Human medicines European public assessment report (EPAR): Nustendi, bempedoic acid,ezetimibe, Date of authorisation: 27/03/2020, Revision: 6, Status: Authorised

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.