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Safety and tolerability of Sacubitril/Valsartan in heart failure patient with reduced ejection fraction
BACKGROUND: Angiotensin receptor blocker and a neprilysin inhibitor (ARNI) has emerged as an innovative therapy for patients of heart failure with reduced ejection fraction (HFrEF). The purpose of this study was to assess the safety and tolerability of Sacubitril/Valsartan in patient with HFrEF in P...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10012729/ https://www.ncbi.nlm.nih.gov/pubmed/36915075 http://dx.doi.org/10.1186/s12872-023-03070-9 |
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author | Khan, Muhammad Nauman Soomro, Najia Aslam Naseeb, Khalid Bhatti, Usman Hanif Rauf, Rubina Balouch, Iram Jehan Moazzam, Ali Bashir, Sonia Ashraf, Tariq Karim, Musa |
author_facet | Khan, Muhammad Nauman Soomro, Najia Aslam Naseeb, Khalid Bhatti, Usman Hanif Rauf, Rubina Balouch, Iram Jehan Moazzam, Ali Bashir, Sonia Ashraf, Tariq Karim, Musa |
author_sort | Khan, Muhammad Nauman |
collection | PubMed |
description | BACKGROUND: Angiotensin receptor blocker and a neprilysin inhibitor (ARNI) has emerged as an innovative therapy for patients of heart failure with reduced ejection fraction (HFrEF). The purpose of this study was to assess the safety and tolerability of Sacubitril/Valsartan in patient with HFrEF in Pakistani population. METHODS: This proof-of-concept, open label non-randomized clinical trial was conducted at a tertiary care cardiac center of Karachi, Pakistan. Patients with HFrEF were prescribed with Sacubitril/Valsartan and followed for 12 weeks for the assessment of safety and tolerability. Safety measures included incidence of hypotension, renal dysfunction, hyperkalemia, and angioedema. RESULTS: Among the 120 HFrEF patients, majority were male (79.2%) with means age of 52.73 ± 12.23 years. At the end of 12 weeks, four (3.3%) patients died and eight (6.7%) dropped out of the study. In the remaining 108 patients, 80.6% (87) of the patients were tolerant to the prescribed dose. Functional class improved gradually with 75.0% (81) in class I and 24.1% (26) in class II, and only one (0.9%) patient in class III at the end of 12 weeks. Hyperkalemia remains the main safety concern with incidence rate of 21.3% (23) followed by hypotension in 19.4% (21), and renal dysfunction in 3.7% (4) of the patients. CONCLUSIONS: Sacubitril/Valsartan therapy in HFrEF patients is safe and moderately tolerated among the Pakistani population. It can be used as first line of treatment for these patients. TRIAL REGISTRATION: NCT05387967. Registered 24 May 2022—Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT05387967 |
format | Online Article Text |
id | pubmed-10012729 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-100127292023-03-15 Safety and tolerability of Sacubitril/Valsartan in heart failure patient with reduced ejection fraction Khan, Muhammad Nauman Soomro, Najia Aslam Naseeb, Khalid Bhatti, Usman Hanif Rauf, Rubina Balouch, Iram Jehan Moazzam, Ali Bashir, Sonia Ashraf, Tariq Karim, Musa BMC Cardiovasc Disord Research Article BACKGROUND: Angiotensin receptor blocker and a neprilysin inhibitor (ARNI) has emerged as an innovative therapy for patients of heart failure with reduced ejection fraction (HFrEF). The purpose of this study was to assess the safety and tolerability of Sacubitril/Valsartan in patient with HFrEF in Pakistani population. METHODS: This proof-of-concept, open label non-randomized clinical trial was conducted at a tertiary care cardiac center of Karachi, Pakistan. Patients with HFrEF were prescribed with Sacubitril/Valsartan and followed for 12 weeks for the assessment of safety and tolerability. Safety measures included incidence of hypotension, renal dysfunction, hyperkalemia, and angioedema. RESULTS: Among the 120 HFrEF patients, majority were male (79.2%) with means age of 52.73 ± 12.23 years. At the end of 12 weeks, four (3.3%) patients died and eight (6.7%) dropped out of the study. In the remaining 108 patients, 80.6% (87) of the patients were tolerant to the prescribed dose. Functional class improved gradually with 75.0% (81) in class I and 24.1% (26) in class II, and only one (0.9%) patient in class III at the end of 12 weeks. Hyperkalemia remains the main safety concern with incidence rate of 21.3% (23) followed by hypotension in 19.4% (21), and renal dysfunction in 3.7% (4) of the patients. CONCLUSIONS: Sacubitril/Valsartan therapy in HFrEF patients is safe and moderately tolerated among the Pakistani population. It can be used as first line of treatment for these patients. TRIAL REGISTRATION: NCT05387967. Registered 24 May 2022—Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT05387967 BioMed Central 2023-03-13 /pmc/articles/PMC10012729/ /pubmed/36915075 http://dx.doi.org/10.1186/s12872-023-03070-9 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Research Article Khan, Muhammad Nauman Soomro, Najia Aslam Naseeb, Khalid Bhatti, Usman Hanif Rauf, Rubina Balouch, Iram Jehan Moazzam, Ali Bashir, Sonia Ashraf, Tariq Karim, Musa Safety and tolerability of Sacubitril/Valsartan in heart failure patient with reduced ejection fraction |
title | Safety and tolerability of Sacubitril/Valsartan in heart failure patient with reduced ejection fraction |
title_full | Safety and tolerability of Sacubitril/Valsartan in heart failure patient with reduced ejection fraction |
title_fullStr | Safety and tolerability of Sacubitril/Valsartan in heart failure patient with reduced ejection fraction |
title_full_unstemmed | Safety and tolerability of Sacubitril/Valsartan in heart failure patient with reduced ejection fraction |
title_short | Safety and tolerability of Sacubitril/Valsartan in heart failure patient with reduced ejection fraction |
title_sort | safety and tolerability of sacubitril/valsartan in heart failure patient with reduced ejection fraction |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10012729/ https://www.ncbi.nlm.nih.gov/pubmed/36915075 http://dx.doi.org/10.1186/s12872-023-03070-9 |
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