Background With the recognition that certain aspects of cardiovasculardisease are specific to sex, the U.S. government has soughtto ensure that federally funded clinical research yields adequatehigh-quality information about heart disease in women.
Methods We tabulated the numbers of men and women in cardiovascularclinical trials funded by the National Heart, Lung, and BloodInstitute (NHLBI) between 1965 and 1998, recording both totalnumbers and the numbers for each type of cardiovascular disease.We analyzed the data according to the sex-specific prevalenceof disease and assessed changes in enrollment over time. Weperformed a similar analysis after excluding all single-sextrials.
Results A total of 398,801 subjects (215,796 women and 183,005men) were enrolled in NHLBI-funded studies of cardiovasculardisease. The overall enrollment rate for women (54 percent)exceeded the prevalence of cardiovascular disease in women inthe general population (49 percent) and increased over time(P=0.002). With single-sex trials excluded, the enrollment ratefor women was 38 percent, which did not change significantlyover time. In studies of coronary artery disease and hypertensionthe rates of enrollment of women were similar to or exceededthe prevalence of these disorders in women. The enrollment rateincreased significantly over time in studies of coronary arterydisease (P<0.001) but not in studies of hypertension or arrhythmia.Women were underenrolled in studies of heart failure, and therate of enrollment did not change significantly over time. Whensingle-sex trials were excluded from the analysis of enrollmentrates according to the prevalence of disease, the results weresimilar. There was no change in enrollment rates over time forany category of disease.
Conclusions Federal efforts to increase the representation ofwomen in clinical trials have been moderately successful primarilybecause of the institution of a small number of large, single-sextrials involving coronary artery disease. There has been nochange in the sex composition of cohorts in the majority ofstudies of cardiovascular disease.
Source Information
From Yale College, New Haven, Conn. (D.J.H.); and the Section of Cardiovascular Medicine, Department of Medicine, University of Wisconsin School of Medicine, Madison (P.S.D.).
Address reprint requests to Dr. Douglas at the Section of Cardiovascular Medicine, University of Wisconsin School of Medicine, 600 Highland Ave., Madison, WI 53792, or at psd{at}medicine.wisc.edu.
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