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news.Daiichi Sankyo has presented the results of a new study, which showed that Welchol (colesevelam HCl) 3.75g/d improved lipid and glycemic measures in patients with high LDL cholesterol and prediabetes (impaired fasting glucose and/or impaired glucose tolerance).
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The randomised, placebo-controlled, double-blind study was presented at the American Association of Clinical Endocrinologists (AACE) 19th Annual Meeting and Clinical Congress in Boston.
Daiichi Sankyo said that these data are consistent with previous studies that have shown Welchol to be safe and effective in lowering A1C, fasting plasma glucose and low-density lipoprotein cholesterol (LDL-C) in adult patients with type 2 diabetes.
The study found that after 16 weeks of treatment, Welchol compared with placebo resulted in a mean reduction of LDL cholesterol levels (-13.9 vs. +1.7%; mean treatment difference of -15.6%), mean non-HDL cholesterol levels (-8.4 vs. +0.7%; mean treatment difference of -9.1%), and mean apoliproprotein B levels (-7.5 vs. +0.6%; mean treatment difference of -8.1%), respectively.
Additionally, Welchol also improved glycemic levels compared with placebo, with a mean reduction in A1C levels and reduction in median fasting plasma glucose levels. Treatment with Welchol increased triglyceride levels relative to placebo.
More patients attained target levels for LDL cholesterol with Welchol compared with placebo at week 16: LDL cholesterol. In addition, more patients receiving Welchol compared with placebo had A1C levels <6% and fasting plasma glucose levels <100mg/dl.
Yehuda Handelsman, medical director of the Metabolic Institute of America in Tarzana, California and investigator of the study, said: “These new findings are important because they provide information on the effects of Welchol to significantly reduce LDL cholesterol, fasting plasma glucose, and A1C levels in patients at high risk for developing type 2 diabetes.
“The evaluation of Welchol in this high risk population underscores recent guidelines established by AACE, which recommended physicians target and treat underlying disorders such as high cholesterol and elevated glucose levels in people with prediabetes.”