CHICAGO -- Merck & Co.'s Arcoxia, a successor to the company's withdrawn Vioxx pain pill, posed the same heart risks in a study as an older arthritis medication. The finding may hinder US approval, a top heart doctor says.
The trial of 34,701 patients, presented yesterday at the American Heart Association meeting , found that those given Arcoxia had the same rate of cardiovascular complications as diclofenac, a decades-old therapy that reduces inflammation. The study also found more patients stopped taking the Merck pill because of high blood pressure.
Merck faces more than 23,000 lawsuits over Vioxx, pulled from the market in 2004 after being tied to higher heart- attack and stroke risks. The Food and Drug Administration the same year rejected Merck's Arcoxia application, asking for more safety data. Merck submitted the diclofenac comparison as part of that review, though some experts now say the results may not persuade the FDA of Arcoxia's safety.
"Showing that you're not inferior to diclofenac doesn't make this an approvable drug," said Steve Nissen, chairman of cardiology at the Cleveland Clinic, the top heart hospital in a US News & World Report ranking. "I think it's nonapprovable," Nissen said Thursday .
Merck said last week it is seeking FDA approval of Arcoxia to treat osteoarthritis, a narrower use than the company sought in 2003. At that time, Merck also asked to have Arcoxia approved to treat six other conditions . The FDA is due to decide on the application in April , the company said last week.
Among patients taking the largest dose of Arcoxia, 90 milligrams, there was also more edema, or fluid retention, and a higher incidence of heart failure, the study found.
Arcoxia is from a class of arthritis medications called Cox-2 inhibitors. The group includes Pfizer Inc.'s Celebrex . Arcoxia is already available in 62 countries and generated sales of $218 million last year.