Drug updated on 7/25/2024
Dosage Form | Film 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 Class | Cardiovascular 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.
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Summary
- 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 (LVEF) below normal.
- The information was derived from 30 systematic reviews/meta-analyses.
- In comparison to ACE inhibitors (ACEIs) and angiotensin receptor blockers (ARBs), sacubitril/valsartan significantly reduces all-cause mortality and hospitalization risks in patients with Heart Failure with Reduced Ejection Fraction (HFrEF).
- For Heart Failure with Preserved Ejection Fraction (HFpEF), Entresto shows a reduction in hospitalizations but does not significantly impact overall mortality compared to ACEIs/ARBs.
- Sacubitril/valsartan contributes positively by preventing renal function decline, especially in HFpEF patients, showing reduced incidence of composite renal impairment compared to RAAS inhibitors.
- Post-Acute Myocardial Infarction benefits include reduced heart failure hospitalization rates and improved LV ejection fraction without significant reductions in cardiovascular mortality or recurrence of myocardial infarction.
- Frequently reported adverse effects include hypotension; however, it does not show a higher risk of hyperkalemia or worsening renal function compared to other neuroendocrine inhibitors like ACEIs/ARBs.
- Subpopulation analysis indicates greater efficacy for symptomatic HFrEF patients classified as NYHA class II/III, older adults, diabetic individuals, those with elevated NT-proBNP levels, and complex heart failure cases among elderly populations.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Entresto (sacubitril and valsartan) Prescribing Information. | 2024 | Novartis Pharmaceuticals Corporation., East Hanover, NJ |