Nonsteroidal anti-inflammatory drugs (NSAIDs) are associated with a number of risk factors that can heighten a patient’s risk of major toxicity. Researchers reporting in Arthritis and Rheumatology have come up with a scoring system to measure a patient’s risk of developing major toxicity from NSAID use.
“While nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly used in rheumatology, they can cause major toxicity. Improving the risk/benefit ratio requires a more precise understanding of risk,” wrote researchers who were led by Daniel H. Solomon, M.D., MPH, Brigham and Women’s Hospital, Boston.
The risk score is designed to predict the chances of a patient developing a major toxicity―such as major adverse cardiovascular events, acute kidney injury, significant gastrointestinal events and mortality―within the first year of taking NSAIDs.
The data for this study was based on the results of previously published randomized controlled clinical trials that included 23,735 patients with osteoarthritis or rheumatoid arthritis. Patients were randomized to receive celecoxib, naproxen or ibuprofen at typically prescribed dosages.
The conditions and circumstances of patients prior to taking NSAIDs could serve as potential predictors of major toxicity, the authors wrote. So, the scoring system included these factors, which included: age, male sex, history of cardiovascular disease, hypertension, diabetes mellitus, tobacco use, statin use, elevated serum creatinine level, hematocrit level, and type of arthritis. Other factors that were considered, included medication use, such as low-dose aspirin for cardiovascular prevention, statins and lipid-lowering medications, or glucocorticoids.
Of 23,735 patients, the one-year risk of major toxicity for NSAID arthritis users was found to be:
- 1–4 percent for 16,273 (68.6 percent) patients
- More than 4 percent for 6,382 (26.9 percent) patients
- Less than 1 percent for 1,080 (4.6 percent) patients
A risk of less than one percent was considered acceptable, but a one-year risk of greater than 4 percent was considered to be too high to suggest taking an NSAID, the authors wrote. For patients with an intermediate risk of between 1-4 percent―which was most patients―the decision to take a NSAID should be determined on a case-by-case basis.
“The risk score accurately categorizes the 1‐year risk of major toxicity among NSAID users and may be useful in identifying patients who can safely use these agents,” the authors wrote. “External validation will be important, but the split-sampling and large cohort in this study suggest that the risk score is likely to be useful in stratifying patients. Testing the risk score in populations that are not receiving proton-pump inhibitors, those with a different distribution of risk factors (i.e., fewer CV risk factors), and patients with different underlying causes of chronic pain will help determine the external validity and generalizability of the risk score.”
Solomon D, Shaw M, Wolski K, et al. “Derivation and Validation of a Major Toxicity Risk Score Among Nonsteroidal Antiinflammatory Drug Users Based on Data From a Randomized Controlled Trail.” Arthritis & Rheumatology (2019), doi: 10.1002/art.40870.