Blom, Dirk J.Breedt, JohannesBurgess, Lesley J.Ebrahim, Iftikhar O.Soma, PrashillaVan der Walt, EugeneNaidoo, PoobalanVan Tonder, AletRaal, Frederick J.2020-01-292020-01-292019-09-21Blom, D.J., Breedt, J., Burgess, L.J. et al. 2019, 'Long-term safety and efficacy of alirocumab in South African patients with heterozygous familial hypercholesterolaemia : the ODYSSEY open-label extension study', Cardiovascular Journal of Africa, vol. 30, no. 5, pp. 279-284.1995-1892 (print)1680-0745 (online)10.5830/CVJA-2019-039http://hdl.handle.net/2263/73010BACKGROUND : 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 HeFH 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 alirocumab 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.en© Clinics Cardive Publishing (Pty) LtdAlirocumabPCSK9 inhibitorsFamilial hypercholesterolaemiaLDL-C goalLipid-lowering therapyCardiovascular riskStatinLow-density lipoprotein cholesterol (LDL-C)Heterozygous familial hypercholesterolaemia (HeFH)Article