But more studies on cardiovascular risks needed, report says
FRIDAY, May 23 (HealthDay News) -- A new antioxidant drug shows benefits in the prevention and treatment of diabetes, but more research on possible cardiovascular risks is needed before it is used widely, a new study indicates.
Preliminary results on the drug, succinobucol, have been presented at medical meetings. The full study is published in the May 24 issue of The Lancet.
"There is more data in the article than in the previous presentation, with greater detail on the prevention of diabetes and glycemic [sugar] control," said study author Dr. Jean-Claude Tardif, director of the research center at the Montreal Heart Institute in Canada.
"There are several interesting findings that include a large reduction of new cases of diabetes and also glycemic control in patients who already have diabetes," Tardif said. "But there needs to be confirmation before it is used widely, because there was no effect on clinical endpoints such as heart attack and stroke."
Some confirmation of the drug's effectiveness is expected from a major trial that is nearing completion, Tardif said. Results of that trial should be published "within the next few months," he said.
Succinobucol is a chemical relative of probucol, a cholesterol-lowering drug taken off the market in the United States in 1995 because of side effects. In addition to its antioxidant effects, succinobucol also reduces inflammation.
The trial reported in The Lancet included 6,144 people, 37 percent of whom had diabetes and all of whom had been hospitalized for a heart attack or the dangerous heart rhythm problem called unstable angina. For two years, half of the participants took succinobucol daily, while the other half took a placebo. All were taking other drugs, such as cholesterol-lowering statins, beta blockers or ACE inhibitors.
Among the participants who did not have diabetes when the study began, 4.2 percent of those not taking succinobucol developed the disease, compared to 1.64 percent of those taking the drug, a 64 percent risk reduction. For those with diabetes, taking succinobucol provided better blood sugar control than not taking the drug.
Atrial fibrillation, a dangerous heartbeat abnormality, was twice as likely to develop during the trial in those taking succinobucol. There was no difference in the incidence of death, cardiac arrest, heart attack, stroke or other cardiovascular endpoints between those taking or not taking the drug.
"The study results need confirmation before it is used widely, because there was no effect on those clinical endpoints," Tardif said. "But that is true of all the drugs now used in diabetes. There is no evidence that they reduce heart attacks and strokes."
The chief side effect of the drug was diarrhea, reported by 23 percent of those taking it. One in seven of those reporting diarrhea stopped taking succinobucol.
Currently available drugs for diabetes are described by the American Diabetes Association.
SOURCES: Jean-Claude Tardif, M.D., director, Montreal Heart Institute Research Center, Canada; May 23, 2008, The Lancet
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