Author + information
- Eileen Hsich, MD* ( and )
- Ileana Piña, MD
- ↵*Department of Cardiovascular Medicine, Section of Heart Failure and Cardiac Transplant Medicine, Cleveland Clinic, 9500 Euclid Avenue, J3-4, Cleveland, Ohio 44195
We appreciate the insightful remarks of Drs. Dhruva and Redberg on our paper (1). We agree that to improve health care for women, we need better reporting of sex-specific results, enrollment of women commensurate with the prevalence of disease, and evidence of net benefit before approval of therapy. The Thoratec HeartMate II (Thoratec Corporation, Pleasanton, California) is a perfect example of this dilemma. There was an under-representation of women in the trial and a trend toward more adverse events. However, the paucity of women prevented a final conclusion. Unfortunately, there was also no alternative life-saving therapy for small women when medical therapy failed and such patients needed long-term mechanical support to bridge them to transplantation. Even pulsatile mechanical devices have a higher incidence of neurologic events and bleeding in women compared with men, which further emphasizes the lack of alternative therapy and the need to better understand sex differences (2). The National Institutes of Health-sponsored Interagency Registry for Mechanically Assisted Circulation database will enable us to follow sex differences prospectively. Because the Thoratec HeartMate II is being used more extensively, the data will continue to accumulate, and sex-specific results will become available.
This dilemma is not unique to heart failure and must change to reduce the cardiovascular disease mortality rate in women. In a study by Blauwet et al. (3) that included 628 cardiovascular trials, only 24% provided sex-specific results. The highest percentage of reporting was in National Institutes of Health-sponsored studies (51% vs. 22%) and those published in general medicine journals when compared with cardiovascular journals (37% vs. 23%). Kim et al. (4) subsequently published a study concentrating on National Heart, Lung, and Blood Institute-funded cardiovascular phase 3 and 4 trials. The mean enrollment of women was lower than the percentage of women with that disease, and 6 of 19 trials did not even publish sex-specific results. This is a disappointment given the federal mandate that requires women and minorities to be included in phase 3 and 4 clinical trials in sufficient numbers to determine the effectiveness of a medical intervention (5).
The effectiveness of any therapy for women can be assessed only if sufficient numbers of women are included in clinical trials. We concur that it would be best to show benefit before approval of any new therapy and that following a post-approval registry is a suboptimal alternative. To make it easier to enroll more women, national organizations should launch educational campaigns to the public regarding the lack of evidence-based sex- and minority-specific therapy. Given the success of the Red Dress Campaign to increase awareness that women are more likely to die of cardiovascular disease than of breast cancer, a similar campaign requesting them to volunteer rather than wait to be approached may be beneficial.
- American College of Cardiology Foundation
- Hsich E.M.,
- Piña I.L.
- Interagency Registry for Mechanically Assisted Circulation (INTERMAC)
- Kim E.S.,
- Carrigan T.P.,
- Menon V.
- ↵U.S. Congress Public Law No. 103-43. National Institutes of Health Revitalization Act of 1993. June 10, 1993.