Addition of Colesevelam Lowers A1c 1 Percent

Welchol (colesevelam Hcl) lowered A1C by a mean 1 percent or greater when added to metformin, insulin, or sulfonylurea-based therapy in 47 percent of patients.

Daiichi Sankyo, Inc., announced last week that data from post-hoc analyses of three pivotal studies demonstrated that the addition of Welchol(TM), (colesevelam HCl) to common diabetes treatment regimens can lower A1C in patients with type 2 diabetes by 1% or greater.  The analyses included all patients receiving Welchol in these studies (n=512). Almost half (47%) of the patients in the analyses had a mean reduction in A1C of 1.04% and nearly a quarter (24%) had a mean reduction as great as 1.40%. 

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

The National Cholesterol Education Program (NCEP) recommends that patients with type 2 diabetes keep their cholesterol levels in check and target an LDL-C goal of <100 mg/dL.  Despite this recommendation, nearly 40 percent of patients with type 2 diabetes have LDL-cholesterol levels greater than 130 mg/dL. Welchol is the first and only therapy approved to treat both type 2 diabetes and high LDL-cholesterol. 
   
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.

"These findings are significant given the critical importance of achieving and maintaining A1C control," said Vivian A. Fonseca, Professor of Medicine and Pharmacology and Chief, Section of Endocrinology, Tulane University Health 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."

Post-hoc analysis of pivotal studies presented at the National Lipid Association’s Annual Scientific Sessions in N.J. May 30, 2008

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