Repatha Significantly Improved Cholesterol Levels in High-Risk Patients with Type 2 Diabetes

Amgen’s evolocumab (Repatha) demonstrated significant cholesterol-lowing benefits in high-risk patients with type 2 diabetes in a clinical trial, according to data presented at the American Diabetes Association 78^th Annual Scientific Sessions.

According to the data, evolocumab significantly reduced low-density lipoprotein cholesterol (LDL-C) and non-high density lipoprotein cholesterol (non-HDL-C) in patients with type 2 diabetes plus hypercholesterolemia or mixed dyslipidemia, taking the maximum tolerated dose of moderate/high-intensity statin therapy.

Evolocumab is a human monoclonal antibody that inhibits proprotein convertase sibtilisin/kexin type 9 (PCSK9). The drug works by binding to and inhibiting circulating PCSK9 from binding to the low-density lipoprotein (LDL) receptor (LDLR), thereby increasing the number of LDLRs available to clear LDL from the blood and lowering LDL-C levels.

The data included results from the BANTING study evaluating the efficacy of evolocumab in lowering LDL-C and improving other lipid levels in patients with type 2 diabetes, according to an Amgen press release. The study evaluated the effect of a 12-week regimen of monthly subcutaneous treatment with evolocumab (420 mg dose) compared with placebo in patients 18 years of age or older.

After the addition of evolocumab to background statin therapy, patients with type 2 diabetes and hypercholesterolemia or mixed dyslipidemia had mean reductions in LDL-C levels of 53.1% and 64.1% from baseline to week 12 and from baseline to the mean of weeks 10 and 12, respectively.

“Diabetes is one of the major controllable risk factors for cardiovascular disease, and many patients demonstrate poorly controlled LDL-C and non-HDL-C levels, despite treatment with statins,” Robert S. Rosenson, MD, principal investigator of the BANTING study, said in a press release. “These data are important, as they demonstrate that additional treatment options, such as Repatha, can help further reduce LDL-C and non-HDL-C in patients who are unable to reach targets with high-intensity statin therapy alone.”

Additionally, adding evolocumab enabled most patients to reach LDL-C levels recommended by current guidelines, according to Amgen. The majority of patients taking evolocumab reached LDL-C levels of <70 mg/dL, as recommended by the American College of Clinical Endocrinologists for patients with type 2 diabetes and 1 or more risk factors. A significantly higher percentage of patients also achieved the ≥50 percent reduction in LDL-C levels recommended by the American College of Cardiology (ACC) and the American Heart Association.

The results are consistent with results from previous phase 3 studies demonstrating evolocumab’s efficacy in reducing LDL-C and non-HDL-C levels in patients with type 2 diabetes.

Reference

New Data Show Amgen's Repatha® (evolocumab) Significantly Reduced LDL-C And Non-HDL-C In High-risk Patients With Type 2 Diabetes [news release]. Amgen’s website. 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/. Accessed June 25, 2018.