Lack of sex-specific safety and efficiency data for high-risk cardiovascular devices
WEDNESDAY, March 2 (HealthDay News) -- There is a lack of sex-specific data relating to the safety and effectiveness of high-risk cardiovascular devices prior to U.S. Food and Drug Administration approval, according to a review published online March 1 in Circulation: Cardiovascular Quality and Outcomes.
Sanket S. Dhurva, M.D., from the University of California in San Francisco, and colleagues systematically reviewed 123 FDA summaries for evidence of details of demographics, remarks on gender bias, and analyses of results by sex for 78 high-risk cardiovascular devices. The devices received FDA premarket approval between 2000 and 2007.
The investigators found that 34 summaries did not detail the sex of the study participants. In studies that reported the sex distribution, an average of 67 percent of the participants were men. There was no change noted in the enrollment of women over time. The relatively low percentage of women was explained in the studies by underlying disease distribution, comparable referral rates for similar procedures, or the reflection of sex distribution in previous trials. There were gender bias comments or analyses in 47 studies (41 percent), and 12 of these found a sex-related difference in device safety or effectiveness.
"Despite federal guidelines, there continues to be a lack of sex-specific reporting of data, which also has been noted in cardiovascular trials," the authors write.
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