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沙库巴曲缬沙坦的真实世界治疗模式:德国的一项纵向队列研究。

Real-world treatment patterns of sacubitril/valsartan: a longitudinal cohort study in Germany.

机构信息

Clinic and Polyclinic for Cardiology, University Hospital Leipzig, Leipzig, Germany.

German Cardiovascular Research Center, Partner Site Göttingen, Göttingen, Germany.

出版信息

Eur J Heart Fail. 2019 May;21(5):588-597. doi: 10.1002/ejhf.1465. Epub 2019 Apr 11.

Abstract

AIMS

To analyse real-world treatment patterns of sacubitril/valsartan (sac/val) using data from a pharmacy database in Germany.

METHODS AND RESULTS

A retrospective cohort study of 26 191 adult patients (aged ≥ 18 years) in the IMS® longitudinal prescriptions database in Germany who were dispensed sac/val from January 2016 to June 2017 was conducted. The analysis included sac/val dose titration assessed in the 6 months from first sac/val prescription; prescriptions of concomitant cardiovascular medications in the 6 months pre- and post-index and compliance and persistence during 12 months post-index. Two-thirds of patients were prescribed the lowest sac/val dose of 50 mg twice daily (b.i.d.) at index and up-titration during the first 6 months was attempted in 41% of these patients. Ten percent of patients prescribed 200 mg b.i.d. at index had to be stably down-titrated; among patients prescribed 50 or 100 mg b.i.d. at index that were up-titrated, > 80% remained on the higher dose. Overall, the mean daily diuretic dose decreased by 25% after initiation of sac/val. High compliance and persistence rates were observed across sac/val doses, increasing with higher sac/val dose at index. Prior dose of angiotensin-converting enzyme inhibitor or angiotensin receptor blocker had only minor impact on first sac/val dose, compliance and persistence.

CONCLUSIONS

Most patients prescribed sac/val are not initiated on the recommended dose nor up-titrated as recommended by the EU Summary of Product Characteristics. Initiation of sac/val was associated with high persistence and compliance and a dose reduction of diuretics. Barriers to up-titration must be explored.

摘要

目的

利用德国一个药房数据库中的数据,分析沙库巴曲缬沙坦( sacubitril/valsartan, sac/val)的真实世界治疗模式。

方法和结果

进行了一项回顾性队列研究,共纳入 26191 例在德国 IMS®纵向处方数据库中年龄≥18 岁的成年患者,这些患者在 2016 年 1 月至 2017 年 6 月期间接受 sac/val 治疗。分析包括在首次 sac/val 处方后的 6 个月内评估 sac/val 剂量滴定情况;在索引前和后 6 个月内同时开具心血管药物的处方情况;以及索引后 12 个月内的依从性和持久性。三分之二的患者在索引时被开具最低剂量的 sac/val(50mg,每日两次[b.i.d.]),其中 41%的患者尝试在第 1 个 6 个月内进行剂量上调。10%的索引时开具 200mg b.i.d.的患者需要稳定地下调剂量;在索引时开具 50 或 100mg b.i.d.并上调剂量的患者中,超过 80%的患者仍维持较高剂量。总体而言, sac/val 起始后,平均日利尿剂剂量减少了 25%。 sac/val 各剂量组的依从性和持久性均较高,随着索引时 sac/val 剂量的增加而增加。起始 sac/val 前的血管紧张素转换酶抑制剂或血管紧张素受体阻滞剂剂量仅对首次 sac/val 剂量、依从性和持久性有轻微影响。

结论

大多数开具 sac/val 的患者未按照欧盟产品特性摘要建议的剂量起始治疗,也未按建议进行剂量上调。 sac/val 的起始治疗与高持久性和高依从性以及利尿剂剂量减少相关。必须探讨阻碍剂量上调的因素。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1e17/6607491/914f081b71af/EJHF-21-588-g001.jpg

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