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May 29, 2018

New study reveals clinical trial enrolment favours men

Findings from a new study authored by Sweden’s Umeå University junior lecturer and PhD student Helena Norberg have revealed that clinical trials designed for heart failure include more men than women.

Findings from a new study authored by Sweden’s Umeå University junior lecturer and PhD student Helena Norberg have revealed that clinical trials designed for heart failure include more men than women.

The study also found that fewer women meet eligibility criteria for the heart failure trials.

Norberg said: “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.”

The study examined the reasons why only 21% women were enrolled in the PARADIGM-HF trial, which compared the effectiveness of an angiotensin receptor neprilysin inhibitor (ARNI) against standard treatment with an angiotensin-converting–enzyme (ACE) inhibitor in patients with heart failure and an ejection fraction of 35% or less.

In order to take part in the trial, the patients had to tolerate target doses of an ACE inhibitor or angiotensin receptor blocker (ARB).

“This excludes many women, particularly older ones, meaning we don’t gain knowledge in this group.”

As part of the newly presented study, the researchers applied the PARADIGM-HF trial’s criteria to 1,924 community-based heart failure patients in Sweden, 43% of whom were women.

When the researchers applied the trial’s requirement to have an ejection fraction of 35% or less, only 401 patients were left, 28% of whom were women.

After employing other participation criteria of the trial, 246 patients were eliminated because they failed to reach the target dose of an ACE inhibitor or ARB and 60 were excluded for other reasons, thereby leaving only 95 eligible patients, 15% or 16% of whom were women.

According to the researchers, the criteria to reach the target dose of an ACE inhibitor or ARB disproportionately excluded women in the community-based heart failure population.

During the study, the researchers also compared a number of characteristics of women and men with heart failure and reduced ejection fraction.

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