Vitale Cristiana, Rosano Giuseppe, Fini Massimo
Department of Medical Sciences, IRCCS San Raffaele Pisana, via della Pisana, 235, 00163, Rome, Italy.
Department of Cardiovascular and Cell Science Research, St. Georges Hospital, London, UK.
Wien Klin Wochenschr. 2016 Dec;128(Suppl 7):433-438. doi: 10.1007/s00508-016-1082-x. Epub 2016 Sep 21.
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.
在测试治疗对心血管疾病疗效的随机临床试验中，老年人和女性的代表性常常不足，尽管这些疾病对他们的影响很大。与年轻患者相比，老年人与疾病相关的发病率更高，服用的药物更多，药物相关不良事件也更多。同样，与男性相比，女性在病理生理学、临床表现和预后方面存在一些差异。因此，在年轻男性中获得的随机临床试验结果不能简单地推广到老年人和女性身上，在这些患者群体中开展研究和临床试验是获取基于证据的知识以了解和管理他们的病情及治疗方法的关键环节。尽管老年人和女性代表性不足的问题已经讨论了数年，并且已经发布了一些国际指南或建议来指导如何改善这两类人群的招募情况，但他们的招募人数仍然不足。特别是，体弱的老年人和患有合并症的人没有被纳入，这对大多数治疗方法的外部有效性和安全性提出了质疑。本综述的目的是批判性地分析当前心血管疾病治疗建议在针对老年人和女性时是如何设计不足的。
