People with prediabetes who took the drug had a 72% reduction in diabetes risk, compared to patients who did not take it, researchers report.
They estimate that one case of diabetes could be prevented if 18 high-risk people were treated with the drug for a year.
The study appears in the March 24 issue of The New England Journal of Medicine.
The findings suggest that millions of people at high risk for diabetes may benefit from taking Actos, but experts urge caution.
Actos (pioglitazone) is in the same drug class as the controversial diabetes drug Avandia. The FDA severely restricted Avandia’s use last fall due to concerns that its use may be associated with an increase in heart attack risk.
Similar concerns have not been raised about Actos, and there are even suggestions that the drug protects the heart. But its use has been linked to fractures related to bone loss, weight gain, fluid retention, and other side effects.
American Diabetes Association vice president for medical affairs Sue Kirkman, MD, says patients at risk for type 2 diabetes should first be encouraged to make lifestyle changes before considering any drug treatment.
“Anytime we talk about long-term drug treatment for prevention, we have to have a very high reassurance that these treatments are both safe and effective,” she says.
Close to 79 million people in the U.S. have prediabetes, meaning that their blood sugar is higher than normal but not yet high enough to be considered diabetes.
The hormone insulin, secreted by the beta cells in the pancreas, helps the body store and use sugar from food. Insulin resistance causes blood sugar levels to rise.
Actos helps control blood sugar levels by making patients more sensitive to their own insulin.
The study included just over 600 people with prediabetes who were also overweight or obese and had at least one other risk factor for type 2 diabetes.
Half the study participants were randomly assigned to be treated with Actos; the other half got a placebo. The patients were followed for an average of 2.4 years.
Over the course of the study, the yearly progression to diabetes was 2% in the Actos-treated patients and 7.6% in the placebo group.
About half the patients who took the insulin-sensitizing drug (48%) saw their blood sugar levels return to normal during treatment, compared to just over one-fourth (28%) of the placebo-treated patients.
Actos-treated patients also had reductions in diastolic blood pressure and increases in HDL “good” cholesterol. Treatment with the diabetes drug was also associated with a 31% decrease in the rate of carotid artery thickening.
But the active treatment was also associated with significantly greater weight gain (8 and 1/2 pounds compared to 1 and 1/2 pounds). And fluid retention was twice as common in the Actos patients (13% vs. 6.4%).
Funding for the study was provided by Actos manufacturer Takeda Pharmaceuticals.
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