Long-term safety and efficacy of alirocumab in South African patients with heterozygous familial hypercholesterolaemia: the ODYSSEY Open-Label Extension study.

Background: Alirocumab reduces low-density lipoprotein cholesterol (LDL-C)levels by up to 61%. The ODYSSEY Open-Label Extension study investigated the effect of alirocumab in patients with heterozygous familial hypercholesterolaemia (HeFH) over 144 weeks. Methods: Eligible patients with Hall had completed an earlier double-blind, randomised, placebo-controlled parent study. Patients were initiated on 75 mg alirocumab Q2W subcutaneous (SC) unless baseline LDL-C was > 8.9 mmol/l, in which case they received 150 mg alirocumah Q2W Dose titration to 150 mg Q2W was at the investigator's discretion. Results: The study enrolled 167 patients and the parent study mean (+/- SD) baseline LDL-C level was 3.65 +/- 1.9 mmol/l. Mean LDL-C level was reduced by 48.7% at week 144: mean on-treatment LDL-C was 2.30 +/- 1.24 mmol/l. Eight patients reported injection-site reactions, with one treatment discontinuation. Treatment emergent anti-drug antibodies were identified in five patients but these did not affect the efficacy. Conclusion: Alirocumab effectively and safely reduced LDL-C in these patients.