Swollen joints, anti-inflammatories are hard on the heart

The anti-inflammatory drugs used by osteoarthritis and rheumatoid arthritis patients could be increasing their risk of cardiovascular disease (CVD).

A 10-year trial involving patients from 13 countries examined the safety and effect of nonsteroidal anti-inflammatory drugs and COX-2-specific inhibitors, according to new research findings that will be presented this week at the 2016 ACR/AHRP Annual Meeting.

Researchers at the Cleveland Clinic Coordinating Center for Clinical Research—in collaboration with colleagues at Brigham and Women’s Hospital—conducted the PRECISION trial, which included 24,000 patients at 923 study sites.

Participants were required to have a known history of cardiovascular events, including myocardial infarction, stroke or coronary revascularization.

Ninety percent of the enrolled patients in the trial and final analysis had osteoarthritis and 10 percent had rheumatoid arthritis. Age and gender distribution did not differ by NSAID treatment assignment. Adherence was 80 percent over at least six months of follow-up, with a median follow-up of 18 months. Cardiovascular, gastrointestinal and renal adverse events and all-cause mortality were analyzed for both subjects with osteoarthritis and rheumatoid arthritis by treatment arms.

"The results of the PRECISION trial offer clinicians increased detail on how to monitor patients who take chronic NSAIDs with a more individualistic approach," said M. Elaine Husni, MD, vice chair, department of rheumatic and immunologic diseases; director at the Cleveland Clinic.

There is an ongoing debate over the benefits and risks of using non-steroidal anti-inflammatory drugs for patients with osteoarthritis and rheumatoid arthritis. Studies have demonstrated adverse cardiovascular outcomes. This lead to the withdrawal of the selective COX-2 inhibitor rofecoxib in 2004.

In response, the FDA mandated cardiovascular safety trial for the remaining selective COX-2 inhibitor, celecoxib. The PRECISION trial was intended to determine whether celecoxib shares the same cardiovascular toxicity observed in the rofecoxib trials using a non-inferiority trial design.

Results will be available at the late-breaking clinical trial presentation on Nov. 15 at 4:30 p.m. (EST).