Approval expected to market Welchol for cholesterol and diabetes
The class of medications known as “resins� have been used to lower cholesterol for over 50 years. The early agents Questran (cholestyramine) and Colestid (colestipol) are powders that are dissolved in a liquid and then drunk. They typically lower bad cholesterol (LDL) levels about 20% but are associated with significant gastro-intestinal side effects and are rarely used today.
In the late 1990’s a new resin was introduced: Welchol (colesevelam). Welchol is available in pill form, lowers bad cholesterol about 20% and does not have the constipation and bloating side effects of the older resins.
When Welchol was used in diabetics physicians started to notice that not only did the cholesterol level drop but the patient’s blood sugar seemed to improve as well. A few years ago the scientists at Daiichi Sankyo, the company that makes Welchol, started to formally study the effects of their medicine on blood sugar control in diabetics.
Blood sugar control can be assessed by measuring a chemical in the blood called glycol-hemoglobin, also known as HgbA1C, which is expressed as percentage amount. HgbA1C’s less than 6.0% are normal, non-diabetic. The higher the HgbA1C, the worse the blood sugar control is. Very poorly controlled diabetics have HgbA1C’s in the 12 to 13% range. A medicine that lowers HgbA1C is considered good for diabetics. Most diabetic medications taken regularly over several months, like Actos, Metformin or Byetta, will lower HgbA1C by 0.3 to 0.8%. The studies with Welchol showed that it lowered HgbA1C by 0.5 to 0.6%.
Daiichi Sankyo has asked the FDA for approval to market Welchol as both a cholesterol lowering agent and an anti-diabetic agent. Approval is expected sometime in the first or second quarter of 2008, at which time Welchol will be the first and only drug indicated to treat both dyslipidemia and diabetes.
