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Sacubitril/valsartan compared to ramipril in high-risk post-myocardial infarction patients stratified according to use of mineralocorticoid receptor antagonists: Insight from the PARADISE MI trial.
- Source :
-
European journal of heart failure [Eur J Heart Fail] 2024 Jan; Vol. 26 (1), pp. 130-139. Date of Electronic Publication: 2023 Nov 29. - Publication Year :
- 2024
-
Abstract
- Aim: It is unknown whether safety and clinical endpoints by use of sacubitril/valsartan (an angiotensin receptor-neprilysin inhibitor [ARNI]) are affected by mineralocorticoid receptor antagonists (MRA) in high-risk myocardial infarction (MI) patients. The aim of this study was to examine whether MRA modifies safety and clinical endpoints by use of sacubitril/valsartan in patients with a MI and left ventricular systolic dysfunction (LVSD) and/or pulmonary congestion.<br />Methods and Results: Patients (n = 5661) included in the PARADISE MI trial (Prospective ARNI vs. ACE Inhibitor Trial to Determine Superiority in Reducing Heart Failure Events After MI) were stratified according to MRA. Primary outcomes in this substudy were worsening heart failure or cardiovascular death. Safety was defined as symptomatic hypotension, hyperkalaemia >5.5 mmol/L, or permanent drug discontinuation. A total of 2338 patients (41%) were treated with MRA. Safety of ARNI compared to ramipril was not altered significantly by ± MRA, and both groups had similar increase in symptomatic hypotension with ARNI. In patients taking MRA, the risk of hyperkalaemia or permanent drug discontinuation was not significantly altered by ARNI (p > 0.05 for all comparisons). The effect of ARNI compared with ramipril was similar in those who were and were not taking MRA (hazard ratio [HR] <subscript>MRA</subscript> 0.96, 95% confidence interval [CI] 0.77-1.19 and HR <subscript>MRA-</subscript> 0.87, 95% CI 0.71-1.05, for the primary endpoint; p = 0.51 for interaction [Clinical Endpoint Committee adjudicated]); similar findings were observed if investigator-reported endpoints were evaluated (p = 0.61 for interaction).<br />Conclusions: Use of a MRA did not modify safety or clinical endpoints related to initiation of ARNI compared to ramipril in the post-MI setting in patients with LVSD and/or congestion.<br /> (© 2023 European Society of Cardiology.)
- Subjects :
- Humans
Ramipril therapeutic use
Ramipril pharmacology
Mineralocorticoid Receptor Antagonists therapeutic use
Mineralocorticoid Receptor Antagonists pharmacology
Prospective Studies
Tetrazoles therapeutic use
Tetrazoles pharmacology
Angiotensin Receptor Antagonists adverse effects
Valsartan therapeutic use
Biphenyl Compounds therapeutic use
Aminobutyrates adverse effects
Drug Combinations
Stroke Volume
Heart Failure
Hyperkalemia drug therapy
Hypotension chemically induced
Myocardial Infarction complications
Myocardial Infarction drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1879-0844
- Volume :
- 26
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- European journal of heart failure
- Publication Type :
- Academic Journal
- Accession number :
- 37933184
- Full Text :
- https://doi.org/10.1002/ejhf.3079