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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

Saturday, May 31, 2008 General News J E 4
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PARSIPPANY, N.J., May 30 Daiichi Sankyo, Inc., announcedtoday that data from post-hoc analyses of three pivotal studies demonstratedthat the addition of Welchol(TM), (colesevelam HCl) to common diabetestreatment regimens can lower A1C in patients with type 2 diabetes mellitus by1% or greater. The analyses included all patients receiving Welchol in thesestudies (n=512). Almost half (47%) of the patients in the analyses had a meanreduction in A1C of 1.04% and nearly a quarter (24%) had a mean reduction asgreat as 1.40%. Type 2 diabetes can put people at risk for serious healthcomplications such as blindness, amputation and kidney failure.(1)

A second post-hoc analysis demonstrated that Welchol lowered A1C andLDL-cholesterol (LDL-C) levels consistently across type 2 diabetes patients,regardless of age, gender or race. These findings were included among fiveposter presentations by Daiichi Sankyo at the National Lipid Association (NLA)Annual Scientific Sessions.

The American Diabetes Association (ADA) recommends that people with type 2diabetes control both blood glucose and cholesterol levels to reduce the riskof developing cardiovascular disease.(2) The National Cholesterol EducationProgram (NCEP) recommends that patients with type 2 diabetes keep theircholesterol levels in check and target an LDL-C goal of <100 mg/dL.(3)Despite this recommendation, nearly 40 percent of patients with type 2diabetes have LDL-cholesterol levels greater than 130 mg/dL.(4) Welchol is thefirst and only therapy approved to treat both type 2 diabetes and highLDL-cholesterol.

"These findings are significant given the critical importance of achievingand maintaining A1C control," said Vivian A. Fonseca, Professor of Medicineand Pharmacology and Chief, Section of Endocrinology, Tulane University HealthSciences Center, and a principal study investigator. "A patient's A1C level isone of our primary markers in determining their risk of developingcardiovascular disease. These analyses show that adding Welchol to the mostcommon type 2 diabetes regimens can help achieve additional A1C loweringacross many different patient types."

Several mechanisms have been proposed for the glucose-lowering effect ofWelchol, including reductions in glucose absorption and effects on glucosemetabolism via nuclear receptors in the intestine and/or the liver. The exactmechanism(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. Welcholwas added to either metformin-, insulin- or sulfonylurea-based therapy inpatients with inadequately controlled type 2 diabetes (A1C 7.5% to 9.5%). Themean baseline A1C of patients in these studies was 8.1% to 8.3%. The primaryendpoint 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 frombaseline in A1C. All patients receiving Welchol were pooled (N=512) andstratified 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%) frombaseline to study end. The results from the post-hoc analyses found thatalmost half (47%) of the patients achieving a reduction of greater than orequal to 0.5% had a mean A1C reduction of 1.04% (P<0.001); 36% of patientsachieving a reduction of greater than or equal to 0.7% had a mean A1Creduction of 1.20% (P<0.001); and 24.1% achieving a reduction of greater thanor 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 pooledand patients were stratified by age (greater than or equal to 65 and less than65 years), gender, and race (Caucasian, Black, and Hispanic). Efficacyparameters incl
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