebo, given four times daily with meals and at bedtime, concurrently with the NSAID. Abdominal pain was rated independently by patients and physicians. A treatment failure was defined as development of a gastric ulcer. Gastric ulcers (0·3 cm in diameter or greater) occurred less frequently (p &lt;0·001) in both misoprostol treatment groups (5·6% 100 μg and 1·4% 200 μg) than in the placebo group (21·7%). The significant difference in ulcer formation between the placebo and the misoprostol treatment groups remained when comparisons were restricted to ulcers greater than 0·5 cm in diameter (12·3% placebo, 4·2% 100 μg misoprostol, and 0·7% 200 μg misoprostol). Mild to moderate, self-limiting diarrhoea was the most frequently reported adverse effect attributed to misoprostol. 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These results provide the first clear indication that NSAID-induced ulcers are preventable.</description><subject>Anti-inflammatory agents</subject><subject>Biological and medical sciences</subject><subject>Drug toxicity and drugs side effects treatment</subject><subject>Drugs</subject><subject>Health care</subject><subject>Medical research</subject><subject>Medical sciences</subject><subject>Nonsteroidal anti-inflammatory drugs</subject><subject>Osteoarthritis</subject><subject>Pain</subject><subject>Pharmacology. 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subjects Anti-inflammatory agents
Biological and medical sciences
Drug toxicity and drugs side effects treatment
Drugs
Health care
Medical research
Medical sciences
Nonsteroidal anti-inflammatory drugs
Osteoarthritis
Pain
Pharmacology. Drug treatments
Toxicity: digestive system
Ulcers
title PREVENTION OF NSAID-INDUCED GASTRIC ULCER WITH MISOPROSTOL: MULTICENTRE, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL
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