Cardiovascular journal of Africa · 2019
Long-term safety and efficacy of alirocumab in South African patients with heterozygous familial hypercholesterolaemia: the ODYSSEY Open-Label Extension study.
Клиническое исследование III фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Blom Dirk J, Breedt Johannes, Burgess Lesley J, Ebrahim Iftikhar O, Ellis Graham, Soma Prashilla, van der Walt Eugene, Naidoo Poobalan, van Tonder Alet, Raal Frederick J
Аннотация
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.
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.
Предметные рубрики MeSH
AdultAgedAntibodies, Monoclonal, HumanizedAnticholesteremic AgentsBiomarkersCholesterol, LDLDouble-Blind MethodDown-RegulationFemaleGenetic Predisposition to DiseaseHeterozygoteHumansHyperlipoproteinemia Type IIMaleMiddle AgedPCSK9 InhibitorsPhenotypeSerine Proteinase InhibitorsSouth AfricaTime FactorsTreatment OutcomeProprotein Convertase 9