Entresto: FDA has expanded indication in chronic heart failure with preserved ejection fraction
The FDA ( US Food and Drug Administration ) has approved the following expanded indication for Entresto ( Sacubitril / Valsartan ): 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.
The label also states LVEF is a variable measure and clinical judgment should be used in deciding whom to treat.
For the first time, there is a treatment with benefit for patients diagnosed with guideline-defined heart failure that includes both those with heart failure with reduced ejection fraction ( HFrEF ) and many with heart failure with preserved ejection fraction ( HFpEF ).
This label expansion is based on efficacy and safety evidence observed in PARAGON-HF, the largest and only phase III active-controlled study to date in patients with guideline-defined HFpEF. The greatest benefit was shown in patients with LVEF below normal.
Entresto is a twice-a-day medicine that reduces the strain on the failing heart. It does this by enhancing protective neurohormonal systems ( i.e., natriuretic peptide system ) while simultaneously inhibiting the harmful effects of the overactive renin-angiotensin-aldosterone system ( RAAS ).
Other common medicines for heart failure, called angiotensin converting enzyme inhibitors ( ACEi ) and angiotensin II receptor blockers ( ARBs ), only block the harmful effects of the overactive RAAS.
Entresto contains the neprilysin inhibitor Sacubitril and the angiotensin receptor blocker Valsartan.
Approximately 6 million Americans are living with chronic heart failure ( CHF ). Approximately 3 million have HFrEF, and of the remaining 3 million, about 2 million have HFpEF with LVEF below normal.
The prevalence of heart failure is increasing as the population ages. Patients often face worsening symptoms that result in frequent hospitalizations for heart failure.
Each hospitalization event is associated with worsening long-term prognosis. Approximately one in four patients are re-admitted for heart failure and 10% may die within 30 days of discharge.
Overall CHF death rates remain significantly high, with up to half of patients dying within five years of a diagnosis of heart failure. ( Xagena )
Source: Novartis, 2021
SARS-CoV-2 uses the angiotensin-converting enzyme ( ACE ) 2 receptor for entry into target cells. ACE2 is predominantly expressed by...
Canagliflozin reduces major cardiovascular events and kidney failure in patients with type 2 diabetes and chronic kidney disease
Results of a new subgroup analysis from the phase 3 CREDENCE study, showing Canagliflozin ( Invokana ) has significantly reduced...
PARAGON-HF trial in heart failure patients with preserved ejection fraction: Entresto misses statistical significance on the primary endpoint
The results from the global phase III PARAGON-HF study, investigating the safety and efficacy of Sacubitril / Valsartan ( Entresto...
Entresto, a combination of Sacubitril and Valsartan, can be initiated early in hospitalized patients after an acute heart failure episode
Data from the TRANSITION study presented at the European Society of Cardiology ( ESC ) Congress in Munich ( Germany...
LCZ696, a combination of Sacubitril and Valsartan, has a cardio-protective effect against myocardial infarction
The new drug LCZ696 is a treatment for chronic heart failure. LCZ696 is better than conventional drugs at reducing cardiac...
The FDA ( Food and Drug Administration ) has strengthened the existing warning about the risk of acute kidney injury...
Hypertension is a common diabetes comorbidity that affects the majority of patients, with the prevalence depending on type of diabetes,...
Angiotensin-converting enzyme inhibitors and receptor blockers were associated with significant lower incidence of appropriate ICD shock in patients with cardiomyopathy
Sudden cardiac death ( SCD ) is a leading cause of mortality in patients with cardiomyopathy. Although angiotensin-converting enzyme inhibitors...
Angiotensin converting enzyme inhibitors ( ACE inhibitors ) and angiotensin receptor blockers ( ARBs; sartans ) are widely prescribed for...