Women under-represented in heart drug trials
Posted on: Tuesday, 2 August 2005, 06:22 CDT
LONDON (Reuters) - Women are under-represented in clinical trials of heart drugs, leaving doctors in the dark as to how treatments may work differently in their bodies, scientists said on Tuesday.
Hormones, body weight and other biochemical factors all mean men and women often respond differently to pharmaceuticals. Yet research on heart disease is skewed heavily toward men.
This is mainly because cardiovascular conditions are erroneously perceived as "male" diseases, according to Dr Verena Stangl of the Charite Hospital, Humboldt-University Berlin, Germany.
"Because too few women participate in heart disease trials we are not sure whether they really benefit from some therapeutic strategies that have shown clinical benefit in trials conducted predominantly in men," she said.
"So, we prescribe drugs to women adapted from evidence-based data obtained from studies conducted mainly in men and we do not really know whether we help or harm the female patients."
Stangl and colleagues reached their conclusions, which were published in the European Heart Journal, after a lengthy review of articles on female-specific aspects of drug therapy.
Her call for increasing the numbers of women in heart trials was backed by a editorial in the journal, which is published by the European Society of Cardiology.
Dr Silvia Priori, associate professor of cardiology at the University of Pavia, Italy, said research showed that of 300 new drugs filed for approval in the United States between 1995 and 2000, only 163 included an analysis by gender.
Yet 11 of the drugs showed a difference in the way a woman's body dealt with the drugs compared with a man's.
Already known gender differences include the fact that women are twice as likely as men to develop a persistent cough if given ACE inhibitors for high blood pressure.
And researchers say that aspirin, while proven to help reduce the risk of heart attacks in men, is of a questionable benefit as a primary preventive in women.
Source: REUTERS
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