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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

cebo (n=141) along with open-label metformin (initiated at 850 mg/d; uptitrated to 1700 mg/d thereafter).  Mean baseline A1C levels were 7.8 percent in the Welchol plus metformin group and 7.5 percent in the metformin plus placebo group.

The study found that initial combination therapy with Welchol and metformin reduced mean A1C levels by 1.1 percent compared with patients receiving metformin plus placebo (-0.8 percent), resulting in a mean treatment difference of -0.3 percent (p<0.01). The study also showed that 67 percent of patients (n=66) achieved the A1C target of less than 7 percent with Welchol plus metformin, compared with 56 percent of patients (n=53) receiving metformin plus placebo, a statistically significant difference (p<0.01).  Additionally, 48 percent of patients (n=61) in the Welchol group attained LDL cholesterol less than 100 mg/dL compared with 18 percent of patients (n=24) in the metformin plus placebo group (p<0.0001).

Welchol in combination with metformin also resulted in significantly greater mean reductions in LDL cholesterol levels (16 percent), mean total cholesterol levels (6 percent), mean non-HDL cholesterol (8 percent), mean apolipoprotein B (8 percent), and median high sensitivity C-reactive protein (hs-CRP) (17 percent) compared with patients treated with metformin plus placebo, (p<0.01 for all). In the study, Welchol plus metformin increased triglycerides by 19 percent (p<0.001) compared with metformin plus placebo.  

Results from a safety analysis of this study showed that initial combination therapy with Welchol and metformin was well-tolerated and had a safety profile similar to that of metformin monotherapy. Compliance with the individual treatment components was greater than 90 percent for both groups.  In patients receiving Welchol plus metformin, the most common gastrointestinal adverse events wer
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