National Centre for Healthcare Research & Pharmacoepidemiology, University of Milano-Bicocca Milan, Milan, Italy.
Laboratory of Healthcare Research & Pharmacoepidemiology, Unit of Biostatistics, Epidemiology and Public Health, Department of Statistics and Quantitative Methods, University of Milano-Bicocca, Milan, Italy.
Eur Heart J. 2018 Oct 21;39(40):3654-3661. doi: 10.1093/eurheartj/ehy420.
Guidelines support use of drug combinations in most hypertensive patients, and recently treatment initiation with two drugs has been also recommended. However, limited evidence is available on whether this leads to greater cardiovascular (CV) protection compared to initial monotherapy.
Using the healthcare utilization database of the Lombardy Region (Italy), the 44 534 residents of the region (age 40-80 years) who in 2010 started treatment with one antihypertensive drug (n = 37 078) or a two-drug fixed-dose combination (FDC, n = 7456) were followed for 1 year after treatment initiation to compare the risk of hospitalization for CV disease associated with the two treatment strategies. To limit the confounding associated with non-randomized between-group comparisons, data were also analysed by: (i) matching the two groups by the high-dimensional propensity score (HDPS) and (ii) comparing, in patients experiencing one or more CV events (n = 2212), the CV event incidence during subperiods in which patients were prescribed mono- or FDC therapy (self-controlled case series design). Compared to initial monotherapy, patients on initial FDC therapy showed a reduced 1 year risk of hospitalization for any CV event (-21%, P < 0.01). This was the case also when groups were compared according to the HDPS analysis (-15%, P < 0.05). Finally, in patients experiencing CV events, the event incidence was much less when, during the 1 year follow-up, they were under FDC therapy than under monotherapy (-56%, P < 0.01). The reduced risk of hospitalization was always significant for ischaemic heart disease and new onset atrial fibrillation, and included hospitalization for cerebrovascular disease and heart failure when monotherapy and FDC therapy were compared within patients.
In a real-life setting, a comparison of the incidence of early CV events during antihypertensive monotherapy and FDC shows that the latter strategy leads to a more effective CV protection. This scores in favour of a two-drug FDC strategy as first step in the hypertensive population.
指南支持在大多数高血压患者中使用药物联合治疗，最近也推荐初始使用两种药物治疗。然而，关于与初始单药治疗相比，这是否会带来更大的心血管（CV）保护作用，证据有限。
利用意大利伦巴第地区（Lombardy Region）的医疗保健利用数据库，对该地区 2010 年开始使用一种降压药物（n=37078）或两种药物固定剂量复方（FDC，n=7456）治疗的 44534 名年龄在 40-80 岁的居民进行了为期 1 年的随访，以比较两种治疗策略与 CV 疾病住院风险的相关性。为了限制非随机分组比较带来的混杂因素，还通过以下两种方法对数据进行了分析：（i）通过高维倾向评分（HDPS）对两组进行匹配；（ii）在经历一次或多次 CV 事件的患者（n=2212）中，比较患者接受单药或 FDC 治疗的亚时段内 CV 事件的发生率（自我对照病例系列设计）。与初始单药治疗相比，初始 FDC 治疗患者 1 年内任何 CV 事件住院风险降低（-21%，P<0.01）。根据 HDPS 分析结果进行比较时也是如此（-15%，P<0.05）。最后，在经历 CV 事件的患者中，与单药治疗相比，在 1 年随访期间接受 FDC 治疗时，事件发生率要低得多（-56%，P<0.01）。与单药和 FDC 治疗在患者内进行比较时，FDC 治疗的住院风险始终显著降低缺血性心脏病和新发心房颤动，且包括脑血管疾病和心力衰竭。
在真实环境中，比较抗高血压单药治疗和 FDC 治疗期间早期 CV 事件的发生率表明，后者策略可带来更有效的 CV 保护作用。这支持在高血压人群中首先采用两药 FDC 策略。
