Score May Help Predict Major Adverse CV Event Risk in NSAID Users

FDA: No CV advantage with naproxen
FDA: No CV advantage with naproxen
A risk score may help predict the 1-year risk for major toxicity in patients taking nonsteroidal anti-inflammatory drugs.

A risk score may help predict the 1-year risk for major toxicity in patients taking nonsteroidal anti-inflammatory drugs (NSAIDs), according to a study published in Arthritis & Rheumatology.

Patients with a diagnosis of or risk factors for cardiovascular disease and comorbid osteoarthritis or rheumatoid arthritis were randomly assigned to take celecoxib, naproxen, or ibuprofen. Two cohorts were established: a risk factor derivation and a risk factor validation cohort. The study’s primary outcome was a composite of major toxicity in participants taking NSAIDs.

In the adjusted model, variables found to predict the primary outcome in the derivation cohort included age (hazard ratio [HR], 1.03; 95% CI, 1.02-1.04), male sex (HR, 1.31; 95% CI, 1.02-1.68), history of cardiovascular disease (HR, 2.75; 95% CI, 2.22-3.39), hypertension (HR, 1.33; 95% CI, 1.01-1.76), diabetes (HR, 1.49; 95% CI, 1.21-1.82), tobacco use (95% CI, 1.53; 95% CI, 1.17-1.99), statin use (HR, 1.33; 95% CI, 1.06-1.65), elevated serum creatinine (HR, 2.54; 95% CI, 1.61-4.01), hematocrit (HR, 2.54; 95% CI, 1.61-4.01), and type of arthritis (HR, 1.70; 95% CI, 1.29-2.23). The model was well calibrated, and there was a C-index of 0.73 and 0.71 in the validation cohort and total cohort, respectively. Up to 4.6% of the cohort had a predicted 1-year major toxicity risk <1%, and 68.6% and 26.9% of patients had a predicted risk of 1% to 4% and >4%, respectively.

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The post-hoc nature of the analysis as well as the lack of an external validation cohort represent study limitations.

“Since NSAIDs represent one of the most common drug groups used chronically in the US, safe use of these agents could provide important public health benefits. Moreover, the factors included in the risk score can be gleaned from most electronic medical records, making the dissemination of such a risk score relatively straightforward,” noted the study authors.


Solomon DH, Shao M, Wolski K, Nissen S, Husni ME, Paynter N. Derivation and validation of a major toxicity risk score among NSAID users based on data from a randomized controlled trial [published online February 23, 2019]. Arthritis Rheumatol. doi: 10.1002/art.40870

This article originally appeared on Clinical Pain Advisor