Type 2 diabetes mellitus: safety and efficacy of evolocumab

  • Rosenson RS & al.
  • Diabetologia
  • 5 Apr 2019

  • curated by Sarfaroj Khan
  • UK Clinical Digest
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Takeaway

  • BANTING study demonstrated that in statin-treated patients with type 2 diabetes mellitus (T2DM) and hypercholesterolaemia or mixed dyslipidaemia, addition of evolocumab significantly reduced low-density lipoprotein-cholesterol (LDL-C) and non-high-density lipoprotein-cholesterol (non-HDL-C).
  • Evolocumab led to favourable changes in post-prandial chylomicrons, very LDL-C (VLDL-C) and LDL-C levels.

Why this matters

  • Several guidelines support more aggressive LDL-C lowering to levels
  • Findings support the efficacy and safety of evolocumab therapy in patients with T2DM and hyperlipidaemia or mixed dyslipidaemia.

Study design

  • Patients with T2DM (n=421) receiving maximally tolerated statin therapy were randomly assigned 2:1 to receive 12 weeks of monthly evolocumab 420 mg (n=280) and placebo (n=141).
  • Primary outcome: mean percentage change in LDL-C from baseline to 12 weeks and to the mean of 10 and 12 weeks.
  • Secondary outcome: mean percentage change in non-HDL-C, other lipids parameters, LDL-C
  • Funding: Amgen Inc.

Key results

  • At 12 and the mean of 10 and 12 weeks, evolocumab vs placebo showed a significant reduction in:
    • LDL-C level (mean difference [MD], 53.1% and 64.1%, respectively; P<.0001>
    • non-HDL-C level (MD, 46.3% and 56.6%, respectively; P<.0001>
  • Evolocumab significantly improved other lipid parameters, and a higher proportion of patients in evolocumab vs placebo group achieved LDL-C
  • Evolocumab showed favourable changes in chylomicron triacylglycerol and cholesterol, VLDL-C and LDL-C level after mixed-meal tolerance test vs placebo group (P<.05>
  • Evolocumab did not show any significant effects on glycaemic parameters and was safe and well tolerated.

Limitations

  • Short-follow-up.