LETTER
Misoprostol and Nonsteroidal Anti-Inflammatory Drugs
Fred E. Silverstein, MD
1 June 1996 | Volume 124 Issue 11 | Page 1015
TO THE EDITOR:
We would like to address some points raised in the editorial by Dr. Levine [1] that accompanied our recent article [2].
As Dr. Levine notes, our trial was the first to provide strong evidence that misoprostol is effective in reducing the risk for serious NSAID-related complications (bleeding, obstruction, and perforation). Reductions in NSAID complications have not been shown by any other medication.
Dr. Levine refers to "infrequent" serious gastrointestinal outcomes related to NSAID use. Although we agree that the absolute risk for these complications is low, widespread NSAID use14 million regular users in the United States [3]indicates a serious health care problem. An annual incidence of 1% translates into an annual occurrence of approximately 140 000 NSAID-related complications that are associated with considerable morbidity, mortality, and costs. The finding that misoprostol reduces the incidence of NSAID-related complications by 40% has important implications for patient care.
We agree that it would be inappropriate to give misoprostol to all persons receiving long-term NSAID therapy. The results of our study, however, defined four risk factors for serious NSAID-related complications: advanced age, history of peptic ulcer disease, history of gastrointestinal bleeding, and history of cardiovascular disease. The identification of such risk factors is important and allows physicians to make rational decisions about a patient's need for misoprostol. For example, in our study, patients with none of the identified risk factors had a less than 1% risk for NSAID-related complications in a 6-month period, whereas those with all four factors had a greater than 10-fold increase in risk.
Previous pharmacoeconomic analyses have concluded that the use of misoprostol to prevent NSAID-induced ulcers is cost-effective in high-risk groups [4]. The results of our trial support the benefits of misoprostol, especially in high-risk patients.
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Author and Article Information
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University of Washington Medical School; Seattle, WA 98195
1. Levine JS. Misoprostol and nonsteroidal anti-inflammatory drugs: a tale of effects, outcomes, and costs [Editorial]. Ann Intern Med. 1995; 123:309-10.
2. Silverstein FE, Graham DY, Senior JR, Davies HW, Struthers BJ, Bittman RM, et al. Misoprostol reduces serious gastrointestinal complications in patients with rheumatoid arthritis receiving nonsteroidal anti-inflammatory drugs. A randomized, double-blind, placebo-controlled trial. Ann Intern Med. 1995; 123:241-9.
3. Roth SH, Bennett RE. Nonsteroidal anti-inflammatory drug gastropathy: recognition and response. Arch Intern Med. 1987; 147:2093-100.
4. Gabriel SE, Jaakkimainen RL, Bombardier C. The cost-effectiveness of misoprostol for nonsteroidal antiinflammatory drug-associated adverse gastrointestinal events. Arthritis Rheum. 1993; 36:447-59.
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