Diabetes Drug Pulls Double Duty

Actos cut risk of second heart attack in patients with type 2 diabetes, study finds

WEDNESDAY, Nov. 16, 2005 (HealthDay News) -- An established drug for type 2 diabetes has a beneficial effect on cardiovascular health, reducing the risk of a second heart attack in diabetic patients by 28 percent.

The authors of a new study calculated that in a three-year period Actos (pioglitazone) would prevent 22 recurrent heart attacks for every 1,000 patients with type 2 diabetes who had suffered a previous heart attack.

The findings were presented Wednesday at the American Heart Association's annual meeting, in Dallas.

"I do not know of any other trial that has shown that any glucose-lowering agent being used today decreases macrovascular events or prolongs life," said study author Dr. Erland Erdmann, of the University of Cologne in Germany. "My attitude would be to use it."

But some caution is warranted, others warned.

"This should draw attention to the use of pioglitazone, and it should get serious consideration, but it's a first, so it needs validation," said Dr. Robert H. Eckel, president of the American Heart Association. "One study should not make a paradigm for management."

Actos was approved to treat type 2 diabetes in July 1999 in the United States, and in October 2000 in Europe. It lowers blood glucose levels by making the cells more sensitive to insulin.

People with type 2 diabetes are at a much higher risk for developing cardiovascular disease. According to the American Diabetes Association, two out of three people with diabetes die from heart disease and stroke.

According to the authors, this study includes one of the largest groups of patients with type 2 diabetes and a previous heart attack to be studied in a randomized, placebo-controlled trial.

In all, 2,445 patients with type 2 diabetes who had had a heart attack at least six months before the start of the study were enrolled. Participants were recruited from 321 medical centers in 19 European countries, and were randomly assigned to receive either Actos or a placebo. They were followed for two-and-a-half years.

All participants also received optimal therapy for diabetes, and most (95 percent) were receiving medication for their previous heart attacks.

"We encouraged investigators to treat patients optimally, according to international diabetes guidelines," Erdmann said.

The risk of having another heart attack, either fatal or nonfatal, was reduced by 28 percent, and the risk of acute coronary syndrome was reduced by 37 percent.

There was a 19 percent reduced risk in a composite endpoint that included the major macrovascular events of nonfatal heart attack, coronary revascularization, acute coronary syndrome and cardiac death.

The effect of Actos was an additive one, conferring more benefit to patients who were on heart medications such as beta blockers, ACE inhibitors and statins.

"Patients who have diabetes and a heart attack benefit from getting pioglitazone on top of optimal treatment of diabetes and coronary heart disease treatment," Erdmann said.

Patients with high triglycerides and low HDL at the beginning of the trial also showed improvements in these measures.

In general, there were few side effects, although some patients in the Actos group did develop edema.

It was unclear, specifically, how the medication exerted its beneficial effect.

"Pioglitazone is known to have many effects, and which one of these has caused the effect, I can in no way tell you," Erdmann said.

Eckel emphasized that candidates for Actos need to be carefully considered and should include those taking only oral medications who are not at risk for heart failure.

More information

For more on complications of type 2 diabetes, visit the American Diabetes Association.

SOURCES: Erland Erdmann, M.D., director, Third Clinic for Internal Medicine, University of Cologne, Germany; Robert H. Eckel, M.D., president, American Heart Association, and professor, medicine, University of Colorado College of Medicine, Denver; Nov. 16, 2005, presentation, American Heart Association annual meeting, Dallas
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