Positive results from trials evaluating Praluent announced

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Sanofi and Regeneron Pharmaceuticals have announced positive results from two Phase IIIb/IV ODYSSEY-DM trials evaluating Praluent (alirocumab) in patients with diabetes and hypercholesterolemia.

The results, unveiled during the 77th Scientific Sessions of the American Diabetes Association (ADA) in San Diego, demonstrated that when Praluent was administered with maximally tolerated doses (MTD) of statins, the primary endpoints of the ODYSSEY DM-INSULIN and ODYSSEY DM-DYSLIPIDEMIA trials were met. Primary endpoints were the significant reduction of low-density lipoprotein cholesterol (LDL-C) and superiority to usual care in reducing non-high-density lipoprotein cholesterol (non-HDL-C), respectively. Additionally, in both studies the majority of patients reached their lipid goals with Praluent 75 mg every two weeks and the overall safety profile was comparable with that of the ODYSSEY Phase III programme.

“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, University of Toronto, Canada. “The positive results from ODYSSEY DM-INSULIN provide valuable information on the efficacy and safety of Praluent in this high cardiovascular risk group.”

“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,” added Dr Robert Henry, 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 atherosclerotic cardiovascular disease manage their lipid profiles.”