Jun 29 2010
Results of a new study demonstrated that initial combination therapy with Welchol® (colesevelam HCl) 3.75 g/d and metformin (initiated at 850 mg/d; uptitrated to 1700 mg/d thereafter) significantly improved glycemic and lipid control in drug-naive adult type 2 diabetes patients with high LDL cholesterol (LDL-C). In the study, treatment with Welchol plus metformin significantly reduced mean A1C levels by 1.1 percent and LDL-C levels by 21 percent. In addition, approximately two-thirds of patients who received Welchol plus metformin achieved the American Diabetes Association (ADA)'s glycemic goal of A1C levels less than 7 percent, which was statistically significant compared with metformin plus placebo alone. Results of the randomized, double-blind, placebo-controlled study were presented today at the 70th Scientific Sessions of the ADA in Orlando.
"In this study, early intervention with Welchol and metformin significantly reduced A1C and LDL cholesterol levels, two important risk factors for cardiovascular disease, in drug-naive adult type 2 diabetes patients with high cholesterol," said Yehuda Handelsman, MD, FACP, FACE, Medical Director of the Metabolic Institute of America in Tarzana, Calif. and investigator of the study. "Notably, these data indicate that initial combination therapy with Welchol and metformin may represent a safe and effective option to help patients with type 2 diabetes reach glycemic and lipid goals."
About 23.6 million, or 8 percent of people in the United States, have diabetes, and approximately 90 to 95 percent of people diagnosed with diabetes have type 2 diabetes. The ADA and the American College of Cardiology emphasize that it is critical to reduce both A1C and LDL cholesterol levels, as more than 50 percent of adults with type 2 diabetes also have elevated LDL cholesterol, greatly increasing their risk of cardiovascular disease. The effect of Welchol on cardiovascular morbidity and mortality has not been determined.
"As the only medication approved to treat both A1C and LDL-C in adults with type 2 diabetes and primary hyperlipidemia, Welchol addresses both of these chronic health conditions and provides physicians with a unique therapeutic approach for the comorbid patient," said Jay M. Feingold, MD, PhD, Vice President of Medical Affairs at Daiichi Sankyo, Inc. "We are encouraged by these study results, which reinforce the benefits of Welchol for treating adult patients with type 2 diabetes and/or elevated LDL cholesterol."
SOURCE Daiichi Sankyo