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Reuters are reporting: Study of Vioxx successor yields mixed results
Quote:
NEW YORK (Reuters) - Merck & Co. on Wednesday said a study showed its experimental arthritis drug, Arcoxia, met its main goal of causing no more blood clot-related heart attacks than a standard treatment, but more patients taking Arcoxia withdrew from the trial due to serious side effects.
The trial pitted two different doses of Arcoxia, the planned successor to Vioxx, against diclofenac, a widely used non-steroidal anti-inflammatory drug (NSAID), among patients with osteoarthritis and rheumatoid arthritis.
Vioxx was pulled off the market in 2004 after findings showed it doubled the risk of heart attack and stroke among long-term users.
Arcoxia, like Vioxx, works by blocking an inflammation-causing protein called COX-2. It is sold in 62 countries, including Europe, but has faced lengthy delays in winning U.S. marketing approval. The medicine has annual global sales of about $250 million, or about 10 percent of the annual sales Vioxx once achieved.
Among patients taking Arcoxia in the so-called MEDAL study, the rate of heart attacks and strokes caused by blood clots was similar to that of patients taking diclofenac, according to a preliminary analysis of the new data.
That equivalent risk starkly contrasts with the four-fold higher risk of heart attacks and stroke seen with Vioxx in a major trial, when it was compared with another widely used NSAID called naproxen.
Even so, Merck described worrisome side effects from Arcoxia in the new trial. It said a significantly higher number of patients taking the drug withdrew due to high blood pressure -- itself a major risk factor for heart disease -- than those taking diclofenac.
Moreover, significantly more patients taking the highest dose of Arcoxia dropped out of the trial due to edema -- swelling of tissues -- and more patients taking high-dose Arcoxia developed congestive heart failure than those taking diclofenac.
Edema typically accompanies congestive heart failure, a condition in which the weakened heart cannot adequately pump blood to the rest of the body.
Significantly more people taking diclofenac dropped out because of gastrointestinal and liver problems than those taking Arcoxia.
"The major concern is the higher hypertension and edema that caused discontinuation (among Arcoxia users)," said Shaojing Tong, an analyst at Mehta Partners. "With these kinds of side effects, I don't think they would pursue further in the U.S. market." ...
Study of vioxx succesor
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