51. Long-term safety and efficacy of alirocumab in South African patients with heterozygous familial hypercholesterolaemia: the ODYSSEY Open-Label Extension study
- Author
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Poobalan Naidoo, Frederick J. Raal, Graham Ellis, Dirk J. Blom, Eugene van der Walt, Prashilla Soma, Alet van Tonder, Lesley J. Burgess, Johannes Breedt, and Iftikhar O. Ebrahim
- Subjects
medicine.medical_specialty ,Statin ,medicine.drug_class ,business.industry ,Cardiovascular Topics ,Extension study ,General Medicine ,030204 cardiovascular system & hematology ,Discontinuation ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,medicine ,lipids (amino acids, peptides, and proteins) ,In patient ,Long term safety ,Open label ,Cardiology and Cardiovascular Medicine ,business ,Lipoprotein cholesterol ,Alirocumab - 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. Conclusions Alirocumab effectively and safely reduced LDL-C in these patients.
- Published
- 2019