PS-C19-5: SAFETY PROFILES OF SACUBITRIL/VALSARTAN IN EARLY POST-MARKETING PHASE VIGILANCE FOR THE INDICATION OF CHRONIC HEART FAILURE AND HYPERTENSION

Abstract

Background: The objective was to investigate and report the safety profile of Sacubitril Valsartan Sodium Hydrate (Sacubitril/Valsartan) (Entresto®) in Early Post-marketing Phase Vigilance (EPPV). Methods: In accordance with the regulation, the 6-month EPPV was conducted for the physicians or pharmacists at all medical institutions to which the drug was delivered. Safety information was collected and tabulated for the indication Chronic Heart Failure (CHF) (August 26, 2020 - February 25, 2021) and Hypertension (September 27, 2021 - March 26, 2022). The adverse drug reactions (ADRs) were classified using the basic terms of Medical Dictionary for Regulatory Activities (MedDRA). In addition, we focused on the five risks (hypotension, renal dysfunction/renal failure, hyperkalemia, angioedema, and dehydration) listed as Safety Specification in the Risk Management Plan (RMP). Results: The estimated number of patients treated with Sacubitril/Valsartan for the indication of CHF and hypertension was 24,898 and 165,000 during the data collection period. The number of ADRs were confirmed to be 850 (345 serious) for CHF and 455 (84 serious) for hypertension. No new safety findings were identified in both EPPVs. For both indications, the most common RMP-related ADRs were hypotension-related ADRs that occurred within 30 days after initiation were 87 (162 had, followed by renal dysfunction-related ADRs. Furthermore, hypotension-related ADRs were 268 (75 serious) for CHF and 93 (three serious) for hypertension. Hypotension-related ADRs that occurred within 30 days after initiation were 87 (162 had an unavailable date of onset) for CHF and 19 (71 had an unavailable date) for hypertension. Regarding renal dysfunction-related ADRs, the number of ADRs were 45 (45serious) for CHF and 19 (19serious) for hypertension. Renal dysfunction-related ADRs that occurred within 30 days after initiation were 17 (23 had an unavailable date of onset) for CHF and three (14 had an unavailable date) for hypertension. The number of hyperkalemia-related ADRs, angioedema, and dehydration were 35 (including 19 serious), five (five serious), and 25 (two serious) for CHF, and nine (five serious), four (four serious), and four (sero serious) for hypertension, respectively. Conclusion: No new safety findings were identified during the 6-month EPPV. Furthermore, there were no differences in safety profile by indication.