GPs are set to prescribe a new NICE-recommended drug shown to prevent strokes and heart attacks in those with raised blood fat that could benefit hundreds of thousands of patients.
NICE published final draft guidance on Friday recommending icosapent ethyl for adults with cardiovascular disease (CVD) who have their low-density lipoprotein (LDL) cholesterol under control with a statin but who remain at high risk of cardiovascular events due to elevated blood triglyceride levels.
The guidance said that icosapent ethyl is ‘likely to be used mostly in a primary care setting’.
Around 425,000 people in England and Wales could now benefit from the oral drug, which is the first licensed treatment shown to reduce the risk of cardiovascular events such as heart attacks and strokes in this group, NICE said.
Clinical trial evidence suggests that icosapent ethyl reduces the ‘risk of cardiovascular events by over a quarter compared with placebo’ for those with raised triglycerides who have LDL cholesterol levels controlled by statins and who have cardiovascular disease, it added.
NICE said: ‘NHS England estimates that between 25% and 35% of people having statin therapy have elevated triglycerides.
‘[But] until now, there have been no medicines for people at risk of cardiovascular events who have raised levels of triglycerides despite having statins with or without ezetimibe (another type of anti-cholesterol medicine).’
Too high levels of triglycerides in the blood can indicate a higher risk of cardiovascular events and can cause damage to arteries in key organs such as the brain or heart.
NICE interim director of medicines evaluation Helen Knight said: ‘Icosapent ethyl is the first licensed treatment of its kind for people who are at risk of heart attacks and strokes despite well-controlled LDL cholesterol because they have raised blood fats.
‘And although lifestyle changes, including diet and exercise, can help to reduce their risk, these may not work for everyone.’
She added that NICE has worked closely with Amarin, which manufacturers the treatment, to ‘identify the population most likely to gain the greatest benefit from icosapent ethyl, striking a balance between effectiveness and the best use of public funding’.
NICE said it expects to publish its final guidance on the drug next month.
The new treatment will be given as two tablets taken twice daily. It costs £144.21 per pack of 120 capsules, although NICE noted that local procurement deals may apply.
Announcing the new guidance, manufacturer Amarin said icosapent ethyl is the ‘first treatment of its kind to be recommended by NICE and contains a unique active substance, a highly purified omega-3 fatty acid eicosapentaenoic acid (EPA >96%)’.
The double-blind randomised phase three clinical trial of more than 8,000 patients over an average of 4.9 years showed that treatment with icosapent ethyl compared to placebo resulted in a 25% relative reduction in the risk of future major adverse CV events.
This comprised a ‘composite of CV death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation or hospitalisation for unstable angina’ and the results represented a 4.8% absolute risk reduction, from 22% in the placebo group to 17.2% in the treatment group.
Dr John Ashcroft, a Derbyshire GP with an interest in cardiovascular medicine told Pulse that ‘virtually all’ the patients eligible for the new treatment will be ‘solely under GP care’.
He added: ‘Patients will not be keen on the number and size of the capsules, GPs on the increased risk of atrial fibrillation and bleeding, CCGs on the cost.
‘It will be interesting to see how rapidly this treatment is taken up. Another add-on treatment, low-dose rivaroxaban; looks to have a slow takeup [but] the patient group here is larger, more easy to identify and the drug has lower risk and monitoring requirements.’
And professor of primary care at Imperial College London Professor Azeem Majeed added: ‘Whether primary can do this depends on workload pressures and having sufficient time to identify patients and discuss treatment options with them.’
Last month, an international panel of experts concluded that additional cholesterol-lowering drugs should be offered in those with a high cardiovascular risk already on a statin.
NICE planned recommendation for icosapent ethyl
Icosapent ethyl is recommended as an option for reducing the risk of cardiovascular events in adults. It is recommended if they have a high risk of cardiovascular events and raised fasting triglycerides (1.7 mmol/litre or above) and are taking statins, but only if they have:
- established cardiovascular disease (secondary prevention), defined as a history of any of the following:
- acute coronary syndrome (such as myocardial infarction or unstable angina needing hospitalisation)
- coronary or other arterial revascularisation procedures
- coronary heart disease
- ischaemic stroke
- peripheral arterial disease, and
- LDL cholesterol levels above 1.04 mmol/litre and below or equal to 2.60 mmol/litre.