Welchol(TM) Lowered A1C by a Mean 1 Percent or Greater When Added to Metformin-, Insulin-, or Sulfonylurea-Based Therapy in 47 Percent of Patients... (alth Sciences Center and a principal stu...)

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Welchol(TM) Lowered A1C by a Mean 1 Percent or Greater When Added to Metformin-, Insulin-, or Sulfonylurea-Based Therapy in 47 Percent of Patients Evaluated

Date:5/30/2008

alth Sciences Center, and a principal study investigator. "A patient's A1C level is one of our primary markers in determining their risk of developing cardiovascular disease. These analyses show that adding Welchol to the most common type 2 diabetes regimens can help achieve additional A1C lowering across many different patient types."

Several mechanisms have been proposed for the glucose-lowering effect of Welchol, including reductions in glucose absorption and effects on glucose metabolism via nuclear receptors in the intestine and/or the liver. The exact mechanism(s) is under investigation.

About the Analyses

For both analyses, data was extracted from three double-blind, placebo-controlled, pivotal Welchol trials involving 1,018 patients. Welchol was added to either metformin-, insulin- or sulfonylurea-based therapy in patients with inadequately controlled type 2 diabetes (A1C 7.5% to 9.5%). The mean baseline A1C of patients in these studies was 8.1% to 8.3%. The primary endpoint in the pivotal Welchol trials was mean change from baseline in A1C. Mean change in LDL-cholesterol was a secondary endpoint.

In the first post-hoc analysis, efficacy parameters included change from baseline in A1C. All patients receiving Welchol were pooled (N=512) and stratified based on individual A1C reductions (greater than or equal to 0.5%, greater than or equal to 0.7%, and greater than or equal to 1.0%) from baseline to study end. The results from the post-hoc analyses found that almost half (47%) of the patients achieving a reduction of greater than or equal to 0.5% had a mean A1C reduction of 1.04% (P<0.001); 36% of patients achieving a reduction of greater than or equal to 0.7% had a mean A1C reduction of 1.20% (P<0.001); and 24.1% achieving a reduction of greater than or equal to 1.0% had a mean A1C reduction of 1.40% (P<0.001).

In the second post-hoc analysis, data from the pivotal studies were pooled and patients were stratified by age (gre
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Welchol(TM) Lowered A1C by a Mean 1 Percent or Greater When Added to Metformin-, Insulin-, or Sulfonylurea-Based Therapy in 47 Percent of Patients...(alth Sciences Center and a principal stu...),Health