Sacubitril and valsartan

(Entresto®)

Sacubitril and valsartan

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Drug updated on 5/17/2024

Dosage FormFilm coated tablet (oral; sacubitril/valsartan: 24/26 mg, 49/51 mg, 97/103 mg); Film coated oral pellets within capsules (oral; sacubitril/valsartan: 6/6 mg, 15/16 mg)
Drug ClassCardiovascular Agents
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal.
  • Indicated for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. ENTRESTO reduces NT-proBNP and is expected to improve cardiovascular outcomes.

Summary
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  • Sacubitril and valsartan (Entresto) is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure, particularly those with left ventricular ejection fraction below normal. It is also used for treating symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older.
  • A total of 29 systematic reviews/meta-analyses focused on Entresto's safety, effectiveness, comparison to other treatments including ACE inhibitors (ACEis) and angiotensin receptor blockers (ARBs), as well as its impact on various populations such as adults with chronic heart failure and pediatric patients.
  • Compared to valsartan alone or ACEis/ARBs therapies, Entresto showed superior outcomes for patients suffering from different types of heart failures without a significant difference in cardiovascular death or all-cause mortality. Additionally, it demonstrated improvements like a reduction in NT-proBNP levels indicating less strain on the patient’s failing hearts.
  • The drug was effective at preventing further deterioration in renal function among these patient groups while reducing hospitalizations due to HF; however, low-dose administration was associated with increased risks compared to high-dose usage suggesting dose-dependent efficacy.
  • Several cost-effectiveness models suggested that Entresto could be considered a cost-effective therapy option for chronic HFrEF patients over their lifetime horizon considering HF being a long-term disease condition.
  • Patients treated by this drug reported improved health-related quality-of-life scores despite hypotension being identified as the most common adverse event, higher than what is observed under ACEI/ARB treatment regimes.
  • Real-world evidence aligned well with controlled trials showing significant reductions both in all-cause mortality rates & HF-related hospitalizations when using Entresto compared against traditional therapies like ACE-I/ARB, especially amongst HFrEF diagnosed individuals.
  • Studies focusing directly upon pediatric populations were scarce, indicating a gap in research or reported outcomes for this patient group.

Product Monograph / Prescribing Information

Document TitleYearSource
Entresto (sacubitril and valsartan) Prescribing Information.2024Novartis Pharmaceuticals Corporation., East Hanover, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
The efficacy and safety of sacubitril/valsartan compared to valsartan in patients with heart failure and mildly reduced and preserved ejection fractions: a systematic review and meta-analysis of randomized controlled trials.2024Journal of Clinical Medicine
Efficacy of angiotensin receptor-neprilysin inhibitor and its renal outcome in heart failure patients: a systematic review of randomized clinical trials.2024Cureus
Efficacy and safety of low‐dose sacubitril/valsartan in heart failure patients: a systematic review and meta‐analysis.2023Clinical Cardiology
Model parameters influencing the cost-effectiveness of sacubitril/valsartan in heart failure: evidence from a systematic literature review.2023The European Journal of Health economics
Efficacy and safety of sacubitril/valsartan compared with acei/arb on health-related quality of life in heart failure patients: a meta-analysis.2023The Annals of Pharmacotherapy
Effects of angiotensin receptor-neprilysin inhibitors versus enalapril or valsartan on patients with heart failure: a systematic review and meta-analysis.2023Cureus
Effectiveness of sacubitril/valsartan in heart failure with reduced ejection fraction using real-world data: an updated systematic review and meta-analysis.2023Current problems in cardiology
Effectiveness and safety of sacubitril/valsartan in heart failure with preserved ejection fraction: a systematic review and meta-analysis.2023Alternative therapies in health and medicine
Sacubitril/valsartan and arrhythmic burden in patients with heart failure and reduced ejection fraction: a systematic review and meta-analysis.2023Heart failure reviews
The angiotensin receptor and neprilysin inhibitor, LCZ696, in heart failure: a meta-analysis of randomized controlled trials.2022Medicine (Baltimore)
Effect of sacubitril/valsartan on the right ventricular function and pulmonary hypertension in patients with heart failure with reduced ejection fraction: a systematic review and meta-analysis of observational studies.2022Journal of the American Heart Association
Sacubitril/valsartan, sodium-glucose cotransporter 2 inhibitors and vericiguat for congestive heart failure therapy.2022Basic & Clinical Pharmacology & Toxicology
Therapeutic effects and safety of early use of sacubitril/valsartan after acute myocardial infarction: a systematic review and meta-analysis.2022Annals of Palliative Medicine
Efficacy of medication therapy for patients with chronic kidney disease and heart failure with preserved ejection fraction: a systematic review and meta-analysis.2022International Urology and Nephrology
Effects of sacubitril/valsartan on life quality in chronic heart failure: a systematic review and meta-analysis of randomized controlled trials.2022Frontiers in Cardiovascular Medicine
Effect of sacubitril/valsartan on the occurrence of cardiac arrhythmias and the risk of sudden cardiac death in heart failure: a meta-analysis of randomized controlled trials.2022Frontiers in Cardiovascular Medicine
Qili qiangxin capsule combined with sacubitril/valsartan for HFrEF: a systematic review and meta-analysis.2022Frontiers in Pharmacology
Effects of sacubitril-valsartan on heart failure patients with mid-range ejection fractions: a systematic review and meta-analysis. 2022Frontiers in Pharmacology
Benefits and adverse effects of sacubitril/valsartan in patients with chronic heart failure: a systematic review and meta-analysis.2021Pharmacology Research & Perspectives
Inpatient initiation of sacubitril/valsartan.2021The Annals of Pharmacotherapy
Sacubitril/valsartan in real-life European patients with heart failure and reduced ejection fraction: a systematic review and meta-analysis.2021ESC Heart Failure
Real-world effectiveness and safety of sacubitril/valsartan in heart failure: a systematic review.2021International Journal of Cardiology
Comparing sacubitril/valsartan against sodium-glucose cotransporter 2 inhibitors in heart failure: a systematic review and network meta-analysis.2021Clinical Drug Investigation
The benefits of sacubitril-valsartan in patients with acute myocardial infarction: a systematic review and meta-analysis.2021ESC Heart Failure
Effect of angiotensin-neprilysin versus renin-angiotensin system inhibition on renal outcomes: a systematic review and meta-analysis.2021Frontiers in Pharmacology
Efficacy and safety of sacubitril-valsartan in patients with heart failure: a systematic review and meta-analysis of randomized clinical trials: a PRISMA-compliant article.2021Medicine
Effect of sacubitril/valsartan on renal function: a systematic review and meta-analysis of randomized controlled trials.2020ESC Heart Failure
Relative efficacy of sacubitril-valsartan, vericiguat, and SGLT2 inhibitors in heart failure with reduced ejection fraction: a systematic review and network meta-analysis.2020Cardiovascular Drugs and Therapy
Effects of sacubitril/valsartan in patients with heart failure and chronic kidney disease: a meta-analysis.2020European Journal of Pharmacology
Beneficial and harmful effects of sacubitril/valsartan in patients with heart failure: a systematic review of randomised clinical trials with meta-analysis and trial sequential analysis.2020Heart Failure and Cardiomyopathies

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