MedicalResearch.com Interview with:
Lawrence Leiter, M.D. MDCM, FRCPC, FACP FACE, FAHA
Chair of the ODYSSEY DM Steering Committee and
Director of the Lipid Clinic at the Li Ka Shing Knowledge Institute
St. Michael’s Hospital
University of Toronto, Canada
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The ODYSSEY DM-INSULIN trial was a randomized, double-blind, placebo-controlled, multicenter study that evaluated alirocumab (Praluent) in 517 patients with insulin treated type 1 and type 2 diabetes with high cardiovascular (CV) risk and hypercholesterolemia despite maximally tolerated dose (MTD) statins. The primary endpoint was percent change in calculated LDL-C from baseline to week 24.
Alirocumab 75 mg every two weeks was added to MTD statins, with the dose increased at week 12 to 150 mg every two weeks if the LDL-C at week 8 was greater than or equal to 70 mg/dL. In fact, only about 20% of the alirocumab treated participants required the higher dose.
Results of the type 2 diabetes study population (n=441) showed that the addition of alirocumab to MTD statin therapy, reduced LDL-C by 48.2 percent from baseline compared to a 0.8 percent increase for placebo. The mean difference between the two treatment arms was -49 percent (p<0.0001). Treatment with alirocumab also improved the overall lipid profile. Furthermore, no new safety issues were identified.
There is a large unmet need for improving cholesterol lowering in patients with diabetes. 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. Additionally, in spite of current standard of care, many people with diabetes continue to have persistent lipid abnormalities resulting in high residual CV risk.
MedicalResearch.com: What should clinicians and patients take away from your report?
Response: The ODYSSEY DM program comprises the first dedicated studies reported to date to evaluate a PCSK9 inhibitor in people with diabetes and hypercholesterolemia at high CV risk. Results from this study evaluating a PCSK9 inhibitor in this patient population provide valuable information on the efficacy and safety of alirocumab in this high CV risk group with type 2 diabetes, and will help guide clinical decision-making beyond statin therapy.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: At this year’s ADA, we presented data from the ODYSSEY DM-INSULIN type 2 diabetes study population. Results from the type 1 diabetes population in this trial will be released at the European Association for the Study of Diabetes (EASD) Congress later this year.
These data are also a positive addition to the overall ODYSSEY clinical trial program, including the ongoing ODYSSEY OUTCOMES study that is investigating the effects of alirocumab on the risk of CV events in more than 18,000 participants, who experienced a coronary event within a year before entering the trial, and will include many individuals with diabetes. These very high cardiovascular risk patients have amongst the greatest unmet needs.
Disclosures: Dr. Leiter receives research support from, provides continuing medical education for, and/or has been on the advisory panel for Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Janssen, Merck, Novo Nordisk, Sanofi, Servier, and Takeda. He receives research support and is a speaker for AstraZeneca, Boehringer Ingelheim, Eli Lilly, GlaxoSmithKline, Janssen, Kowa, the Medicines Company, Merck, Novo Nordisk, Sanofi, and Servier.
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Citation: ADA 2017 presentation
Results from ODYSSEY DM-INSULIN and ODYSSEY DM-DYSLIPIDEMIA — the first dedicated studies evaluating Sanofi and Regeneron’s Praluent® (alirocumab) in individuals with diabetes who are at high cardiovascular risk and are taking lipid lowering therapy — will be unveiled this weeked at the American Diabetes Association (ADA) meeting in San Diego. Findings as part of the meeting’s official symposium “Inhibition of PCSK9 in Dyslipidemia Patients with Diabetes,
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