April 26, 2018
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Alirocumab with statin reduces LDL in atherosclerotic CVD, familial hypercholesterolemia

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Alirocumab with a high-intensity statin lowered LDL in patients with atherosclerotic CVD or heterozygous familial hypercholesterolemia, according to a study published in The American Journal of Cardiology.

Peter A. McCullough, MD, MPH, vice chief of internal medicine and professor of medicine at Baylor University Medical Center in Dallas, and colleagues analyzed data from 2,449 patients with atherosclerotic CVD and 1,050 patients without the condition from five ODYSSEY trials. Of these patients, 575 had heterozygous familial hypercholesterolemia (FH) with atherosclerotic CVD and 682 had the condition without atherosclerotic CVD.

Patients were assigned alirocumab (Praluent, Sanofi/Regeneron) or placebo and all were on a maximally tolerated dose of statin.

The primary efficacy endpoint was the percent change in LDL from baseline to 24 weeks. Researchers also assessed percent changes in apolipoprotein B, non-HDL, lipoprotein(a) and triglycerides and the achievement of LDL less than 70 mg/dL at 24 weeks.

Characteristics and lipid levels at baseline were similar in patients assigned alirocumab and those assigned placebo.

From baseline to 24 weeks, LDL reductions ranged from 46.6% to 51.3% in patients who took 75 mg/150 mg alirocumab every 2 weeks and 54.1% to 61.9% in those who took 150 mg alirocumab every 2 weeks. The reductions in both groups continued up to 78 weeks.

Reductions of LDL with alirocumab were independent of heterozygous FH and atherosclerotic CVD status (P for interaction > .05).

In patients with atherosclerotic CVD, there were significant changes in non-HDL, ApoB, triglycerides and Lp(a) in the alirocumab group compared with the placebo group. The results did not vary by intensity of statin therapy.

Safety profiles were similar in alirocumab and placebo for patients with atherosclerotic CVD and/or heterozygous FH, although injection-site reactions were more common in the alirocumab group.

“Patients with a history of [atherosclerotic] CVD, and especially those with [atherosclerotic] CVD and [heterozygous] FH, are at an increased risk of further events,” McCullough and colleagues wrote. “These data demonstrate that in these high-risk patient populations, further LDL-C reduction is achievable with alirocumab.” – by Darlene Dobkowski

Disclosures: McCullough reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.