Division of Cardiology, Department of Internal Medicine, Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Taipei, Taiwan.
Graduate Institute of Clinical Medical Sciences, College of Medicine, Chang Gung University, Taipei, Taiwan.
J Clin Hypertens (Greenwich). 2018 Dec;20(12):1731-1738. doi: 10.1111/jch.13413. Epub 2018 Oct 30.
Two or more antihypertensive agents are required to achieve blood pressure control for the most hypertensive patients. However, comparison of clinical outcomes between fixed-dose combinations (FDC) and free-equivalent combinations of renin-angiotensin system (RAS) inhibitor and thiazide diuretic is lacking nowadays. Patients who were newly diagnosed with hypertension between July 1st, 2008 and December 31st, 2011 and prescribed with FDC (n = 13 176) or free combinations of RAS inhibitors and thiazide diuretic (n = 4392) were identified from the National Health Insurance Research Database of Taiwan and matched in 3:1 ratio using the propensity score method. The primary end point was major adverse cardiovascular events (MACE). The secondary end points were hospitalization of heart failure, new diagnosis of chronic kidney disease, and the initiation of dialysis. Compared with he FDC group was associated with better medication adherence compared with the free combination group. FDC of RAS inhibitor and thiazide diuretic reduced MACE (hazard ratio [HR]: 0.85; 95% confidence interval [CI]: 0.74-0.97; P = 0.017), hospitalization for heart failure and initiation of dialysis compared with the free combination regimens. The outcome benefits of FDC was mainly driven by reduced cardiovascular and renal events in the patients with proportion of days covered <80%. In this retrospective claims database analysis, compared with the free combination regimens, the use of FDC of RAS inhibitor and thiazide diuretic was associated with improved medication compliance and clinical outcomes in the management of hypertension, particularly in the patients with poor medication adherence.
对于大多数高血压患者，需要使用两种或更多种降压药物来控制血压。然而，目前缺乏肾素-血管紧张素系统（RAS）抑制剂和噻嗪类利尿剂的固定剂量组合（FDC）与自由等效组合在临床结局方面的比较。
从台湾全民健康保险研究数据库中确定了 2008 年 7 月 1 日至 2011 年 12 月 31 日期间新诊断为高血压并开处方 FDC（n=13176）或 RAS 抑制剂和噻嗪类利尿剂自由组合（n=4392）的患者，并使用倾向评分法以 3:1 的比例进行匹配。主要终点是主要不良心血管事件（MACE）。次要终点是心力衰竭住院、新诊断的慢性肾脏病和开始透析。
与自由组合组相比，FDC 组的药物依从性更好。与自由组合方案相比，RAS 抑制剂和噻嗪类利尿剂的 FDC 可降低 MACE（风险比[HR]：0.85；95%置信区间[CI]：0.74-0.97；P=0.017）、心力衰竭住院和开始透析的风险。FDC 的获益主要是由于覆盖天数<80%的患者心血管和肾脏事件减少。在这项回顾性索赔数据库分析中，与自由组合方案相比，RAS 抑制剂和噻嗪类利尿剂的 FDC 的使用与改善的药物依从性和高血压管理的临床结局相关，尤其是在药物依从性差的患者中。
