SOURCES: Walter Kernan, M.D., professor, medicine, Yale School of Medicine, New Haven, Conn.; Joel Zonszein, M.D., director, Clinical Diabetes Center, Montefiore Medical Center, New York City; Richard Libman, M.D., vice chairman, neurology, Long Island Jewish Medical Center, New Hyde Park, N.Y.; Gerald Bernstein, M.D., endocrinologist, Friedman Diabetes Institute, Lenox Hill Hospital, New York City; Feb. 17, 2016, New England Journal of Medicine, online; and Feb. 17, 2016, presentation, American Stroke Association annual meeting, Los Angeles
WEDNESDAY, Feb. 17, 2016 (HealthDay News) -- The diabetes drug Actos (pioglitazone) appears to protect people who've already had a stroke from suffering a second stroke, a new study finds.
Along with standard treatment after a stroke -- including blood thinners, and blood pressure and cholesterol medication -- the addition of Actos reduced the odds of another stroke by 24 percent compared to a placebo, the researchers said.
"Actos represents a new option for patients who have had a stroke to help prevent a future stroke," said lead researcher Dr. Walter Kernan, a professor of medicine at Yale School of Medicine in New Haven, Conn.
For the study, Kernan and colleagues randomly assigned nearly 4,000 patients who had suffered a stroke or a mini-stroke to Actos or a placebo. None of the patients had diabetes but they did have evidence of insulin resistance, putting them at risk for the blood-sugar disease.
Over nearly five years of follow-up, 9 percent of those taking Actos had another stroke or heart attack, compared with nearly 12 percent of those receiving placebo, the researchers found.
Nearly 4 percent of those taking Actos developed diabetes, compared with nearly 8 percent of those taking the placebo, the study showed.
The report was published online Feb. 17 in the New England Journal of Medicine. The study was also scheduled to be presented Wednesday at the American Stroke Association's annual meeting, in Los Angeles. Funding for the study was provided by the U.S. National Institutes of Health.
No one knows how Actos works to prevent stroke, Kernan said. The best guess is that the drug reduces inflammation, improves insulin resistance, helps manage fats in the body and "favorably affects the function of blood vessels," he said. "These could explain its effects on recurrence of stroke and heart attack."
Insulin resistance may also play a part in the risk for stroke, Kernan said. "This trial provides fairly strong evidence that insulin resistance is an important new target for prevention of stroke," he said. "This trial takes preventive neurology in a new direction and opens up new opportunities for the care of patients."
Whether Actos will ever be used to prevent stroke depends on how these findings are evaluated by the medical community, Kernan said.
"Actos may be an option for patients who have had a stroke or mini-stroke, but its role will have to emerge from a debate among scientists about our results," he said.
Dr. Richard Libman is vice chairman of neurology at Long Island Jewish Medical Center in New Hyde Park, N.Y. He said this new finding may add to the ability to prevent recurrent strokes, but it needs to be confirmed before the drug can be widely used.
"This is the first study to show that treating these patients with a medication which improves insulin resistance can also decrease the risk of having a subsequent stroke or heart attack," he said. "It is only a single study, but it is compelling."
Dr. Gerald Bernstein is an endocrinologist at the Friedman Diabetes Institute of Lenox Hill Hospital in New York City. "This is a straightforward look at a few thousand people over a reasonable period showing the benefits and liabilities of Actos," he said. "The question we are left with is whether we have something that is all upside and no downside."
The drug was linked to some serious side effects. People who took Actos in the study were more likely to gain 10 pounds or more, have swelling of the feet and ankles, and broken bones that required surgery or hospitalization, the researchers found.
One day Actos may be a drug used to help prevent stroke, but more knowledge is needed before it can become a regular part of stroke treatment, Kernan said.
For more information on stroke, visit the American Stroke Association.