UM study flags major gap in clinical trial evidence

Women’s experience with heart disease is different from men’s, and improving women’s heart health depends on the healthcare system catching up and translating what we know into better prevention, diagnosis and treatment. But a University of Manitoba-led study highlights a major barrier to that progress; women remain underrepresented in large cardiovascular outcomes trials that help shape treatment guidelines.

Published in Diabetes, Obesity and Metabolism, the study examined sex differences in trial representation and outcomes for SGLT-2 inhibitors and GLP-1 receptor agonists, two of the most widely used newer glucose-lowering medication classes in patients with and without type 2 diabetes. Across 25 cardiovascular outcome trials involving more than 185,000 participants, both drug classes were associated with significant reductions in cardiovascular and kidney events in both women and men. However, women were underrepresented, making up roughly one-third of participants.

“This study is particularly significant given the well-documented sex differences in cardiovascular risk factors, disease presentation, and outcomes," says Dr. Setor K. Kunutsor, Section of Cardiology, Department of Internal Medicine, Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba. "It highlights the persistent underrepresentation of women in cardiovascular outcomes trials. We need to improve the inclusiveness of future trials to ensure that treatment recommendations are truly evidence-based for everyone.”