In the study, patients treated with a combination of Zetia and AEGR-733 achieved a LDL reduction of 35% after four weeks. Patients treated with Zetia alone achieved a 20% reduction in LDL cholesterol. There was no difference in discontinuation rates between the patients treated with the combination of AEGR-733 plus Zetia compared to those treated with Zetia alone. In addition, treatment with both 5mg and 7.5mg doses of AEGR-733 were shown to be as effective as monotherapy.
“These results are a demonstration of the potential broad applicability of AEGR-733 in treatment as a monotherapy and in combination with current lipid lowering therapies,” said Fredrick Samaha, associate professor of medicine, University of Pennsylvania School of Medicine.
“There is a clear unmet medical need in the management of hypercholesterolemia and this class of compounds, known as MTP-inhibitors, has the potential to play an important role as treatment patterns continue to evolve in the direction of combination therapy.”
Final study results for the current trial are expected in the first quarter of 2007. Aegerion plans to initiate several additional phase II trials in early 2007, including one that will examine the LDL lowering efficacy of various doses of AEGR-733 used in combination with Lipitor compared with the agents used as monotherapy.