Max
06-14-2002, 02:55 PM
Experts Split on Cox-2 Arthritis Drug Safety Data
Fri Jun 14, 1:25 PM ET
By Richard Woodman
STOCKHOLM (Reuters) - Drugmakers and rheumatologists were split on Friday over how to interpret key data comparing the cardiovascular safety of new Cox-2 inhibitor painkillers against traditional aspirin-like drugs.
The issue has been a hot topic ever since a clinical trial comparing Merck and Co.'s arthritis drug Vioxx against naproxen showed that patients on the older anti-inflammatory medicine suffered fewer blood clots than those taking Vioxx.
It was rekindled at the annual meeting of the European League against Rheumatism in Stockholm, which discussed recent findings showing that the same is true with Merck's follow-on drug Arcoxia for the treatment of acute pain.
The meeting heard that the rate of serious cardiovascular clot-related events in a study involving more than 3,000 patients was about 1.5 per 100 patients per year for those patients on Arcoxia--twice the rate observed for those taking naproxen.
But the rate of adverse events with Arcoxia was no worse than that seen in patients on an inactive placebo, adding apparent weight to the theory that naproxen has a cardioprotective effect similar to aspirin.
Sean Curtis, director of clinical research at Merck, said in an interview that the findings with Arcoxia were "very consistent" with what had been seen with Vioxx.
"What you see is that there is no evidence of a difference against placebo, whereas when you compare it against naproxen there is approximately a twofold difference," he said. "The data support the hypothesis that due to a potent and sustained anti-platelet effect, naproxen is acting like an aspirin and has a cardioprotective effect."
However, Merck announced earlier this week that US regulators had requested extra data, including cardiovascular safety data, on Arcoxia and that it did not now plan to refile the drug until the second half of 2003.
The US company has been in talks with the Food and Drug Administration ( news - web sites) since the withdrawal of the original US application for Arcoxia on March 15. It is now carrying out further trials involving 6,000 patients to answer the safety concerns.
Meanwhile, other researchers told the meeting that their findings refuted the theory that naproxen has a cardioprotective effect and warned that the drug should not be used for this purpose.
Scientists at Stanford University Medical Center, Palo Alto, California said they had found no protective effect from naproxen in patients with rheumatoid arthritis who were not already on aspirin.
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Fri Jun 14, 1:25 PM ET
By Richard Woodman
STOCKHOLM (Reuters) - Drugmakers and rheumatologists were split on Friday over how to interpret key data comparing the cardiovascular safety of new Cox-2 inhibitor painkillers against traditional aspirin-like drugs.
The issue has been a hot topic ever since a clinical trial comparing Merck and Co.'s arthritis drug Vioxx against naproxen showed that patients on the older anti-inflammatory medicine suffered fewer blood clots than those taking Vioxx.
It was rekindled at the annual meeting of the European League against Rheumatism in Stockholm, which discussed recent findings showing that the same is true with Merck's follow-on drug Arcoxia for the treatment of acute pain.
The meeting heard that the rate of serious cardiovascular clot-related events in a study involving more than 3,000 patients was about 1.5 per 100 patients per year for those patients on Arcoxia--twice the rate observed for those taking naproxen.
But the rate of adverse events with Arcoxia was no worse than that seen in patients on an inactive placebo, adding apparent weight to the theory that naproxen has a cardioprotective effect similar to aspirin.
Sean Curtis, director of clinical research at Merck, said in an interview that the findings with Arcoxia were "very consistent" with what had been seen with Vioxx.
"What you see is that there is no evidence of a difference against placebo, whereas when you compare it against naproxen there is approximately a twofold difference," he said. "The data support the hypothesis that due to a potent and sustained anti-platelet effect, naproxen is acting like an aspirin and has a cardioprotective effect."
However, Merck announced earlier this week that US regulators had requested extra data, including cardiovascular safety data, on Arcoxia and that it did not now plan to refile the drug until the second half of 2003.
The US company has been in talks with the Food and Drug Administration ( news - web sites) since the withdrawal of the original US application for Arcoxia on March 15. It is now carrying out further trials involving 6,000 patients to answer the safety concerns.
Meanwhile, other researchers told the meeting that their findings refuted the theory that naproxen has a cardioprotective effect and warned that the drug should not be used for this purpose.
Scientists at Stanford University Medical Center, Palo Alto, California said they had found no protective effect from naproxen in patients with rheumatoid arthritis who were not already on aspirin.
More from > Health - Reuters
Next Story: Gene Key in Weight Gain From Psychiatric Drugs
Fri Jun 14, 1:29 PM ET - (Reuters)