In the PARADIGM-HF trial, currently the largest ever clinical study in heart failure, patients with heart failure and reduced ejection fraction (HF-REF) were given LCZ696 or enalapril combined with the current best therapy regimen for heart failure treatment.
The compound's safety and efficacy are still being investigated and market clearance has not yet been received in Canada.
The PARADIGM-HF results, also published in the New England Journal of Medicine, indicated that when combined with current optimal care and versus combining the ACE-inhibitor enalapril with optimal care, LCZ696 cut the risk of death from cardiovascular causes by 20% (p=0.00004), the heart failure hospitalisations by 21% (p=0.00004) and the risk of all-cause mortality by 16% (p=0.0005).
Altogether, the data indicated a 20% risk decrease on the main objective, a composite measure of cardiovascular death or heart failure hospitalisation (p=0.0000002).
The PARADIGM-HF trial was a randomised, double-blind Phase III trial studying the effectiveness and safety of LCZ696 versus enalapril in 8,442 patients with HF-REF. The baseline characteristics demonstrated that the patients recruited were typical HF-REF patients with NYHA Class II-IV heart failure. The sudy was specifically designed to establish if LCZ696 could cut cardiovascular mortality by at least 15% compared to enalapril. Patients were given LCZ696 or enalapril combined with the current best treatment regimen. The main goal was a composite of time to first occurrence of either cardiovascular death or heart failure hospitalisation.
Secondary objectives were change in the clinical summary score for heart failure symptoms and physical limitations (as assessed by Kansas City Cardiomyopathy Questionnaire) at 8 months; time to all-cause mortality; time to new onset atrial fibrillation; and time to occurrence of renal dysfunction.
The study data indicated that side effects were manageable, with a smaller number of patients taking LCZ696 discontinuing study medication for any adverse event versus those on enalapril (10.7% vs 12.3%, respectively, p=0.03). The LCZ696 arm had more hypotension and non-serious angioedema but less renal impairment, hyperkalemia and cough than the enalapril group.
LCZ696 is an ARNI (Angiotensin Receptor Neprilysin Inhibitor) that acts in a number of ways on the neurohormonal systems of the heart, blocking receptors exerting harmful effects, while at the same time promoting protective mechanisms.
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