CORRESPONDENCE: LETTER TO THE EDITOR
The Need for Sex-Specific Data Prior to Food and Drug Adminstration Approval
Sanket S. Dhruva, MD and
Rita F. Redberg, MD, MSc*
* Department of Medicine, University of California, San Francisco, 505 Parnassus Avenue, Suite M-1180, San Francisco, California 94143-0124 (Email: redberg{at}medicine.ucsf.edu).
We read with great interest the recent paper by Hsich and Piña (1) that examined the many aspects in which we lack data for heart failure in women. We wholeheartedly agree that heart failure trials must include more women and must provide more sex-specific data, and we further believe that there must be evidence of net benefit in women before Food and Drug Administration approval for devices to be implanted in critically ill patients.
For example, the authors mention that the recent approval of the Thoratec HeartMate II (Thoratec Corporation, Pleasanton, California) will allow more implantation of ventricular assist devices in women and will provide prospective data through the Interagency Registry for Mechanically Assisted Circulation registry. However, the device was approved based on data from only 44 women, who constituted 23% of the overall study population. The Food and Drug Administration's Summary of Safety and Effectiveness Data for this device noted that the small number of women "makes it difficult to draw any conclusions regarding differences in safety profile of the device between men and women" (2). Even so, it is worrisome that women had an increased rate of some important adverse events, including a 3-fold higher incidence of stroke (18% vs. 6% in men) and trends toward a higher incidence of bleeding and infection events. These risks may be worthwhile if the device had proven benefit, but it is concerning that the device's success rate did not meet the pre-specified end point for success (2).
Therefore, we agree with the authors that a post-approval registry to collect data on outcomes in women for this device will provide needed information. However, requiring evidence of benefit in women before Food and Drug Administration approval for implanted devices would be an important step toward ensuring that we are providing safe care for women with heart failure.
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References
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1. Hsich EM, Piña IL. Heart failure in women: a need for prospective data J Am Coll Cardiol 2009;54:491-498.[Abstract/Free Full Text]2. Summary of Safety and Effectiveness Data. PMA 060040. Thoratec HeartMate® II Left Ventricular Assist System (LVAS). April 2008 http://www.accessdata.fda.gov/cdrh_docs/pdf6/P060040b.pdf 2009Accessed August 10, 2009.
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