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New Diabetes Drug Seems Safe for Heart: Study

Onglyza study reflects new cautious approach to oversight of diabetes medicines, experts say
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Over the course of more than two years, the researchers found the patients who took the diabetes drug were at no greater risk for a heart attack than those who took the dummy pill.

The study showed that cardiovascular death, heart attack, stroke, or hospitalization for unstable angina, coronary revascularization (angioplasty), or heart failure occurred in about 12.8 percent of patients who took the drug, compared to 12.4 percent of those in the placebo group -- not a significant difference.

However, "our data also show an increase in hospitalization for heart failure in patients who received saxagliptin, which was not expected and deserves further study," the study chairman, Dr. Eugene Braunwald of the TIMI Study Group, cardiovascular division at Brigham and Women's and Harvard Medical School, said in the hospital news release.

But the drug had real benefits, as well. "Patients who received saxagliptin also had better control of blood sugar levels and a reduced need for insulin therapy," noted the study's co-principal investigator, Dr. Itamar Raz, of Hadassah Medical Center, Israel.

Raz added that the diabetes drug also prevented the progression of microalbuminuria, a condition that occurs when a type of protein called albumin is spilling into the urine due to kidney damage.

Two diabetes experts unconnected to the study said the findings should help ease the minds of patients and physicians.

"The treatment of patients with diabetes has been challenging in recent years," said Dr. Sripal Bangalore, director of research in the cardiac catheterization laboratory at NYU Langone Medical Center, New York City. "It is reassuring to see a mega trial . . . re-assuring the cardiovascular safety of saxagliptin given for a median of two years," he added.

"The pessimistic way of looking at this is that the drug was no better than placebo [in reducing heart risks] and had higher risk of heart failure and hypoglycemic events," Bangalore said. "Hopefully, the investigators will publish more data from the trial showing improvement in microvascular events."

Dr. Tara Narula is associate director of the cardiac care unit at Lenox Hill Hospital in New York City. She agreed that "there currently exists a tremendous amount of confusion regarding which diabetes drugs are safe to use in patients at risk for or with established cardiovascular disease."

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