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Evolocumab reduces LDL, non-HDL in high-risk patients with type 2 diabetes
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ORLANDO, Fla. — Treatment with the PCSK9 inhibitor evolocumab on top of maximally tolerated statin therapy resulted in significant reductions in LDL cholesterol and non-HDL cholesterol among patients with type 2 diabetes and hypercholesterolemia or mixed dyslipidemia enrolled in the BANTING study.
Among 421 patients, the addition of evolocumab (Repatha, Amgen) to statin therapy reduced LDL by 53.1% from baseline to week 12 and by 64.1% from baseline to the mean of weeks 10 and 12 (P < .0001 for both). The mean reduction in non-HDL was 47% at week 12 and 57% at the mean of weeks 10 and 12 (P < .0001 for both), according to a press release.
The findings were reported at the American Diabetes Association Scientific Sessions.
“These data are important, as they demonstrate that additional treatment options, such as Repatha, can help further reduce LDL and non-HDL in patients who are unable to reach targets with high-intensity statin therapy alone,” Robert S. Rosenson, MD, director of cardiometabolic disorders at Icahn School of Medicine at Mount Sinai, stated in the release.
The BANTING study evaluated the effects of 12 weeks of monthly subcutaneous injections of evolocumab 420 mg compared with placebo on LDL and other lipid parameters in patients with type 2 diabetes. Those enrolled had varying degrees of glycemic control, but HbA1c of less than 10%; were receiving stable pharmacologic therapy for diabetes for at least 6 months; and were taking a maximally tolerated dose of moderate- or high-intensity statin. The mean age was 62 years, nearly half were women and most were white.
In other results, 84.5% of patients assigned evolocumab on top of statin therapy achieved a target LDL of less than 70 mg/dL vs. 15.4% of the placebo group at week 12 and 92.7% vs. 14.8%, respectively, at the mean of weeks 10 and 12. Additionally, 65.5% of the evolocumab-plus-statin group achieved a 50% or greater reduction in LDL at week 12 vs. 0.8% of the placebo group and 84.2% vs. 0.7%, respectively, at the mean of weeks 10 and 12.
The researchers noted that evolocumab did not impact glycemic control. Adverse events were comparable between the groups.
Evolocumab is FDA approved to reduce the risk for MI, stroke and coronary revascularization in adults with established CVD; as an adjunct to diet, alone or in combination with other lipid-lowering therapies to reduce LDL in adults with primary hyperlipidemia; and as an adjunct to diet and other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia who require additional lowering of LDL. – by Katie Kalvaitis
Reference:
Rosenson RS, et al. 128-OR. Presented at: American Diabetes Association 78th Scientific Sessions; June 22-26, 2018; Orlando, Fla.
Disclosures: Rosenson reports relationships with Akcea Therapeutics, Amgen, AstraZeneca, Eli Lilly and Company, Kowa Pharmaceuticals, Regeneron, Sanofi, The Medicines Company and UpToDate. Please see the abstract for all other authors’ relevant financial disclosures.