Cristiana Vitale1, Massimo Fini2, Ilaria Spoletini2, Mitja Lainscak3, Petar Seferovic4, Giuseppe Mc Rosano5. 1. Department of Medical Sciences, IRCCS San Raffaele, Roma, Italy. Electronic address: Cristiana.vitale@sanraffaele.it. 2. Department of Medical Sciences, IRCCS San Raffaele, Roma, Italy. 3. Internal Medicine, Faculty of Medicine, University of Ljubljana, Slovenia. 4. Department of Cardiology, University of Belgrade, Belgrade, Serbia. 5. Department of Medical Sciences, IRCCS San Raffaele, Roma, Italy; Internal Medicine, Faculty of Medicine, University of Ljubljana, Slovenia; Department of Cardiology, University of Belgrade, Belgrade, Serbia; Cardiovascular and Cell Sciences Institute, St George's Hospital Medical School, London, UK.
Abstract
BACKGROUND: Elderly and women have been often under-represented in randomised clinical trials (RCTs) testing the effect of treatments on cardiovascular diseases (CVDs) even though these diseases highly affect both of them. AIMS: Taking into account these issues, the aim of this review is to critically analyse the topic of under-representation of elderly and women in cardiovascular RCTs. CONCLUSIONS: Compared to their younger counterparts, elderly have a higher incidence of disease-related morbidities, take more medicines and account for more adverse drug related events. Similarly, women present several differences in CVD pathophysiology, clinical manifestations and outcomes in comparison to their male counterparts. For these reasons, the results of RCTs obtained in younger men cannot be simply translated in elderly and women. Unfortunately, although international guidelines have been published to increase the enrolment of elderly and women, their recruitment is still insufficient. Thus, the inclusion of these subgroups in cardiovascular RCTs is a key aspect to acquire evidence-based knowledge in the understanding and management of CVDs in elderly and women. Copyright Â
BACKGROUND: Elderly and women have been often under-represented in randomised clinical trials (RCTs) testing the effect of treatments on cardiovascular diseases (CVDs) even though these diseases highly affect both of them. AIMS: Taking into account these issues, the aim of this review is to critically analyse the topic of under-representation of elderly and women in cardiovascular RCTs. CONCLUSIONS: Compared to their younger counterparts, elderly have a higher incidence of disease-related morbidities, take more medicines and account for more adverse drug related events. Similarly, women present several differences in CVD pathophysiology, clinical manifestations and outcomes in comparison to their male counterparts. For these reasons, the results of RCTs obtained in younger men cannot be simply translated in elderly and women. Unfortunately, although international guidelines have been published to increase the enrolment of elderly and women, their recruitment is still insufficient. Thus, the inclusion of these subgroups in cardiovascular RCTs is a key aspect to acquire evidence-based knowledge in the understanding and management of CVDs in elderly and women. Copyright Â
Authors: Shelley A Sternberg; Mirko Petrovic; Graziano Onder; Antonio Cherubini; Denis O'Mahony; Jerry H Gurwitz; Francesco Pegreffi; Robin Mason; Jennifer Akerman; Lisa McCarthy; Andrea Lawson; Joyce Li; Wei Wu; Paula A Rochon Journal: Eur Geriatr Med Date: 2021-04-09 Impact factor: 1.710
Authors: Maria Ukhanova; Sheila Markwardt; Jon P Furuno; Laura Davis; Brie N Noble; Ana R Quiñones Journal: J Am Geriatr Soc Date: 2021-05-06 Impact factor: 7.538