Drug updated on 5/2/2024
| 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.
Summary
- Sacubitril/Valsartan (Entresto) is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure, as well as treating symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older.
- A total of 25 systematic reviews/meta-analyses were reviewed which focused on the safety and effectiveness of Sacubitril/Valsartan compared to other treatments such as ACE inhibitors, Angiotensin II receptor blockers, Sodium-Glucose Cotransporter 2 Inhibitors, and Vericiguat.
- The drug showed benefits in improving renal function among patients with chronic kidney disease (CKD), reducing their risk of progressing to end-stage renal disease when compared against ACEI or ARBs; it also significantly lowered serum creatinine elevation incidence among CKD patients.
- Across multiple studies, Sacubitril/Valsartan consistently reduced the risk of cardiovascular death or heart failure hospitalization better than ACEI or ARBs; however hypotension was more associated with its usage indicating a need for monitoring this side effect.
- For Heart Failure with Reduced Ejection Fraction (HFrEF) patient subgroup, Sacubitril/Valsartan outperformed ACEI/ARBs by reducing hospitalizations due to heart failure while improving Kansas City Cardiomyopathy Questionnaire clinical scores.
- While not as evident within Heart Failure with Preserved Ejection Fraction populations (HFpEF), some evidence suggests that use of Sacubitril/Valsartan can still lead to reduced risks related to both hospitalization from heart failures and cardiovascular deaths within these groups too.
- Real-world data indicates that using this drug leads significant reductions in all-cause mortality rates alongwith fewer instances requiring hospitalisation due to failing hearts - findings consistent across controlled trials.
- Despite its initial cost, Sacubitril/Valsartan is considered a cost-effective therapy for chronic HFrEF patients across multiple geographic regions; it also holds competitive profile against other novel heart failure treatments like SGLT2 inhibitors and Vericiguat in terms of reducing hospitalization due to heart failure and cardiovascular death.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Entresto (sacubitril and valsartan) Prescribing Information. | 2024 | Novartis Pharmaceuticals Corporation., East Hanover, NJ |