An alternative to statins? New drug ‘halves cholesterol’
Treatment with fewer side effects arrives in UK
A BREAKTHROUGH drug that can halve cholesterol levels without the side effects of statins goes on sale tomorrow.
Heralded as a ‘sea change’ in heart treatments, Repatha is the first new cholesterol-busting medication since the 1980s.
The drug – the first alternative treatment for people who suffer unpleasant side effects from statins – reduced levels of ‘bad’ LDL cholesterol by 55 per cent in clinical trials.
It can also be taken alongside statins, and patients who took both for 12 weeks were shown to have cholesterol levels 75 per cent lower than those given statins alone.
Repatha has been approved as a safe and effective treatment by the European Medicines Agency, so when stocks of the drug arrive in Britain tomorrow it can be prescribed by private doctors immediately.
But the drug will not be made available to NHS patients for at least eight months. Heath service rationing body Nice is currently reviewing whether Repatha offers sufficient value for money, with a report due next April.
The drug, which is also known as evolocumab, has a list price of £170 per dose, taken fortnightly via a prefilled pen injection. Over the course of a year this is more than £4,000 per patient, although the NHS will be offered a discount on the price.
Statins are incredibly cheap in comparison, costing the NHS about £20 a year per patient.
Daily statin pills are taken by more than seven million people in the UK, and have been credited with cutting the risk of heart attacks and strokes for those with high cholesterol. The NHS changed its advice 12 months ago to encourage GPs to prescribe statins to even more patients, making them available to anyone with a 10 per cent chance of having a heart attack.
This means 17million adults – nearly all over-40s – are now eligible.
But many GPs and patients are concerned about over-prescription of statins, which can cause side effects such as muscle and joint pain. Experts hope Repatha will mean that high-risk patients – for example those who have already suffered a heart attack – will now have another option if they cannot tolerate statins’ side effects.
In addition, researchers say around 45 per cent of patients at high risk for cardiovascular disease cannot adequately lower their cholesterol levels with statins – and it is hoped the new drug will be more effective.
However, others point out that Repatha comes with its own side effects, including the common cold in 5 per cent of patients and throat infections in 3 per cent.
While it is proven the drug lowers cholesterol, its manufacturer Amgen is conducting trials involving 27,500 patients in an attempt to show it saves lives, with results expected in 2017.
Repatha removes ‘ bad’ LDL cholesterol more powerfully than existing drugs. It works by blocking PCSK9, a naturally-occurring protein that interferes with the liver’s ability to remove cholesterol from the blood.
Dr Terry McCormack, a GP in Whitby and secretary of the British Hypertension Society, said last night: ‘Statins transformed our management of raised cholesterol and our understanding of this key risk factor for strokes and heart attacks.
‘But our best efforts with statins – which remain the front line of therapy alongside low-fat diets, exercise and smoking cessation – still leave a significant number of patients with inadequately controlled cholesterol levels.’
Dr Dermot Neely, a consultant at the Royal Victoria Infirmary in Newcastle, added: ‘We now have a new treatment option which may be considered in patients who are resistant to statins or unable to take them.’
But London cardiologist Dr Aseem Malhotra urged caution.
‘This new drug looks promising but what is more important is whether it reduces deaths – and as yet there is no proof that it does,’ he said. ‘We need to see hard data that it actually shows beneficial outcomes.’
Earlier this year Scott Wasserman, Amgen’s executive medical director, described the drug as a ‘sea change’ for patients with heart disease.
‘Need to prove it reduces deaths’