Author Interviews, Gender Differences, Heart Disease, JAMA / 25.06.2014
Heart Failure: Some Women May Benefit More Than Men from CRT-D Therapy
MedicalResearch.com Interview with:
David Strauss, M.D., Ph.D., Senior Author
Medical Officer
Center for Devices and Radiological Health
U.S. Food and Drug Administration, Silver Spring, Md
MedicalResearch: What are the main findings of the study?
Dr. Strauss: The underrepresentation of women in clinical trials for cardiac resynchronization therapy (CRT) devices, as with other devices, has made it difficult to assess differences in the safety and effectiveness of these devices for women vs. men. The FDA is exploring the potential of pooling and analyzing data from multiple trials to bridge the knowledge gap for certain subpopulations (such as women) often underrepresented in medical device clinical trials. By conducting one such meta-analysis, the FDA found that women benefit from cardiac resynchronization therapy (CRT) significantly more than men do.
(more…)