Efficacy and safety of alirocumab in individuals with type 2 diabetes mellitus with or without mixed dyslipidaemia: Analysis of the ODYSSEY LONG TERM trial.
Atherosclerosis
; 276: 124-130, 2018 09.
Article
en En
| MEDLINE
| ID: mdl-30059843
ABSTRACT
BACKGROUND AND AIMS:
Alirocumab, a monoclonal antibody to proprotein convertase subtilisin/kexin type 9, significantly reduces low-density lipoprotein cholesterol (LDL-C). We evaluated the efficacy and safety of alirocumab in individuals with type 2 diabetes mellitus (T2DM) with versus without mixed dyslipidaemia (MDL, defined as baseline LDL-C ≥70â¯mg/dL [1.8â¯mmol/L] and triglycerides ≥150â¯mg/dL [1.7â¯mmol/L]).METHODS:
Data from 812 individuals with T2DM, from the placebo-controlled, 78-week, Phase 3 ODYSSEY LONG TERM trial of alirocumab 150â¯mg every 2 weeks (Q2W), on a background of maximally tolerated statins⯱â¯other lipid-lowering therapies, were pooled according to MDL status. Efficacy endpoints included percentage change from baseline to Week 24 in calculated LDL-C and other lipids/lipoproteins.RESULTS:
In individuals with T2DM who received alirocumab 150â¯mg Q2W, mean LDL-C changes from baseline to Week 24 were -62.6% (vs. -6.0% with placebo) in those with MDL and -56.1% (vs. 5.6%) in those without MDL, with no significant between-group difference (p-interactionâ¯=â¯0.0842). Risk-based LDL-C goals (<70 [1.8â¯mmol/L] or <100â¯mg/dL [2.6â¯mmol/L]) were achieved by 69.1% and 72.4% of alirocumab-treated individuals with and without MDL, respectively. Mean reductions in non-high-density lipoprotein cholesterol (49.2% and 47.8%) and apolipoprotein B (50.2% and 49.1%) with alirocumab were also similar in those with and without MDL, respectively. Treatment-emergent adverse event rates were comparable between alirocumab-treated individuals with T2DM, with and without MDL.CONCLUSIONS:
Reductions in LDL-C and other lipids with alirocumab, as well as safety and tolerability, were comparable between individuals with T2DM and with versus without MDL.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Inhibidores de Serina Proteinasa
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Diabetes Mellitus Tipo 2
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Dislipidemias
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Inhibidores de PCSK9
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LDL-Colesterol
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Anticuerpos Monoclonales
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Anticolesterolemiantes
Tipo de estudio:
Clinical_trials
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Diagnostic_studies
Límite:
Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Atherosclerosis
Año:
2018
Tipo del documento:
Article