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news.Aegerion Pharmaceuticals has reported positive final results of Phase II clinical trials involving its lead cholesterol management compound, either alone or in combination with Zetia.
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In the study measuring LDL-cholesterol reduction, patients treated with a combination of 10mg of Merck & Co. and Schering-Plough’s Zetia (ezetimibe) and 10mg AEGR-733, experienced LDL-C reductions of 46%. Patients treated with 10mg of ezetimibe alone experienced a 20% reduction in LDL-C levels.
Significantly greater reductions in total cholesterol, non-HDL-cholesterol, Lp(a), and apoB were observed in the group receiving combined AEGR-733 and ezetimibe. There was no difference in the rate of discontinuations between the groups treated with AEGR-733 plus ezetimibe versus those treated with ezetimibe alone.
In a separate analysis of these data, the ability of AEGR-733 alone or in combination with ezetimibe was assessed for its ability to cause weight loss. Over the course of this study, patients were counseled on a low fat/low cholesterol diet but with no emphasis on total calories or weight reduction. Drug treatment consisted of ezetimibe alone (10mg), AEGR-733 in escalating doses at 5mg, then 7.5mg, then 10mg, or a combination of the two drugs for 12 weeks. Weight was monitored over the course of the study.
Jerry Wisler, Aegerion Pharmaceuticals’ president and CEO, said: “These trial results support the LDL-cholesterol lowering effects of AEGR-733 to clinically relevant target levels. In addition, there are a considerable number of patients that cannot tolerate statin therapy and have few other avenues for robust cholesterol reduction.”