ODYSSEY FH I and II Trial design: Participants with heterozygous familial hypercholesterolemia on statin therapy were randomized to alirocumab 75 mg SQ.

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Presentation transcript:

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 < 0.0001). 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 < 0.0001). The dose of alirocumab was up-titrated in 38.6% of participants; this reduction was maintained to 52 weeks (p < 0.0001) (p < 0.0001) 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