Heart failure medication clinical trial enrolment favours men, according to a new study presented at Heart Failure 2018 and the World Congress on Acute Heart Failure this week in Vienna, Austria.
The study, which investigated the reasons why just 21 per cent of patients enrolled in the PARADIGM-HF trial were women, found that fewer women meet eligibility criteria for trials of heart failure medication.
The PARADIGM-HF trial compared the efficacy of an angiotensin receptor neprilysin inhibitor (ARNI) versus standard treatment with an angiotensin converting enzyme (ACE) inhibitor in patients with heart failure and an ejection fraction of 35 per cent. To participate in the trial, patients had to first tolerate fixed target doses of ACE inhibitor or angiotensin receptor blocker (ARB), which disproportionately excluded women.
The study authors found that older age, lower weight, and worse kidney function were the variables most significantly associated with women’s failure to achieve a target dose of an ACE inhibitor or ARB.
Helena Norberg, author of the study, junior lecturer and PhD student at Umeå University, Sweden, said: “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.”