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A New Class of Drugs for Improving Blood Sugars – Bile Acid Resins

When our publisher, Steve Freed, BSPharm, and I first got together it was because I had found a soluble fiber product that lowered cholesterol levels and seemed to help control glucose levels. Steve explained that this fiber worked as a “bile acid sequestrant. Now he has found a whole class of drugs that work the same way, without the muss and fuss of mixing powder.

A New Class of Drugs for Improving Blood Sugars – Bile Acid Resins

Special Report by Steve Freed, BSPharm, Publisher
Welchol (colesevelam), a “bile acid resin” originally approved by the FDA in May 2000, was used in combination with diet and exercise—only to treat people with high cholesterol. Produced in an oral tablet formulation, Welchol was a welcome change from most drugs in this class which were powders that had to be mixed with juice or water and drank as quickly as possible. Recently, studies have shown that Welchol can also help improve glucose control in people with type 2 diabetes. As a result of the diabetes benefits found in these studies, Welchol was approved by the FDA in January 2008 for use with diet and exercise to improve glucose control in people with type 2 diabetes. Also, in a recent study in Arch Intern Med. 2008;168(14):1531-1540, it was also shown to improve glucose and cholesterol control in patients with type 2 diabetes using oral medications and insulin.

Welchol, What Is It?
Welchol is a prescription-only oral medication that falls into the class of lipid lowering agents called bile acid resins. Welchol is composed of a polymer (a long chain of repeating sticky units) that is not absorbed by our intestines. It is typically taken orally as either six tablets (625 mg each) once daily, or three tablets twice daily with plenty of liquid (at least 8 oz) and a meal.

How Does It Work?
Normally cholesterol comes from two sources, what our body makes and what we eat in our diet. The liver makes bile acids which help us digest and absorb fats, includingfat-soluble products like certain vitamins (Vitamins A, D, E K). The liver borrows cholesterol from our body to produce these bile acids which are normally recycled in our guts creating a ‘bile acid pool.’ Welchol, a bile acid resin, sticks to bile acids in our intestines and prevents them from being recycled into this ‘pool.’ Then, the liver has to borrow more cholesterol from our bodies to make more bile acids, causing a decrease in cholesterol levels. This is how Welchol decreases cholesterol.

With regard to its use in diabetes, studies have shown that Welchol improves blood glucose concentra­tions and decreases the A1c

The question is, how does Welchol do this? The real answer is that we simply do not know. There seems to be a relationship between insulin production and insulin resistance with the way our body produces bile acids. Welchol may increase insulin production by the pancreas and decrease the amount of carbohydrates absorbed by the gut along with decreasing glucose produced by the liver. This, in turn, helps improve diabetes control.

Who Benefits from Welchol?
Welchol works best for people who have both high cholesterol  and elevated glucose concentrations.

The GLOW (Glucose-Lowering effect of Welchol) Study demon­strated that patients with A1c levels over 8% had the greatest success when Welchol was added to their metformin or sulfonylurea medica­tions (like glyburide, glipizide & glimepiride). The A1c decreased by 1%. People with diabetes also experienced significant drops in post-prandial (after meal) glucose concentrations and lower LDL (the bad cholesterol) levels as well. This implies that Welchol is best suited for people with type 2 diabetes uncontrolled by other medications as well as high cholesterol.

Welchol has been studied in combination with most diabetes medications except Januvia (sitagliptin) and Actos (pioglita­zone), and Avandia (rosiglitazone) to a limited extent. Therefore, it is recommended that if you are taking one of these medications you discuss the benefits versus risks with your health care provider. At this time, Welchol has been approved as an “add on” therapy, not as the only drug used to treat diabetes.

What Can You Expect from Welchol?
Because Welchol sticks to fatty substances, it can inhibit the absorp­tion of fat-soluble vitamins (A, D, E (.& K). Welchol users may benefit from taking a daily multivitamin. Welchol can also inhibit or decrease the absorption of other medications (such as glyburide) and thus should be separated from other medications by at least 4 hours. In addition, Welchol and other bile acid resins have been shown to increase triglyc­eride levels and should be avoided in people with high triglycerides (>300 mg/dL).

Although most people easily tolerated Welchol, some potential adverse events include constipation, nasal congestion, heartburn, hypo­glycemia, nausea and high blood pressure.

The studies have shown a drop in A1c of 0.5% to 1%.

The Bottom Line
The bottom line is simple; there is a new agent that gives people with type 2 diabetes another option for glucose control. Even better is the dual action that may be beneficial for people who need tighter glucose control and cholesterol lowering all in one tablet. For more information on Welchol and an instructional video on the how this medication works visit www.Welchol.com.