Study Will Compare Heart Risk of COX-2 and NSAIDs

December 21, 2005
Pharmaceutical Executive
Volume 0, Issue 0

Doctors and academics are praising Pfizer’s plan to allow the Cleveland Clinic to compare Celebrex with two NSAIDs. Is the company courageous, or is it taking to big of a risk?

A new study aims to finally settle the questions and fears surrounding the only cox-2 inhibitor still on the market, Celebrex (celecoxib). The Clevland Clinic's Cardiovascular Coordinating Center will conduct a trial comparing Celebrex with two NSAIDs -- ibuprofen and naproxen -- among arthritis patients with heart disease.

    Experts are hailing the comparison as an important step in understanding the risks and benefits of common arthritis medications.

    "I think it's a good idea. I'm glad there is going to be a systematic and organized look at the safety and efficacy of these," said Gary Firestein, professor and chief of rheumatology, allergy, and immunology at University of California San Diego. "Right now people are mostly just guessing."

    The Cleveland Clinic will recruit approximately 20,000 participants over 18 months. These patients will participate in the trial for at least two years, until 715 heart events are observed, explained Steven Nissen, lead investigator and medical director of the Cardiac Coordinating Center. He added that the study could be stopped prematurely if a safety monitoring board decides one or more of the drugs are too risky to continue.

    The trial will include primarily patients with heart disease, along with a few who have high risk factors. This is the only way to really get significant data on any heart risks associated with these treatments, explained Nissen, who is also the president-elect of the American College of Cardiology.

    "You can't learn anything if you can't study the population that's actually at risk," he said.

    Glenn Birnbaum, an emergency room physician and medical marketing consultant, said the results of the study would influence prescribing behavior, if they answer the most pressing questions about these products. In addition to comparing efficacy, rate of cardiac side effects, and mortality rates, Birnbaum wants a comparison of the rates of gastrointestinal bleeding.

    Steven Chen, assistant professor at the University of Southern California's School of Pharmacy, is also interested in comparing the safety of these products on the stomach.

    "Celebrex has never been shown to be any safer on the stomach than traditional NSAIDs," he said via e-mail.

    Although Pfizer will provide funding, the study will be governed by an independent board of academics. The members will not be able to accept consulting fees, Nissen said.

    "Maximum transparency is essential," he said. "Public confidence has been really shaken, particularly for clinical trials for this class of drugs."

    Nissen agreed that the trial poses a risk for Pfizer, because no one really knows what the results will indicate and it will cost at least $100 million.

"It's really courageous," he said. "I'm delighted to see that Pfizer is really willing to answer these questions."

    But Chen believes that Pfizer can only gain from the results of this trial. Celebrex has suffered because of the fear associated with COX-2 inhibitor drugs, although it is less specific to the COX-2 enzyme than Bextra or Vioxx are.

    "If Celebrex ends up causing more heart attacks then they might as well forget about making any more money on it, which is where it's headed anyway," he said via e-mail. "If they're able to show that Celebrex is as safe as the other traditional NSAIDs, then Celebrex will make a big comeback."