Durability of alirocumab effect: Data from an open-label extension to the ODYSSEY program for patients with heterozygous familial hypercholesterolemia
| Autor: | John R. Guyton, Robert Dufour, G. Kees Hovingh, Michel Farnier, Gisle Langslet, Marie T. Baccara-Dinet, Chantal Din-Bell, Garen Manvelian |
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| Rok vydání: | 2017 |
| Předmět: |
Pediatrics
medicine.medical_specialty Apolipoprotein B Endocrinology Diabetes and Metabolism Population Familial hypercholesterolemia 030204 cardiovascular system & hematology 03 medical and health sciences 0302 clinical medicine Endocrinology Internal medicine Internal Medicine medicine In patient 030212 general & internal medicine Adverse effect education Alirocumab education.field_of_study Nutrition and Dietetics biology business.industry General Medicine medicine.disease biology.protein Physical therapy Open label Cardiology and Cardiovascular Medicine business Lipoprotein |
| Zdroj: | Annales d'Endocrinologie. 78:301 |
| ISSN: | 0003-4266 |
| Popis: | Purpose To evaluate the overall durability of the effect of alirocumab in patients with heterozygous familial hypercholesterolemia (HeFH) using data from the ODYSSEY open-label extension (OLE) of four phase 3 trials (FHI, FHII, LONG-TERM, HIGH-FH) assessing long-term efficacy and safety for up to 40 months. Methods Patients received alirocumab 75 mg (FHI, FHII, LONG-TERM) or 150 mg (HIGH-FH) once every 2 weeks. From Week 12, dose adjustment of alirocumab was allowed as per investigator's clinical judgement. Results A total of 985 patients (mean age 54.4 years, 55.8% male) were included in OLE safety population. At OLE enrollment, 978 patients were receiving statins with 627 other lipid-lowering therapy. At the time of analysis, 938 patients had completed ≥ 1 year of treatment; 5.7% had discontinued treatment (2.2% due to adverse events). Of those who started OLE on 75 mg dose, 537/909 (59.1%) were maintained on that dose throughout. At Week 48 of OLE, the mean LDL-C was 79.7 mg/dL, a mean reduction of 46.9% compared with baseline levels of the parent studies. Other lipid changes included reductions at Week 48 in non-high density lipoprotein cholesterol (40.3%), total cholesterol (29.7%), lipoprotein(a) (25.6%), and apolipoprotein B (37.5%). Overall, 762/985 (77.4%) patients reported treatment-emergent adverse events during OLE (up to 73 weeks). Injection site reactions reported by 49 patients (5.0%) were mild and self-limited. Conclusion In this OLE study of patients with HeFH, alirocumab demonstrated a durable and robust treatment effect, yielding a 47% reduction in LDL-C at Week 48 compared with baseline levels. |
| Databáze: | OpenAIRE |
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