Effect of Mipomersen on LDL-Cholesterol Levels in Patients Treated by Regular Apheresis
Status:
Completed
Trial end date:
2015-06-01
Target enrollment:
Participant gender:
Summary
Elevated LDL-cholesterol is a major risk factor for heart disease. In patients with heart
disease LDL-cholesterol should be lowered to levels below 70 mg/dl to prevent progression of
disease. In most patients life style modification together with lipid lowering drug therapy
is sufficient to achieve this goal. In some patients with severe forms of
hypercholesterolemia, this may not be sufficient to reach goals and regular lipid apheresis
(a costly and time intensive form of therapy) may be performed. Mipomersen is a new drug
(apoB antisense oligonucleotide) that can lower LDL-cholesterol even in the most severe forms
of LDL-hypercholesterolemia by 25-47%. It is unknown whether and to what extent mipomersen
can decrease LDL-cholesterol in patients treated with regular apheresis. Phase 1 of the study
will test how 6 months of weekly therapy with mipomersen affects LDL-cholesterol in patients
with severe LDL-hypercholesterolemia treated with regular apheresis. Phase 2 will test in how
many patients this will result in a meaningful reduction of apheresis time, apheresis
frequency or if apheresis can be stopped completely.