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Previous Volume 343:475-480 August 17, 2000 Number 7 Next

	Full Text PDF Editorial by Buring, J. E. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited PubMed Citation

ABSTRACT

Background With the recognition that certain aspects of cardiovascular disease are specific to sex, the U.S. government has sought to ensure that federally funded clinical research yields adequate high-quality information about heart disease in women.

Methods We tabulated the numbers of men and women in cardiovascular clinical trials funded by the National Heart, Lung, and Blood Institute (NHLBI) between 1965 and 1998, recording both total numbers and the numbers for each type of cardiovascular disease. We analyzed the data according to the sex-specific prevalence of disease and assessed changes in enrollment over time. We performed a similar analysis after excluding all single-sex trials.

Results A total of 398,801 subjects (215,796 women and 183,005 men) were enrolled in NHLBI-funded studies of cardiovascular disease. The overall enrollment rate for women (54 percent) exceeded the prevalence of cardiovascular disease in women in the general population (49 percent) and increased over time (P=0.002). With single-sex trials excluded, the enrollment rate for women was 38 percent, which did not change significantly over time. In studies of coronary artery disease and hypertension the rates of enrollment of women were similar to or exceeded the prevalence of these disorders in women. The enrollment rate increased significantly over time in studies of coronary artery disease (P<0.001) but not in studies of hypertension or arrhythmia. Women were underenrolled in studies of heart failure, and the rate of enrollment did not change significantly over time. When single-sex trials were excluded from the analysis of enrollment rates according to the prevalence of disease, the results were similar. There was no change in enrollment rates over time for any category of disease.

Conclusions Federal efforts to increase the representation of women in clinical trials have been moderately successful primarily because of the institution of a small number of large, single-sex trials involving coronary artery disease. There has been no change in the sex composition of cohorts in the majority of studies 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.

Full Text of this Article

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Enrollment of Women in Cardiovascular Clinical Trials
Meinert C. L., Gilpin A. K., Cheung A. M., Naglie G., Douglas P. S.
Extract | Full Text  
N Engl J Med 2000; 343:1972-1973, Dec 28, 2000. Correspondence

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