Amgen Inc. issued the following announcement on June 23.
Amgen (NASDAQ:AMGN) today announced new data that show Repatha® (evolocumab) significantly reduced low-density lipoprotein cholesterol (LDL-C) and non-high density lipoprotein cholesterol (non-HDL-C) in patients with Type 2 diabetes and hypercholesterolemia or mixed dyslipidemia, taking the maximum tolerated dose of moderate/high-intensity statin therapy. BANTING was a dedicated study evaluating the efficacy of Repatha (monthly dosing), in lowering LDL-C and improving other lipid levels in patients with Type 2 diabetes. In addition to meeting criteria for hypercholesterolemia or mixed dyslipidemia, patients in the trial had varying degrees of glycemic control. Data were presented at the American Diabetes Association 78th Annual Scientific Sessions.
"Diabetes affects more than 20 million Americans and managing their uncontrolled cholesterol levels remains a critical unmet need," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "The findings of the BANTING study clearly demonstrate the ability for Repatha to help these patients reach their targets."
Results from the BANTING study show that in patients with Type 2 diabetes and hypercholesterolemia or mixed dyslipidemia (n=421), the addition of Repatha to background statin therapy resulted in significant reductions in LDL-C levels (53.1 percent and 64.1 percent mean reduction from baseline to week 12 and from baseline to the mean of weeks 10 and 12, respectively; p<0.0001).
Type 2 diabetes is often associated with dyslipidemia, a condition characterized by low "good" cholesterol or HDL-C and elevated "bad" cholesterol or LDL-C.
"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," said Robert S. Rosenson, M.D., Icahn School of Medicine at Mount Sinai, and principal investigator of the BANTING study.* "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."
In addition to producing significant reductions in LDL-C levels, the addition of Repatha to background statin therapy enabled most patients to reach LDL-C levels recommended by current guidelines. The majority of patients in the Repatha group reached LDL-C levels of <70 mg/dL (84.5 percent versus 15.4 percent of patients in the placebo group at week 12 and 92.7 percent versus 14.8 percent of patients in the placebo group at the mean of weeks 10 and 12)1 as recommended by the American College of Clinical Endocrinologists for patients with Type 2 diabetes and one or more risk factors.
Treatment with Repatha was also associated with a significantly higher percentage of patients achieving the ≥50 percent reduction in LDL-C levels recommended by the American College of Cardiology (ACC) and the American Heart Association (AHA)5 (65.5 percent versus 0.8 percent LDL-C reduction in Repatha versus patients in the placebo group at week 12 and 84.2 percent versus 0.7 percent LDL-C reduction in Repatha versus patients in the placebo group at the mean of weeks 10 and 12). Repatha also reduced several other lipid parameters, including non-HDL-C (47 percent versus 1 percent reduction with placebo at week 12, and 57 percent versus 1 percent reduction with placebo at the mean of weeks 10 and 12).1 Non-HDL-C levels are a known risk factor for cardiovascular events in patients with Type 2 diabetes and together with LDL-C levels represent one of the primary targets of therapy recommended by guidelines.These results are consistent with results from previous Phase 3 studies demonstrating Repatha's efficacy in reducing LDL-C and non-HDL-C levels in patients with Type 2 diabetes independent of glycemia, insulin use, renal function and cardiovascular disease status at baseline.
The safety profile in BANTING was consistent with the established safety profile of Repatha
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