Patients with a frail heart need not give up – well not so soon – because the National Institute for Health and Care Excellence (NICE) approved the other day a revolutionary medicine – Sacubitril Valsartan – for moderate to severe heart failure (HF) unresponsive to standard treatment with ACEIs or ARBs. The evidence-based guidance was published in the British Medical Journal yesterday.
Sacubitril valsartan can potentially help 100,000 individuals in the UK with moderate to severe heart failure. Big number! Since more than 30,000 people in the UK are hospitalized each year on account of heart failure exacerbations. The new drug has been shown to prevent death from HF.
The guidance was published yesterday after a careful observation of the evidence available. NICE has recommended the use of Sacubitrial Valsartan as an option in the HF patients who:
- have New York Heart Association (NYHA) class II-IV symptoms
- have a reduced left ventricular ejection fraction (LVEF) i.e., ≤35%
- are currently taking angiotensin‑converting enzyme (ACE) inhibitors or angiotensin II receptor‑blockers (ARBs)
Sacubitril Valsartan is not recommended in patients with normal LVEF because there is no definitive evidence whether it works in such patients.
The approval of the new drug gives the doctors a novel, and a better, option to treat patients whose condition remains unstable with ACEIs or ARBs – both of which are the gold standard of treatment in patients with HF. However, patients with advanced disease need rigorous medical therapies and strict control of the disease. This leaves both doctors and patients frustrated. The frustration converts to fear of death in such patients.
Amidst air of despair and fear of death among such patients, the approval of the new drug comes as a breath of fresh air, or hope.
Sacubitrial varsatan is nothing short of a medical miracle for such patients.
“ACE inhibitors have been the initial gold standard treatment for chronic heart failure for almost 25 years. However, for some people their symptoms persist despite them being on the maximum dose,” said Carole Longson, Director of the NICE Health Technology Evaluation Centre.
“This recommendation will help ease the symptoms of very ill people, improve their quality of life and help them to take part in normal daily activities. It should also reduce their need for hospital treatment.”
Heart Failure – The Global Burden
Heart failure is a gradual loss of functioning of heart occurring as a result of damage to the heart muscle. The failing heart does not pump sufficient blood to meet body’s requirements. The chief causes of HF, in most of the cases, are prolonged high blood pressure, hypertension, heart attack, diabetes and family history.
The symptoms of HF include breathlessness, fatigue, lethargy, and weight gain from fluid retention.
There is a whole class of drugs that is used to treat HF in patients. ACEIs and ARBs belong to the said class. Treatment of HF involves combination therapy.
Globally, heart failure is a prevalent condition. Its incidence is increasing i.e., affecting 410,000 and five million people in England and the United States respectively. Each year, around 400,000-700,000 new cases of heart failure are diagnosed. The number of deaths in the US due to HF has nearly doubled since 1979.
However, with early diagnosis and proper treatment, people with HF can live a healthy, normal life.
About Sacubitril Valsartan
Sacubitril Valsartan, a combination drug, is the first of the new class of drugs called angiotensin receptor neprilysin inhibitors. It restricts action of neprilysin, an enzyme that prevents the dilation of blood vessels, thereby reducing blood pressure. Reduced blood pressure relieves the heart that is usually compensated and overburdened in HF patients. ACEIs slow the disease progression by blocking stress chemicals and by decreasing blood pressure.
Branded and marketed as Entresto, sacubitril valsartan, is the product of Novartis.
The main clinical evidence of sacubitril valsartan’s efficacy and superiority over other standard treatment came from the PARADIGM-HF trial. Compared to Enalapril, an ACE inhibitor, sacubitril valsartan was found to be clinically more effective in terms of reduced hospitalizations and cardiovascular mortality.
Like other drugs, sacubitril valsartan has adverse reactions. These include low blood pressure (hypotension), raised blood potassium (hyperkalemia), and kidney problems.
Sacubitril valsartan is the first non-cancer drug to gain access to market through the Medicines and Healthcare Products Regulatory Agency’s early access to medicines scheme. Normally, it is the cancer drugs that gain fast approval through the said route.
Entresto costs around £3 a day i.e., £1,200 per person per year. It is administered orally in patients not currently taking an ACE inhibitor or ARB in either 100 mg twice daily or 50 mg twice daily. The dose is then doubled to 200 mg twice daily over a period of two to four weeks in patients who can tolerate it.