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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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."
She said the new trial has it upside and downside. "The results are truly noteworthy in that patients taking saxagliptin had significantly improved rates of blood sugar control, less microalbuminuria and no evidence of increased or decreased rates of ischemic [vessel blockage] events," Narula said. "However, the study median duration was only two years and a longer time of drug therapy or longer follow-up may be required to reveal any real signal of improvement or exacerbation of cardiovascular outcomes."
Another study, also presented Monday at the European heart meeting and published in the New England Journal of Medicine, looked at the safety profile of Nesina (alogliptin), another newly FDA-approved diabetes drug.
The study, which was funded by the drug's maker, Takeda, involved nearly 5,400 patients with type 2 diabetes and a history of heart events (heart attack or angina requiring hospitalization). Patients received either Nesina or a placebo and were followed for an average of 18 months.
The researchers, led by Dr. William White of the University of Connecticut School of Medicine, said they found no increase in cardiovascular events for those using Nesina compared to those on a placebo.