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使用单片复方制剂的高血压患者药物持久性提高、心血管事件减少和全因死亡率降低:START 研究结果。

Improved Persistence to Medication, Decreased Cardiovascular Events and Reduced All-Cause Mortality in Hypertensive Patients With Use of Single-Pill Combinations: Results From the START-Study.

机构信息

Department of Nephrology and Hypertension, University Hospital Erlangen, Friedrich Alexander University Erlangen Nürnberg, Germany (R.E.S.).

Cardiology Pasing, Faculty of Medicine, Munich and University of the Saarland, Homburg/Saar, Germany (S.W.).

出版信息

Hypertension. 2023 May;80(5):1127-1135. doi: 10.1161/HYPERTENSIONAHA.122.20810. Epub 2023 Mar 29.

DOI:10.1161/HYPERTENSIONAHA.122.20810
PMID:36987918
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10112936/
Abstract

BACKGROUND

Single-pill combination improves adherence and persistence to medication in hypertension. It remains unclear whether this also reduces cardiovascular outcomes and all-cause mortality. We analyzed whether single-pill combinations are superior to identical multiple pills on persistence to medication, cardiovascular outcomes, and all-cause mortality.

METHODS

This was a retrospective claims data (German AOK PLUS) analysis. Data from hypertensive patients ≥18 years treated with renin-angiotensin system combinations given as single pill or identical multipills covering the years 2012 to 2018 were analyzed and followed up to at least 1 year. After 1:1 propensity score matching, persistence to medication, cardiovascular events, and all-cause mortality were compared using non-parametric tests. Results were reported as incidence rate ratios and hazard ratios.

RESULTS

After propensity score matching data from 57 998 patients were analyzed: 10 801 patients received valsartan/amlodipine, 1026 candesartan/amlodipine, 15 349 ramipril/amlodipine, and 1823 amlodipine/valsartan/hydrochlorothiazide as single pill or identical multipill. No relevant differences in patient characteristics were observed within the 4 groups. In all groups, a significant lower all-cause mortality, a significant a higher persistence to medication, a significant lower event rate in 15 out of 20 comparisons, and a tendency in the remaining 5 comparisons was observed under single pills compared with multipill combinations.

CONCLUSIONS

Antihypertensive combination therapy reduces all-cause mortality and cardiovascular events when provided as single pill compared to identical drugs as multipills. This strongly supports the European Society of Cardiology/European Society of Hypertension and International Society of Hypertension guidelines recommending the use of a single-pill combination and thus should be more rigorously implemented into daily clinical practice.

摘要

背景

单片复方制剂可提高高血压患者对药物的依从性和持续性。目前尚不清楚这是否也能降低心血管结局和全因死亡率。我们分析了单片复方制剂是否优于相同的多片药物,在药物持续性、心血管结局和全因死亡率方面的表现。

方法

这是一项回顾性索赔数据分析(德国 AOK PLUS)。分析了 2012 年至 2018 年期间使用肾素-血管紧张素系统联合治疗的≥18 岁高血压患者的数据,这些患者接受的治疗为单片制剂或相同的多片制剂。对至少随访 1 年的数据进行了分析。在 1:1 倾向评分匹配后,使用非参数检验比较药物持续性、心血管事件和全因死亡率。结果以发生率比和风险比报告。

结果

在倾向评分匹配后,对 57998 例患者的数据进行了分析:10801 例患者接受缬沙坦/氨氯地平、1026 例患者接受坎地沙坦/氨氯地平、15349 例患者接受雷米普利/氨氯地平、1823 例患者接受氨氯地平/缬沙坦/氢氯噻嗪作为单片制剂或相同的多片制剂。在这 4 组中,患者的特征无明显差异。在所有组中,与多片制剂相比,单一片剂显著降低了全因死亡率,显著提高了药物持续性,在 20 次比较中有 15 次观察到事件发生率显著降低,其余 5 次比较中也呈现出降低的趋势。

结论

与多片药物相比,降压联合治疗作为单片制剂可降低全因死亡率和心血管事件。这强烈支持欧洲心脏病学会/欧洲高血压学会和国际高血压学会指南推荐使用单片复方制剂,因此应更严格地将其纳入日常临床实践中。

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