HealthDay News — Women are well-represented in some cardiovascular disease clinical trials, but representation of women is low for trials in certain conditions, according to a study published in the May 8 issue of the Journal of the American College of Cardiology.
Pamela E. Scott, Ph.D., from the U.S. Food and Drug Administration in Silver Spring, Md., and colleagues used publicly available FDA reviews to assess enrollment of women in trials supporting 36 cardiovascular medication approvals from 2005 to 2015. They calculated participation-to-prevalence ratio (PPR), and a PPR between 0.8 and 1.2 reflected similar representation of women in the trial and the disease population.
The researchers found that the proportion of women enrolled ranged from 22 to 81 percent (mean, 46 percent). The calculated PPR was within or above the desirable range for atrial fibrillation (0.8 to 1.1), hypertension (0.9), and pulmonary arterial hypertension (1.4) but was low for heart failure (0.5 to 0.6), coronary artery disease (0.6), and acute coronary syndrome/myocardial infarction (0.6). There was little indication of clinically meaningful gender differences in efficacy or safety, with gender differences described in labeling for four drugs.
“More work is needed to identify the factors responsible for under-representation of women in cardiovascular clinical trials and develop gender-focused strategies that enhance their recruitment and participation,” the authors write.