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New Data Demonstrated Efficacy and Safety of Initial Combination Therapy with Welchol(R) (colesevelam HCl) and Metformin in Drug-Naive Adult Type 2 Diabetes Patients
Date:6/26/2010

can 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.(3,4,5)  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."

About the Study (Posters #684 and #633)(1,6)

The randomized, double-blind, placebo-controlled, parallel-group study was conducted at approximately 38 sites within the U.S., Mexico, Colombia, and India, and included a three-week screening period to confirm disease diagnosis followed by 16 weeks of randomized treatment.  The study evaluated patients aged 18 to 79 years diagnosed with type 2 diabetes (A1C 6.5 to 10.0 percent, inclusive) and who were drug-naive – defined as never having received treatment for their diabetes, or not having received diabetes medication for three months prior to screening – with LDL cholesterol levels greater than or equal to 100 mg/dL and triglyceride levels less than 500 mg/dL.  In total, 286 patients with type 2 diabetes and high cholesterol were randomized to receive either Welchol (colesevelam HCl) 3.75 g/d (n=145) or pla
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SOURCE Daiichi Sankyo
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