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