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Experimental Drug Aids Patients With Hyperlipidemia

AMG 145 lowered lipoprotein(a) levels better than placebo (August 28)

Lipoprotein(a), or Lp(a), is seen as a risk factor for cardiovascular disease. With few therapies available for lowering Lp(a) levels, researchers sought to evaluate the impact of Amgen’s AMG 145 as a therapy for hyperlipidemia. As part of the LAPLACE–TIMI 57 trial, 631 patients with hypercholesterolemia who were receiving statins were randomly assigned to receive AMG 145 at one of three different doses every 2 weeks or one of three different doses every 4 weeks versus placebo. Lp(a) and other lipid parameters were measured at baseline and at week 12.

Compared with placebo, AMG 145 at doses of 70 mg, 105 mg, and 140 mg every 2 weeks reduced Lp(a) levels at 12 weeks by 18%, 32%, and 32%, respectively (P < 0.001 for each dose vs. placebo). The drug at doses of 280 mg, 350 mg, and 420 mg every 4 weeks reduced Lp(a) by 18%, 23%, and 23% respectively (P < 0.001 for each dose vs. placebo). The reduction in Lp(a) correlated with the reduction in low-density lipoprotein-cholesterol (LDL-C).

The effect of AMG 145 on Lp(a) levels was consistent regardless of patients’ age, sex, race, history of diabetes, and previous statin regimen. Patients with higher levels of Lp(a) at baseline had larger absolute reductions but comparatively smaller percentage reductions in Lp(a) with AMG 145 compared with patients who had lower baseline Lp(a) values.

In summary, AMG 145 significantly reduced Lp(a) by up to 32% in subjects with hypercholesterolemia who were receiving a statin.

Sources: Circulation 2013;128:962–969; ClinicalTrials.gov; and Amgen

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