title: Under-representation of elderly and women in clinical trials.
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.
  
  
  OBJECTIVE
  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.
authors.affiliation: Department of Medical Sciences, IRCCS San Raffaele, Roma, Italy. Electronic address: Cristiana.vitale@sanraffaele.it.
authors.forename: Cristiana
authors.initials: C
authors.lastname: Vitale
authors.affiliation: Department of Medical Sciences, IRCCS San Raffaele, Roma, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Fini
authors.affiliation: Department of Medical Sciences, IRCCS San Raffaele, Roma, Italy.
authors.forename: Ilaria
authors.initials: I
authors.lastname: Spoletini
authors.affiliation: Internal Medicine, Faculty of Medicine, University of Ljubljana, Slovenia.
authors.forename: Mitja
authors.initials: M
authors.lastname: Lainscak
authors.affiliation: Department of Cardiology, University of Belgrade, Belgrade, Serbia.
authors.forename: Petar
authors.initials: P
authors.lastname: Seferovic
authors.affiliation: 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.
authors.forename: Giuseppe Mc
authors.initials: GM
authors.lastname: Rosano
mesh_terms: D000367:Age Factors; D002317:Cardiovascular Agents / Q000627:therapeutic use; D002318:Cardiovascular Diseases / Q000188:drug therapy / Q000453:epidemiology*; D002986:Clinical Trials as Topic; D005260:Female; D014943:Global Health; D006801:Humans; D015994:Incidence; D008297:Male; D009017:Morbidity / Q000639:trends; D010358:Patient Participation / Q000639:trends*; D012737:Sex Factors; D015996:Survival Rate / Q000639:trends
chemical_list: D002317:Cardiovascular Agents
keywords: Cardiovascular; Clinical trials; Elderly; Heart failure; Pharmacology; Prognosis; Women