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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.; Letierce, Alexia; Samuel, Rita; Del Prato, Stefano; Leiter, Lawrence A.; Müller‐Wieland, Dirk; Cariou, Bertrand; Colhoun, Helen M.; Henry, Robert R.; Tinahones, Francisco J.; Bujas‐Bobanovic, Maja; Domenger, Catherine
- Abstract
Aim: 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). Materials and Methods: 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. Results: The randomized population comprised 413 individuals (intention‐to‐treat population, <italic>n</italic> = 409; safety population, <italic>n</italic> = 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; <italic>P</italic> < .0001). Overall, 63.6% of alirocumab‐treated individuals were maintained on 75 mg every 2 weeks. Alirocumab also reduced LDL cholesterol (−43.0%), apolipoprotein B (−32.3%), total cholesterol (−24.6%) and LDL particle number (−37.8%) at week 24 vs UC (all <italic>P</italic> < .0001). Consistent with the overall trial comparison, alirocumab reduced non‐HDL cholesterol to a greater degree within each UC stratum at week 24. The incidence of treatment‐emergent adverse events was 68.4% (alirocumab) and 66.4% (UC). No clinically meaningful effect on glycated haemoglobin, or change in number of glucose‐lowering agents, was seen. Conclusions: 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.
- Subjects
STATINS (Cardiovascular agents); DYSLIPIDEMIA; TYPE 2 diabetes; RANDOMIZED controlled trials; PROPROTEIN convertases; HYPOGLYCEMIC agents; ANTICHOLESTEREMIC agents
- Publication
Diabetes, Obesity & Metabolism, 2018, Vol 20, Issue 6, p1479
- ISSN
1462-8902
- Publication type
Article
- DOI
10.1111/dom.13257