Impact of alirocumab on lipid profile in patients with type 2 diabetes

Takeaway

• In patients with type 2 diabetes mellitus (T2DM) who were at high cardiovascular risk, alirocumab significantly reduced low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB) and LDL particle number and significantly increased HDL-C compared with usual care overall.
• Reduction in ApoB was greater with alirocumab compared with ezetimibe, fenofibrate or no additional lipid-lowering therapy.

Why this matters

• ODYSSEY DM-DYSLIPIDEMIA trial showed that alirocumab was superior to usual care overall in reducing non-HDL-C vs fenofibrate and was generally well tolerated.

Study design

• A post-hoc analysis of ODYSSEY DM-DYSLIPIDEMIA trial included 186 patients with T2DM who were randomly assigned to receive alirocumab (n=128) or usual care (n=58).
• Primary outcome: percentage change in LDL-C, non-HDL-C, ApoB, LDL particle number, lipoprotein (a) [Lp (a)], triglycerides (TGs), TG-rich lipoprotein (TRL) and HDL-C.
• Funding: Sanofi and Regeneron Pharmaceuticals, Inc.

Key results

• From baseline to 24 weeks, alirocumab vs usual care significantly reduced the risk for:
  • non-HDL-C (least square [LS] mean difference standard error [SE], −35.0% [3.9]);
  • ApoB (LS mean difference [SE], −34.7% [3.6]);
  • LDL-C (LS mean difference [SE], −47.3% [5.2]);
  • LDL particle number (LS mean difference [SE], −40.8% [4.1]); and
  • Lp(a) (LS mean difference [SE], −29.9% [5.4]); P<.0001 for all.
• Fenofibrate was associated with a reduction in TGs vs usual care (LS mean difference [SE], 9.6% [10.0]; P=.3371).
• Overall, alirocumab significantly increased HDL-C vs usual care (LS mean difference [SE], 7.9% [3.6]; P=.0295).
• Patients who received ralirocumab achieved ApoB <80 mg/dL (67.9%) and non-HDL-C <100 mg/dL (60.9%).
• No difference was observed in TGs and adverse event frequency between alirocumab (67.2%) and usual care (70.7%).
• Alirocumab did not show any effects on glycaemic parameters or use of antihyperglycaemic agents.

Limitations

• Post-hoc analysis.