Metabolic HealthPCSK9 Inhibitor Alirocumab Outperforms Usual Care in Diabetic Mixed Dyslipidemia
The ODYSSEY DM-Dyslipidemia trial enrolled patients with type 2 diabetes and mixed dyslipidemia whose cholesterol remained uncontrolled despite maximally tolerated statin therapy. Participants received either alirocumab, a PCSK9 inhibitor, or usual care, which could include ezetimibe or fenofibrate. The primary goal was to see whether alirocumab more effectively reduced non-HDL cholesterol, a key cardiovascular risk marker. Secondary goals included assessing LDL-C, triglycerides, apolipoprotein levels, and glycemic parameters. A subgroup analysis compared alirocumab directly against fenofibrate. The trial, sponsored by Sanofi and completed after its 2016 launch, aimed to establish both the superiority and safety of alirocumab in this high-risk diabetic population still struggling with residual lipid risk beyond what statins can address.