1. ODYSSEY FH I and II
Trial design: Participants with heterozygous familial hypercholesterolemia on statin therapy were randomized to alirocumab 75 mg SQ injection (up-titration possible to 150 mg) every 2 weeks (n = 490) vs. placebo SQ injection every 2 weeks (n = 245).
Percent change in LDL-C from baseline to 24 weeks
Results
In FH I: From baseline to 24 weeks, the change in LDL-C: -48.8% for alirocumab vs. 9.1% for placebo (p < ). The dose of alirocumab was up-titrated in 43.4% of participants; this reduction was maintained to 52 weeks
In FH II: From baseline to 24 weeks, the change in LDL-C: -48.7% for alirocumab vs. 2.8% for placebo (p < ). The dose of alirocumab was up-titrated in 38.6% of participants; this reduction was maintained to 52 weeks
(p < )
(p < )
9.1
2.8 %
Conclusions
-48.8
-48.7
Among patients with heterozygous familial hypercholesterolemia, alirocumab resulted in a large reduction in LDL-C compared with placebo, which was maintained to 52 weeks
FH I
FH II
Alirocumab
Placebo
Presented by Dr. John Kastelein at ESC 2014