The real-world safety of sacubitril / valsartan among older adults (≥75): A pharmacovigilance study from the FDA data.
| Autor: | Lerman TT; Department of Internal Medicine F-Recanati, Beilinson Hospital, Rabin Medical Center, Petah Tikva, Israel; Department of Cardiology, Rabin Medical Center, Petah Tikva, Israel; The Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address: tsahilerman@gmail.com., Greenberg N; Department of Internal Medicine F-Recanati, Beilinson Hospital, Rabin Medical Center, Petah Tikva, Israel; The Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel., Fishman B; The Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Leviev Heart Center, Sheba Medical Center, Ramat-Gan, Israel., Goldman A; The Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Leviev Heart Center, Sheba Medical Center, Ramat-Gan, Israel; Department of Internal Medicine F, Sheba Medical Center, Ramat-Gan, Israel., Talmor-Barkan Y; Department of Cardiology, Rabin Medical Center, Petah Tikva, Israel; The Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel., Bauer M; Adelson School of Medicine, Ariel University, Ariel, Israel., Goldberg I; Department of Internal Medicine F-Recanati, Beilinson Hospital, Rabin Medical Center, Petah Tikva, Israel; The Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Institute of Hematology, Davidoff Cancer Center, Beilinson Hospital, Rabin Medical Center, Petah Tikva, Israel., Goldberg E; Department of Internal Medicine F-Recanati, Beilinson Hospital, Rabin Medical Center, Petah Tikva, Israel; The Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel., Kornowski R; Department of Cardiology, Rabin Medical Center, Petah Tikva, Israel; The Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel., Krause I; Department of Internal Medicine F-Recanati, Beilinson Hospital, Rabin Medical Center, Petah Tikva, Israel; The Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel., Levi A; Department of Cardiology, Rabin Medical Center, Petah Tikva, Israel; The Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel., Cohen E; Department of Internal Medicine F-Recanati, Beilinson Hospital, Rabin Medical Center, Petah Tikva, Israel; The Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. |
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| Jazyk: | angličtina |
| Zdroj: | International journal of cardiology [Int J Cardiol] 2024 Feb 15; Vol. 397, pp. 131613. Date of Electronic Publication: 2023 Nov 27. |
| DOI: | 10.1016/j.ijcard.2023.131613 |
| Abstrakt: | Background: Heart failure is a major cause of morbidity and mortality among older adults. Sacubitril-Valsartan (Sac/Val) has been shown to improve patients' outcomes; however, its safety profile among older adults has not been adequately examined. We therefore aimed to examine its safety profile among this population. Methods: We conducted a retrospective pharmacovigilance study utilizing the FDA's database of safety reports (FAERS). We employed disproportionality analysis comparing Sac/Val to angiotensin receptor blockers (ARBs). We aim to evaluate the reporting of pre-defined adverse events associated with Sac/Val (hypotension, acute kidney injury (AKI), hyperkalemia and angioedema) in two age groups: adults (< 75 years) and older adults (≥ 75). For each subgroup, we calculated reporting odds ratio (ROR) and compared them by calculating P for interaction. Results: The FAERS database encompassed 18,432 unique reports of Sac/Val. Of them, 12,630 (68.5%) subjects were adults (< 75 years), and 5802 (31.5%) were older adults (≥ 75 years), with a median age (IQR) of 68 (59-77). When compared to ARBs, Sac/Val was associated with higher reporting of hypotension, lower reporting of acute kidney injury (AKI) and hyperkalemia, and similar reporting of angioedema. Notably, we did not observe a significant interaction between the age subgroups and the risk estimates (AKI: P Conclusions: In this postmarking study, none of the prespecified adverse events was reported more frequently in older adults. These findings provide reassurance for safety use of Sac/Val in older adults. (Copyright © 2023 Elsevier B.V. All rights reserved.) |
| Databáze: | MEDLINE |
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