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对德国一组接受沙库巴曲缬沙坦治疗的患者的临床参数特征和演变的早期见解。

Early insights into the characteristics and evolution of clinical parameters in a cohort of patients prescribed sacubitril/valsartan in Germany.

作者信息

Wachter Rolf, Viriato Daniel, Klebs Sven, Grunow Stefanie S, Schindler Matthias, Engelhard Johanna, Proenca Catia C, Calado Frederico, Schlienger Raymond, Dworak Markus, Balas Bogdan, Bruce Wirta Sara

机构信息

a Clinic and Policlinic for Cardiology , University Hospital Leipzig , Leipzig , Germany.

b Global Health Economics and Outcomes Research , Novartis Pharma AG , Basel , Switzerland.

出版信息

Postgrad Med. 2018 Apr;130(3):308-316. doi: 10.1080/00325481.2018.1442090. Epub 2018 Feb 28.

Abstract

OBJECTIVES

This study aimed to provide early insights into sacubitril/valsartan (sac/val) prescription patterns and the demographic and clinical characteristics of patients prescribed sac/val in primary care and cardiology settings in Germany.

METHODS

The study used electronic medical records from the German IMS® Disease Analyzer database. Patients with ≥1 prescription for sac/val during 1 January-31 December 2016 (n = 1643) were identified and followed up for ≤12 months from first prescription. Patients with ≥1 heart failure (HF) diagnosis during the study period, ≥1 additional HF diagnosis in the full history of the database, and ≥1 prescription for an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker and a β-blocker during the study period, without a prescription for sac/val (n = 25,264), were included as a reference cohort. Changes in clinical parameters in the 12 months before and after sac/val initiation were investigated and compared with those from the PARADIGM-HF study.

RESULTS

The characteristics of patients prescribed sac/val more closely resembled those of patients enrolled in PARADIGM-HF (e.g. younger age, higher proportion of men than women, lower systolic blood pressure) than patients in the reference cohort. Most patients were initiated on the lowest dose of sac/val irrespective of clinical setting. Significant decreases (p < 0.001) in NT-proBNP and glycated haemoglobin levels were observed following sac/val initiation.

CONCLUSIONS

Patients prescribed sac/val had similar baseline demographics and clinical characteristics to those from PARADIGM-HF, and most patients were initiated on the lowest dose. Changes in clinical parameters before and after initiation mirrored findings from the PARADIGM-HF study.

摘要

目的

本研究旨在对沙库巴曲缬沙坦(沙库/缬)的处方模式以及在德国初级医疗和心脏病学环境中开具沙库/缬处方的患者的人口统计学和临床特征进行早期洞察。

方法

本研究使用了来自德国IMS®疾病分析数据库的电子病历。确定了在2016年1月1日至12月31日期间有≥1次沙库/缬处方的患者(n = 1643),并从首次处方开始随访≤12个月。将在研究期间有≥1次心力衰竭(HF)诊断、在数据库完整病史中有≥1次额外HF诊断以及在研究期间有≥1次血管紧张素转换酶抑制剂或血管紧张素受体阻滞剂和β受体阻滞剂处方但无沙库/缬处方的患者(n = 25,264)纳入作为参考队列。研究了沙库/缬起始前后12个月内临床参数的变化,并与PARADIGM-HF研究的结果进行了比较。

结果

与参考队列中的患者相比,开具沙库/缬处方的患者的特征与PARADIGM-HF研究中纳入的患者更相似(例如,年龄较小、男性比例高于女性、收缩压较低)。无论临床环境如何,大多数患者开始使用最低剂量的沙库/缬。沙库/缬起始后,NT-proBNP和糖化血红蛋白水平显著降低(p < 0.001)。

结论

开具沙库/缬处方的患者的基线人口统计学和临床特征与PARADIGM-HF研究中的患者相似,且大多数患者开始使用最低剂量。起始前后临床参数的变化反映了PARADIGM-HF研究的结果。

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