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Clinical Summary

Alirocumab tied to improved lipids in diabetes with atherosclerotic

Takeaway

  • Alirocumab reduces atherogenic cholesterol and LDL particle number (LDL-PN) among people with type 2 diabetes (T2D) and atherosclerotic cardiovascular disease (ASCVD). 
  • These patients had high non-HDL-cholesterol (HDL-C)/LDL-cholesterol (LDL-C) levels despite maximally tolerated statin treatment.

Study design

  • Analysis of alirocumab efficacy and safety in pooled data from ODYSSEY DM-DYSLIPIDEMIA (n=142) and ODYSSEY DM-INSULIN (n=177), in people with T2D, high LDL-C/non-HDL-C, and established ASCVD despite maximum tolerated statin dose.
  • Funding: Sanofi; Regeneron Pharmaceuticals, Inc.

Key results

  • Alirocumab was tied to significantly reduced non-HDL-C, LDL-C, apolipoprotein B (ApoB), and LDL-PN from baseline to week 24 vs controls in both studies.
  • At week 24, vs control, a significantly greater proportion achieved:
    • Non-HDL-C <100 mg/dL (<2.59 mmol/L);
    • LDL-C <70 mg/dL (<1.81 mmol/L); and
    • ApoB <80 mg/dL vs control (all P<.0001).
  • For LDL-C <70 mg/dL vs controls these proportions were 74.9% vs 27.6% in DM-DYSLIPIDEMIA and 77.8% vs 6.8% in DM-INSULIN.
  • Overall, 66.7% (alirocumab) and 67.3% (control) reported treatment-emergent adverse events.
    • These events were serious in 9.5% (drug) vs 8.8% (control) in DM-DYSLIPIDEMIA and 9.0% (drug) vs 9.4% (control) in DM-INSULIN.

Limitations

  • Studies had different designs.

References


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