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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

e diarrhea (12 percent) and nausea (12 percent); the most common non-gastrointestinal adverse events were headache (8 percent), influenza (8 percent), and dizziness (6 percent).  Mild hypoglycemia was reported in two patients treated with Welchol (colesevelam HCl) and metformin compared with three patients receiving metformin and placebo.  By the end of the study, weight decreased by 2.1 kg in each group.  

About Welchol

Approved in 2000 to lower LDL cholesterol and in 2008 as add-on therapy for glycemic control in adults with type 2 diabetes, Welchol is approved by the U.S. Food and Drug Administration (FDA) as an adjunct to diet and exercise to reduce elevated LDL-C and improve glycemic control in adults with primary hyperlipidemia and type 2 diabetes, two chronic health conditions.  Welchol should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis.  Welchol has not been studied in type 2 diabetes as monotherapy or in combination with a dipeptidyl peptidase 4 inhibitor and has not been extensively studied in combination with thiazolidinediones.  Welchol has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias.  Welchol is available in two formulations, Welchol tablets and Welchol® for Oral Suspension.

In clinical studies of adult patients with type 2 diabetes, Welchol lowered A1C, fasting plasma glucose and LDL-C, important risk factors for cardiovascular disease.*  In clinical studies of patients with elevated LDL-C, Welchol lowered LDL-C when used as monotherapy, when added to statin therapy, or as initial combination with statin therapy.(7)

*The effect of Welchol on cardiovascular morbidity and mortality has not been determined.

IMPORTANT INFORMATION ABOUT WELCHOL (colesevelam HCl)


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SOURCE Daiichi Sankyo
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