Not enough women take part in heart drug trials

Aug 3 2005

Scientists say because women are under-represented in the clinical trials of heart drugs, doctors are left in the dark as to how treatments may work differently in their bodies.

Apparently hormones, body weight and other biochemical factors mean men and women often respond differently to pharmaceuticals, and yet research on heart disease is heavily balanced towards men.

According to Dr Verena Stangl of the Charite Hospital, Humboldt-University in Berlin, this is mainly because cardiovascular conditions are erroneously perceived as "male" diseases.

She says because too few women participate in heart disease trials it is unsure whether they really benefit from some therapeutic strategies that have shown clinical benefit in trials conducted predominantly in men.

Consequently drugs are prescribed to women which are adapted from evidence-based data, obtained from studies conducted mainly in men, and it is not really known whether they help or harm the female patient.

Stangl and colleagues reached their conclusions after a lengthy review of articles on female-specific aspects of drug therapy.

Stangl's call for increasing the numbers of women in heart trials is supported by an 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, says research has shown that of 300 new drugs filed for approval in the United States, between 1995 and 2000, only 163 included an analysis by gender, and yet 11 of the drugs showed a difference in the way a woman's body dealt with the drugs compared with a man's.

One of the already known gender differences includes 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.

The research is published in the European Heart Journal.