GAUSS: AMG 145 Shows Potential in Reducing LDL-C Levels in Statin-Intolerant Patients

Subcutaneous administration of AMG 145, a monoclonal antibody to PCSK9, significantly reduced LDL cholesterol levels and was associated with short-term tolerability in statin-intolerant patients, according to results from the GAUSS Study released on Nov. 5 as part of AHA 2012 and simultaneously released in the Journal of the American Medical Association.

The 12-week study conducted between July 2011 and May 2012 at 33 international sites randomized 160 statin-intolerant adult patients to one of five groups: AMG 145 alone at doses of 280 mg, 350 mg, or 420 mg; AMG 145 at 420 mg plus 10 mg of ezetimibe; or 10 mg of ezetimibe plus placebo. Of those patients, treatment with AMG 145 produced LDL-C reductions ranging from 41 percent to 63 percent, without significant muscle-related side effects. Specifically, data showed at 12 weeks mean changes in LDL cholesterol levels  of −67 mg/dL for the AMG 145, 280-mg, group; −70 mg/dL for the 350-mg group; −91 mg/dL for the 420-mg group; and −110 mg/dL for the 420-mg/ezetimibe group compared with −14 mg/dL for the placebo/ezetimibe group.

According to the study investigators, "these reductions are comparable with those achieved with maximal doses of the most efficacious statins." Given the increasing number of patients at cardiovascular risk who are unable to tolerate effective doses of statins because of muscle-related side effects, the GAUSS results suggest that AMG 145 could provide a potential therapeutic option for this high-risk patient group that currently has few treatment options. The investigators note, however, that larger and longer-term trials are needed to confirm the results.

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