title: Are elderly and women under-represented in cardiovascular clinical trials? Implication for treatment.
abstract: Elderly and women have been often under-represented in randomised clinical trials testing the effect of treatments on cardiovascular diseases even though these diseases highly affect both of them.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 pathophysiology, clinical manifestations and outcomes in comparison to their male counterparts. For these reasons the results of randomised clinical trials obtained in younger men cannot be simply translated in elderly and women and the conduction of research and clinical trials in these patient populations is a key aspect to acquire evidence-based knowledge in the understanding and management of their conditions and treatment.Although the under-representation of elderly and women has been discussed for several years and several international guidelines or recommendation have been published to suggest how to improve the recruitment of these two populations, their recruitment is still insufficient. In particular, frail elderly and those with co-morbidities are not included questioning the external validity and the safety of most treatments.Aim of this review is to critically analyse how current recommendations for treatments of cardiovascular disease are not adequately devised for elderly and women.
authors.affiliation: Department of Medical Sciences, IRCCS San Raffaele Pisana, via della Pisana, 235, 00163, Rome, Italy. cristiana.vitale@gmail.com.
authors.forename: Cristiana
authors.identifier: http://orcid.org/0000-0003-1111-9894
authors.initials: C
authors.lastname: Vitale
authors.affiliation: Department of Cardiovascular and Cell Science Research, St. Georges Hospital, London, UK.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Rosano
authors.affiliation: Department of Medical Sciences, IRCCS San Raffaele Pisana, via della Pisana, 235, 00163, Rome, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Fini
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D063506:Ageism / Q000517:prevention & control*; D002318:Cardiovascular Diseases / Q000000981:diagnostic imaging / Q000628:therapy*; D002986:Clinical Trials as Topic / Q000458:organization & administration*; D004608:Eligibility Determination / Q000458:organization & administration*; D019317:Evidence-Based Medicine / Q000458:organization & administration; D005260:Female; D006297:Health Services Accessibility / Q000458:organization & administration*; D006801:Humans; D008297:Male; D018579:Patient Selection; D010818:Practice Patterns, Physicians' / Q000458:organization & administration
keywords: Cardiovascular; Elderly; Randomised clinical trials; Under-representation; Women