Exploring Sex Differences in Cardiovascular Outcomes of Emerging Drug Therapies

Recent advances in cardiovascular pharmacology have spotlighted that biological sex profoundly influences not only drug responses, but also the real-world clinical outcomes and safety profiles of cardiovascular therapies. While previous research and collections have discussed sex-based mechanisms and drug response variability, there remains a critical need to investigate how these differences translate into actual patient outcomes—particularly as new and emerging drug modalities rapidly enter clinical practice.Historically, women have been underrepresented in both clinical and preclinical studies, contributing to persistent knowledge gaps and uncertainty about the sex-specific risks, benefits, and adverse event profiles associated with contemporary cardiovascular medications—including biologics, gene therapies, and novel small molecules. Moreover, sex-based disparities in post-marketing safety signals, pharmacovigilance data, and regulatory decision-making are still poorly addressed in the literature.This Research Topic seeks to fill those gaps by focusing explicitly on clinically meaningful cardiovascular outcomes—such as arrhythmias, thrombotic events, myocardial injury, vascular dysfunction, and major adverse cardiac events—associated with emerging and recently authorized cardiovascular drugs. We are particularly interested in submissions that explore molecular, physiological, and clinical factors mediating sex-specific differences in harm susceptibility and benefit, as well as studies that directly inform real-world patient safety, regulatory guidance, and future precision medicine approaches.We welcome articles addressing, but not limited to, these key themes:o Sex-based differences in real-world cardiovascular outcomes and adverse events with new therapies (biologics, cell/gene-based drugs, targeted small molecules).o Translational studies connecting sex-specific mechanisms to measurable patient outcomes in diverse populations.o Post-marketing surveillance, pharmacovigilance/real-world evidence on sex-specific risk signals and safety events.o Regulatory science and implications of sex differences for clinical trial design, labeling, and guideline development.o Strategies for integrating sex-disaggregated data into cardiovascular drug development and post-approval monitoring.o Gaps in trial recruitment, real-world practice, or safety reporting affecting diverse populations and under-represented sexes.By drawing on real-world data, post-marketing analyses, and translational research, this collection aims to catalyze a new level of clarity on how sex differences change the landscape of benefit, risk, and harm in the era of emerging cardiovascular medicines. Submissions may include original research, clinical sub-analyses, real-world data studies, reviews, and regulatory or guideline-focused perspectives. Topic editors: Anca Butuca, Claudiu Morgovan, Adina Frum, Carmen Dobrea, Rodrigo O. Maranon, Sharlene Lopes Pereira Source: https://www.frontiersin.org/research-topics/80709/exploring-sex-differences-in-cardiovascular-outcomes-of-emerging-drug-therapies