Randomized trial of low-dose misoprostol and naproxen vs. nabumetone to prevent recurrent upper gastrointestinal haemorrhage in users of non-steroidal anti-inflammatory drugs
Authors: Chan, F. K. L.1; Sung, J. J. Y.1; Ching, J. Y. L.1; Wu, J. C. Y.1; Lee, Y. T.1; Leung, W. K.1; Hui, Y.1; Chan, L. Y.1; Lai, A. C. W.1; Chung, S. C. S.2
Source: Alimentary Pharmacology & Therapeutics, Volume 15, Number 1, January 2001 , pp. 19-24(6)
Publisher: Blackwell Publishing
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Abstract:
Background: Prophylactic misoprostol or non-steroidal anti-inflammatory drugs (NSAIDs) with low gastric toxicity (nabumetone) has been shown to reduce mucosal injury. Aim: To compare nabumetone vs. co-therapy of naproxen with low-dose misoprostol for secondary prevention of upper gastrointestinal bleeding in NSAID users. Methods: NSAID users presenting with upper gastrointestinal bleeding were enrolled if they required long-term NSAIDs. After ulcer healing, they were randomized to receive: naproxen (500-1000 mg/day) and misoprostol (200 μg b.d.), or nabumetone (1000-1500 mg/day) and placebo misoprostol for 24 weeks. The primary end-point was recurrent upper gastrointestinal bleeding. The secondary end-point was the proportion of patients suffering from major gastrointestinal events including ulcer bleeding, symptomatic ulcers and severe dyspepsia. Results: A total of 90 patients were included in the intention-to-treat analysis (misoprostol/naproxen 45, nabumetone 45). Recurrent bleeding occurred in 10 patients (22.2%) receiving misoprostol/naproxen compared with three (6.7%) receiving nabumetone (relative risk 3.33, 95% CI: 0.98-11.32, P=0.069). The proportion of patients suffering from major gastrointestinal events at 24 weeks was 31.1% in the misoprostol/naproxen group and 28.9% in the nabumetone group. Conclusions: Misoprostol/naproxen is not superior to nabumetone for secondary prevention of upper gastrointestinal bleeding. Neither low-dose misoprostol nor nabumetone is adequate for high-risk NSAID users.Document Type: Research article
Affiliations: 1: Department of Medicine & Therapeutics, The Chinese University of Hong Kong, Hong Kong 2: Department of Surgery, The Chinese University of Hong Kong, Hong Kong
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