Analysis: Newest diabetes drugs pass test

WEST PALM BEACH, Fla., July 10 (UPI) -- An analysis of studies suggests two of the newest diabetes medications appear safe and effective in helping patients control sugar levels, researchers said Tuesday.

The two drugs, exenatide -- an injectable agent sold as Byetta -- and sitagliptin -- the oral drug Januvia -- utilize the incretin molecular pathway, slowing the speed at which the stomach empties, making people feel fuller and helping them from overeating. In turn, this action of the agents helps lower blood sugar.

"Incretin therapy offers an alternative to currently available (diabetes) agents for adults with type 2 diabetes, with modest efficacy and a favorable weight-change profile," said Renee Amori, who recently completed a fellowship in endocrinology at Tufts-New England Medical Center in Boston.

In the analysis to be published in Wednesday's editions of the Journal of the American Medical Association, Amori cited 51 studies on the new agents, approved in 2005 (Byetta) and 2006 (Januvia) by the Food and Drug Administration.

Because most of the studies only looked at treatments that ran 12 to 24 weeks, the researchers noted: "Careful postmarketing surveillance for adverse effects and continued evaluation in longer term studies and in clinical practice are required to determine the role of this new class among current pharmacotherapies for type 2 diabetes."

The agents were approved either for use by themselves or with other standard oral treatments for diabetes. The need for additional oral agents is acute: "Fewer than half of U.S. adults with type 2 diabetes reach a hemoglobin A1c level of less than 7 percent -- a standard-of-care goal -- despite several available therapies," Amori said. "Ineffective implementation of existing pharmacotherapies is a significant factor contributing to suboptimal care."

Most individuals in the United States being treated with oral diabetic medications are prescribed more than one class of agents to control the disease. About 20 million people in the United States have diabetes.

Uncontrolled diabetes is a risk factor for heart attacks, strokes, kidney disease, loss of vision and other symptoms that result in major deficits in quality of life and mortality. The American Heart Association considers that having a diagnosis of diabetes is equivalent to having suffered a heart attack.

"Incretin-based therapy is increasing daily as an efficient drug for type 2 diabetes," Stanley Mirsky, an endocrinologist at Lenox Hill Hospital in New York and author of the new book "Diabetes Survival Guide," told United Press International.

"It is a class of drug that enables special cells in the intestine to send messages to the pancreas, liver and satiety centers in the brain, plus it slows the flow of food from the stomach to the intestine avoiding the rush of sugar into the blood stream," he said.

"Since it does not cause weight gain and 85 percent of the type 2 diabetics are obese, by itself or in combination with other diabetic drugs, it is very promising," he added.

Mirsky said that he has patients that have lost 9.5 pounds to 26 pounds on the oral form rather than injectable incretin stimulants in combination with metformin, an older drug commonly administered to patients with diabetes.

In the JAMA paper, Amori noted that there was a slight increase in infections -- especially urinary track infections and nasal infections -- with the new agents. Although the increase was small, the vast numbers of individuals on diabetes therapies could make even a small increase in the infection rate a serious hit on healthcare resources.

Recent studies on other diabetes drugs have suggested more serious side effects, so the apparent lack of major adverse events with the incretin-enhancing drugs is good news for the diabetic population and their caregivers, Mirsky said.

The research was supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases, part of the National Institutes of Health, and by a grant to the Dr. Gerald J. and Dorothy R. Friedman New York Foundation for Medical Research.