Department of Advanced Biomedical Sciences, Federico II University of Naples.
Mediterranea Cardiocentro, Napoli.
J Cardiovasc Med (Hagerstown). 2021 Apr 1;22(4):246-258. doi: 10.2459/JCM.0000000000001159.
The purpose of this work was to reach the consensus of a multidisciplinary and multistakeholder Italian panel on the value of polypill in cardiovascular disease, with respect to the clinical, technological, economic and organizational dimension. A three-step modified Delphi method was used to establish consensus. Eleven experts in the area of cardiology, pharmaceutical technology, general practice, hospital pharmacy, pharmacology, and health economics participated in the expert panel. To identify existing evidence concerning the value of polypill in the prevention of patients with cardiovascular disease, a systematic literature review was carried out according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses statement guidelines. In the first round, 22 statements were distributed to the panel. Panel members were asked to mark 'agree' or 'disagree' for each statement and provide any comments. The same voting method was again used for the second round. In the first round nine statements met consensus. In the second round, 10 statements reached consensus. Overall, consensus was reached for 19 statements representing five value polypill domains: clinical, technological, economic and organizational. During a final web meeting with all panel members consensus document open points were discussed. Panel members agreed to recognize polypill as effective in reducing cardiovascular events, blood pressure and lipids, cardiovascular risk and the weight of therapy, in therapeutic adherence improvement, in the absence of differences in bioavailability between drugs administered in fixed or free combinations and the better cost-effectiveness profile compared with standard care. This document represents a knowledge framework to inform decision makers of the value of polypill in cardiovascular prevention.
这项工作的目的是在意大利，一个多学科和多利益相关者小组就多效药丸在心血管疾病方面的价值达成共识，涉及临床、技术、经济和组织层面。采用三步修正德尔菲法来达成共识。11 名心脏病学、药物技术、全科医学、医院药学、药理学和卫生经济学领域的专家参加了专家组。为了确定多效药丸在预防心血管疾病患者方面的价值的现有证据，根据系统评价和荟萃分析报告的首选项目准则进行了系统文献回顾。在第一轮中，向专家组分发了 22 项声明。小组成员被要求对每个声明标记“同意”或“不同意”，并提供任何意见。第二轮也使用相同的投票方法。在第一轮中，有 9 项声明达成共识。在第二轮中，又有 10 项声明达成共识。总体而言，有 19 项声明代表五个多效药丸价值领域达成了共识：临床、技术、经济和组织。在与所有小组成员进行的最后一次网络会议上，讨论了共识文件的开放点。小组成员一致认为，多效药丸可有效降低心血管事件、血压和血脂、心血管风险和治疗负担，改善治疗依从性，固定或自由联合给药药物的生物利用度无差异，与标准护理相比具有更好的成本效益比。这份文件代表了一个知识框架，旨在为决策者提供多效药丸在心血管预防方面的价值信息。
