Nustendi
Authorised
This medicine is authorised for use in the European Union
bempedoic acid / ezetimibe
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Nustendi is a medicine for lowering levels of cholesterol in the blood. It contains the active substances bempedoic acid and ezetimibe.
The medicine is used to reduce blood cholesterol levels in adults with primary hypercholesterolaemia or mixed dyslipidaemia (conditions that cause high levels of fats, including cholesterol, in the blood). Patients taking the medicine are required to be on a low-fat diet.
The medicine is also used to reduce the risk of heart problems in adults with, or at high risk for, problems affecting the heart and blood circulation, such as heart attack, stroke or other problems of the circulatory system caused by fatty deposits build up in the walls of the arteries (atherosclerosis).
Nustendi is used in combination with a statin, or without a statin in patients who cannot take statins and who are already taking ezetimibe. In these patients, Nustendi replaces the ezetimibe they are already taking.
Nustendi can only be obtained with a prescription; the medicine is available as a tablet taken by mouth once a day.
For more information about using Nustendi, see the package leaflet or contact your doctor or pharmacist.
The active substances in Nustendi, bempedoic acid and ezetimibe, work in different ways to lower blood cholesterol.
Bempedoic acid works by blocking an enzyme in the liver called adenosine triphosphate citrate lyase, which is involved in making cholesterol. This leads to a reduction of the level of low-density lipoprotein (LDL) cholesterol, known as ‘bad’ cholesterol, in the blood and also reduces other fatty substances made by the liver.
Ezetimibe works by binding to a gut protein called ‘Niemann-Pick C1 Like 1’, preventing cholesterol from being absorbed into the blood from the gut.
Primary hypercholesterolaemia or mixed dyslipidaemia
Two studies showed that bempedoic acid and ezetimibe (the active substances of Nustendi) effectively reduced LDL cholesterol levels in patients with hypercholesterolaemia and heart disease or who were at high risk of heart disease. High cholesterol is a risk factor for heart disease.
The first study involved 382 patients also taking the maximum tolerated doses of statins. After three months, LDL cholesterol levels were reduced by 36% in patients taking bempedoic acid and ezetimibe compared with a reduction of 23% with ezetimibe alone, 17% with bempedoic acid alone and an increase of around 2% with placebo (a dummy treatment).
The second study involved 269 patients with high cholesterol levels who could not take a statin or were taking a low dose of a statin. All the patients were also taking ezetimibe. After three months, LDL cholesterol levels were reduced by 23% in patients taking bempedoic acid in addition to ezetimibe compared with an increase of around 5% in patients taking placebo and ezetimibe.
Atherosclerotic cardiovascular disease
Nilemdo was studied in almost 14,000 adults who were intolerant to statins and who had or were at high risk for cardiovascular disease. After at least 2 years of treatment, 11.7% (819 out of 6,992) of patients given Nilemdo experienced a cardiovascular event (meaning death, heart attack, stroke, or surgery to restore blood flow to the heart), compared with 13.3% (927 out of 6,978) of patients given placebo. Of these patients, about 1,600 were already treated with ezetimibe (the other active substance of Nustendi) at the start of the study. In this group, bempedoic acid also reduced the risk of major cardiovascular events compared with placebo.
For the full list of side effects and restrictions with Nustendi, see the package leaflet.
The most common side effects with Nustendi (which may affect up to 1 in 10 people) are hyperuricaemia (high blood levels of uric acid) and constipation.
Nustendi must not be used in pregnant or breast-feeding women. When Nustendi is taken in combination with a statin called simvastatin, it can increase the risk of side effects of simvastatin. Therefore, Nilemdo must not be used with doses of simvastatin higher than 40 mg daily. Nustendi must not be taken with a statin in patients with active liver disease or with unexplained high levels of serum transaminases (blood test results that could indicate liver problems).
Nustendi was shown to reduce levels of LDL cholesterol in adults with hypercholesterolaemia or mixed dyslipidaemia and the active substances in this medicine were shown to lower the risk of major cardiovascular events in adults who have or are at high risk for cardiovascular disease. The safety profile of Nustendi was considered acceptable. Nustendi may increase the risk of side effects of statins and these should be managed appropriately. The European Medicines Agency therefore decided that Nustendi’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nustendi have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Nustendi are continuously monitored. Side effects reported with Nustendi are carefully evaluated and any necessary action taken to protect patients.
Nustendi received a marketing authorisation valid throughout the EU on 27 March 2020.
Product information
Latest procedure affecting product information:
R/0047
18/11/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Nustendi
- Active substance
- Bempedoic acid
- Ezetimibe
- International non-proprietary name (INN) or common name
- bempedoic acid
- ezetimibe
- Therapeutic area (MeSH)
- Hypercholesterolemia
- Dyslipidemias
- Anatomical therapeutic chemical (ATC) code
- C10B
Pharmacotherapeutic group
Lipid modifying agentsTherapeutic indication
Hypercholesterolaemia and mixed dyslipidaemia
Nustendi is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:
• in combination with a statin in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin in addition to ezetimibe
• alone in patients who are either statin-intolerant or for whom a statin is contraindicated, and are unable to reach LDL-C goals with ezetimibe alone,
• in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statin
Cardiovascular disease
Nustendi is indicated in adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:
• in patients on a maximum tolerated dose of a statin and not adequately controlled with additional ezetimibe treatment or,
• in patients who are either statin-intolerant, or for whom a statin is contraindicated, and not adequately controlled with ezetimibe treatment or,
• in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets.
For study results with respect to effects on LDL-C, cardiovascular events and populations studied see section 5.1.
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