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

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11110%2F15%3A10314377" target="_blank" >RIV/00216208:11110/15:10314377 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00064165:_____/15:10314377

Výsledek na webu

<a href="http://dx.doi.org/10.1093/eurheartj/ehv370" target="_blank" >http://dx.doi.org/10.1093/eurheartj/ehv370</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1093/eurheartj/ehv370" target="_blank" >10.1093/eurheartj/ehv370</a>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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). Methods and results 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; 257.9% vs. placebo) at Week 24 in patients randomized to alirocumab in FHI and from 3.5 mmol/L (134.6 mg/dL) to 1.8 mmol/L (67.7 mg/dL; 251.4% 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

Název v anglickém jazyce

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

Popis výsledku anglicky

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). Methods and results 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; 257.9% vs. placebo) at Week 24 in patients randomized to alirocumab in FHI and from 3.5 mmol/L (134.6 mg/dL) to 1.8 mmol/L (67.7 mg/dL; 251.4% 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

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

FA - Kardiovaskulární nemoci včetně kardiochirurgie

OECD FORD obor

—

Projekt

—

Návaznosti

V - Vyzkumna aktivita podporovana z jinych verejnych zdroju

Rok uplatnění

2015

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

European Heart Journal

ISSN

0195-668X

e-ISSN

—

Svazek periodika

36

Číslo periodika v rámci svazku

43

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

8

Strana od-do

2996-3003

Kód UT WoS článku

000366492300010

EID výsledku v databázi Scopus

2-s2.0-84941168232