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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

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 hydroxymethylglutaryl-coenzyme (HMG CoA) reductase inhibitor (statin)
  • improve glycemic control in adults with type 2 diabetes mellitus

Important Limitations of Use

  • Welchol should not be used for glycemic control in 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

Contraindications

Welchol is contraindicated in individuals with a history of bowel obstruction, those with serum triglyceride (TG) concentrations of >500 mg/dL, or with a history of hypertriglyceridemia-induced pancreatitis.

Warnings and Precautions

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

Welchol can increase serum TG concentrations particularly when used in combination with sulfonylureas or insulin. Caution should be exercised when treating patients with TG levels >300 mg/dL.

Welchol may decrease the absorption of fat-soluble vitamins A, D, E, and K. Patients on vitamin supplements should take their vitamins at least 4 ho
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SOURCE Daiichi Sankyo
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