A phase III randomized trial evaluating alirocumab 300 mg every 4 weeks as monotherapy or add-on to statin: ODYSSEY CHOICE I

The phase III ODYSSEY CHOICE I study evaluated the efficacy, long-term safety, and tolerability of alirocumab 300 mg every 4 weeks, with possible adjustment to 150 mg every 2 weeks at Week 12, in patients at moderate to very-high cardiovascular disease (CVD) risk, both on and off statins. Patients with LDL-C levels ≥1.8 mmol/L or ≥2.6 mmol/L, depending on their CVD risk, were included. The study randomized patients in a 4:2:1 ratio to receive alirocumab 300 mg every 4 weeks, placebo, or alirocumab 75 mg every 2 weeks for 48 weeks.

Efficacy results showed significant LDL-C reductions from baseline to Weeks 21-24 with alirocumab 300 mg every 4 weeks compared to placebo, with mean reductions of 56.9% in non-statin patients and 65.8% in statin-treated patients. These reductions were maintained through Week 48. Patients not achieving target LDL-C levels at Week 8 had their doses adjusted to 150 mg every 2 weeks (14.7% and 19.3% of patients respectively in the no statin and concomitant statin populations), reducing LDL-C variability.

Safety results indicated similar rates of treatment-emergent adverse events between alirocumab and placebo groups, apart from higher injection-site reactions in the alirocumab 300 mg every 4 weeks group, mostly mild.

Conclusion

Alirocumab 300 mg every 4 weeks, with potential dose adjustment, is an effective and well-tolerated option for LDL-C lowering in patients at high CVD risk, in addition to maximally tolerated statins and ezetimibe.

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