MONDAY, Nov. 14 (HealthDay News) -- A single dose of AMG145 lowers low-density lipoprotein-cholesterol (LDL-C), total cholesterol, apolipoprotein (apo)-B levels, and suppresses unbound pro-protein convertase subtilisin/kexin type 9 (PCSK9), according to a study presented at the American Heart Association's Scientific Sessions 2011, held from Nov. 12 to 16 in Orlando, Fla.
Clapton Dias, Ph.D., from Amgen Inc. in Thousand Oaks, Calif., and colleagues investigated whether AMG145 lowered circulating LDL-C levels. Healthy individuals, aged 18 to 45 years, with LDL-C ranging from 100 to 190 mg/dL, body mass index within 18 to 32 kg/m², and no co-medications 14 days before inclusion were randomized to receive either AMG145 or placebo. Five cohorts received subcutaneous doses and two cohorts received intravenous doses. The primary end point was the measurement of safety and tolerability after a single dose.
The investigators found that, compared to placebo, a single AMG145 dose lowered the mean LDL-C by up to 64 percent. The extent to which LDL-C was lowered, time to nadir, and duration of LDL-C lowering each had a dose-dependent relationship. AMG145 also lowered total cholesterol and apo-B. Serum triglycerides, high-density lipoprotein-cholesterol and apo-A1 were not affected by AMG145. Serum unbound PCSK9 was potently suppressed by AMG145, and this dose-response decrease correlated well with the decreases in LDL-C, total cholesterol, and apo-B. Treatment-emergent adverse event incidence was similar between patients treated with AMG145 or placebo, with no AMG145 dose correlation. There were no serious adverse events or study discontinuations due to an adverse event.
"AMG145 decreased unbound PCSK9 levels and lowered circulating LDL-C, total cholesterol, and apo-B," the authors write.
All of the study authors disclosed financial relationships with Amgen Inc., manufacturer of AMG145.
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