Takeaway
- Alirocumab reduces atherogenic cholesterol and LDL particle number (LDL-PN) among people with type 2 diabetes (T2D) and atherosclerotic cardiovascular disease (ASCVD).
- These patients had high non-HDL-cholesterol (HDL-C)/LDL-cholesterol (LDL-C) levels despite maximally tolerated statin treatment.
Study design
- Analysis of alirocumab efficacy and safety in pooled data from ODYSSEY DM-DYSLIPIDEMIA (n=142) and ODYSSEY DM-INSULIN (n=177), in people with T2D, high LDL-C/non-HDL-C, and established ASCVD despite maximum tolerated statin dose.
- Funding: Sanofi; Regeneron Pharmaceuticals, Inc.
Key results
- Alirocumab was tied to significantly reduced non-HDL-C, LDL-C, apolipoprotein B (ApoB), and LDL-PN from baseline to week 24 vs controls in both studies.
- At week 24, vs control, a significantly greater proportion achieved:
- Non-HDL-C <100 mg/dL (<2.59 mmol/L);
- LDL-C <70 mg/dL (<1.81 mmol/L); and
- ApoB <80 mg/dL vs control (all P<.0001).
- For LDL-C <70 mg/dL vs controls these proportions were 74.9% vs 27.6% in DM-DYSLIPIDEMIA and 77.8% vs 6.8% in DM-INSULIN.
- Overall, 66.7% (alirocumab) and 67.3% (control) reported treatment-emergent adverse events.
- These events were serious in 9.5% (drug) vs 8.8% (control) in DM-DYSLIPIDEMIA and 9.0% (drug) vs 9.4% (control) in DM-INSULIN.
Limitations
- Studies had different designs.
References
References