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Title: Alirocumab vs usual lipid-lowering care as add-on to statin therapy in individuals with type 2 diabetes and mixed dyslipidaemia: The ODYSSEY DM-DYSLIPIDEMIA randomized trial.
Authors: Ray, Kausik K
Leiter, Lawrence A
Müller-Wieland, Dirk
Cariou, Bertrand
Colhoun, Helen M
Henry, Robert R
Tinahones, Francisco J
Bujas-Bobanovic, Maja
Domenger, Catherine
Letierce, Alexia
Samuel, Rita
Del Prato, Stefano
Keywords: PCSK9;mixed dyslipidaemia;non-HDL cholesterol;type 2 diabetes
metadata.dc.subject.mesh: Antibodies, Monoclonal
Antibodies, Monoclonal, Humanized
Anticholesteremic Agents
Blood Glucose
Cholesterol, HDL
Diabetes Mellitus, Type 2
Double-Blind Method
Drug Administration Schedule
Drug Therapy, Combination
Glycated Hemoglobin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypoglycemic Agents
Lipid Metabolism
Middle Aged
Proprotein Convertase 9
Treatment Outcome
Issue Date: 23-Mar-2018
Abstract: To compare alirocumab, a proprotein convertase subtilisin-kexin type 9 inhibitor, with usual care (UC) in individuals with type 2 diabetes (T2DM) and mixed dyslipidaemia not optimally managed by maximally tolerated statins in the ODYSSEY DM-DYSLIPIDEMIA trial (NCT02642159). The UC options (no additional lipid-lowering therapy; fenofibrate; ezetimibe; omega-3 fatty acid; nicotinic acid) were selected prior to stratified randomization to open-label alirocumab 75 mg every 2 weeks (with increase to 150 mg every 2 weeks at week 12 if week 8 non-HDL cholesterol concentration was ≥2.59 mmol/L [100 mg/dL]) or UC for 24 weeks. The primary efficacy endpoint was percentage change in non-HDL cholesterol from baseline to week 24. The randomized population comprised 413 individuals (intention-to-treat population, n = 409; safety population, n = 412). At week 24, the mean non-HDL cholesterol reductions were superior with alirocumab (-32.5% difference vs UC, 97.5% confidence interval -38.1 to -27.0; P  In individuals with T2DM and mixed dyslipidaemia on maximally tolerated statin, alirocumab showed superiority to UC in non-HDL cholesterol reduction and was generally well tolerated.
metadata.dc.identifier.doi: 10.1111/dom.13257
Appears in Collections:Producción 2020

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