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Diabetes Drugs and Heart Risk

New Studies Link Avandia, but Not Actos, to Heart Attacks

Study: Actos Has Heart Attack-Stroke Benefit, Not Risk

The second JAMA study analyzes clinical trial data on Actos. It comes from Cleveland Clinic researchers A. Michael Lincoff, MD, and colleagues -- including Nissen.

The study shows that Actos does not increase risk of heart attack but instead reduces diabetes patients' risk of heart attack, stroke, and death by 18%.

"We can say with confidence that Actos not only does not have the risk seen with Avandia, but has a benefit beyond that," Lincoff tells WebMD. "I am a cardiologist, not a diabetologist. But if a drug of this class is thought to be a good drug for a diabetic patient, Actos has benefit beyond its blood sugar and insulin-resistance indications for reducing death and heart attack and stroke; all reduced about 20%."

An editorial accompanying the studies notes that the two drugs have "strikingly different" effects on heart attack risk. Editorialist Daniel H. Solomon, MD, PhD, is associate professor of medicine at Harvard Medical School and a rheumatologist in the division of pharmacoepidemiology at Brigham and Women's Hospital, Boston.

"While this is by no means definitive -- we don't absolutely know the two drugs are different -- there is increasing evidence the two agents produce different effects regarding [heart attack and stroke] complications. If one is thinking about taking one of these drugs, one should take this into account," Solomon tells WebMD.

GSK takes issue with the Lincoff study. The company notes that much of the data comes from a study funded by Actos maker Takeda Pharmaceuticals.

"No clinical head-to-head trial data specifically evaluates cardiovascular risk between Avandia and Actos; however, the head-to-head data that does exist, and the overwhelming majority of comparative observational data, show no significant differences in cardiovascular events," the GSK statement says. "Analyzed studies show no difference in the [heart attack and stroke] effects of Avandia versus other oral antidiabetic medicines, including Actos."

Lincoff says the new analysis offers new information on Actos.

"The previous study showed the reduction in heart attacks in a high-risk group of patients," he says. "This now includes patients at lower risk, without established risk of heart disease, and we saw the same results. There is the same benefit in all subgroups. All of the data points in the same direction. It is much more reassuring that these results are indicative of the real outcomes in patients."

Robert Spanheimer, MD, Takeda's senior medical director for diabetes, agrees that the Lincoff study strengthens the conclusions of the Takeda-funded study of Actos's heart-related effects.

"This information, combined with the [earlier] study, should give patients the confidence that Actos does not increase heart attack-related events or mortality," Spanheimer tells WebMD.

Actos, Avandia: New Drug Class, New Side Effects

Actos and Avandia are the two available members of a class of drugs called thiazolidinediones, TZDs, or PPAR agonists. They're also called glitazones, after the suffix used in the drugs' generic names.

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