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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

ion in A1C levels (-0.12 vs. -0.03 percent; mean treatment difference of -0.10 percent; p=0.02) and significant reduction in median fasting plasma glucose levels (-4.0 mg/dL vs. -2.0 mg/dL; median treatment difference of -2.0 mg/dL; p=0.02).  Treatment with Welchol increased triglyceride levels relative to placebo (median treatment difference: 14.3 percent; p<0.001).

Significantly more patients attained target levels for LDL cholesterol with Welchol compared with placebo at week 16: LDL cholesterol <100 mg/dL (29 vs. 11 percent; p<0.001).  In addition, more patients receiving Welchol compared with placebo had A1C levels <6% (37 vs. 25 percent; p=0.05) and fasting plasma glucose levels <100 mg/dL (normalization of glucose) (40 vs. 23 percent; p=0.06).  In the study, Welchol was well-tolerated and patients did not gain weight.  One case of hypoglycemia was reported in each treatment group.  The frequency of treatment-emergent adverse events was similar in the Welchol and placebo groups (53 vs. 58 percent, respectively).  The drug-related adverse events were largely gastrointestinal in nature (constipation, diarrhea and indigestion).  There were no patient deaths in the study.  Two patients in both groups reported a serious adverse event – erectile dysfunction and polycystic ovaries for the two patients receiving Welchol – but none were considered related to the study drug or resulted in study withdrawal.

About Welchol

Approved in 2000 to lower LDL cholesterol and in 2008 as add-on therapy for glycemic control in adults, 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 th
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SOURCE Daiichi Sankyo
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