000048360 001__ 48360
000048360 005__ 20210121114540.0
000048360 0247_ $$2doi$$a10.1093/eurheartj/ehv370
000048360 0248_ $$2sideral$$a94049
000048360 037__ $$aART-2015-94049
000048360 041__ $$aeng
000048360 100__ $$aKastelein, J.J.P.
000048360 245__ $$aODYSSEY FH i and FH II: 78 week results with alirocumab treatment in 735 patients with heterozygous familial hypercholesterolaemia
000048360 260__ $$c2015
000048360 5060_ $$aAccess copy available to the general public$$fUnrestricted
000048360 5203_ $$aAims 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.
000048360 540__ $$9info:eu-repo/semantics/openAccess$$aby-nc$$uhttp://creativecommons.org/licenses/by-nc/3.0/es/
000048360 590__ $$a15.064$$b2015
000048360 591__ $$aCARDIAC & CARDIOVASCULAR SYSTEMS$$b3 / 124 = 0.024$$c2015$$dQ1$$eT1
000048360 592__ $$a7.264$$b2015
000048360 593__ $$aCardiology and Cardiovascular Medicine$$c2015$$dQ1
000048360 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion
000048360 700__ $$aGinsberg, H.N.
000048360 700__ $$aLangslet, G.
000048360 700__ $$aKees Hovingh, G.
000048360 700__ $$aCeska, R.
000048360 700__ $$aDufour, R.
000048360 700__ $$aBlom, D.
000048360 700__ $$0(orcid)0000-0001-7043-0952$$aCiveira, F.$$uUniversidad de Zaragoza
000048360 700__ $$aKrempf, M.
000048360 700__ $$aLorenzato, C.
000048360 700__ $$aZhao, J.
000048360 700__ $$aPordy, R.
000048360 700__ $$aBaccara-Dinet, M.
000048360 700__ $$aGipe, D.A.
000048360 700__ $$aGeiger, M.J.
000048360 700__ $$aFarnier, M.
000048360 7102_ $$11007$$2610$$aUniversidad de Zaragoza$$bDpto. Medicina, Psiqu. y Derm.$$cArea Medicina
000048360 773__ $$g36, 43 (2015), 2996-3003$$pEur. heart j.$$tEUROPEAN HEART JOURNAL$$x0195-668X
000048360 8564_ $$s340969$$uhttps://zaguan.unizar.es/record/48360/files/texto_completo.pdf$$yVersión publicada
000048360 8564_ $$s101566$$uhttps://zaguan.unizar.es/record/48360/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada
000048360 909CO $$ooai:zaguan.unizar.es:48360$$particulos$$pdriver
000048360 951__ $$a2021-01-21-11:15:40
000048360 980__ $$aARTICLE