Vraagtekens bij nieuwe pijnstiller.*
De ontstekingsremmer en pijnstiller Arcoxia kan volgens prominente Amerikaanse deskundigen beter van de markt worden gehaald. Uit een internationale trial onder ruim 34.0000 gebruikers, de grootste ooit gehouden naar de veiligheid voor hart en bloedvaten, blijkt dat in vergelijking met de pijnstiller diclofenac de kans op hartfalen ruim 2x zo groot is. Verder stopten ruim 2x keer zoveel mensen met de trial als gevolg van oedeem, ook een voorbode van hartproblemen, of ten gevolge van hoge bloeddruk.
Heart
experts say Merck arthritis drug too risky
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 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withdrawn in September 2004 based on evidence of heart attacks and strokes in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. (April 2007) (Opm. Al jaren is bekend dat Diclofenac, ook genaamd Voltaren, ook al de nodige bijwerkingen geeft. In dit nieuws vindt u daar verschillende artikelen over. Meer over gezonde natuurlijke oplossingen bij ontstekingen, artrose en artritis.)