First Cardiology Clinic, Medical School, National and Kapodistrian University of Athens, Hippokration Hospital, Athens, Greece.
Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institut für Klinische Pharmakologie und Toxikologie, Berlin, Germany.
J Hypertens. 2020 Jun;38(6):1016-1028. doi: 10.1097/HJH.0000000000002381.
The 2018 European Society of Cardiology/European Society of Hypertension Guidelines for the management of arterial hypertension raised the need for evidence to support the use of single-pill combination (SPC) therapy in preference to free-dosed therapy for hypertension. This systematic rapid evidence assessment sought to determine if initiating SPC therapy improves adherence, blood pressure (BP) control and/or cardiovascular outcomes vs. initiation of free-dose combination therapy.
Rapid evidence assessment conducted in MEDLINE, EMBASE, and Cochrane Library (1 January 2013-11 January 2019) to identify studies investigating SPC therapy for adults with hypertension. Information on adherence/persistence, BP lowering/goal attainment, and cardiovascular outcomes/events were extracted via two-phase screening process. Studies not focusing on adherence, persistence, or compliance with SPC therapy were excluded. Methodological quality was assessed using appropriate scales.
Of 863 citations, 752 failed to meet inclusion or were duplicates. Twenty-nine studies remained following full-text screening. Just four studies (14%) were randomized controlled studies; 25 (86%) were observational. A range of SPC therapies were studied, with calcium channel blocker/angiotensin receptor blocker combinations most common (11/29 studies). Adherence and persistence were generally higher with SPC vs. free-dose combination therapy; 15 studies (54%) directly compared adherence and four (14%) compared persistence. Patients achieving BP targets ranged from 25 to 89%. Despite all studies investigating patients with hypertension only 16 (55%) reported change in BP. Few studies reported on cardiovascular outcomes. Methodological reporting was often suboptimal.
Adherence and/or persistence were generally higher in patients taking antihypertensives as SPC vs. free-dose combination; however, methodological reporting was suboptimal to facilitate comparison. Specifically designed, well reported studies are required to determine if the increased adherence/persistence seen in patients on SPC regimen leads to improved BP control and/or cardiovascular outcomes.
2018 年欧洲心脏病学会/欧洲高血压学会指南提出，需要有证据支持使用单片复方制剂（SPC）治疗优于自由剂量联合治疗高血压。本系统快速证据评估旨在确定起始 SPC 治疗是否比起始自由剂量联合治疗更能提高依从性、血压（BP）控制和/或心血管结局。
在 MEDLINE、EMBASE 和 Cochrane Library（2013 年 1 月 1 日至 2019 年 1 月 11 日）中进行快速证据评估，以确定研究 SPC 治疗高血压成人的研究。通过两阶段筛选过程提取关于依从性/持久性、BP 降低/目标达标和心血管结局/事件的信息。未关注 SPC 治疗依从性、持久性或顺应性的研究被排除在外。使用适当的量表评估方法学质量。
在 863 条引文中，有 752 条不符合纳入标准或为重复项。经过全文筛选后，仍有 29 项研究。只有 4 项研究（14%）为随机对照研究；25 项（86%）为观察性研究。研究了多种 SPC 治疗方法，其中钙通道阻滞剂/血管紧张素受体阻滞剂联合最常见（29 项研究中的 11 项）。与自由剂量联合治疗相比，SPC 治疗的依从性和持久性通常更高；15 项研究（54%）直接比较了依从性，4 项研究（14%）比较了持久性。达到 BP 目标的患者比例从 25%到 89%不等。尽管所有研究均仅纳入高血压患者，但只有 16 项（55%）报告了 BP 的变化。很少有研究报告心血管结局。方法学报告通常不理想。
与自由剂量联合治疗相比，服用抗高血压药物的 SPC 患者的依从性和/或持久性通常更高；然而，方法学报告不理想，难以进行比较。需要进行专门设计、报告良好的研究，以确定 SPC 治疗方案中观察到的患者依从性/持久性提高是否导致 BP 控制和/或心血管结局改善。
