Influence of diabetes on sacubitril/valsartan titration and clinical outcomes in patients hospitalized for heart failure.

Autor: Witte KK; Department of Internal Medicine I, University Hospital, RWTH Aachen University, Aachen, DE; and Leeds Institute of Cardio and Metabolic Medicine, University of Leeds, Leeds, UK., Wachter R; Department of Cardiology, Leipzig University Hospital, Leipzig, Germany., Senni M; Cardiovascular Department & Cardiology Unit, Ospedale Papa Giovanni XXIII, Bergamo, Italy., Belohlavek J; 2nd Department of Medicine, Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague, Prague, Czech Republic., Straburzynska-Migaj E; 1st Department of Cardiology, Poznan University of Medical Sciences, Poznan, Poland., Fonseca C; Hospital de Sao Francisco Xavier, Lisbon, Portugal., Lonn E; Department of Medicine and Population Health Research Institute, McMaster University, Hamilton, Canada., Noè A; Cardio Renal and Metabolic Department, Novartis Pharma AG, Basel, Switzerland., Schwende H; Cardio Renal and Metabolic Department, Novartis Pharma AG, Basel, Switzerland., Butylin D; Cardio Renal and Metabolic Department, Novartis Pharma AG, Basel, Switzerland., Chiang Y; Cardio, Renal and Metabolic Department, Novartis Pharmaceuticals, East Hanover, NJ, USA., Pascual-Figal D; Department of Cardiology, Hospital Virgen de la Arrixaca, University of Murcia, Murcia, Spain & Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain.
Jazyk: angličtina
Zdroj: ESC heart failure [ESC Heart Fail] 2023 Feb; Vol. 10 (1), pp. 80-89. Date of Electronic Publication: 2022 Sep 20.
DOI: 10.1002/ehf2.14166
Abstrakt: Aims: Diabetes mellitus is associated with worse outcomes and lower attainment of disease-modifying therapies in patients with heart failure with reduced ejection fraction (HFrEF). This post hoc analysis of TRANSITION compared the patterns of tolerability and uptitration of sacubitril/valsartan in patients with HFrEF stabilized after hospital admission due to acute decompensated HF depending on the presence or absence of diabetes as a co-morbidity.
Methods: TRANSITION, a randomized, open-label study compared sacubitril/valsartan initiation pre-discharge vs. post-discharge (up to14 days) in 991 patients hospitalized for acutely decompensated HFrEF. The impact of diabetes status on tolerability and safety was studied at 10-week and 26-week post-randomization.
Results: Among the 991 patients analysed at baseline, 460 (46.4%) had diabetes and exhibited a higher risk profile. At 10 weeks, sacubitril/valsartan target dose (97/103 mg bid) was achieved in a similar proportion of patients in each subgroup, when initiated pre-discharge or post-discharge respectively [diabetes subgroup: 47% (n = 105/226) vs. 50% (n = 115/228); relative risk ratio (RRR), 0.923; P = 0.412; non-diabetes subgroup: 45% (n = 119/267) vs. 51% (n = 133/261); RRR, 0.878; P = 0.155]. The proportions of patients achieving and maintaining either 49/51 mg or 97/103 mg bid [diabetes subgroup: 61.1% (n = 138/226) vs. 67.5% (n = 154/228); RRR, 0.909; P = 0.175; non-diabetes subgroup: 62.9% [n = 168/267] vs 69.3% [n = 181/261]; RRR, 0.906; P = 0.118] or any dose for ≥2 weeks leading to Week 10 [diabetes subgroup: 85% (n = 192/226) vs. 88.2% (n = 201/228); RRR, 0.966; P = 0.356; non-diabetes subgroup: 86.9% (n = 232/267) vs. 90.8% (n = 237/261); RRR, 0.963; P = 0.215] were also similar in each subgroup, when initiated pre-discharge or post-discharge, respectively. At 10 weeks, hypotension and renal dysfunction rates were similar, although hyperkalaemia was higher among patients with diabetes (15.9% vs. 9.5%). The rate of permanent discontinuation due to adverse events was similar in the diabetes and non-diabetes subgroups at 10 weeks, respectively: pre-discharge (7.5% vs. 7.1%) or post-discharge (5.7% vs. 4.2%). Similar patterns of uptitration and tolerability were observed at 26 weeks. Cardiac biomarkers including NT-proBNP (P < 0.005) and hs-TnT (P < 0.005) reduced significantly from baseline levels in both subgroups at Weeks 4 and 10; however, the response was greater among patients without diabetes. Mortality (diabetes vs. non-diabetes subgroups: 3.3% vs 4.0%; P = 0.438) and HF rehospitalization (diabetes vs. non-diabetes subgroups: 36.3% vs. 33.0%; P = 0.295) did not differ between the groups at 26 weeks.
Conclusions: Despite a higher risk profile among patients with diabetes, sacubitril/valsartan initiation either before or shortly after discharge in hospitalized patients with HFrEF resulted in comparable rates of dose up-titration and tolerability as in those without diabetes.
(© 2022 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)
Databáze: MEDLINE
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