MILOS - bempedoic acid / ezetimibe in hypercholesterolaemia
Research type
Research Study
Full title
Non-interventional study on the treatment with bempedoic acid and/or its fixed-dose combination with ezetimibe in routine clinical practice in patients with primary hypercholesterolemia or mixed dyslipidemia (MILOS).
IRAS ID
314451
Contact name
Katharina Wenz-Poeschl
Contact email
Sponsor organisation
Daiichi Sankyo Europe GmbH
Duration of Study in the UK
2 years, 4 months, 2 days
Research summary
Cardiovascular disease is the leading cause of death in the world, and this is directly related to levels of cholesterol in the blood. Whilst many people can improve the balance of the different types of cholesterol in their blood by exercise, weight loss and changes to diet, some patients are unable to achieve a healthy balance (e.g as a result of genetic factors) and require treatment.
The drug under study is called bempedoic acid (also known as Nilemdo). Patients taking part in the study will be taking bempedoic acid on its own, or in combination with another drug, called ezetimibe. This combination is known as Nustendi.
These drugs were approved in early 2020 for use in adult patients with primary hypercholesterolaemia or mixed dyslipidaemia.
The study is observational, which means that patients in the study will be receiving one of these drugs as part of their routine care, and there are no additional procedures required for the study.
The aim of the study is to characterize the risks and benefits of the two drugs in normal clinical practice in adult patients with primary hypercholesterolaemia or mixed dyslipidaemia and to gain insight into the effectiveness and safety of the two treatments.
Information will be collected from 5000 patients around the world for a minimum of 1 year and a maximum of 2 years (1 year in the UK). In the UK, patients will be recruited from both hospital and GP centres.
The study is funded by the manufacturer of Nilemdo and Nustendi, Daiichi Sankyo Europe GmbH.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
22/EE/0214
Date of REC Opinion
17 Oct 2022
REC opinion
Further Information Favourable Opinion