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Paragigm HF Trial

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3 views7 pages

Paragigm HF Trial

Uploaded by

malikumer63
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
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Prospective Comparison of ARNI With

ACEI to
Determine Impact on Global Mortality and
Morbidity in Heart Failure - PARADIGM-HF
Description
The goal of the trial was to evaluate treatment with the combined
neprilysin inhibitor (sacubitril)/angiotensin-receptor blocker (valsartan)
(LCZ696) compared with enalapril among participants with heart failure
due to reduced ejection fraction (EF).
Study Design
• Randomized
• Double Blind
Patient Populations
• Older than 18 years of age with heart failure due to reduced LVEF,NYHA CLASS II-
IV and B-type natriuretic peptide (BNP) ≥150 pg/ml or NT-proBNP ≥600 pg/ml
• Number of enrolees: 8,442
• Duration of follow-up: median 27 months
• Mean patient age: 64 years
• EF: 30%
Exclusions
• Symptomatic hypotension
• Estimated glomerular filtration rate <30 ml/min/1.73 m2
• Serum potassium >5.2 mmol/L
• Angioedema
Primary Endpoints:
• Cardiovascular death or hospitalization for heart failure
Drug/Procedures Used:
• Participants with heart failure (New York Heart Association class II-IV) due to
reduced EF (≤40%) were randomized to LCZ696 200 mg twice daily (n = 4,187)
versus enalapril 10 mg twice daily (n = 4,212) in addition to standard therapy.
Concomitant Medications:
• Digitalis: 29%
• Beta-blocker: 93%
• Mineralocorticoid antagonist: 54%
Outcomes of the Trial
• The trial was stopped early, according to prespecified rules,
after a median follow-up of 27 months, because the
boundary for an overwhelming benefit with ARNI had been
crossed. At the time of study closure, the primary outcome
had occurred in 914 patients (21.8%) in the LCZ696 group
and 1117 patients (26.5%) in the enalapril group . A total of
711 patients (17.0%) receiving LCZ696 and 835 patients
(19.8%) receiving enalapril died of these patients, 558
(13.3%) and 693 (16.5%), respectively, died from
cardiovascular causes . As compared with enalapril, LCZ696
also reduced the risk of hospitalization for heart failure by
21% (P<0.001) and decreased the symptoms and physical
limitations of heart failure (P=0.001). The LCZ696 group
had higher proportions of patients with hypotension and
nonserious angioedema but lower proportions with renal
impairment, hyperkalemia, and cough than the enalapril
group.
Conclusion
ARNI (Sacubitril/Valasartan) was superior to enalapril in
reducing the risks of death and of hospitalization in
Patients with HFrEF.

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