A post-hoc analysis of PARADIGM-HF data has demonstrated that fewer heart failure patients with reduced ejection fraction ( HFrEF ) treated with Entresto ( Sacubitril / Valsartan ) tablets were readmitted to the hospital for heart failure or for any cause within 30 days of discharge from a heart failure hospitalization compared to patients treated with Enalapril.
Data were presented at the American Heart Association ( AHA ) Scientific Sessions 2015.
The analysis compared numbers and rates of 30-day readmissions after discharge from heart failure hospitalizations between patients who were randomized to treatment with Entresto and those who received Enalapril.
The primary outcome analyzed was investigator-reported readmissions for any cause within 30 days of discharge from a heart failure hospitalization.
Researchers found that, compared to patients taking Enalapril:
44% fewer individual patients taking Entresto were readmitted to the hospital for heart failure within 30 days of discharge from a heart failure hospitalization, with odds of readmission ( including patients who were readmitted more than once during the study ) 38% lower with Entresto treatment after discharge;
36% fewer individual patients taking Entresto were readmitted to the hospital for any cause within 30 days of discharge from a heart failure hospitalization, with odds of readmission ( including patients who were readmitted more than once during the study ) 26% lower with Entresto treatment after discharge
The 8,442-patient PARADIGM-HF study is the largest clinical trial ever conducted in heart failure.
In the study, Entresto demonstrated clinically relevant and statistically significant superiority to guideline-recommended ACE-inhibitor Enalapril, reducing the risk of cardiovascular death or heart failure hospitalization by 20% ( the primary endpoint ) at a median follow-up of 27 months.
Entresto also improved overall survival by 16% versus Enalapril, driven by the lower incidence of cardiovascular death.
The study was stopped earlier than anticipated after the Data Monitoring Committee overseeing the study found that Entresto significantly reduced the risk of cardiovascular death and that the primary endpoint had been met.
Entresto is a twice-a-day medicine that reduces the strain on the failing heart. It does this by enhancing the protective neurohormonal systems of the heart ( NP system ) while simultaneously suppressing the harmful effects of the overactive renin-angiotensin-aldosterone system ( RAAS ).
Other heart failure medicines only block the harmful effects of the overactive RAAS.
Entresto contains the neprilysin inhibitor Sacubitril, which is a new molecular entity, and the angiotensin receptor blocker ( ARB; sartan ) Valsartan.
Entresto film-coated tablets are available in three dosage strengths: 24/26 mg, 49/51 mg, and 97/103 mg ( Sacubitril / Valsartan ). These doses are referred to as 50 mg, 100 mg, and 200 mg in the clinical trial literature including the New England Journal of Medicine publication of the results of PARADIGM-HF.
The target treatment dose of Entresto is 97/103 mg twice daily.
In heart failure, lower readmission rates may correlate with improved patient prognosis and lower costs to the healthcare system.
Thirty-day readmission rates are a key performance metric for acute care and long-term care hospitals. To help promote high-quality, patient-centered care and accountability, the Centers for Medicare & Medicaid Services ( CMS ) launched the Hospital Readmissions Reduction Program in October 2012.
This program reduces Medicare payments to those hospitals with comparatively high rates of 30-day readmissions for certain conditions, including heart failure.
Entresto received approval to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure ( NYHA Class II-IV ) and reduced ejection fraction.
Entresto is usually administered in conjunction with other heart failure therapies, in place of an ACE inhibitor or other angiotensin receptor blocker ( ARB; sartan ). ( Xagena )
Source: Novartis, 2015