Reporting of sex-specific outcomes in trials of interventions for cardiovascular disease: Has there been progress?

Abstract

In the past decade, the leading international cardiology societies have released statements that emphasize the importance of sex-specific reporting of the findings of clinical trials in cardiovascular research. To find out whether this has led to improvement, we compared sex-specific reporting of efficacy and safety outcomes for trials of cardiovascular drug interventions presented at the major clinical trials sessions of the European Society of Cardiology (ESC), American Heart Association (AHA) and the American College of Cardiology (ACC) before and after publication of these statements. We found that sex-specific efficacy and safety outcomes of the most influential cardiovascular intervention trials are still not systematically presented.

The Canadian Women’s Heart Health Alliance ATLAS on the Epidemiology, Diagnosis, and Management of Cardiovascular Disease in Women — Chapter 8: Knowledge Gaps and Status of Existing Research Programs in Canada

“… 51 Further, sex-specific data reporting remains low among randomized clinical trials of pharmacological interventions for CVD. 55 …”

“… 51 , 60 Further, a review of randomized controlled trials of pharmacological interventions for CVD has not shown an increase in sex-specific reporting of results since guidelines calling for sex-specific reporting have been published. 55 …”

Platelet P2Y12 signalling pathway in the dysregulated immune response during sepsis

“…Recent studies have researched whether blocking P2Y 12 during cardiovascular events provides diverse outcomes based on the sexes. Several studies have shown that ticagrelor and prasugrel exhibit similar effects in preventing cardiovascular events in both men and women (Husted et al, 2014;Schreuder et al, 2020;Vogel et al, 2021); thus, the management of cardiovascular diseases may not require a special sexspecific therapy. Consequently, other studies identified substantial differences between male and female patients (Ranucci et al, 2019;Waissi et al, 2020).…”

Cardiometabolic profile of 15057 elderly Spanish workers: association of sociodemographic variables and tobacco consumption

“…Populations over 60 years of age are heterogeneous and influenced by several factors, among which we find sex and socioeconomic level [7]; in such a way that over 60 years of age, cardiovascular diseases are more frequent in women and increase with age [8]. Therefore, it is very important to study Cardiovascular Risk Factors (CVRF) separately between women and men [9].…”