Women and research on cardiovascular diseases in Europe: a report from the European Heart Health Strategy (EuroHeart) project

Abstract

Cardiovascular diseases represent the major cause of mortality in women and in men.1,2 However, gender differences in the clinical presentation of cardiovascular diseases have been demonstrated3 and some therapeutic options may not be equally effective and safe in men and women.4 Furthermore, gender differences in pharmacokinetics and pharmacodynamics may contribute to a different response to cardiovascular drugs in women when compared with men.5,6 Accordingly, preventive and therapeutical interventions should be tested in populations that fairly represent the gender distribution. In contrast, under-representation of women in cardiovascular trials has been clearly demonstrated in the past. The European Heart Health Strategy (EuroHeart) project of the European Society of Cardiology (ESC) and the European Heart Network (EHN), co-funded by the European Commission, addressed the issue of women representation in cardiovascular clinical research in Europe. The enrolment of women in cardiovascular clinical trials funded by the NHLBI was 38% between 1965 and 19987 and 27% between 1997 and 2006.8 Furthermore, only 13 of 19 studies reported gender-based outcomes. In the European cardiovascular clinical trials of the same period, the proportion of women enrolled varied between 16 and 25%, although the female prevalence of clinical conditions under study in the general population was similar to that of men. In 2005, the European Medicines Agency and the ESC Policy Conference on Cardiovascular Diseases in Women recommended a significant representation of women in clinical trials.3 The current representation of women in European cardiovascular research has been assessed in the EuroHeart project. Observational studies; randomized clinical trials, including meta-analyses; European registries; Guidelines and Statements of European Scientific Societies, published between 2006 and June 2009, have been analysed, focusing on the number and percentage of women enrolled, age of participants, time of follow-up, availability of the analysis of …