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BANTING

Posted on 24 July 2018 | Posted in Evolocumab
Trial EvolocumaB efficAcy aNd safeTy IN type 2 diabetes mellitus on backGround statin therapy (BANTING)
Aim To evaluate the effect of a 12-week regimen of monthly subcutaneous treatment with evolocumab 420 mg versus placebo, on low-density lipoprotein cholesterol (LDL-C) and other lipid parameters in patients with type 2 diabetes and hypercholesterolemia or mixed dyslipidemia while on optimized background statin therapy
Study design Randomized, double-blind, parallel-group placebo-controlled trial. Patients were randomized to monthly subcutaneous treatment with evolocumab 420 mg or placebo
Patient population 421 patients with type 2 diabetes and hypercholesterolemia or mixed dyslipidemia while on optimized background statin therapy, with had varying degrees of glycaemic control
Primary efficacy endpoint Co-primary endpoints:

  • mean percent change in LDL-C from baseline to week 12
  • the mean of weeks 10 and 12 change in LDL-C from baseline to week 12
Other endpoints Secondary endpoints included proportion of patients who reached LDL-C levels <70 mg/dL, LDL-C reduction ≥50 percent and reduction in levels of other atherogenic lipids including non-high-density lipoprotein cholesterol (non-HDL-C).
Key results The addition of evolocumab to background statin therapy led to:

  • 53.1% reduction in LDL-C from baseline to week 12 (p<0.001)
  • 64.1% reduction in LDL- from baseline to the mean of weeks 10 and 12 (p<0.0001)

Other results included:

  • Proportion attaining LDL-C goal at week 12: 84.5% versus 15.4% on placebo
  • Proportion attaining LDL-C goal (mean weeks 10 and 12): 92.7% versus 14.8 on placebo

Reduction in other lipid parameters including non-HDL-C (47% versus 1% reduction with placebo at week 12, and 57% versus 1% with placebo at the mean of weeks 10 and 12)

The safety profile in BANTING was consistent with the established safety profile of evolocumab

Author conclusion These data are important, as they demonstrate that additional treatment options, such as evolocumab, can help further reduce LDL-C and non-HDL-C in type 2 diabetes patients who are unable to reach targets with high-intensity statin therapy alone.
Publication Oral presentation. Robert S. Rosenson, Martha L. Daviglus, Peter Reaven. American Diabetes Association 78th Scientific Sessions 2018.128-OR.
Link Amgen press release 23 June, 2018

https://www.amgen.com/media/news-releases/2018/06/new-data-show-amgens-repatha-evolocumab-significantly-reduced-ldlc-and-nonhdlc-in-highrisk-patients-with-type-2-diabetes/

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