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Participation of Women in Clinical Trials Supporting FDA Approval of Cardiovascular Drugs

Journal of the American College of Cardiology, 2018-05, Vol.71 (18), p.1960-1969 [Peer Reviewed Journal]

2018 ;Published by Elsevier Inc. ;Copyright Elsevier Limited May 8, 2018 ;ISSN: 0735-1097 ;EISSN: 1558-3597 ;DOI: 10.1016/j.jacc.2018.02.070 ;PMID: 29724348

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Title:
Participation of Women in Clinical Trials Supporting FDA Approval of Cardiovascular Drugs
Author: Scott, Pamela E. ; Unger, Ellis F. ; Jenkins, Marjorie R. ; Southworth, Mary Ross ; McDowell, Tzu-Yun ; Geller, Ruth J. ; Elahi, Merina ; Temple, Robert J. ; Woodcock, Janet
Subjects: Acute coronary syndromes ; Age ; Angina pectoris ; Cardiac arrhythmia ; Cardiology ; Cardiovascular disease ; Cardiovascular diseases ; cardiovascular diseases/therapy ; Clinical trials ; Coronary artery ; Coronary artery disease ; Coronary vessels ; Descriptive labeling ; drug efficacy ; drug safety ; Drugs ; Effectiveness ; Enrollments ; FDA approval ; Fibrillation ; Food and Drug Administration ; Gender ; Gender aspects ; Gender differences ; Heart attacks ; Heart diseases ; Heart failure ; Hypertension ; Mathematical analysis ; Medical research ; Myocardial infarction ; Patients ; Pulmonary hypertension ; Regulatory agencies ; Representations ; Safety ; Sex differences ; Womens health ; women’s health
Is Part Of: Journal of the American College of Cardiology, 2018-05, Vol.71 (18), p.1960-1969
Description: Concerns exist that women are underrepresented in trials of cardiovascular medications. The authors sought to examine women’s participation and the reported safety and efficacy by gender for pivotal cardiovascular disease (CVD) trials submitted to the U.S. Food and Drug Administration (FDA) supporting marketing applications. On the basis of publicly available FDA reviews, the authors assessed enrollment of women in trials supporting 36 drug approvals from 2005 to 2015. Prevalence-corrected estimates for the participation of women were calculated as the percentage of women among trial participants divided by the percentage of women in the disease population (participation to prevalence ratio [PPR]), with a range between 0.8 and 1.2 reflecting similar representation of women in the trial and disease population. Sex differences in efficacy and safety were assessed. The proportion of women enrolled ranged from 22% to 81% (mean 46%). The calculated PPR by disease area was within or above the desirable range for atrial fibrillation (0.8 to 1.1), hypertension (0.9), and pulmonary arterial hypertension (1.4); PPR was <0.8 for heart failure (0.5 to 0.6), coronary artery disease (0.6), and acute coronary syndrome/myocardial infarction (0.6). The authors found little indication of clinically meaningful gender differences in efficacy or safety. Gender differences in efficacy or safety were described in labeling for 4 drugs. Women were well represented in trials of drugs for hypertension and atrial fibrillation, and overrepresented for pulmonary arterial hypertension. Representation of women fell below a PPR of 0.8 for trials in heart failure, coronary artery disease, and acute coronary syndrome. Minimal gender differences in drug efficacy and safety profiles were observed. [Display omitted]
Publisher: United States: Elsevier Inc
Language: English
Identifier: ISSN: 0735-1097
EISSN: 1558-3597
DOI: 10.1016/j.jacc.2018.02.070
PMID: 29724348
Source: Geneva Foundation Free Medical Journals at publisher websites
Alma/SFX Local Collection

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Participation of Women in Clinical Trials Supporting FDA Approval of Cardiovascular Drugs

2018 ;Published by Elsevier Inc. ;Copyright Elsevier Limited May 8, 2018 ;ISSN: 0735-1097 ;EISSN: 1558-3597 ;DOI: 10.1016/j.jacc.2018.02.070 ;PMID: 29724348

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