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New medication shows promise as lipid-lowering therapy for rare cholesterol disorder
Date:11/2/2012

se was 40 mg per day. At the end of the efficacy phase, LDL-C levels were reduced by an average of 50 percent from baseline. Approximately one-third of the patients experienced levels of LDL-C that were less than 100 mg/dl close to the recommended therapeutic goals at some point during the study, and concomitant lipid-lowering therapy was modified in a subset of these patients during the safety phase. Despite these changes in treatment, patients' mean LDL-C levels were still reduced by 38 percent at the end of the study.

"The magnitude of this reduction in LDL-C and the fact that some patients reached or approached the LDL-C therapeutic goals is truly remarkable for this high risk population that historically doesn't respond to lipid-lowering drugs," said the study's lead author, Marina Cuchel, MD, PhD, research assistant professor of Medicine at Penn. "A reduction in LDL-C of this magnitude is certainly expected to favorably alter the clinical course of this devastating disease."

Senior study author Daniel J. Rader, MD, chief, Division of Translational Medicine and Human Genetics at Penn, has treated HoFH patients for more than two decades. In the early 1990s, Rader worked with colleagues to determine that mutations in MTP were the cause of a rare condition characterized by absent LDL in the blood, establishing MTP as a therapeutic target to reduce LDL. His colleagues then went on to discover the MTP inhibitor lomitapide at Bristol-Myers Squibb (BMS). Rader led a study at Penn in the late 1990s showing that lomitapide substantially reduced LDL in patients with moderately elevated LDL. However, because the agent caused some gastrointestinal side effects and increased liver fat, BMS decided to abandon further development of lomitapide for a much larger population of patients with elevated levels of cholesterol. Rader convinced BMS to donate the drug to Penn so that he could continue to develop it in patients with HoFH. Based on its mechanism a
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Contact: Jessica Mikulski
jessica.mikulski@uphs.upenn.edu
215-349-8369
University of Pennsylvania School of Medicine
Source:Eurekalert

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