The prevalence of coronary heart disease increases with advancing age. However, there is evidence that older patients and women were underrepresented in coronary heart disease clinical trials prior to the year 2000. To determine whether the participation of the elderly and women in published clinical trials has increased during recent years, we conducted a review of recent clinical trials of acute coronary syndromes (ACS).
Design and Measurements
We conducted a search of MEDLINE and the Cochrane Central Register of Controlled Trials to identify clinical trials of ACS published from May, 2007 to May, 2009. Trials were excluded if they enrolled <50 patients, were sub-studies of previously published trials, or initiated treatment more than 3 weeks after the acute cardiac event.
Eighty trials, enrolling a total of 68,016 subjects, met our pre-established criteria. Nearly 30% (n= 23) had explicit exclusion criteria based on age. Only 13.8% of study participants were ≥75 years and 27.7% of subjects were women. These percentages remain below the representation of all U.S. adults experiencing an ACS in recent years who were ≥75 years of age (41.9%) or women (41.5%). The average age of all study participants was 61.6 years (SD=3.8). There was a significant association between the mean age of a study participant and the proportion of women enrolled in the trial.
Older adults and women remain underrepresented in recent clinical trials of patients hospitalized with an ACS. These exclusions may hinder efforts to inform evidence-based clinical decision-making in these high-risk patient populations.