Pfizer Plans Celebrex Heart Study

NEW YORK – Pfizer Inc. on Monday said it is sponsoring a study, expected to begin early next year, to further assess its COX-2 medication Celebrex in osteoarthritis patients at high risk for cardiovascular disease, though it remains confident in the long-term cardiovascular safety of Celebrex.

The study, which will enroll more than 4,000 patients worldwide, is part of a larger program begun more than 18 months ago. Pfizer will discuss the study design with the Food and Drug Administration and other regulatory agencies before finalizing details and start date.

“Our strong confidence in the CV safety of Celebrex is based on the substantial body of experience that has accumulated over several years in multiple completed studies and ongoing trials,” said Joseph Feczko, president of worldwide development, in a statement. “In fact, small mechanistic studies suggest that Celebrex’s anti-inflammatory properties as well as additional unique Celebrex-specific characteristics may improve vascular function in patients with established coronary artery disease.”

Earlier this month, Merck & Co. withdrew its Vioxx product on increased risk of heart attack and stroke. Last week Pfizer warned that patients taking its own Bextra drug – in the same class of anti-inflammatories as both Vioxx and Celebrex – may also have an increased risk of stroke and heart attack.

Pfizer said more than 27 million patients in the United States have been prescribed Celebrex, which was approved by the FDA 1998. Patients treated in clinical studies of up to four years show no increased safety concerns.