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Though acute coronary syndromes are the leading cause of death in U.S. women, an analysis of clinical trials showed that enrollment among women remained disproportionately low from 1994 to 2010, reported Dr. Kristian Kragholm and coauthors at Duke Clinical Research Institute.
An analysis of data in 76,148 non–ST-segment elevation acute coronary syndrome patients from 11 phase III clinical trials found that women comprised just 33.3% of participants, which did not change significantly over the 17-year period. Women consistently had higher incidence of diabetes, hypertension, and heart failure, the authors reported.
Use of ACE inhibitors/angiotensin II receptor blockers, thienopyridines, beta-blockers, and lipid-lowering drugs significantly increased over time for both sexes, as did use of coronary angiography and percutaneous coronary intervention. Observed in-hospital, 30-day, and 6-month mortality decreased significantly in both men and women, Dr. Kragholm and colleagues said.
The findings suggest that “current efforts to representatively enroll women in NSTE ACS trials are insufficient,” the authors wrote. “Because safety and efficacy findings may differ according to sex, this disparity could undermine generalizability of clinical trial results to treatment of the overall NSTE ACS population.”
Read the full article here.
Though acute coronary syndromes are the leading cause of death in U.S. women, an analysis of clinical trials showed that enrollment among women remained disproportionately low from 1994 to 2010, reported Dr. Kristian Kragholm and coauthors at Duke Clinical Research Institute.
An analysis of data in 76,148 non–ST-segment elevation acute coronary syndrome patients from 11 phase III clinical trials found that women comprised just 33.3% of participants, which did not change significantly over the 17-year period. Women consistently had higher incidence of diabetes, hypertension, and heart failure, the authors reported.
Use of ACE inhibitors/angiotensin II receptor blockers, thienopyridines, beta-blockers, and lipid-lowering drugs significantly increased over time for both sexes, as did use of coronary angiography and percutaneous coronary intervention. Observed in-hospital, 30-day, and 6-month mortality decreased significantly in both men and women, Dr. Kragholm and colleagues said.
The findings suggest that “current efforts to representatively enroll women in NSTE ACS trials are insufficient,” the authors wrote. “Because safety and efficacy findings may differ according to sex, this disparity could undermine generalizability of clinical trial results to treatment of the overall NSTE ACS population.”
Read the full article here.
Though acute coronary syndromes are the leading cause of death in U.S. women, an analysis of clinical trials showed that enrollment among women remained disproportionately low from 1994 to 2010, reported Dr. Kristian Kragholm and coauthors at Duke Clinical Research Institute.
An analysis of data in 76,148 non–ST-segment elevation acute coronary syndrome patients from 11 phase III clinical trials found that women comprised just 33.3% of participants, which did not change significantly over the 17-year period. Women consistently had higher incidence of diabetes, hypertension, and heart failure, the authors reported.
Use of ACE inhibitors/angiotensin II receptor blockers, thienopyridines, beta-blockers, and lipid-lowering drugs significantly increased over time for both sexes, as did use of coronary angiography and percutaneous coronary intervention. Observed in-hospital, 30-day, and 6-month mortality decreased significantly in both men and women, Dr. Kragholm and colleagues said.
The findings suggest that “current efforts to representatively enroll women in NSTE ACS trials are insufficient,” the authors wrote. “Because safety and efficacy findings may differ according to sex, this disparity could undermine generalizability of clinical trial results to treatment of the overall NSTE ACS population.”
Read the full article here.