A phase III randomized trial evaluating alirocumab 300 mg every 4 weeks as monotherapy or add-on to statin: ODYSSEY CHOICE I
Roth Eli M et al. Atherosclerosis vol. 254 (2016): 254-262

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.
Useful resources
För att läsa den här sidan måste du logga in eller registrera dig.
Referenser
-
Roth EM, Goldberg AC, Catapano AL, et al. Antibody-Based Therapy for the Prevention of Hypercholesterolemia: A Focus on PCSK9 Inhibition. Atherosclerosis. 2016;254:254-262