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Waldmann, Elisa; Vogt, Anja; Crispin, Alexander; Altenhofer, Julia; Riks, Ina; Parhofer, Klaus G. (2018): Corrigendum to: “Effect of mipomersen on LDL-cholesterol in patients with severe LDL-hypercholesterolaemia and atherosclerosis treated by lipoprotein apheresis (The MICA-Study)” [Atherosclerosis 259 (2017 Apr) 20–25]. In: Atherosclerosis, Vol. 275: pp. 461-462
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Aims: In this study we evaluated the effect of mipomersen in patients with severe LDL-hypercholesterolaemia and atherosclerosis treated by lipid lowering drugs and regular lipoprotein apheresis. Methods: This prospective, randomized, controlled phase II single centre trial enrolled 15 patients (9 males, 6 females; 59±9ys, BMI 27±4kg/m2) with established atherosclerosis, LDL-cholesterol ≥130mg/dL(3.4mmol/L) despite maximal possible drug therapy, and fulfilling German criteria for regular lipoprotein apheresis. All patients were on stable lipid lowering drug therapy and regular apheresis for >3 months. Patients randomized to treatment (n = 11) self-injected mipomersen 200mg sc weekly at day 4 after apheresis for 26 weeks. Patients randomized to control (n = 4) continued apheresis without injection. The primary endpoint was the change in pre-apheresis LDL-cholesterol. Results: Of the patients randomized to mipomersen 3 discontinued the drug early (<12 weeks therapy) for side effects. For these another 3 were recruited and randomized. Further 4 patients discontinued mipomersen between 12 and 26 weeks for side effects (moderate to severe injection site reactions n = 3 and elevated liver enzymes n = 1). In those treated for >12 weeks, mipomersen reduced pre-apheresis LDL-cholesterol significantly by 22.6 ± 17.0%, from a baseline of 4.8 ± 1.2mmol/L to 3.7 ± 0.9mmol/L, while there was no significant change in the control group (+1.6 ± 9.3%), with the difference between the groups being significant (p=0.006). Mipomersen also decreased pre-apheresis lipoprotein(a) (Lp(a)) concentration from a median baseline of 40.2mg/dL (32.5,71) by 15% (-19.4,3.6) though without significance (p=0.3). Conclusions: Mipomersen reduces LDL-cholesterol (significantly) and Lp(a) (non-significantly) in patients on maximal lipid-lowering drug therapy and regular apheresis but often is associated with side effects.