Heart failure trial enrolment rules are discriminating against women patients, a European conference has heard.
Helena Norberg of Umea University, Sweden, and colleagues carried out a study of recruitment into a trial of heart failure medication. This trial compared an angiotensin receptor neprilysin inhibitor drug with standard treatment with an angiotensin-converting-enzyme inhibitor drug.
But in order to participate, patients had to be able to tolerate target doses of certain drugs.
The researchers applied the trial criteria to a group of 1,924 heart failure patients in Sweden. To begin with the group was 43% women. After the inclusion requirements were applied, only 16% of the group were women.
Ms Norberg and her team state: "Clinical trial enrolment favours men." They presented their findings on Monday (29 May) at Heart Failure 2018 and the World Congress on Acute Heart Failure, held 26 to 29 May 2018 at the Messe Wien in Vienna, Austria.
Ms Norberg: "One of the gold standard requirements for participating in a clinical trial of heart failure medication is that patients must first reach a fixed target dose of the currently recommended treatment. This excludes many women, particularly older ones, meaning we don’t gain knowledge in this group."
She adds: "These target doses were calculated from trials conducted primarily in men with heart failure, who tend to be younger and have better kidney function. Future trials in heart failure should use achievement of maximum tolerated doses, rather than fixed target doses, as entry criteria to ensure that women are more represented."
Norberg, H. et al. Are target doses relevant for women with heart failure? implications for sacubitril-valsartan. Presented on 28 May 2018 at Heart Failure 2018 and the World Congress on Acute Heart Failure.
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