WEDNESDAY, Nov. 7 (HealthDay News) -- Subcutaneously administered AMG145, a monoclonal antibody to plasma proprotein convertase subtilisin/kexin type 9 (PCSK9), correlates with significant reductions in low-density lipoprotein cholesterol (LDL-C) levels in patients who are intolerant to statins due to muscle-related side effects, according to research published online Nov. 5 in the Journal of the American Medical Association to coincide with presentation at the American Heart Association's Scientific Sessions 2012, held from Nov. 3 to 7 in Los Angeles.
David Sullivan, M.D., of the Royal Prince Alfred Hospital in Camperdown, Australia, and colleagues assessed the efficacy and tolerability of AMG145 in patients with statin intolerance in a 12-week randomized, double-blind, placebo- and ezetimibe-controlled, dose-ranging study. Participants included 160 adults who were randomized equally to one of five groups: AMG145 at doses of 280, 350, or 420 mg; AMG145 420 mg plus 10 mg ezetimibe; or placebo plus 10 mg ezetimibe. Placebo and AMG145 were administered subcutaneously every four weeks.
The researchers found that, at week 12, the mean changes in LDL-C were −41, −43, and −51 percent for the AMG145 280 mg, 350 mg, and 420 mg groups, respectively, and −63 percent for the 420 mg AMG145 plus ezetimibe group, all of which were significantly different from the −15 percent for placebo/ezetimibe. AMG145 was associated with reports of four serious adverse events and the most common treatment-emergent adverse event was myalgia.
"In this phase 2 study of patients selected on the basis of prior statin intolerance, treatment with subcutaneous administration of a monoclonal antibody to PCSK9, AMG145, achieved significant reductions in LDL-C and was associated with short-term tolerability," the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Amgen, which funded the study and manufactures the study drug.
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