ODYSSEY
Trial question
What is the role of alirocumab in patients at high risk for CV events?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
38.0% female
62.0% male
N = 2341
2341 patients (884 female, 1457 male).
Inclusion criteria: patients at high risk for CV events who had LDL cholesterol levels ≥ 70 mg/dL and were receiving treatment with statins at the maximum tolerated dose, with or without other lipid-lowering therapy.
Key exclusion criteria: age < 18 years, LDL cholesterol < 70 mg/dL, fasting serum triglycerides > 400 mg/dL.
Interventions
N=1553 alirocumab (150 mg as a single 1 ml subcutaneous injection every 2 weeks for 78 weeks).
N=788 placebo (matching placebo as a single 1 ml subcutaneous injection every 2 weeks for 78 weeks).
Primary outcome
Change in calculated LDL cholesterol level at 24 weeks
-61%
0.8%
0.0 %
-15.3 %
-30.5 %
-45.8 %
-61.0 %
Alirocumab
Placebo
Significant
decrease ▼
NNT = 1
Significant decrease in change in calculated LDL cholesterol level at 24 weeks (-61% vs. 0.8%; ARD -61.9, 95% CI -64.3 to -59.4).
Secondary outcomes
Significant decrease in change in calculated LDL cholesterol at 78 weeks (-52.4% vs. 3.6%; ARD -56, 95% CI -59.1 to -52.8).
Significant decrease in change in total cholesterol (-37.8% vs. -0.3%; ARD -37.5, 95% CI -39.1 to -35.9).
Significant increase in change in HDL cholesterol (4% vs. -0.6%; AD 4.6%, 95% CI 3.3 to 5.9).
Safety outcomes
No significant difference in any adverse event and adverse event leading to study-drug discontinuation.
Significant difference in myalgia (5.4% vs. 2.9%).
Conclusion
In patients at high risk for CV events who had LDL cholesterol levels ≥ 70 mg/dL and were receiving treatment with statins at the maximum tolerated dose, with or without other lipid-lowering therapy, alirocumab was superior to placebo with respect to change in calculated LDL cholesterol level at 24 weeks.
Reference
Robinson JG, Farnier M, Krempf M et al. Efficacy and safety of alirocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015 Apr 16;372(16):1489-99.
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