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单片复方制剂与自由联合等效药物对高血压患者治疗依从性及主要不良心血管事件的影响:一项真实世界分析

Effect of single-pill versus free equivalent combinations on persistence and major adverse cardiovascular events in hypertension: a real-world analysis.

作者信息

Simonyi Gábor, Burnier Michel, Narkiewicz Krzysztof, Rokszin György, Abonyi-Tóth Zsolt, Kovács Gábor, Potukuchi Praveen Kumar, Abdel-Moneim Mohamed, Farsang Csaba

机构信息

Metabolic Centre, South-Buda Centrum Hospital - St. Imre University Teaching Hospital, Budapest, Hungary.

Faculty of Biology and Medicine, University of Lausanne, Lausanne, Switzerland.

出版信息

J Hypertens. 2025 Mar 1;43(3):405-412. doi: 10.1097/HJH.0000000000003916. Epub 2024 Dec 6.

Abstract

OBJECTIVES

Hypertension guidelines recommend the use of single-pill combinations (SPCs) of antihypertensive drugs to improve treatment persistence and blood pressure control. This study aimed to investigate the long-term effects of ramipril/amlodipine (R/A) SPC versus free equivalent dose combinations (FEC) on cardiovascular outcomes and treatment persistence.

METHODS

This retrospective, observational study analysed the database of the Hungarian National Health Insurance Fund. The study included patients with hypertension aged at least 18 years who were initiated on R/A SPC or FEC of different dose combinations (R/A 5/5, 5/10, 10/5 and 10/10 mg) between 2012 and 2018, with follow-up for up to 60 months. Imbalances in baseline characteristics were reduced with propensity score-based sub-classification. All analyses were performed with Cox proportional hazard model and propensity score sub-classification to adjust the imbalances in baseline characteristics. Drug persistence and MACEs were the primary and secondary endpoints, respectively.

RESULTS

Overall, 104 882 patients with SPC and 68 324 patients with FEC-treated hypertension were included. The R/A 5/5 mg combination represented the largest proportion (62%). The nonpersistence rate was significantly lower with SPC than with FEC from month 1 to month 24 in the R/A 5/5 mg combination ( P  < 0.001) and during the entire observation period in the remaining combinations. The MACE rate was significantly reduced with all R/A SPCs versus FECs. No effects on age and sex on both endpoints were noted.

CONCLUSION

This study further supports the beneficial effects of the use of SPC on 60-month persistence and MACEs in hypertension.

摘要

目的

高血压指南推荐使用抗高血压药物的单片复方制剂(SPC)来提高治疗依从性和血压控制水平。本研究旨在调查雷米普利/氨氯地平(R/A)单片复方制剂与自由等效剂量联合用药(FEC)对心血管结局和治疗依从性的长期影响。

方法

这项回顾性观察性研究分析了匈牙利国家健康保险基金的数据库。该研究纳入了年龄至少18岁、在2012年至2018年间开始使用不同剂量组合(R/A 5/5、5/10、10/5和10/10mg)的R/A单片复方制剂或自由等效剂量联合用药的高血压患者,随访时间长达60个月。基于倾向评分的亚分类减少了基线特征的不平衡。所有分析均采用Cox比例风险模型和倾向评分亚分类来调整基线特征的不平衡。药物依从性和主要不良心血管事件(MACE)分别为主要和次要终点。

结果

总体而言,纳入了104882例接受单片复方制剂治疗的患者和68324例接受自由等效剂量联合用药治疗的高血压患者。R/A 5/5mg组合占比最大(62%)。在R/A 5/5mg组合中,从第1个月到第24个月,单片复方制剂组的非依从率显著低于自由等效剂量联合用药组(P<0.001),在其余组合的整个观察期内也是如此。与自由等效剂量联合用药相比,所有R/A单片复方制剂组的主要不良心血管事件发生率均显著降低。未发现年龄和性别对两个终点有影响。

结论

本研究进一步支持了使用单片复方制剂对高血压患者60个月依从性和主要不良心血管事件的有益作用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/87be/11789606/ea300a73ba48/jhype-43-405-g001.jpg

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