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Ulcer Prevention with Misoprostol in Chronic NSAIS Users
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IN RESPONSE:
The finding that misoprostol significantly reduced the frequently of both gastric and duodenal ulcer development in patients with arthritis who required long-term therapy with NSAIDs was established from a statistical comparison of two treatment groups and a randomized, placebo-controlled clinical trial [1]. The validity of that finding was not based on logistic regression modeling. Drs. Heudebert and McKinney question some of the study's peripheral and minor conclusions. To identify subgroups of patients receiving NSAIDs at increased risk for ulceration, we used logistic regression to examine the effects of the demographic and medical history measures. Gastric erosions and alcohol use had been suggested as possible risk factors. Heudebert and McKinney cite Concato and colleagues [2], who based the 10:1 event-to-variable ratio on data from Harrell and associates [3], who in turn refer to it only as a “rough rule of thumb”. We agree that, because of the small number of outcomes, the possible effects of age, sex, and so forth might be missed. We also agree that care should be taken in both using and interpreting the results of multivariate statistical models. However, we do not agree that our conclusions were overstated. Importantly, none of the variables that we examined is known to be what Heudebert and McKinney call “important ulcerogenic risk factors”. We doubt that the data as we presented it would mislead the reader. Our goal was to begin to identify high-risk patient subgroups that could be the focus of further studies. Our study lacked significant power to critically examine the small complementary role of these minor factors. The number of patients studied was sufficient to validly test the basic question and to establish the benefits of misoprostol therapy compared with placebo in reducing the development of gastric or duodenal ulcers in patients receiving long-term NSAID therapy.
David Y. Graham, MD
Veterans Affairs Medical Center; 2002 Holcombe Boulevard; Houston, TX 77030
The Editors welcome submissions for possible publication in the Letters section. Authors of letters should:
•Include no more than 300 words of text, three authors, and five references
•Type with double-spacing
•Send three copies of the letter, an authors' form signed by all authors, and a cover letter describing any conflicts of interest related to the contents of the letter.
Letters commenting on an Annals article will be considered if they are received within 6 weeks of the time the article was published. Only some of the letters received can be published. Published letters are edited and may be shortened; tables and figures are included only selectively. Authors will be notified that the letter has been received. If the letter is selected for publication, the author will be notified about 3 weeks before the publication date. Unpublished letters cannot be returned.
Annals welcomes electronically submitted letters.
- Copyright ©2004 by the American College of Physicians
