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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

5.7 to 6.4 percent are considered to have prediabetes and are at high risk for developing type 2 diabetes.(6)  In patients diagnosed with type 2 diabetes, more than 50 percent also have elevated LDL cholesterol.(7)

About the Study

Poster  #403 – Colesevelam HCI to Treat Hypercholesterolemia and Improve Glycemia in Prediabetes: A Randomized, Prospective Study(1,8)

This 16-week, randomized, placebo-controlled, double-blind, multinational study evaluated patients aged 18 to 79 years with high LDL cholesterol and prediabetes, who met the following criteria: LDL cholesterol levels >/=100 mg/dL; triglycerides <500 mg/dL; 2-hour post-oral glucose tolerance test (OGTT) glucose >/=140 mg/dL to <200 mg/dL; and/or fasting plasma glucose >/=110 to </=125 mg/dL.  A total of 216 patients were randomized to receive Welchol (colesevelam HCI) (3.75 g per day) or matching placebo.  The primary endpoint of the study was the percent change in LDL cholesterol from the start of the study to week 16 with last observation carried forward.  Secondary endpoints included changes in other lipid parameters, fasting plasma glucose, A1C, 2-hour post-OGTT glucose from the start of the study to week 16, as well as attainment of LDL cholesterol goal targets.

The study found that after 16 weeks of treatment, Welchol compared with placebo resulted in a statistically significant mean reduction of LDL cholesterol levels (-13.9 vs. +1.7 percent; mean treatment difference of -15.6 percent), mean non-HDL cholesterol levels (-8.4 vs. +0.7 percent; mean treatment difference of -9.1 percent), and mean apoliproprotein B levels (-7.5 vs. +0.6 percent; mean treatment difference of -8.1 percent), respectively, p<0.001.  Welchol also improved glycemic levels compared with placebo, with a significant mean reduct
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SOURCE Daiichi Sankyo
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