AHA: Arcoxia (etoricoxib) May Not Increase Risk of Cardiovascular Events

November 13, 2006

CHICAGO -- Arcoxia (etoricoxib), an investigational Cox-2 inhibitor, has a cardiovascular safety profile similar to diclofenac, an old line NSAID, according to pooled data on almost 35,000 arthritis patients.

CHICAGO, Nov. 13 -- Arcoxia (etoricoxib), an investigational Cox-2 inhibitor, has a cardiovascular safety profile similar to diclofenac, an old line NSAID, according to pooled data on almost 35,000 arthritis patients.

After an average of 18 months treatment with drug, 320 patients treated with Arcoxia and 323 patients in the diclofenac group had thrombotic cardiovascular events, said Christopher P. Cannon, M.D., of Brigham and Women's Hospital in Boston, lead author of the MEDAL (Multinational Etoricoxib and Diclofenac Arthritis Long-term) study.

Dr. Cannon reported the results today at a late-breaking clinical trials plenary session at the American Heart Association meeting here. Simultaneously, the findings were published online by The Lancet.

The event rate was 1.24 per 100 patient years for Arcoxia and 1.30 per 100 patient years for diclofenac, with a hazard ratio of 0.95 (95% CI 0.81-1.11) for Arcoxia compared with diclofenac, he said.

MEDAL was a pre-specified pooled analysis from three trials of 24,913 patients with osteoarthritis and 9,787 patients with rheumatoid arthritis.

Patients were randomized to 60 mg or 90 mg of Arcoxia or 150 mg of diclofenac daily. The average treatment duration was 18 months.

It was designed to demonstrate non-inferiority of Arcoxia as measured by the hazard ratio for thrombotic cardiovascular events.