Enrollment of women in cardiovascular drug trials reviewed by FDA from 2007 to 2008

1. Enrollment of women in cardiovascular drug trials reviewed by FDA from 2007 to 2008 Umarjee S., Lemtouni S., Fadiran E., Parekh A. Office of Women’s Health, Office of the Commissioner, Food and Drug Administration. Abstract Results – Demographics of subjects in all cardiovascular drug trials Results – Demographics of subjects in cardiovascular drug trials by indication Results – Demographics of subjects in cardiovascular drug trials by indication (continued) By Sex: By Sex: Purpose. Cardiovascular disease is the number one killer of women. Yet, historically, women were either excluded or under-represented in cardiovascular drug (CVD) clinical trials in the United States. The US FDA has made a conscious effort to ensure that women are adequately represented in CVD, and other, clinical trials. Progress has been made since the 1992 GAO Report, and having regulations and guidances on the reporting of data by sex has helped. The purpose of this study was to assess the participation of women in the FDA-reviewed CVD trials from 2007 to 2008. Methods. FDA clinical reviews of efficacy and safety data for 35 New Drug Applications (NDAs) submitted from Jan. 2007 to Dec. 2008 were reviewed to evaluate participation in the clinical trials by age, race, and sex. Results. Drugs reviewed were indicated for pulmonary arterial hypertension, (PAH, 4 NDAs), hypertension (HTN, 13 NDAs), acute coronary syndrome (ACS, 5 NDAs), heart failure (HF, 3 NDAs), arrhythmia (3 NDAs), and other conditions (7 NDAs). Data (Table 1 below) demonstrate that women are still under-represented in some cardiovascular areas. Hypertension drug trials enrolled nearly equal percentages of women and men. PAH trials enrolled nearly twice as many women as men; however, this imbalance is reflective of the disease prevalence. ACS, HF, and anti-arrhythmic drug trials included far more men than women. Both ACS and HF have a slightly higher prevalence in men than women (age may also be a confounding factor), but may not be enough to justify the sex disparity in enrollment. By Race: Table 1. Enrollment in clinical trials of various indications by sex. By Age: Note: “Other” includes subjects for whom race was unspecified, and who may belong to one of the other four races. 282 (1.39%) 5258 (25.83%) 14820 (72.79%) Conclusions By Age: • Hypertension drug trials enrolled nearly equal percentages of women and men. • PAH included nearly twice as many females as males. This imbalance is reflective of the difference in prevalence between the two sexes. • ACS, HF, and anti-arrhythmic drug trials included far more men than women. Both ACS and HF have a slightly higher prevalence in men than women, but not enough to justify the sex disparity in enrollment. • Sex, and especially age and race, should be reported in a more uniform format. For example, certain studies only reported race as “Caucasian,” “Black,” or “Other,” while others reported the enrollment of several different races. • The inclusion of women in clinical trials for CVDs has improved over the years although an imbalance still exists. The data from this study show that enrollment of women in clinical drug trials for ACS and HF, two serious public health conditions in aging women, was not proportional to the prevalence of these conditions in them. Unknown (%) 4,198 (2.13%) 835 (6.25%) 2,331 (5.96%) 742 (0.78%) 282 (1.39%) 0 (0%) 8 (0.05%) Note: Age demographics were not available for all studies. Conclusion. The inclusion of women in clinical trials for CVDs has improved over the years although an imbalance still exists. The data from this study show that women continue to be under-represented in the clinical trials of drugs for certain cardiovascular diseases. By Race: Objectives • Awareness of the differences between men and women in enrollment in cardiovascular drug trials. • Recognition of the need for inclusion levels in cardiovascular drug trials to be proportional to the prevalence of the disease by sex. Note: “Other” includes subjects for whom race was unspecified, and who may belong to one of the other four races. Note: Age demographics were not available for all studies.