Lizard saliva may treat diabetes

Lois M. Collins Deseret News

University of Utah researchers have found that a drug for type 2 diabetes made from lizard saliva performs as well in real-world settings as it did in clinical trials. And that's information insurers are increasingly seeking as they decide which medications to pay for as part of health insurance coverage.

The researchers from the Utah Pharmacotherapy Outcomes Research Center, will present their findings next week at the International Society for Pharmacoeconomics and Outcomes Research in Toronto.

"Usually, clinical trials involve a relatively small number of patients in order to get approval for marketing," said Diana I. Brixner, Ph.D., executive director of the center and professor and chair of the Department of Pharmacotherapy in the College of Pharmacy. "Before payers are willing to pay the increased cost (for a new medication,) they want an indication if it works in a larger population, different than in clinical trials."

The U. researchers looked at exenatide, a drug for people with type 2 diabetes. The clinical trials showed the drug helped control glucose levels and promoted weight loss, important because the vast majority of people with that form of diabetes are overweight. But patients in clinical trials are subjected to tight controls that aren't necessarily part of "real world" therapy. And that could make a difference to outcomes.

The researchers looked at outcomes, using a national database, for a group of patients that they closely matched for age and other factors to those who participated in the original clinical trials. They wanted to see if the results were the same. And they found they were.

The exenatide, which works differently than most drugs used to treat type 2 diabetes, does not replace standard oral therapies. Indications are that those who are not able to control glucose well using those other therapies have enhanced success when the exenatide is added, she said.

Nearly 21 million Americans have type 2 diabetes, the result of either the body's inability to produce enough insulin or the cells' inability to use it. Insulin breaks down sugars and starches that cells need to live and if they don't get it, the eyes, kidneys, nerves and heart can be damaged.

The U. scientists matched the clinical trial participants against a database of 12,000 real-world diabetics who had taken exenatide for at least six months, along with other therapies, winnowing it down to a close 2,000-person mirror of the original trial participants. In those clinical trials, patients saw a "marked drop" in A1C levels (a measure of average blood sugar levels) and 70 percent lost weight.

"We found the outcomes of lowering the A1C levels and weight loss similar to those in the clinical trials," Brixner said. "That's very encouraging for decision-makers and payers to feel that if they are paying more for new (treatments) they can expect to see similar results.

"Those being expected to pay for a drug are asking for this type of information more and more," she said. "It has become the standard."

There is debate on whether the government should fund a center dedicated to comparing clinical trials and real-world results.

The exenatide study was conducted with an unrestricted grant from the drug manufacturers, Amylin Pharmaceuticals and Eli Lilly and Company.

E-mail: lois@desnews.com

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