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Amylin to Present Data Showing Investigational Metreleptin Treatment Led to Long-Term Improvements in Diabetes and Lipid Control in Patients with Lipodystrophy
Date:4/15/2011

therapy to market."

Study Findings

The findings involve an analysis of 55 lipodystrophy patients who received metreleptin treatment – the largest lipodystrophy cohort reported to date. At baseline, 75 percent of patients had diabetes and were not achieving adequate glycemic control (A1C greater than or equal to 7 percent), and 75 percent of patients had hypertriglyceridemia (triglycerides greater than or equal to 200 mg/dL). Metreleptin treatment resulted in robust reductions from baseline in both measures, an effect that was evident within four months post treatment initiation and sustained for up to several years of treatment. In patients with diabetes, mean A1C decreased from 9.4 percent at baseline to under 7.0 percent at year three; in patients with hypertriglyceridemia at baseline, median triglyceride concentrations decreased from 500 mg/dL at baseline to under 200 mg/dL at year three.

Adverse events were generally consistent with known co-morbid conditions of lipodystrophy (pancreatitis, proteinuria, autoimmune/chronic hepatitis) or expected pharmacological effects of metreleptin (weight loss or insulin-induced hypoglycemia in the setting of improved insulin sensitivity in patients on high doses of insulin).

About Lipodystrophy

Lipodystrophy syndromes are characterized by abnormalities in adipose (fat) tissue distribution. Because patients with lipodystrophy do not have enough fat tissue, they typically also have a deficiency of leptin, a hormone secreted by fat cells that plays a key role in regulating metabolism. Beginning typically in childhood or adolescence, patients affected by lipodystrophy experience a loss of subcutaneous fat, which can result in multiple, often severe metabolic abnormalities, including extreme insulin resistance, very high triglyceride levels, difficult-to-control diabetes and hepatic steatosis (excess fat accumulation in the liver). These abnormalities put patients at a high r
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SOURCE Amylin Pharmaceuticals, Inc.
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