Lafeber Melvin, Spiering Wilko, Visseren Frank Lj, Grobbee Diederick E, Bots Michiel L, Stanton Alice, Patel Anushka, Prabhakaran Dorairaj, Webster Ruth, Thom Simon, Rodgers Anthony
1 Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, the Netherlands.
2 Department of Vascular Medicine, University Medical Center Utrecht, The Netherlands.
Eur J Prev Cardiol. 2017 Jun;24(9):951-961. doi: 10.1177/2047487317695616. Epub 2017 Mar 8.
Aims Cardiovascular fixed-dose combination pills, or polypills, may help address the widespread lack of access and adherence to proven medicines. Initiation of polypill-based care typically entails switching from current separately taken medications. Given the heterogeneity in usual care, there is interest in the impact of polypill treatment across different patterns of prior medication regimen. Methods A total of 2004 participants with established cardiovascular disease or estimated 5-year cardiovascular risk of over 15% were randomised to polypill-based treatment (aspirin 75 mg, simvastatin 40 mg, lisinopril 10 mg and either atenolol 50 mg or hydrochlorothiazide 12.5 mg) or usual care. Baseline medications were classified by potency relative to polypill components. Estimated cardiovascular risk reduction was calculated by combining risk factor changes with results seen in meta-analyses of previous randomised trials. Results For cholesterol reduction conferred by polypills, there was a dose response across baseline statin groups, with mean low-density lipoprotein (LDL)-cholesterol differences of 0.37, 0.22, 0.14 and 0.07 mmol/L among patients taking no statin, less potent, equipotent and more potent statin at baseline, respectively. Similarly there were differences in mean systolic BP of 5.4, 6.2, 3.3 and 1.8 mmHg among patients taking 0, 1, 2 or 3 BP-lowering agents. Among patients taking more potent statins at baseline, there was no significant difference in LDL-cholesterol but there were benefits for BP and aspirin adherence. Similar results were seen among patients taking 3 BP-lowering agents at baseline. Switching to a polypill-based strategy resulted in estimated cardiovascular relative risk reductions across a wide range of usual care patterns of antiplatelet, statin and BP-lowering therapy prescribing. Conclusion Adherence benefits from switching to a polypill resulted in risk factor changes that were at least as good as usual care across a wide variety of treatment patterns, including equally potent or more potent regimens. The benefits of switching to polypill-based care were greatest among those stepped up from partial treatment or less potent treatment.
目的 心血管固定剂量复方药丸，即多效药丸，可能有助于解决普遍存在的难以获取和坚持使用经证实有效的药物的问题。启动基于多效药丸的治疗通常需要从当前单独服用的药物转换。鉴于常规治疗的异质性，人们对多效药丸治疗在不同既往用药方案模式中的影响感兴趣。方法 共有2004名已确诊心血管疾病或估计5年心血管风险超过15%的参与者被随机分配接受基于多效药丸的治疗（阿司匹林75毫克、辛伐他汀40毫克、赖诺普利10毫克以及阿替洛尔50毫克或氢氯噻嗪12.5毫克）或常规治疗。根据相对于多效药丸成分的效力对基线用药进行分类。通过将危险因素变化与先前随机试验的荟萃分析结果相结合来计算估计的心血管风险降低情况。结果 对于多效药丸降低胆固醇的效果，在基线他汀类药物组之间存在剂量反应，在基线未服用他汀类药物、效力较低、效力相当和效力较高的他汀类药物的患者中，平均低密度脂蛋白（LDL）胆固醇差异分别为0.37、0.22、0.14和0.07毫摩尔/升。同样，在服用0、1、2或3种降压药物的患者中，平均收缩压差异分别为5.4、6.2、3.3和1.8毫米汞柱。在基线服用效力较高他汀类药物的患者中，LDL胆固醇没有显著差异，但在血压和阿司匹林依从性方面有获益。在基线服用3种降压药物的患者中也观察到类似结果。转换为基于多效药丸的策略导致在广泛的抗血小板、他汀类药物和降压治疗处方的常规治疗模式中估计的心血管相对风险降低。结论 转换为多效药丸带来的依从性获益导致危险因素变化，在各种治疗模式中至少与常规治疗一样好，包括效力相当或更高的治疗方案。从部分治疗或效力较低的治疗升级而来的患者中，转换为基于多效药丸的治疗的获益最大。
