Efficacy of Evolocumab vs low‐density lipoprotein cholesterol apheresis in patients with familial hypercholesterolemia and high cardiovascular risk (EVOLAFER01)

다국어 초록 (Multilingual Abstract)

Low‐density lipoprotein (LDL) apheresis has been considered the last option to treat refractory hyperlipidemia in patients with familiar hypercholesterolemia (FH). Evolocumab is a monoclonal antibody which has shown significant reduction of low‐density lipoprotein cholesterol (LDL‐C) serum levels and cardiovascular events.
The aim of the study was to examine the comparative impact of LDL‐apheresis vs Evolocumab vs the combination of both LDL‐apheresis and Evolocumab on lipid and lipoprotein parameters, and other metabolic/inflammatory measures.
Non‐randomized open case series study of 10 adult patients diagnosed with FH already on long‐term LDL‐apheresis therapy. The study was developed in three consecutive phases to compare LDL‐apheresis, Evolocumab treatment and the combination of both. Laboratory parameters were collected pre and post LDL‐apheresis and before Evolocumab administration. The primary endpoint was the reduction of LDL‐C during the three phases.
Reduction of LDL‐C levels with Evolocumab were 31.4% vs LDL‐apheresis from 153 ± 35 mg/dL to 105 ± 56 mg/dL (P < .001). Reduction of Lp(a) was also significantly higher with Evolocumab (45.5%) than LDL‐apheresis from 36 (6‐119) to 20 (3‐41) mg/dL, P = .027. In addition, HDL‐C and apo‐A increased after Evolocumab treatment, from 41 ± 6 to 46 ± 8 mg/dL (P = .003) and from 124 ± 13 to 144 ± 25 mg/dL (P = .001), respectively. No changes in immunological or inflammatory parameters were observed and no serious adverse events were recorded.
Evolocumab reduces LDL‐C and Lp(a) more effectively than LDL‐apheresis and combination of Evolocumab plus LDL‐apheresis could be a therapeutic alternative to get lower LDL‐C and Lp(a) levels in patients with very high cardiovascular risk.