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Randomized trial of low‐dose misoprostol and naproxen vs. nabumetone to prevent recurrent upper gastrointestinal haemorrhage in users of non‐steroidal anti‐inflammatory drugs
Author(s) -
Chan F. K. L.,
Sung J. J. Y.,
Ching J. Y. L.,
Wu J. C. Y.,
Lee Y. T.,
Leung W. K.,
Hui Y.,
Chan L. Y.,
Lai A. C. W.,
Chung S. C. S.
Publication year - 2001
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1046/j.1365-2036.2001.00890.x
Subject(s) - nabumetone , misoprostol , medicine , naproxen , randomized controlled trial , gastroenterology , upper gastrointestinal bleeding , nonsteroidal , pregnancy , endoscopy , alternative medicine , pathology , abortion , biology , genetics
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.