A year ago the U.S. Food and Drug Administration approved a new drug to treat type 2 diabetes. But few of us ever heard of it.
Until now. Studies presented at the annual convention of the American Association of Clinical Endocrinologists in Houston on Friday finally caught our attention.
The senior author of one of those studies spoke at length with me at the convention. Yehuda Handelsman, an endocrinologist in private practice in Tarzana, California, led a 16-week multi-center international study comparing how well Welchol (colesevelam HCl), Avandia, and Januvia did. In the study they randomized 169 people to evaluate the effects of these three oral diabetes medications on glycemic control and lipid profiles when added to metformin.
Each of them "significantly improved glycemic control and were generally safe and well-tolerated" in the study. But only Welchol also significantly reduced LDL (bad) cholesterol. In fact, the LDL levels of people taking both Avandia and Januvia significantly increased.
This is important news for those of us with diabetes, because the LDL levels of most of us is too high. Diabetes and high levels of LDL are two key components of the metabolic syndrome.
Welchol (pronounced like well-call with a silent "h") is in fact the only drug that the FDA has approved both for controlling blood glucose and LDL cholesterol, as Dr. Handlesman emphasized to me when I interviewed him. While only recently did the FDA approve Welchol for controlling type 2 diabetes, it was way back in the year 2000 that the agency approved Welchol to reduce LDL cholesterol.
The FDA hasn't approved Welchol to be taken alone for glucose control. And it does work better in combination with other drugs, Dr. Handelsman told me.
Dr. Yehuda Handelsman Led the new Diabetes Study of Welchol
"But if somebody has high LDL, I can give it for that," he says. "Then, they could get the benefit of the glucose effect, and it would not be off-label."
Using just one drug to control both LDL and blood glucose is big news. But the news is even bigger than that. Welchol is one of the very few drugs that we have to control our blood glucose that can actually help us to lose weight.
Only Byetta leads to significant weight loss. Even metformin and Januvia, usually considered to be weight neutral, may lead to a bit of weight gain, Dr. Handelsman says. "But Welchol is a bit in the other direction" toward weight loss. Insulin, the sulfonylureas, and the TZDs Avandia and Actos all lead to substantial weight gain.
Welchol is one of the safest drugs we have because it "has no systemic side effects that we know of" since we don't absorb it. "That's what gives it its safety margin."
For example, it is the only such Category B drugs that pregnant women can take. Category A would include drugs that are proven safe for pregnant women -- but we don't have any, Dr. Handelsman says. "Category B drugs are those that have not shown any problems in animals or humans -- they are not proven to be that but they have not shown any problems." The statins, he adds, "are Category D, which would cause huge damage to the fetus."
Welchol is not a statin and does not have a huge effect like a statin does. The statins, of course have serious side effects. My article here on "Statin Rage," the 35 or so comments, and the comprehensive "Review of Statin Effects" in the American Journal of Cardiovascular Drugs last year amply document that fact.
Welchol reduces LDL cholesterol about 16 percent, Dr. Handlesman told me. Welchol is in the family of drugs known as bile acid sequestrants. It sequesters -- attaches -- bile acids, which are made from a lot of cholesterol, Dr. Handelsman explained, and takes them out of our bodies. "Otherwise, when the bile acids finish their job on food they are 95 percent reabsorbed by the body to recirculate -- using the same cholesterol."
Other bile acid sequentrants like Questran weren't popular with patients, because you needed to take something like 20 grams a day. "They are a very untasty terrible power, almost like a detergent," he says. But the company that developed Welchol made it far more efficient and by far more convenient to use, so we need only about 3.5 grams per day.
That company is Tokyo-based Daiichi Sankyo, established in 2005 from the merger of two leading Japanese pharmaceutical companies. The U.S. subsidiary, Daiichi Sankyo Inc., headquartered in Parsippany, New Jersey, markets Welchol here.
So why has Welchol been so little known in the diabetes community until now?
Daiichi Sankyo is "too quiet," Dr. Handelsman concluded. "Maybe they didn't have a good PR firm," he added with a grin. As we talked, a representative of the company's new PR firm, WeissComm Partners in New York, was listening quietly.
WeissComm Partners set up the interview, and I know that from now on we will be hearing a lot about Welchol and its ability to control both blood glucose and LDL cholesterol.