Non-interventional post-authorization multi-database safety study to assess the risk of myotoxicity, hepatotoxicity and acute pancreatitis in statin-exposed heart failure patients with or without concomitant use of sacubitril/valsartan (Entresto®)

First published 31/03/2017

Last updated 17/06/2025

EU PAS number:

EUPAS18358

Study

Finalised

Documents

Study protocol

Initial protocol

LCZ696B2015-Redacted-Protocol

English (1.44 MB - PDF)View document

Updated protocol

LCZ696B2015-v02-Redacted-Protocol

First published: 22/02/2024

English (529.62 KB - PDF)View document

Study results

Study report

LCZ696B2015_Final-Study-Report_for redaction_Redacted.pdf

English (4.29 MB - PDF)View document

Other information

ENCePP Seal

ENCePP Seal documents

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