Bramlage P, März W, Westermann D, Weisser B, Wirtz J H, Zeymer U, Baumgart P, van Mark G, Laufs U, Krämer B K, Unger T
Institut für Pharmakologie und Präventive Medizin, Mahlow, Deutschland.
Medizinische Klinik V (Nephrologie, Hypertensiologie, Rheumatologie, Endokrinologie, Diabetologie), Medizinische Fakultät Mannheim, Universität Heidelberg, Heidelberg, Deutschland.
Herz. 2018 May;43(3):246-257. doi: 10.1007/s00059-017-4554-5. Epub 2017 Mar 24.
The multifactorial origin of cardiovascular diseases has led to polypharmacy in primary and secondary prophylaxis with evidence-based medications, such as statins, antihypertensive drugs and platelet aggregation inhibitors. The number of prescribed drugs correlates inversely to adherence and can lead to treatment failure. Fixed-dose combination drugs (polypills) could increase the medication adherence of patients, reduce risks and prevent cardiovascular events.
This review is based on publications that were retrieved from Medline (via PubMed) and The Cochrane Library. The clinical database ClinicalTrials.gov. was also considered.
In the studies on primary prevention conducted to date, fixed-dose combinations showed a superior control of risk factors, e.g. hypertension and low-density lipoprotein (LDL) cholesterol compared to placebo and at least non-inferiority compared to usual care. In secondary prevention, the effect of the polypill is mostly on the reduction of blood pressure and LDL cholesterol in non-adherent patients; however, evidence that fixed-drug combinations reduce cardiovascular morbidity and mortality compared to standard therapy is lacking.
The polypill can be considered as an alternative to polypharmacy after a risk-benefit assessment, especially in non-adherent patients. Ongoing studies are investigating the effect of the polypill on cardiovascular events. Current polypills are limited by the lack of sufficient dosages of the individual components to avoid overtreatment and undertreatment at the individual treatment level.
心血管疾病的多因素起源导致在一级和二级预防中使用多种循证药物进行联合用药,如他汀类药物、抗高血压药物和血小板聚集抑制剂。所开药物的数量与依从性呈负相关,并可能导致治疗失败。固定剂量复方药物(多效药丸)可提高患者的用药依从性,降低风险并预防心血管事件。
本综述基于从Medline(通过PubMed)和Cochrane图书馆检索到的出版物。还考虑了临床数据库ClinicalTrials.gov。
在迄今为止进行的一级预防研究中与安慰剂相比,固定剂量复方药物对风险因素(如高血压和低密度脂蛋白(LDL)胆固醇)的控制效果更佳,与常规治疗相比至少不逊色。在二级预防中,多效药丸的作用主要是降低未坚持服药患者的血压和低密度脂蛋白胆固醇;然而,缺乏证据表明与标准治疗相比,固定复方药物可降低心血管发病率和死亡率。
经过风险效益评估后,多效药丸可被视为联合用药之外的另一种选择方案,尤其是对未坚持服药的患者。正在进行的研究正在调查多效药丸对心血管事件影响。目前的多效药丸因缺乏足够剂量各成分,难以避免个体治疗水平上的过度治疗和治疗不足。