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Red Alert on Women’s Hearts (WP 6)

Women and Cardiovascular Research in Europe. Click here to download the full report.

Cardiovascular diseases represent the major cause of mortality in women and in men. The results of large randomised clinical trials allowed the introduction of preventive measures and effective treatments with a significant improvement of survival and reduction of disability. However, sex and gender differences in the clinical presentation of cardiovascular diseases have been demonstrated and some therapeutic options may not be equally effective and safe in men and women. Under-representation of women in cardiovascular research has been clearly demonstrated in the past and, recently, efforts to enrol a larger number of women in clinical trials have been made.

One of the objectives of Work Package 6 of the EuroHeart project, conducted jointly by the European Heart Network and the European Society of Cardiology, was to assess the representation of women in cardiovascular research in Europe. A search was conducted in order to identify publications (European or international with European representation) of randomised clinical trials which enrolled women and men or women only.

The 62 randomised clinical trials published since 2006 and analysed here, enrolled overall 380,891 participants and 127,716 were women (33.5%) (See table 1 on page 31 for a summary). Mean age of participants was 66.3 years and mean follow-up 2.7 years. The percentage of women enrolled in each trial ranges from 15% to 60%, but only 31/62 trials (50%) reported the analysis of the results by gender. The representation of women in the clinical trials is not homogeneous. Trials performed on blood pressure-lowering therapies, diabetes, atrial fibrillation and stroke enrolled approximately 40% of women, while trials performed on cholesterol-lowering therapy and on management and treatment of ischemic heart disease and heart failure enrolled about 30% of females.

Most of the clinical trials and metanalyses on cardiovascular diseases did not report a significantly lower efficacy of interventions in the outcomes in women when compared with men. For some therapies there is even a suggestion for greater efficacy in women than in men, as in the case of cardiac resynchronisation therapy in heart failure or thrombolysis after ischemic stroke. Women may have more frequently adverse effects, such as for newer glucose-lowering agents, or in the treatment of acute coronary syndromes, where they appear to be more prone to bleedings. Some trials provided conflicting results in women, for example in the assessment of the efficacy of early-invasive strategies in acute coronary syndromes.

Although gender issues are addressed, Scientific Guidelines do not generally provide specific recommendations for prevention or treatment in women. Thus, despite an increase in the number and proportion of women enrolled in cardiovascular clinical trials, there is still an under-representation of women, particularly in the field of cholesterol lowering therapy, ischemic heart disease and heart failure, which may have affected the reliability of subgroup analysis. Furthermore, approximately 50% of the trials did not report an analysis of the results by gender. Clinical trials enrolling only female patients or clinical trials enrolling a significant proportion of women to allow for prespecified gender analysis should be conducted. Initiatives which contribute to increase the awareness in Europe that cardiovascular diseases are the major cause of death in women and to improve the knowledge of risk factors, presentation and treatment of cardiovascular diseases in women should be encouraged. 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 cardiovascular medicine and a larger representation of women in clinical trials.