The study included patients with a diagnosis of heterozygous familial hypercholesterolemia who were receiving the maximum tolerated dose of randomized statin alirocumab 75 mg subcutaneously every other week (n = 490) versus placebo (n = 245). At 24 weeks of treatment, a reduction in 48.8% of baseline levels of LDL alirocumab versus 9.1% with placebo (p <0.0001) were observed.
The alirocumab was well tolerated and must be discontinued because of intolerance in a percentage almost identical to the placebo (3.1% versus 3.7%). In patients with heterozygous familial hypercholesterolemia, the alirocumab resulted in a significant reduction in LDL cholesterol compared with placebo and this reduction was maintained at 52 weeks.
John J P Kastelen
2014-08-31
Original title: Efficacy and safety of alirocumab in patients with heterozygous familial hypercholesterolemia not adequately controlled with current lipid-lowering therapy: results of ODYSSEY FH I and FH II studies.