A novel class of drugs may be the answer for people who cannot achieve satisfactory cholesterol levels with or without statins, according to three phase II studies presented here at the American Heart Association Scientific Sessions.
In the GAUSS study of statin-intolerant patients, the administration of 450 mg of AMG 145 achieved a 51% reduction in LDL cholesterol at 12 weeks, according to Evan A. Stein, MD, PhD, of the Metabolic and Atherosclerosis Research Center in Cincinnati, and colleagues.
In GAUSS, patients already taking ezetimibe (Zetia) had a further reduction of 61% with the novel monoclonal antibody delivered subcutaneously every 4 weeks, compared with a 15% drop in LDL-C in the placebo-plus-ezetimibe group (P<0.001).
In the RUTHERFORD trial, Frederick Raal, MD, of the University of Witwatersrand in Johannesburg, South Africa, and colleagues reported that patients with heterozygous familial hypercholesterolemia and on statins also were able to achieve a significant 55% reduction in LDL-C at 12 weeks with the 420-mg dose of AMG 145 (P≤0.05).
Finally, two pooled studies of RN316 in hypercholesterolemic patients on high or maximal doses of statins showed that the two highest doses of RN3316 -- 3 mg/kg and 6 mg/kg -- were significantly associated with reductions in LDL-C and total cholesterol, according to Barry Gumbiner, PhD, and colleagues from Pfizer.
07/11/2012 : By Chris Kaiser / MedPage Today.
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