PCSK9 inhibition reduces atherogenic lipid levels in T2DM patients with mixed dyslipidemia
Alirocumab versus usual lipid-lowering care as add-on to statin therapy in individuals with type 2 diabetes and mixed dyslipidaemia: The ODYSSEY DM-DYSLIPIDEMIA randomized trialLiterature - Ray KK, Leiter LA, Müller-Wieland D, et al. - Diab Obes Metabol 2018; published online ahead of print
The mean percentage changes from baseline to week 24 with alirocumab vs. UC were:
- non-HDL-c: -37.3 (SE: 3.0)% vs. –4.7 (SE: 3.3)%; –32.5% difference; P<0.0001
- LDL-c: -43.3% vs. -0.3%; -43% difference; P<0.0001
- Total cholesterol: -27.4% vs. -2.8%; -24.6% difference; P<0.0001
- TGs: -13.0% vs. -8.8%; -4.2% difference; P=0.2191
- HDL-c: +14.5% vs. +8.2%; 6.2% difference; P=0.0026
- ApoB: -33.8% vs. -1.6%; -32.3% difference; P<0.0001
- Lp(a): -23.7% vs. +3.7%; -27.4% difference; P<0.0001
- LDL-p number: -41.6% vs. -3.9%; -37.8% difference; P<0.0001
- LDL-p size: -1.5% vs. +0.3%; -1.8% difference; P<0.0001
Results for the UC strata were similar to the overall analysis.
At week 24, more than two-thirds of alirocumab-treated individuals achieved levels of non-HDL-c <2.59 mmol/L (<100 mg/dL), LDL-c <1.81 mmol/L (<70 mg/dL) and ApoB <80 mg/dL. In addition, a greater proportion of individuals in the alirocumab group versus UC achieved a reduction in LDL-c from baseline of ≥50% (55.2% vs 3.8%).
In individuals with T2DM and mixed dyslipidemia who are not adequately controlled despite maximally tolerated statin therapy, the addition of the PCSK9 inhibitor alirocumab reduced more effectively their atherogenic lipid levels compared with the usual lipid-lowering therapeutic approaches.