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

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.

KEYWORDS:

• Electronic medical records
• heart failure with reduced ejection fraction
• patient characteristics
• PARADIGM-HF
• sacubitril/valsartan

Acknowledgments

Medical writing support was provided by Laura Knapp, PhD, of PharmaGenesis London, London, UK, with funding from Novartis Pharma AG.

Declaration of financial/other interests

R Wachter has been a consultant for or received speaker’s bureau from Bayer, Berlin Chemie, Boehringer Ingelheim, Bristol-Myers Squibb, CVRx, Johnson & Johnson, Medtronic, Novartis, Pfizer, Sanofi, and Servier. His institution has received research funding from Boehringer Ingelheim, the European Union and Bundesministerium für Bildung und Forschung. D Viriato, F Calado, R Schlienger, and B Balas are employees of Novartis Pharma AG. S Klebs and M Dworak are employees of Novartis Pharma GmbH. S Bruce Wirta is an employee of Novartis Sweden AB. SS Grunow and J Engelhard are employees of QuintilesIMS Germany (IMS HEALTH GmbH & Co. OHG), and M Schindler is an employee of QuintilesIMS Switzerland, which received funding from Novartis Pharma AG to perform the study. CC Proenca is an employee of Wellmera AG. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.

Ethical standards

This study was performed in accordance with the guidelines for Good Practice of Secondary Data Analysis.

Supplemental data

Supplemental data for this article can be accessed here.

Additional information

Funding

This study was funded by Novartis Pharma AG.