@article{ref1,
title="Derivation and validation of a major toxicity risk score among NSAID users based on data from a randomized controlled trial",
journal="Arthritis and rheumatology",
year="2019",
author="Solomon, Daniel H. and Shao, Ming and Wolski, Kathy and Nissen, Steven and Husni, M. Elaine and Paynter, Nina",
volume="71",
number="8",
pages="1225-1231",
abstract="BACKGROUND: While non-steroidal anti-inflammatory drugs (NSAIDs) are used commonly in rheumatology, they cause major toxicity. Improving the risk-benefit ratio requires a more precise understanding of risk. <br><br>METHODS: We derived and validated a risk score for major toxicity among NSAID users enrolled in a randomized controlled trial. Patients with known cardiovascular disease or cardiovascular risk factors who had osteoarthritis or rheumatoid arthritis were split into derivation and validation cohorts. Subjects were randomized to celecoxib, naproxen, or ibuprofen at typical dosages. The risk score predicted the one-year occurrence of major toxicity among NSAID users, including major adverse cardiovascular events, acute kidney injury, significant gastrointestinal events, and mortality. Variables significantly associated with major toxicity were candidates for inclusion in the final regression model. After derived models were found to have similar model fit in the validation set, the cohorts were combined, allowing calculation of a risk score. <br><br>RESULTS: In the derivation cohort, significant variables included age, male sex, history of cardiovascular disease, hypertension, diabetes, tobacco use, statin use, elevated serum creatinine, hematocrit, and type of arthritis. The C-index was 0.73 in the validation cohort and 0.71 in the total cohort; the model was well calibrated. In the total population with complete data (n = 23,735), 1,080 (4.6%) had predicted one-year risk <1%, 16,273 (68.6%) had predicted risk 1-4%, and 6,382 (26.9%) had predicted risk >4%. <br><br>CONCLUSION: The risk score accurately categorizes the one-year risk of major toxicity among NSAID users and may be useful in identifying patients who can safely use these agents. This article is protected by copyright. All rights reserved.<br><br>This article is protected by copyright. All rights reserved.<p /> <p>Language: en</p>",
language="en",
issn="2326-5191",
doi="10.1002/art.40870",
url="http://dx.doi.org/10.1002/art.40870"
}