Long-term safety and efficacy of alirocumab in South African patients with heterozygous familial hypercholesterolaemia : the ODYSSEY open-label extension study

Loading...
Thumbnail Image

Authors

Blom, Dirk J.
Breedt, Johannes
Burgess, Lesley J.
Ebrahim, Iftikhar O.
Soma, Prashilla
Van der Walt, Eugene
Naidoo, Poobalan
Van Tonder, Alet
Raal, Frederick J.

Journal Title

Journal ISSN

Volume Title

Publisher

Clinics Cardive

Abstract

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 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.

Description

Keywords

Alirocumab, PCSK9 inhibitors, Familial hypercholesterolaemia, LDL-C goal, Lipid-lowering therapy, Cardiovascular risk, Statin, Low-density lipoprotein cholesterol (LDL-C), Heterozygous familial hypercholesterolaemia (HeFH)

Sustainable Development Goals

Citation

Blom, 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.