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Heart experts say Merck arthritis drug too risky





April 05, 2007

By Ransdell Pierson

NEW YORK (Reuters) - Two prominent U.S. heart experts said studies of Merck & Co. Inc. arthritis drug Arcoxia revealed risks that should prevent its approval in the United States and that the drug posed unacceptable dangers in the 63 countries where it is already sold. The concerns were expressed on Thursday by Steven Nissen, head of cardiology at the Cleveland Clinic, and Dr. Curt Furberg, a professor of public health at Wake Forest University who is a member of the Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration.

Nissen and Furberg said in interviews they were concerned that patients taking Arcoxia in a large international trial had a higher incidence of edema, elevated blood pressure and congestive heart failure than patients taking the standard treatment, diclofenac. "All versions of Arcoxia should be taken off the market now," said Furberg. He and Nissen had been outspoken critics of Merck's older arthritis drug, Vioxx, before it was withdrawn in September 2004 based on evidence of heart attacks and strokes in long-term users. "This is a genie I don't want to see let out of the bottle," said Nissen, a recent president of the American College of Cardiology who predicted the FDA will refuse to approve the medicine.

BENEFITS VS RISK

Merck spokesman Chris Loder said he disagreed with Nissen's and Furberg's assessment. "The product has been evaluated and re-evaluated by regulators in 63 countries, including the European Union," said Loder. He said regulators continue to believe the drug's benefits outweigh its risks.





Arcoxia, which works through the same mechanism as Vioxx, is awaiting U.S. approval for treatment of osteoarthritis and had 2006 global sales of $265 million. The so-called "MEDAL" international Arcoxia trial, whose more than 34,000 participants make it one of the largest cardiovascular safety studies ever conducted, showed that patients taking Arcoxia had a similar number of heart attacks and strokes as those taking diclofenac. The drug thereby met its primary goal of the study.

But more than twice as many arthritis patients taking the highest 90-milligram dose of Arcoxia developed congestive heart failure -- a dangerous condition in which the heart is unable to adequately pump blood -- than those taking diclofenac.

Moreover, roughly twice as many patients on the 90 milligram dose of Arcoxia dropped out of the trial because of edema, swollen tissues that are also a sign of possible heart damage. That is the approved dose overseas for rheumatoid arthritis, the potentially crippling and less-common inherited form of arthritis. Smaller 30-milligram and 60-milligram doses are used to treat osteoarthritis, the more common form of arthritis caused by wear and tear of joints.

Similarly, roughly twice as many patients given the 90-milligram dose of Arcoxia dropped out of the trial due to increases in blood pressure. And a significantly higher percentage taking the 60-milligram dose of Arcoxia also dropped out due to elevated blood pressure.

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