Sacubitril/valsartan (Entresto, Novartis) has been made available in the UK for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF).
Sacubitril/valsartan has been shown to significantly reduce the risk of cardiovascular death and first hospitalisation for heart failure by 20% when compared to ACE-inhibitor, enalapril (absolute risk reduction: 4.7%).
“The availability of this new treatment in heart failure could change how heart failure patients are treated,” says Iain Squire, professor of Cardiovascular Medicine, University of Leicester and honorary consultant physician, University Hospitals of Leicester NHS Trust and chair of the British Society for Heart Failure. “For many patients with heart failure, outcomes remain poor and there is clear room for therapies that improve on what we have available at the moment. Doctors can now offer suitable patients an option that has been shown in a large clinical trial to cut the risk of death and reduce the number of hospitalisations.”
Sacubitril/valsartan was studied in the largest heart failure trial conducted to date, PARADIGM-HF, involving 8,442 patients with HFrEF. The trial was stopped early due to a clear benefit of sacubitril/valsartan over enalapril. The study demonstrated that sacubitril/valsartan was superior to enalapril in reducing the risks of cardiovascular mortality and first hospitalisation for heart failure. Analysis of safety data showed that sacubitril/valsartan had a similar tolerability profile to enalapril.
Novartis is working with NICE (National Institute for Health and Care Excellence) and the Scottish Medicines Consortium (SMC) to ensure as many eligible patients as possible will be able to benefit from sacubitril/valsartan once it has been appraised. Sacubitril/valsartan was the first non-oncology drug to be entered into the Government’s Early Access to Medicines Scheme (EAMS) and as such, any guidance from NICE should be implemented by the NHS within 30 days.
“There is a real need for new and effective treatments that can reduce the number of hospitalisations and mortality in patients with heart failure,” says Dimitrios Georgiopoulos, chief scientific officer, Novartis Pharmaceuticals UK. “Despite use of current treatments and availability of clinical guidelines, 40% of patients die within a year of first hospital admission for heart failure and survival rates are worse than certain types of cancer, such as breast and prostate. In an area of high unmet need, sacubitril/valsartan gives doctors a new option that can potentially improve the outcomes of many of their heart failure patients.”