New NICE guidance recommends bempedoic acid with ezetimibe as an option for treating primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet in adults for whom statins are contraindicated or not tolerated, and ezetimibe alone does not control LDL-C well enough.
Bempedoic acid (Nilemdo) and ezetimibe can be given as separate tablets or a fixed-dose combination (Nustendi). NICE said that around 70,000 adults in England will be eligible for the treatment, if statins have not worked for them.
Bempedoic acid inhibits ATP citrate lyase, an enzyme involved in cholesterol synthesis. Unlike statins, which can cause myopathy and rhabdomyolysis, the action of bempedoic acid is liver-specific and the drug is inactive in skeletal muscle.
Oral treatment option
The efficacy of bempedoic acid was demonstrated in four randomised, double-blind, placebo-controlled trials involving 3,623 adults with hypercholesterolaemia or mixed dyslipidaemia.
Commenting on the draft NICE guidance issued last month, Professor Kausik Ray, professor of public health and honorary consultant cardiologist at Imperial College London, said: 'Until now, patients with hypercholesterolaemia who cannot tolerate statins have had limited treatment options to effectively reduce their LDL-C levels, which is a leading modifiable risk factor of cardiovascular disease.
'Today’s announcement is fantastic news for patients as it marks the first new oral treatment options for high cholesterol to be made available in over a decade.
'Availability of treatments such as these is essential in tackling cardiovascular disease, the leading cause of death in the UK. When it comes to heart health and cholesterol, there is no such thing as "too low LDL-C", highlighting the importance of treatments for high-risk patients.'
Meindert Boysen, deputy chief executive and director of the Centre for Health Technology Evaluation at NICE, said: 'High cholesterol, if left untreated, can lead to a range of serious health conditions.
'Although statins and other treatments are used successfully by a large portion of the population, some people may require other options to control their cholesterol. We are pleased to be able to recommend bempedoic acid with ezetimibe as a new treatment option for these individuals.'