PARIS & TARRYTOWN, N.Y.—Sanofi and Regeneron Pharmaceuticals Inc. announced June 11 positive results from two Phase 3b/4 ODYSSEY-DM trials in patients with diabetes. In the studies, Praluent (alirocumab), when administered on top of maximally tolerated doses (MTD) of statins, significantly reduced low-density lipoprotein cholesterol (LDL-C), the primary endpoint of the ODYSSEY DM-INSULIN study, and was superior to usual care in reducing non-high-density lipoprotein cholesterol (non-HDL-C), the primary endpoint of the ODYSSEY DM-DYSLIPIDEMIA study.
Both studies also found that a majority of patients reached their lipid goals with Praluent 75 mg every two weeks, with an overall safety profile comparable to the ODYSSEY Phase 3 program.
The results were unveiled as part of the official symposium of the 77th Scientific Sessions of the American Diabetes Association in San Diego, titled “Inhibition of PCSK9 in Dyslipidemia Patients with Diabetes.”
“Patients with long-standing diabetes, including insulin-treated patients, are at high risk of cardiovascular disease,” said Dr. Lawrence Leiter, chair of the ODYSSEY DM steering committee and director of the Lipid Clinic at the Li Ka Shing Knowledge Institute at St. Michael’s Hospital of the University of Toronto. “The positive results from ODYSSEY DM-INSULIN provide valuable information on the efficacy and safety of Praluent in this high cardiovascular risk group.”
Most people with diabetes will develop atherosclerotic cardiovascular disease (ASCVD). Despite current standard of care, nearly 70 percent of people age 65 or older with diabetes die from some form of heart disease, and 16 percent die of stroke, note Sanofi and Regeneron.
“Mixed dyslipidemia is common in people with type 2 diabetes and further increases [cardiovascular] risk, and yet it is difficult to treat with available therapies,” said Dr. Robert Henry, a member of the ODYSSEY DM Steering Committee and director of the Center for Metabolic Research at the VA San Diego Healthcare System. “The results of ODYSSEY DM-DYSLIPIDEMIA showed that in a real-world setting, Praluent, on top of maximally tolerated doses of statins, significantly reduced non-HDL-C, another measure of bad cholesterol, and was superior to usual care. Praluent may be another option for physicians who need to further help their diabetes patients with clinical ASCVD manage their lipid profiles.”
In the previously reported results from the ODYSSEY LONG TERM study in which all patients were treated with Praluent 150 mg on top of MTD statins, Praluent reduced LDL-C by 60 percent from baseline in patients with diabetes at week 24.4.
Praluent inhibits the binding of PCSK9 (proprotein convertase subtilisin/kexin type 9) to the LDL receptor and thereby increases the number of available LDL receptors on the surface of liver cells, which results in lower LDL-C levels in the blood.
Praluent is approved in more than 50 countries worldwide, including the United States, Japan, Canada, Switzerland, Mexico and Brazil, as well as the European Union. In the United States, Praluent is approved for use as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical ASCVD who require additional lowering of LDL-C. In the European Union, Praluent is approved for the treatment of adult patients with primary hypercholesterolemia (HeFH and non-familial) or mixed dyslipidemia as an adjunct to diet (1) in combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach their LDL-C goals with the maximally tolerated statin or (2) alone or in combination with other lipid-lowering therapies for patients who are statin intolerant, or for whom a statin is contraindicated.