A recent study shows that the people most likely to be affected by heart disease — older adults and women — are the least represented in randomized clinical trials for cholesterol-lowering medications.
Older adults are more likely than young adults to have heart and vascular disease while the leading cause of death in women is heart disease, according to a press release from Johns Hopkins Medicine.
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But in an analysis of the trends in the types of 485,409 people enrolled in 60 studies from 1990 to 2018, researchers at Johns Hopkins Medicine found that despite some progress, older adults and women are still vastly underrepresented in lipid-lowering therapy trials compared to their disease burden.
The findings, which came as part of a study published in the journal JAMA Network Open, suggest that even recent trials don't reflect actual patient populations.
“We want to ensure that the types of patients who will be using these drugs are the ones included in the clinical trials, so that we can determine if these medications are safe and effective for the people who are prescribed them,” said senior author Erin Michos, M.D., M.H.S., associate professor of medicine at the Johns Hopkins University School of Medicine in a statement.
“Although we did see an improvement over the years in representation of women and older adults, that progress was rather modest,” Michos said. “Clearly more still needs to be done to shift the balance to represent our patient demographics.”
The report on these studies showed the percentage of trial participants 65 or older increased from 32% from the early 1990s to 42% in the most recent trials that researchers analyzed. Still, a little more than 30 of the 60 trials conducted reported findings specifically for older adults.
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According to researchers, older Americans should be included in trials because as people age, the way they metabolize drugs may change. They could also develop other health conditions that could change how effective their treatment could be.
Like the findings for older adults, researchers found similar results for the representation of women, with slightly more than half of the 60 trials reporting effectiveness by gender. There was a reported increase from 20% in the early 1990s to about 33% in the most recent trials that researchers evaluated.
But of the trails that included women, many only involved women who were past menopause or who were unable to have children. In particular, studies excluded people who were pregnant or breastfeeding.
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