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New Data Demonstrate Welchol(R) (colesevelam HCl) Significantly Improved Lipid and Glycemic Measures in Patients With High LDL Cholesterol and Prediabetes
Date:4/23/2010

e 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 has not been studied in children younger than 10 years of age or in pre-menarchal girls.  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.(2)

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

IMPORTANT INFORMATION ABOUT WELCHOL (colesevelam HCl)

Indications

Welchol is indicated as an adjunct to diet and exercise to:

  • reduce elevated low-density lipoprotein cholesterol (LDL-C) in patients with primary hyperlipidemia (Fredrickson Type IIa) as monotherapy or in combination with an hydroxymethyl-glutaryl-coenyme (HMG CoA) reductase inhibitor
  • reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia, as monotherapy or in combination with a statin after failing an adequate trial of diet therapy
  • improve glycemic control in adults with type 2 diabetes mellitus

Important Limitati
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SOURCE Daiichi Sankyo
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