Bempedoic acid is a new treatment for high cholesterol. It can be used when statins are not suitable and ezetimibe is not working well enough on its own.
Why is this new treatment needed?
Statins are the first line of treatment for people at high risk of diseases of the heart and blood vessels or have high cholesterol or high cholesterol and triglycerides in the blood (known as primary hypercholesterolaemia and mixed dyslipidaemia), whether or not this is inherited in the genes. Some people may need other treatments to bring their cholesterol under control, especially those who can’t take statins or can only take a lower dose.
At the moment, the next step recommended by NICE (the National Institute for Health and Care Excellence, who offer guidance to health professionals) is to offer ezetimibe, which can be taken on its own or in combination with a statin at the highest dose. Like statins, ezetimibe is a low-cost medication with an excellent long-term record of safety and effectiveness. It is suitable for anyone at high risk of diseases of the heart and blood vessels, whether or not they have had a previous event such as a heart attack or stroke.
If ezetimibe with a statin or on its own does not bring non-HDL cholesterol or LDL cholesterol down enough to reach the recommended target (usually a 40% reduction from start) then the only remaining options until now have been PCSK9 inhibitors. These are more expensive and are usually given as twice-monthly injections, and NICE have strict criteria for who can take them. They are only available for people who have had a previous event such as a heart attack or stroke and to people with familial hypercholesterolaemia (FH, an inherited condition).
Now, NICE has recommended bempedoic acid in combination with ezetimibe for:
- people who are unable to take statins
- and ezetimibe alone does not lower their non-HDL cholesterol or LDL cholesterol enough
- and who do not meet the strict criteria for a PCSK9 inhibitor.
How do you take bempedoic acid?
There are currently two medicines available which both come as a tablet:
- Bempedoic acid (Nilemdo) 180mg once a day – this is bempedoic acid only.
- Bempedoic acid 180mg and ezetimibe 10mg (Nustendi) once a day – a combination of both medications in one tablet.
These can both be taken with or without food.
How does bempedoic acid work?
Like statins, bempedoic acid lowers cholesterol in the blood by reducing the production of cholesterol in the liver. Statins block an enzyme known as HMG-CoA reductase. Bempedoic acid works in a similar way, by slowing down a different enzyme in the cholesterol production pathway known as ATP citrate lyase – but only in the liver. This means there are more LDL receptors in the liver, which helps to remove more LDL cholesterol from the blood.
Unlike statins, bempedoic acid only works in the liver so it is much less likely to cause side effects affecting the muscles – one of the main reasons some people can’t take statins.
How much can it lower cholesterol levels?
In clinical trials, bempedoic acid (Nilemdo) on its own has been shown to reduce LDL cholesterol by between 17-28% after 12 weeks.
When combined with ezetimibe, bempedoic acid lowers LDL cholesterol by approximately a further 28%.
It's important to eat a healthy diet alongside medicines to lower your cholesterol, to keep your risk of disease as low as possible.
How long does it take to work?
Once you have started taking bempedoic acid, your doctor should arrange to check your cholesterol levels within two to three months to see how well it’s working.
How much does it cost?
Bempedoic acid is available on the NHS on prescription.
Does it lower the risk of heart disease?
Bempedoic acid has been found to be safe and effective in clinical trials, but its long-term effect on diseases of the heart and blood vessels is not yet known. The CLEAR Outcomes study is a clinical trial that’s happening now. It aims to find out whether bempedoic acid can lower the risk of serious events such as heart attacks and strokes in people at high risk of disease who have high cholesterol and can’t take statins.
Does it cause side effects?
Like all medicines, bempedoic acid can cause side effects, although not everybody will experience them. The most common side effect that has been reported so far is an increase in blood uric acid levels and the risk of gout (gout happens when there is too much uric acid in the blood). Other side effects reported include:
- pain in the extremities (shoulders, legs and arms)
- constipation (when taken with ezetimibe).
If you’re taking simvastatin or pravastatin
Your doctor should be aware of drug interactions if you are taking a low intensity statin such as Simvastatin and Pravastatin – as the risk of muscle pain or other muscle side effects may be higher. Policies for using these combinations should be made locally, along with specialist advice.