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New data suggest alirocumab may be appropriate treatment option for individuals living with T2DM who need help managing their cardiovascular risk.
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Sanofi Diabetes Update:
For use with Ex-US media only
New data suggest alirocumab may be appropriate treatment option for individuals living with T2DM who need help managing their cardiovascular risk
June 9, 2019 – San Francisco, Calif., United States (U.S.)
Mixed dyslipidemia (MD), which is characterized by elevated triglycerides (TG) and decreased levels of high-density lipoprotein cholesterol (HDL-C)1, is often observed in individuals living with type 2 diabetes mellitus (T2DM) and may contribute to increased cardiovascular (CV) risk.2,3
Non-high-density lipoprotein cholesterol (non-HDL-C) and apolipoprotein B (ApoB), rather than TG, are hypothesized to be more useful predictors of CV risk and important therapeutic targets for people living with MD.1,4
The open-label ODYSSEY DM-DYSLIPIDEMIA trial investigated the effect of alirocumab (ALI; 75 mg every 2 weeks [Q2W] with possible increase to 150 mg Q2W at Week 12) or usual care (UC) on top of maximally-tolerated statins (or no statins if intolerant) in individuals with T2DM and MD, at high CV risk. In this overall population, alirocumab showed superiority in non- HDL-C reduction (primary endpoint) vs. UC and was generally well tolerated.5
This post-hoc subgroup analysis of the ODYSSEY DM-DYSLIPIDEMIA trial studied the effect of alirocumab vs. usual care (UC; ezetimibe [EZE], fenofibrate [FENO], or no additional lipid-lowering therapy) on non-HDL-C and other lipids in individuals with T2DM and baseline non-HDL-C ≥100 mg/dL, TG ≥200 mg/dL, and low HDL-C <40 mg/dL (men) or <50 mg/dL (women) on maximally-tolerated statin therapy.6
Findings will be presented as an oral presentation at the American Diabetes Association (ADA) 79th Scientific Sessions in San Francisco, Calif., U.S., on Sunday, 9 June (2:45 – 3:00 pm PDT).
Alirocumab was effective at further reducing atherogenic lipids in a subgroup of individuals with T2DM, high TG and low HDL-C levels, already on maximally-tolerated statin dose, and generally well tolerated with no clinically relevant impact on glycemic parameters
“This data suggests that PCSK9 inhibitors may provide a clinical benefit for appropriate adult patients with type 2 diabetes,” said Helen Colhoun, M.D., Ph.D., AXA Chair of Medical Informatic and Life Course Epidemiology, University of Edinburgh; the study’s lead author and member of the ODYSSEY DM Steering Committee.
Dr. Colhoun continued, “This post-hoc analysis of the ODYSSEY DM- DYSLIPIDEMIA trial found that alirocumab was well tolerated by this subgroup of patients. It was also effective at further reducing atherogenic lipids for individuals living with type 2 diabetes, high triglycerides and low HDL-C levels, already on maximally-tolerated statin therapy.”
Juan Maya, M.D., Global Medical Head of Cardiology and Primary Care at Sanofi, added, “Nearly one third of patients with type 2 diabetes also face cardiovascular disease.2 These results presented at the ADA Scientific Sessions demonstrate that alirocumab may be an appropriate treatment option to help people living with type 2 diabetes manage their lipid levels.”
Summary of analysis
In this post-hoc analysis of ODYSSEY DM-DYSLIPIDEMIA in individuals with T2DM, elevated TG and low HDL-C (<40/50 mg/dL, men/women) on background maximally-tolerated statin therapy, alirocumab significantly reduced non-HDL-C, ApoB, Lipoprotein(a) and low-density lipoprotein (LDL) particle number and increased HDL-C, compared with UC and was generally well tolerated.6
The safety profile of alirocumab was consistent with previous studies in individuals with diabetes, and no new safety issues were observed. Frequency of any treatment emergent adverse events was similar between the alirocumab and UC groups (67.2% vs. 70.7%).6
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