Cardiovascular disease causes 40% of all deaths in the EU but has traditionally been regarded as a male disease, keeping women largely out of clinical trials to develop new drugs.
Yet cardiovascular disease is also the leading cause of death among women and this one-size-fits-all approach is putting women's health at risk, according to experts.
Marco Stramba-Badiale, director of the Department of Geriatrics and Cardiovascular Medicine at IRCCS Istituto Auxologico Italiano in Milan, said regulatory agencies should adopt strict rules on the inclusion of women in clinical trials and a systematic gender analysis.
"The gender balance should become a formal requirement and not only a recommendation for the performance of clinical trials," Stramba-Badiale told EurActiv.
"Scientific societies, patients’ associations and foundations should cooperate with European institutions, national health care authorities and regulatory agencies to promote scientific research on gender issues in medicine and a larger representation of women in clinical trials," Stramba-Badiale added.
A revision of the EU's Clinical Trials Directive is under review by the European Parliament and the Council.
A thorough gender mainstreaming approach in the directive can contribute to achieving more female participation, said Sascha Marschang, policy coordinator for Health Systems at the European Public Health Alliance (EPHA).
"Women should be included in all phases of clinical trials. The gender, age and race dimensions must be considered in clinical trial design and implementation. To me, there’s very little doubt that women should be included in the investigation, recruitment and implementation of clinical trials," Marschang told EurActiv.
The European Institute of Women’s Health (EIWH) supports those calls, saying clinical studies should systematically assess the effects of medicines among men and women.
"The EIWH holds the view that it is important to ensure that men and women are enrolled in clinical trials at all stages of drug development in order to define the risks and benefits associated with drug therapy for both male and female patients," the organisation said.
Since for women, physiological changes and hormonal levels during childbearing years and menopause may affect the efficacy and safety of a drug, the influence of these parameters should be studied during drug development, according to EIWH.
"For a long time, scientists referred to women as a sub-population when in fact women make up over half of the world’s population," EIWH stated.
Marschang said there this has to be addressed through a change in "mentalities".
"From a public health perspective, it is unacceptable that one half of the population is underrepresented in clinical trials when, on the top of that, they have a longer life expectancy than men and consume more medicines," EPHA's policy coordinator.
"It is precisely because of these sex or gender differences that we need to know how medicines affect women and men at different stages of their lives. The barriers need to be tackled," Marschang said.
A leading cause of death
Cardiovascular disease kills 43% in women and 36% in men in the EU, according to a study jointly conducted by the European Society of Cardiology and the European Heart Network.
Coronary heart disease by itself is the most common cause of death in the EU, responsible for more than 681,000 deaths annually. Some 14% of women and 15% of men die from coronary disease but women are much more likely to die within a year of having had a heart attack, Stramba-Badiale said.
The Italian physician says stroke is the second most common cause of death in women and affects more women than men. And although cardiovascular disease has declined over the last 40 years, this decline has been smaller for women. New cases for women are rising, he said, and due to their greater longevity, the CVD burden can be said to have shifted gradually onto women.
The EuroHeart study also showed that only 33% of trials participants are women and that approximately half of the trials did not report an analysis of the results by gender.
Stramba-Badiale said one reason behind women's lower enrolment in cardiovasular disease tests may be due to their "misperception of risk" of cardiovascular diseases, which he said are the main cause of death also in women.