Clinical–Alimentary TractStratifying the risk of NSAID-related upper gastrointestinal clinical events: Results of a double-blind outcomes study in patients with rheumatoid arthritis☆,☆☆
Section snippets
Materials and methods
Rheumatoid arthritis patients aged ≥50 years (or ≥40 years and receiving corticosteroid therapy) and who were expected to require NSAIDs for ≥ 1 year were eligible. Exclusion criteria included use of aspirin or other antiplatelet agents, anticoagulants, misoprostol, sucralfate, proton pump inhibitors, or prescription-strength histamine2-receptor antagonists (lower over-the-counter doses were allowed: cimetidine 400 mg daily, ranitidine 150 mg daily, famotidine 20 mg daily, nizatidine 150 mg
Results
The 8076 patients enrolled were followed up for a median of 9 months (range, 0.5–13 months). Baseline characteristics in the 2 study groups were similar3: 97% met American College of Rheumatology criteria for rheumatoid arthritis, 26% were aged ≥65 years, 56% took corticosteroids at entry, 83% took disease-modifying agents, 42% were seropositive for Helicobacter pylori, and 8% had a history of clinical upper GI events. There were 177 confirmed upper GI clinical events and 53 confirmed
Discussion
This large, prospective, double-blind GI outcomes trial in patients with rheumatoid arthritis identified prior upper GI clinical events, age older than 65 years, and severe disability caused by rheumatoid arthritis as important risk factors for developing upper GI events, with approximately 2- to 4-fold increases in risk for each individual factor. In patients taking the nonselective NSAID naproxen, the annualized incidence of clinically significant upper GI events was more than 14% in patients
Acknowledgements
Dr. Laine is a consultant or has received research support from Merck, Pharmacia, and Pfizer. Dr. Hawkey has received research funding from AstraZeneca, Alizyme, Boehringer Ingelheim, Boots Healthcare, Glaxo Wellcome, Merck, Merckle, NicOx, Novartis, Parke Davis, Pfizer/Pharmacia, Searle, SmithKline Beecham, and Wyeth Lederle. Dr. Bombardier is a consultant for Merck Research Laboratories, Schering Canada, and Wyeth-Ayerst Research; is a Member of the Advisory Board for Abbott Laboratories
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Address requests for reprints to: Loren Laine, M.D., Gastrointestinal Division, Department of Medicine, University of Southern California School of Medicine, 2025 Zonal Avenue, Los Angeles, California 90033. e-mail: [email protected]; fax: (323) 226-7573.
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Supported by Merck and Co., Whitehouse Station, New Jersey.