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PARADIGM-HF: ENTRESTO reduced 15-day HF readmissions vs enalapril
ENTRESTO demonstrated fewer 15-day HF readmissions in a post hoc analysis1
15-day HF readmissions
PARADIGM-HF: Readmission was defined as the second hospitalization within 30 days of the first hospitalization after initiation of study drug.
PARADIGM-HF: ENTRESTO reduced 30-day HF readmissions vs enalapril
ENTRESTO demonstrated fewer 30-day HF readmissions in a post hoc analysis1,2*†
30-day HF readmissions
PARADIGM-HF: Readmission was defined as the second hospitalization within 30 days of the first hospitalization after initiation of study drug.1 *Vs enalapril. †Among patients hospitalized at least once for HF, patient characteristics were similar at baseline between treatment groups.
PARADIGM-HF PRIMARY END POINT KM CURVE
PARADIGM-HF: Time to first occurrence of CV death or HF hospitalization4
ARR=absolute risk reduction; CI=confidence interval; HR=hazard ratio; KM=Kaplan—Meier; NNT=number needed to treat; RRR=relative risk reduction.
The median follow-up duration was 27 months and patients were treated for up to 4.3 years.
There was a reduction in each component: CV death 20% RRR, 3.2% ARR; HF hospitalization 21% RRR, 2.8% ARR.
PARADIGM-HF STUDY READMISSION ANALYSES LIMITATIONS
PARADIGM-HF post hoc study limitations2
Post hoc study was not a prespecified analysis of the PARADIGM-HF study
Patients were not randomized to treatment with ENTRESTO® or enalapril at the time of index hospitalization
The apparent differences in readmission rate noted in this analysis could be attributed to differences in the patients
Analysis focused on HF readmissions following investigator-reported HF hospitalizations, which were vulnerable to misclassification
The primary unit of subsequent analysis was hospitalizations rather than patients
15-day readmissions for HF is not a routinely examined time point in quality and clinical assessments, and such early time points may not reflect causality
PIONEER-HF: ENTRESTO reduced 8-week HF readmissions vs enalapril
Inpatient initiation of ENTRESTO in stabilized patients resulted in fewer HF readmissions‡ at 8 weeks3
8-week HF readmissions: Prespecified Exploratory End point
‡PIONEER-HF: Readmission was defined as the first hospitalization after inpatient initiation of study drug.3
PIONEER-HF PRIMARY END POINT
PIONEER-HF was a multicenter, randomized, double-blind, active controlled clinical trial of in-hospital initiation of ENTRESTO (n=440) compared with enalapril (n=441) among HF patients with reduced EF (LVEF≤40%) who had been stabilized following admission for ADHF. At the primary efficacy outcome, time-averaged proportional change in NT-proBNP concentration from baseline through weeks 4 and 8, ENTRESTO was superior to enalapril (P<.001).
PIONEER-HF STUDY READMISSION ANALYSIS LIMITATIONS
PIONEER-HF study limitations3
The study was powered for changes in NT-proBNP and secondary and exploratory end points should be interpreted with caution
The event rate of HF readmission was a prespecified exploratory end point from the PIONEER-HF trial
The median time for patients to meet the stabilization criteria was less than 3 days after initial presentation to the hospital3
PIONEER-HF STABILIZATION CRITERIA
In PIONEER-HF, hospitalized patients were determined to be stabilized when they met all the following criteria:
BP=blood pressure; IV=intravenous.
ENTRESTO was started in the hospital in a diverse set of stabilized patients3
Patients enrolled in PIONEER-HF reflect the patients you are likely to treat in your hospital
PIONEER-HF SELECTED DEMOGRAPHIC INFORMATION
*Patients were determined to be ACEi/ARB-naive if they were not receiving either medication at the time of index hospitalization.
Whether in the outpatient or inpatient setting, you can start with ENTRESTO across a wide range of patient types3,5,7
PIONEER-HF: demonstrated safety profile in inpatient initiations
PIONEER-HF ADVERSE EVENTS
†Cardiac failure congestive and acute kidney injury were per investigator discretion on the Case Report Form.
For key safety outcomes, the ENTRESTO group and the enalapril group were generally comparable with regard to rates of worsening renal function, hyperkalemia, symptomatic hypotension, or angioedema7
Adverse event profile was comparable to the PARADIGM-HF trial3,5
No new safety signals were observed3,5
Safety data were collected for only 8 weeks, therefore adverse events that take longer to transpire may not have appeared in this study. Safety information should be interpreted in the context of prior trials with longer duration3
The ACC Expert Consensus Decision Pathway now supports the initiation of ENTRESTO during hospitalization for systolic HF8
Hospitalization is a pivotal opportunity to improve clinical trajectory in systolic HF patients—start ENTRESTO as a first-choice therapy in stabilized patients to help reduce risk of CV death and hospitalization for heart failure
ACC EXPERT CONSENSUS DECISION PATHWAY
A plan to initiate ENTRESTO can be considered as soon as the patient is admitted and therapy can be started once the patient is stabilized‡
Reprinted from the Journal of the American College of Cardiology; volume 74/issue 15; Hollenberg SM, Warner Stevenson L, Ahmad T, et al; 2019 ACC Expert Consensus Decision Pathway on Risk Assessment, Management, and Clinical Trajectory of Patients Hospitalized with Heart Failure; pp. 1966-2011; 2019; with permission from Elsevier.
ACC=American College of Cardiology; CV=cardiovascular.
‡Criteria for stabilization: systolic blood pressure ≥100 mm Hg for previous 6 hours; no escalation of IV diuretics or vasodilators within previous 6 hours; no IV inotropic therapy within previous 24 hours.
§Adequate decongestion, hemodynamically stable, and no complication.
∥ENTRESTO is not indicated in acute heart failure.
ENTRESTO IS AN ESSENTIAL HF TREATMENT—A FIRST CHOICE
INSTEAD OF AN ACEi/ARB FOR YOUR PATIENTS WITH SYSTOLIC HFVIEW FULL GUIDELINES