Safety analysis of sacubitril/valsartan in patients with heart failure in Vitória, Espírito Santo
Autor(a) principal: | |
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Data de Publicação: | 2020 |
Outros Autores: | , , , , , |
Tipo de documento: | preprint |
Idioma: | eng |
Título da fonte: | SciELO Preprints |
Texto Completo: | https://preprints.scielo.org/index.php/scielo/preprint/view/862 |
Resumo: | Background: Sacubitril/valsartan has proven its efficacy to reduce cardiovascular mortality, all-cause mortality and sudden death in heart failure with reduced ejection fraction (HFrEF). Thus, it becomes important to evaluate the safety profile of the medication in clinical practice. Objectives: This study aimed to assess safety outcomes on the use of sacubitril/valsartan in patients with HFrEF attended in a Brazilian specialized service. Methods: Prospective observational study that included patients with HFrEF from a specialized ambulatory service, in functional class II-IV, initiated on sacubitril/valsartan as per clinical indication, with a four-month follow-up. Primary outcomes were the occurrence of symptomatic arterial hypotension, hyperkalemia and reduction of renal function. Serum potassium values, blood pressure and creatinine clearance were analyzed at inclusion and at the end of follow-up. A 5% significance level was considered for comparisons. Results: Twenty-six patients were analyzed, 57.7% male, mean age 57.8 ± 10 years, average left ventricle ejection fraction 29.9 ± 7.7%. Symptomatic hypotension occurred in 53.8%, hyperkalemia in 19.2% and reduction of renal function in 6.7%. There was significant difference from initial to final systolic (122 ± 24mmHg versus 109 ± 15mmHg; p=0.024) and diastolic (76 ± 18mmHg versus 66 ± 12mmHg; p=0.022) blood pressure, but no difference in serum potassium (4.8 ± 0.4mEq/L versus 5.0 ± 0.3mEq/L; p=0.07) and creatinine clearance (65 ± 23mL/min/1.73m² versus 66 ± 29mL/min/1.73m²; p=0.89). Conclusions: Symptomatic hypotension was the most frequent side-effect of sacubitril/valsartan. Reduction of blood pressure was observed at the end of follow-up, but no reduction of renal function or significant increase of serum potassium. |
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Safety analysis of sacubitril/valsartan in patients with heart failure in Vitória, Espírito SantoHeart FailureTherapeuticsAcute Renal FailureHypotensionHyperkalemiaBackground: Sacubitril/valsartan has proven its efficacy to reduce cardiovascular mortality, all-cause mortality and sudden death in heart failure with reduced ejection fraction (HFrEF). Thus, it becomes important to evaluate the safety profile of the medication in clinical practice. Objectives: This study aimed to assess safety outcomes on the use of sacubitril/valsartan in patients with HFrEF attended in a Brazilian specialized service. Methods: Prospective observational study that included patients with HFrEF from a specialized ambulatory service, in functional class II-IV, initiated on sacubitril/valsartan as per clinical indication, with a four-month follow-up. Primary outcomes were the occurrence of symptomatic arterial hypotension, hyperkalemia and reduction of renal function. Serum potassium values, blood pressure and creatinine clearance were analyzed at inclusion and at the end of follow-up. A 5% significance level was considered for comparisons. Results: Twenty-six patients were analyzed, 57.7% male, mean age 57.8 ± 10 years, average left ventricle ejection fraction 29.9 ± 7.7%. Symptomatic hypotension occurred in 53.8%, hyperkalemia in 19.2% and reduction of renal function in 6.7%. There was significant difference from initial to final systolic (122 ± 24mmHg versus 109 ± 15mmHg; p=0.024) and diastolic (76 ± 18mmHg versus 66 ± 12mmHg; p=0.022) blood pressure, but no difference in serum potassium (4.8 ± 0.4mEq/L versus 5.0 ± 0.3mEq/L; p=0.07) and creatinine clearance (65 ± 23mL/min/1.73m² versus 66 ± 29mL/min/1.73m²; p=0.89). Conclusions: Symptomatic hypotension was the most frequent side-effect of sacubitril/valsartan. Reduction of blood pressure was observed at the end of follow-up, but no reduction of renal function or significant increase of serum potassium.SciELO PreprintsSciELO PreprintsSciELO Preprints2020-06-29info:eu-repo/semantics/preprintinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://preprints.scielo.org/index.php/scielo/preprint/view/86210.1590/SciELOPreprints.862enghttps://preprints.scielo.org/index.php/scielo/article/view/862/1193Copyright (c) 2020 Roberto Ramos Barbosa, Natassia S. S. Campos Gomes, Layane Bonfante Batista, Pietro Dall'Orto Lima, Renato Giestas Serpa, Osmar Araujo Calil, Luiz Fernando Machado Barbosahttps://creativecommons.org/licenses/by/4.0info:eu-repo/semantics/openAccessBarbosa, Roberto RamosGomes, Natassia S. S. CamposBatista, Layane BonfanteLima, Pietro Dall'OrtoSerpa, Renato GiestasCalil, Osmar AraujoBarbosa, Luiz Fernando Machadoreponame:SciELO Preprintsinstname:SciELOinstacron:SCI2020-06-28T15:26:52Zoai:ops.preprints.scielo.org:preprint/862Servidor de preprintshttps://preprints.scielo.org/index.php/scieloONGhttps://preprints.scielo.org/index.php/scielo/oaiscielo.submission@scielo.orgopendoar:2020-06-28T15:26:52SciELO Preprints - SciELOfalse |
