A new drug combination for heart failure, which has proven superior to current treatments for the condition in trials, has been licensed for use in the UK.
Sacubitril/valsartan (Entresto) has been licensed in the UK for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF).
“For a number of years, treatment of heart failure has changed little and relied on drugs that have been available for decades”
The drug, which combines two active elements and is marketed by Novartis, is an angiotensin receptor neprilysin inhibitor.
Neprilysin inhibits peptides in dilating blood vessels, reducing blood pressure and therefore decreasing the heart’s workload. Valsartan is an angiotensin II receptor blocker and also lowers blood pressure.
It was studied in the largest heart failure trial conducted to date, involving 8,442 patients. The PARADIGM-HF 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 admission for heart failure, and that it had a similar tolerability profile to the ACE inhibitor.
Sacubitril/valsartan reduced the absolute risk of cardiovascular death and first hospitalisation for heart failure by 4.7%, compared to the ACE inhibitor enalapril, according to the trial results published in the New England Journal of Medicine.
Professor Peter Weissberg
The reduced absolute risk of CVD death was 3.2% for sacubitril/valsartan compared with enalapril, and the reduced risk of first hospital admission was 2.8%.
Sacubitril/valsartan was previously available to some UK patients under the government’s early access to medicines scheme for promising unlicensed drugs.
Last September, it became the first non-oncology drug to be made available via the scheme, though this has now been superseded by its full marketing authorisation.
However, to become widely available to NHS patients it must now also be approved by the National Institute for Health and Care Excellence and the Scottish Medicines Consortium.
Novartis said it was currently working with both organisations to “ensure as many eligible patients as possible will be able to benefit from sacubitril/valsartan once it has been fully appraised”.
NICE has already provisionally recommended sacubitril valsartan in draft guidance published in December 2015, with final guidelines expected in May.
The draft recommended the drug for HFrEF in patients with New York Heart Association class II to III symptoms, who are on a stable dose of ACE inhibitors and have a left ventricular ejection fraction of 35% or less.
“Sacubitril/valsartan introduces an entirely new class of drug with a unique mechanism of action, therefore widening the therapeutic options available”
Professor Peter Weissberg, medical director at the British Heart Foundation, noted that heart failure treatment had “changed little” over recent years and relied on drugs available for decades.
“Sacubitril/valsartan introduces an entirely new class of drug with a unique mechanism of action, therefore widening the therapeutic options available for patients with heart failure,” he said.
But he said: “As with any new drug, it will take time and further research to establish the true benefits of sacubitril/valsartan and to learn which patients can and can’t tolerate its potential side effects.
“While promising, it’s important to stress that this treatment is not a cure for heart failure, which affects over half a million people in the UK,” he added.
Heart failure affects around 550,000 people in the UK. It currently accounts for one million in-patient bed days and 5% of all emergency and medical admissions to UK hospitals.