Clinical Profile of a Nonselected Population Treated With Sacubitril/Valsartan Is Different From PARADIGM-HF Trial

J Cardiovasc Pharmacol. 2018 Aug;72(2):112-116. doi: 10.1097/FJC.0000000000000603.

Abstract

Our aim is to describe the characteristics of the patients receiving sacubitril/valsartan (SV) in daily clinical practice. This is a prospective registry in 10 hospitals including all patients who started SV in everyday clinical practice. From October 2016 to March 2017, 427 patients started treatment with SV. The mean age was 68.1 ± 12.4 years, and 30.5% were women (22.0% in PARADIGM-HF, P < 0.001). Comparing our cohort with patients included in PARADIGM-HF, baseline treatment was different, with a lower ratio of angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers (2.7 vs. 3.5, P < 0.001), and a higher proportion of patients with implantable cardioverter defibrillator (53.8% vs. 15%, P < 0.001), and cardiac resynchronization therapy (25.8% vs. 5%, P < 0.001). Treatment with mineralocorticoid receptor antagonists was more frequent (76.7% vs. 60.0%, P < 0.001), and the use of beta-blockers was similar (94.6% vs. 93.0%, P = 0.43). We observed more patients in functional class III-IV (30.4 vs. 24.8, P = 0.015), higher levels of Nt pro-BNP [3421 (904-4161) vs. 1631 (885-3154) pg/mL] and worse renal function (creatinine level 1.3 ± 0.7 vs. 1.1 ± 0.3 mg/dL, P < 0.001). In real life, patients receiving SV have a higher risk profile than in the pivotal trial, poorer functional class, higher levels of natriuretic peptides, and worse renal function.

Publication types

  • Comparative Study
  • Multicenter Study
  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aminobutyrates / adverse effects
  • Aminobutyrates / therapeutic use*
  • Angiotensin II Type 1 Receptor Blockers / adverse effects
  • Angiotensin II Type 1 Receptor Blockers / therapeutic use*
  • Biomarkers / blood
  • Biphenyl Compounds
  • Drug Combinations
  • Female
  • Health Status
  • Heart Failure / diagnosis
  • Heart Failure / drug therapy*
  • Heart Failure / physiopathology
  • Humans
  • Kidney / physiopathology
  • Male
  • Middle Aged
  • Natriuretic Peptide, Brain / blood
  • Neprilysin / antagonists & inhibitors*
  • Peptide Fragments / blood
  • Prospective Studies
  • Protease Inhibitors / adverse effects
  • Protease Inhibitors / therapeutic use*
  • Randomized Controlled Trials as Topic
  • Recovery of Function
  • Registries
  • Risk Factors
  • Spain
  • Tetrazoles / adverse effects
  • Tetrazoles / therapeutic use*
  • Time Factors
  • Treatment Outcome
  • Valsartan

Substances

  • Aminobutyrates
  • Angiotensin II Type 1 Receptor Blockers
  • Biomarkers
  • Biphenyl Compounds
  • Drug Combinations
  • Peptide Fragments
  • Protease Inhibitors
  • Tetrazoles
  • pro-brain natriuretic peptide (1-76)
  • Natriuretic Peptide, Brain
  • Valsartan
  • Neprilysin
  • sacubitril and valsartan sodium hydrate drug combination