dc.title.none.fl_str_mv |
Safety analysis of sacubitril/valsartan in patients with heart failure in Vitória, Espírito Santo |
title |
Safety analysis of sacubitril/valsartan in patients with heart failure in Vitória, Espírito Santo |
spellingShingle |
Safety analysis of sacubitril/valsartan in patients with heart failure in Vitória, Espírito Santo Barbosa, Roberto Ramos Heart Failure Therapeutics Acute Renal Failure Hypotension Hyperkalemia |
title_short |
Safety analysis of sacubitril/valsartan in patients with heart failure in Vitória, Espírito Santo |
title_full |
Safety analysis of sacubitril/valsartan in patients with heart failure in Vitória, Espírito Santo |
title_fullStr |
Safety analysis of sacubitril/valsartan in patients with heart failure in Vitória, Espírito Santo |
title_full_unstemmed |
Safety analysis of sacubitril/valsartan in patients with heart failure in Vitória, Espírito Santo |
title_sort |
Safety analysis of sacubitril/valsartan in patients with heart failure in Vitória, Espírito Santo |
author |
Barbosa, Roberto Ramos |
author_facet |
Barbosa, Roberto Ramos Gomes, Natassia S. S. Campos Batista, Layane Bonfante Lima, Pietro Dall'Orto Serpa, Renato Giestas Calil, Osmar Araujo Barbosa, Luiz Fernando Machado |
author_role |
author |
author2 |
Gomes, Natassia S. S. Campos Batista, Layane Bonfante Lima, Pietro Dall'Orto Serpa, Renato Giestas Calil, Osmar Araujo Barbosa, Luiz Fernando Machado |
author2_role |
author author author author author author |
dc.contributor.author.fl_str_mv |
Barbosa, Roberto Ramos Gomes, Natassia S. S. Campos Batista, Layane Bonfante Lima, Pietro Dall'Orto Serpa, Renato Giestas Calil, Osmar Araujo Barbosa, Luiz Fernando Machado |
dc.subject.por.fl_str_mv |
Heart Failure Therapeutics Acute Renal Failure Hypotension Hyperkalemia |
topic |
Heart Failure Therapeutics Acute Renal Failure Hypotension Hyperkalemia |
description |
Background: Sacubitril/valsartan has proven its efficacy to reduce cardiovascular mortality, all-cause mortality and sudden death in heart failure with reduced ejection fraction (HFrEF). Thus, it becomes important to evaluate the safety profile of the medication in clinical practice. Objectives: This study aimed to assess safety outcomes on the use of sacubitril/valsartan in patients with HFrEF attended in a Brazilian specialized service. Methods: Prospective observational study that included patients with HFrEF from a specialized ambulatory service, in functional class II-IV, initiated on sacubitril/valsartan as per clinical indication, with a four-month follow-up. Primary outcomes were the occurrence of symptomatic arterial hypotension, hyperkalemia and reduction of renal function. Serum potassium values, blood pressure and creatinine clearance were analyzed at inclusion and at the end of follow-up. A 5% significance level was considered for comparisons. Results: Twenty-six patients were analyzed, 57.7% male, mean age 57.8 ± 10 years, average left ventricle ejection fraction 29.9 ± 7.7%. Symptomatic hypotension occurred in 53.8%, hyperkalemia in 19.2% and reduction of renal function in 6.7%. There was significant difference from initial to final systolic (122 ± 24mmHg versus 109 ± 15mmHg; p=0.024) and diastolic (76 ± 18mmHg versus 66 ± 12mmHg; p=0.022) blood pressure, but no difference in serum potassium (4.8 ± 0.4mEq/L versus 5.0 ± 0.3mEq/L; p=0.07) and creatinine clearance (65 ± 23mL/min/1.73m² versus 66 ± 29mL/min/1.73m²; p=0.89). Conclusions: Symptomatic hypotension was the most frequent side-effect of sacubitril/valsartan. Reduction of blood pressure was observed at the end of follow-up, but no reduction of renal function or significant increase of serum potassium. |
publishDate |
2020 |
dc.date.none.fl_str_mv |
2020-06-29 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/preprint info:eu-repo/semantics/publishedVersion |
format |
preprint |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
https://preprints.scielo.org/index.php/scielo/preprint/view/862 10.1590/SciELOPreprints.862 |
url |
https://preprints.scielo.org/index.php/scielo/preprint/view/862 |
identifier_str_mv |
10.1590/SciELOPreprints.862 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
https://preprints.scielo.org/index.php/scielo/article/view/862/1193 |
dc.rights.driver.fl_str_mv |
https://creativecommons.org/licenses/by/4.0 info:eu-repo/semantics/openAccess |
rights_invalid_str_mv |
https://creativecommons.org/licenses/by/4.0 |
eu_rights_str_mv |
openAccess |
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application/pdf |
dc.publisher.none.fl_str_mv |
SciELO Preprints SciELO Preprints SciELO Preprints |
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SciELO Preprints SciELO Preprints SciELO Preprints |
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reponame:SciELO Preprints instname:SciELO instacron:SCI |
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SciELO |
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SciELO Preprints |
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