ODYSSEY FH i and FH II: 78 week results with alirocumab treatment in 735 patients with heterozygous familial hypercholesterolaemia

Kastelein, J.J.P. ; Ginsberg, H.N. ; Langslet, G. ; Kees Hovingh, G. ; Ceska, R. ; Dufour, R. ; Blom, D. ; Civeira, F. (Universidad de Zaragoza) ; Krempf, M. ; Lorenzato, C. ; Zhao, J. ; Pordy, R. ; Baccara-Dinet, M. ; Gipe, D.A. ; Geiger, M.J. ; Farnier, M.

Resumen: Aims To assess long-term (78 weeks) alirocumab treatment in patients with heterozygous familial hypercholesterolaemia (HeFH) and inadequate LDL-C control on maximally tolerated lipid-lowering therapy (LLT). Met hods and resul ts In two randomized, double-blind studies (ODYSSEY FH I, n = 486; FH II, n = 249), patients were randomized 2: 1 to alirocumab 75 mg or placebo every 2 weeks (Q2W). Alirocumab dose was increased at Week 12 to 150 mg Q2W if Week 8 LDL-C was =1.8 mmol/L (70 mg/dL). Primary endpoint (both studies) was percentage change in calculated LDL-C from baseline to Week 24. Mean LDL-C levels decreased from 3.7 mmol/L (144.7 mg/dL) at baseline to 1.8 mmol/L (71.3 mg/dL; 2 57.9% vs. placebo) at Week 24 in patients randomized to alirocumab in FH I and from 3.5 mmol/L (134.6 mg/dL) to 1.8 mmol/L (67.7 mg/dL; 2 51.4% vs. placebo) in FH II (P < 0.0001). These reductions were maintained through Week 78. LDL-C = 1.8 mmol/L (regardless of cardiovascular risk) was achieved at Week 24 by 59.8 and 68.2% of alirocumab-treated patients in FH I and FH II, respectively. Adverse events resulted in discontinuation in 3.4% of alirocumab-treated patients in FH I (vs. 6.1% placebo) and 3.6% (vs. 1.2%) in FH II. Rate of injection site reactions in alirocumab-treated patients was 12.4% in FH I and 11.4% in FH II (vs. 11.0 and 7.4% with placebo). Conclusion In patients with HeFH and inadequate LDL-C control at baseline despite maximally tolerated statin + other LLT, alirocumab treatment resulted in significant LDL-C lowering and greater achievement of LDL-C target levels and was well tolerated.

Idioma: Inglés

DOI: 10.1093/eurheartj/ehv370

Año: 2015

Publicado en: EUROPEAN HEART JOURNAL 36, 43 (2015), 2996-3003
ISSN: 0195-668X

Factor impacto JCR: 15.064 (2015)

Categ. JCR: CARDIAC & CARDIOVASCULAR SYSTEMS rank: 3 / 124 = 0.024 (2015) - Q1 - T1

Factor impacto SCIMAGO: 7.264 - Cardiology and Cardiovascular Medicine (Q1)

Tipo y forma: Artículo (Versión definitiva)

Área (Departamento): Area Medicina (Dpto. Medicina, Psiqu. y Derm.)