PMID- 38000538 OWN - NLM STAT- Publisher LR - 20231209 IS - 1876-4738 (Electronic) IS - 0914-5087 (Linking) DP - 2023 Nov 22 TI - Relevant adverse events and drug discontinuation of sacubitril/valsartan in a real-world Japanese cohort: REVIEW-HF registry. LID - S0914-5087(23)00276-9 [pii] LID - 10.1016/j.jjcc.2023.11.005 [doi] AB - BACKGROUND: The characteristics, tolerability, and outcomes in patients with heart failure (HF) who are treated with sacubitril/valsartan remain unclear in Japan. METHODS: We conducted a nationwide multicenter study to evaluate the features and outcomes of patients newly prescribed sacubitril/valsartan for the management of HF. We analyzed adverse events (AEs) related to sacubitril/valsartan at 3 months, which were defined as hypotension, worsening renal function, hyperkalemia, and angioedema. Additionally, the association between AEs and outcomes was examined. RESULTS: Among 993 patients, the mean age was 70 years and 291 (29.3 %) were female, and 22.8 % had left ventricular ejection fraction >/=50 %. Of them, 20.8 % had systolic blood pressure (sBP) <100 mmHg, and 19.5 % had estimated glomerular filtration rate (eGFR) <30 ml/min/1.73 m(2) at baseline, which were the populations excluded from the eligibility in landmark trials. AEs related to sacubitril/valsartan were observed in 22.5 % of the patients at 3 months. Overall, 22.6 % of patients discontinued sacubitril/valsartan, and hypotension was the most common event leading to drug discontinuation. After adjustment, patients who had worse HF symptoms (New York Heart Association III or IV), sBP <100 mmHg, and eGFR <30 ml/min/1.73 m(2) were associated with a higher risk of AEs related to sacubitril/valsartan. Additionally, patients experiencing AEs had a higher risk of cardiovascular death or HF hospitalization than those who did not. CONCLUSION: In Japan, sacubitril/valsartan was also prescribed to patients not eligible for landmark trials, and AEs were observed at a relatively high rate from soon after treatment initiation. Physicians should closely monitor patients for these events, especially in patients anticipated to have a higher risk of AEs. CI - Copyright (c) 2023 Elsevier Ltd. All rights reserved. FAU - Matsumoto, Shingo AU - Matsumoto S AD - Division of Cardiovascular Medicine, Department of Internal Medicine, Toho University Faculty of Medicine, Tokyo, Japan; British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK. Electronic address: shingomatsumoto0606@gmail.com. FAU - McMurray, John J V AU - McMurray JJV AD - British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK. FAU - Nasu, Takahito AU - Nasu T AD - Division of Cardiology, Department of Internal Medicine, Iwate Medical University, Iwate, Japan. FAU - Ishii, Shunsuke AU - Ishii S AD - Department of Cardiovascular Medicine, Kitasato University School of Medicine, Kanagawa, Japan. FAU - Kagiyama, Nobuyuki AU - Kagiyama N AD - Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan; Department of Digital Health and Telemedicine, R&D, Tokyo, Japan. FAU - Kida, Keisuke AU - Kida K AD - Department of Pharmacology, St. Marianna University School of Medicine, Kanagawa, Japan. FAU - Fujimoto, Wataru AU - Fujimoto W AD - Department of Cardiology, Hyogo Prefectural Awaji Medicine Center, Hyogo, Japan. FAU - Kikuchi, Atsushi AU - Kikuchi A AD - Division of Cardiology, Osaka General Medical Center, Osaka, Japan. FAU - Ijichi, Takeshi AU - Ijichi T AD - Department of Cardiology, Tokai University School of Medicine, Kanagawa, Japan. FAU - Shibata, Tatsuhiro AU - Shibata T AD - Division of Cardiovascular Medicine, Department of Internal Medicine, Kurume University School of Medicine, Kurume, Japan. FAU - Ikeda, Takanori AU - Ikeda T AD - Division of Cardiovascular Medicine, Department of Internal Medicine, Toho University Faculty of Medicine, Tokyo, Japan. FAU - Kanaoka, Koshiro AU - Kanaoka K AD - Department of Medical and Health Information Management, National Cerebral and Cardiovascular Center, Osaka, Japan; Department of Cardiovascular Medicine, Nara Medical University, Nara, Japan. LA - eng PT - Journal Article DEP - 20231122 PL - Netherlands TA - J Cardiol JT - Journal of cardiology JID - 8804703 SB - IM OTO - NOTNLM OT - Adverse event OT - Asia OT - Heart failure with preserved ejection fraction OT - Heart failure with reduced ejection fraction OT - Sacubitril/valsartan COIS- Declaration of competing interest S.M. has received research grants and personal fees from Abott, Bayer Pharma, Boehringer Ingelheim, Daiichi-Sankyo, Medtronic, Novartis, Ono Pharma, Orbus Neich, Otsuka Pharma, and the Uehara Memorial Foundation. J.J.V.M. received payments through Glasgow University from work on clinical trials, consulting, and other activities from: Amgen, AstraZeneca, Bayer, Cardurion, Cytokinetics, GSK, KBP Biosciences, and Novartis. Personal consultancy fees from: Alnylam Pharma, Bayer, BMS, George Clinical PTY Ltd., Ionis Pharma., Novartis, Regeneron Pharma., River 2 Renal Corporation. Personal lecture fees: Abbott, Alkem Metabolics, Astra Zeneca, Blue Ocean Scientific Solutions Ltd., Boehringer Ingelheim, Canadian Medical and Surgical Knowledge, Emcure Pharma. Ltd., Eris Lifesciences, European Academy of CME, Hikma Pharmaceuticals, Imagica health, Intas Pharma, J.B. Chemicals & Pharma. Ltd., Lupin Pharma, Medscape/Heart.Org, ProAdWise Communications, Radcliffe Cardiology, Sun Pharma., The Corpus, Translation Research Group, and Translational Medicine Academy. J.J.V.M is a director of Global Clinical Trial Partners Ltd. J.J.V.M. is supported by a British Heart Foundation Centre of Research Excellence Grant RE/18/6/34217 and the Vera Melrose Heart Failure Research Fund. N.K. receives honorarium from Novartis Pharma, Boehringer-Ingelheim Japan, Eli Lilly Japan K.K, and Otsuka Pharma, and is affiliated with a department endowed by AMI Inc., Fukuda Denshi, KYOCERA, InterReha, and Philips Japan. T.S. has received honoraria from Novartis Pharmaceuticals KK, Boehringer Ingelheim, and Otsuka Pharmaceuticals Co. Ltd. A.K. has received honoraria from Novartis Pharma. EDAT- 2023/11/25 07:42 MHDA- 2023/11/25 07:42 CRDT- 2023/11/24 19:27 PHST- 2023/09/10 00:00 [received] PHST- 2023/11/10 00:00 [revised] PHST- 2023/11/16 00:00 [accepted] PHST- 2023/11/25 07:42 [pubmed] PHST- 2023/11/25 07:42 [medline] PHST- 2023/11/24 19:27 [entrez] AID - S0914-5087(23)00276-9 [pii] AID - 10.1016/j.jjcc.2023.11.005 [doi] PST - aheadofprint SO - J Cardiol. 2023 Nov 22:S0914-5087(23)00276-9. doi: 10.1016/j.jjcc.2023.11.005.