Ray, Kausik KLeiter, Lawrence AMüller-Wieland, DirkCariou, BertrandColhoun, Helen MHenry, Robert RTinahones, Francisco JBujas-Bobanovic, MajaDomenger, CatherineLetierce, AlexiaSamuel, RitaDel Prato, Stefano2023-01-252023-01-252018-03-23http://hdl.handle.net/10668/12122To 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.enAttribution-NonCommercial-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-nd/4.0/PCSK9mixed dyslipidaemianon-HDL cholesteroltype 2 diabetesAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAnticholesteremic AgentsBlood GlucoseCholesterol, HDLDiabetes Mellitus, Type 2Double-Blind MethodDrug Administration ScheduleDrug Therapy, CombinationDyslipidemiasFemaleGlycated HemoglobinHumansHydroxymethylglutaryl-CoA Reductase InhibitorsHypoglycemic AgentsLipid MetabolismMaleMiddle AgedProprotein Convertase 9Treatment Outcomeresearch article29436756open access10.1111/dom.132571463-1326PMC5969299https://onlinelibrary.wiley.com/doi/pdfdirect/10.1111/dom.13257https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5969299/pdf