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Title: Adding Colesevelam to Treatment Improves Glucose Profile in Diabetics: Presented at AACE

"Adding Colesevelam to Treatment Improves Glucose Profile in Diabetics: Presented at AACE"

By Ric Susman ORLANDO, Fla -- May 20, 2008 -- Adding the cholesterol-lowering agent colesevelam hydrochloride to a diabetes regimen that already includes sulfonylurea-based treatments appears to aid patients in maintaining glycaemic control, researchers noted here at the 17th Annual Meeting and Clinical Congress of the American Association of Clinical Endocrinologists (AACE). "In patients with type 2 diabetes ... who were not adequately controlled with sulfonylurea, alone or in combination with other anti-diabetes agents, treatment with colesevelam significantly reduced haemoglobin A1C (Hb A1C), and significantly reduced fasting plasma glucose," said Vivian A. Fonseca, MD, Professor of Medicine, Tullis-Tulane Alumni Chair in Diabetes, and Chief, Section of Endocrinology, Tulane University Medical Center, New Orleans, Louisiana. In this pooled analysis of 3 randomised, double-blind studies, Dr. Fonseca's team examined results from 653 diabetic men and women taking sulfonylurea monotherapy or sulfonylurea in combination therapy. Two studies lasted for 26 weeks, and 1 study lasted for 16 weeks. "This [addition of colesevelam] ultimately resulted in a significantly greater percentage of patients achieving a reduction in A1C from baseline [that was] greater than or equal to .7%," Dr. Fonseca noted in a poster presentation here May 17. The researchers analysed the patients in 2 separate groups: those patients who were randomised to colesevelam (n = 326) and those in the control group receiving placebo (n = 327). Dr. Fonseca said there was a mean reduction of .35% in Hb A1C among the patients in the colesevelam arm. Among placebo subjects, treatment resulted in an increase of Hb A1C of .018% -- resulting in a significant mean treatment difference of -.53% at study end ([P < .001).

Dr. Fonseca said that patients taking colesevelam reduced fasting plasma glucose by a mean of 1.4 mg/dL, whereas fasting plasma glucose increased by 12.2 mg/dL in the placebo group (P = .001).

"The object of this [analysis] was to evaluate the glucose-lowering efficacy of colesevelam hydrochloride in all patients with type 2 diabetes inadequately controlled on existing sulfonylurea [diabetes] therapy who participated in any of the 3 primary studies with colesevelam hydrochloride," Dr. Fonseca explained.

There were 183 men and 143 women in the colesevelam group, and 172 men and 155 women in the placebo arm. Most of the patients were Caucasian; about 25% were Hispanic. The average age of patients in this study was approximately 57 years of age.

This study was funded by Novartis Pharmaceuticals Corporation.

[Presentation title: The Glucose-Lowering Effects of COL HCL in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin-Based Therapy: A Pooled Analysis. Abstract 230]

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