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Title: Cholesterol-Lowering Drug Combined With Metformin Improves Glucose Control: Presented at AACE

"Cholesterol-Lowering Drug Combined With Metformin Improves Glucose Control: Presented at AACE"

By Maribeth Stephens SEATTLE, WA -- April 16, 2007 -- When colesevelam hydrochloride -- a bile acid sequestrant designed to reduce cholesterol levels -- was added to the metformin-based regimen in patients with uncontrolled type 2 diabetes, their haemoglobin A1c (HbA1c) levels were reduced compared with patients who did not receive colesevelam, researchers said here at the American Association of Clinical Endocrinologists 16[^th Annual Meeting and Clinical Congress (AACE).

Lead investigator Harold Bays, MD, medical director and president, Louisville Metabolic and Atherosclerosis Research Center, Louisville, Kentucky, United States, presented the study in a poster session on April 14^th.

In an earlier, smaller study of 65 patients with type 2 diabetes, HbA1c levels were reduced by 0.5% when colesevelam was added to an existing oral antidiabetic therapy.

"Having a pilot study that showed favourable effects, it was felt reasonable to do a much larger-scale trial and definitively look at this [potential effect]," Dr. Bays explained.

In the double-blind, parallel-group multicentre investigation, Dr. Bays and colleagues randomised 159 patients to colesevelam and 157 to placebo. Mean age in the colesevelam group was 55.7 years and 56.9 years in the placebo group. HbA1c was 8.2% in the colesevelam group and 8.1% in the placebo group.

Subjects had type 2 diabetes not adequately controlled on metformin alone or metformin in combination with additional oral antidiabetic agents. Subjects were receiving a stable dose of metformin, or metformin plus other oral anti-diabetic agent(s), for at least 90 days. Patients entered a 2 week single-blind, placebo run-in, after which they were randomised to 26 weeks of colesevelam 3.8 g daily or placebo added to their baseline metformin-based regimen.

"When you look at the bottom line results, what you find is a significant reduction in the [HbAlc level] at week 26. In the colesevelam group, that reduction is 0.54%," said Dr. Bays. "In addition, this drug also did what you expected it to do with regard to improving lipid levels." Placebo corrected, the colesevelam group achieved a reduction in low-density lipoprotein cholesterol of about 16%, he said.

Regarding safety, the most frequently reported drug-related adverse events were constipation (6.9%) and dyspepsia (3.1%) in the colesevelam group. In the placebo group, the reported adverse events were dyspepsia (3.2%) and diarrhoea (2.5%).

"It's really, really interesting to have this drug that does two things that I think endocrinologists want to accomplish, and that is to improve both glucose and lipid control in their patients, and do it safely," Dr. Bays concluded.

[Presentation title: Addition of Colesevelam HCL to Patients with Type 2 Diabetes Mellitus Inadequately Controlled on a Metformin-Based Therapy Improves Glycemic Control. Abstract 204]

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