Key result
Women remain underrepresented in OAC trials and face specific risks like abnormal uterine bleeding.
Why the study?
Women have often been under-represented in drug studies without sex-specific outcome analyses, leaving areas of uncertainty regarding the efficacy and safety of oral anticoagulants in women.
What are the sex and gender differences in the efficacy and safety of oral anticoagulants?
What are the sex and gender differences in the efficacy and safety of oral anticoagulants?
Answers are grounded in this paper and cite their sources.
This narrative review highlights the critical need for gender-specific analyses and adequate representation of women in clinical trials evaluating oral anticoagulants.
Gender sensitive medicine refers to the need to individualize epidemiology, diagnosis, knowledge of disease presentation, and therapy based also on sex and gender. An impressive amount of scientific literature deals now with sex and gender differences in disease. Not so much, yet, on individualized therapeutic approaches. Part of the reason lies in how studies that deal with the pharmacology, efficacy and safety of drugs are conducted. Often women are under-represented, and/or no gender specific analysis of outcomes is performed. As a consequence, in many fields of medicine, not as much is known about important and life-saving drug dosage, safety and efficacy in women as in men. Oral anticoagulants are not the exception, even if new regulations are operative regarding inclusion of women in all phases of drug studies. The result is that there are many areas of uncertainty or outright confusion regarding the efficacy and safety of oral anticoagulants in women that need to be addressed.
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Faioni et al. (2025) conducted a review in Atrial fibrillation and venous thromboembolism. Oral anticoagulants (DOACs and VKAs) was evaluated. Women remain underrepresented in oral anticoagulant trials and face specific risks like abnormal uterine bleeding, emphasizing the need for sex- and gender-specific pharmacokinetic and outcome analyses.
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