Celecoxib Seems to Carry No Greater CV Risk Than Nonselective NSAIDs in Patients with Arthritis

By Amy Orciari Herman

Edited by Susan Sadoughi, MD, and André Sofair, MD, MPH

The COX-2 inhibitor celecoxib does not confer greater cardiovascular risk than nonselective nonsteroidal anti-inflammatory drugs (NSAIDs) in patients with arthritis, according to an industry-supported, noninferiority trial. The findings were published on Sunday in the New England Journal of Medicine and presented at the American Heart Association's annual meeting in New Orleans.

Over 24,000 adults who required daily NSAID treatment for arthritis pain and had elevated CV risk were randomized to receive celecoxib (100 mg twice daily), ibuprofen (600 mg three times daily), or naproxen (375 mg twice daily). Patients were treated for an average of 20 months and followed for roughly 30 months. Over two-thirds discontinued treatment during the trial.

In the intent-to-treat analysis, the primary composite outcome — CV death, myocardial infarction, or stroke — occurred in 2.3% of the celecoxib group, 2.5% of the naproxen group, and 2.7% of the ibuprofen group. Celecoxib's noninferiority was maintained in the on-treatment analysis.

Dr. Allan Brett, editor-in-chief of NEJM Journal Watch General Medicine, says the findings "should not be interpreted as proving CV safety, since there was no untreated control group for comparison. Therefore, the trial shouldn't really change clinical practice. Patients at high CV risk should generally avoid use of celecoxib or traditional NSAIDs."

Writing in Circulation, Dr. Garret Fitzgerald, a leading authority on NSAIDs, agrees. He notes, "There are so many problems with the interpretation of [this trial] that it fails to inform clinical practice."