- 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.
- 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.
- 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>