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March 31, 2008 (Chicago) -- The diabetes pill Actos beat out an older diabetes drug, Amaryl, at slowing the buildup of plaque in the heart arteries of people with type 2 diabetes and cardiovascular disease, researchers report.
Atherosclerosis, or plaque buildup in the inner lining of the arteries, is particularly aggressive in patients with diabetes, often leading to heart attacks and strokes. Nearly three-fourths of people with diabetes die from cardiovascular disease.
"This represents, to our knowledge, the first demonstration of the ability of any blood-sugar-lowering agent to slow the progression of coronary atherosclerosis in patients with diabetes," says researcher Steven E. Nissen, MD, chairman of cardiovascular medicine at Cleveland Clinic.
"This will change the paradigm of how we treat people with diabetes," he tells WebMD. "It's not how much you lower blood sugar, but how you lower it."
The study was presented at the annual meeting of the American College of Cardiology and simultaneously released online by The Journal of the American Medical Association.
Nissen and colleagues studied more than 350 people with type 2 diabetes and cardiovascular disease. About half were given Actos, a member of a relatively new class of antidiabetic agents known as thiazolidinediones.
The rest were given Amaryl. It's a member of the class of agents known as sulfonylureas that have been available for decades and represent one of the most commonly prescribed classes of diabetic therapy.
All took medication for heart disease.
Actos and Amaryl work very differently. Actos makes the body more sensitive to insulin. Amaryl stimulates the pancreas to release more insulin.
Actos carries a "black box" warning that the drug may trigger heart failure, but it has not been linked to any increased risk of heart attack.
All the participants underwent ultrasounds at the start of the study and about 18 months later to determine changes in the plaque buildup within the coronary arteries.
Results showed that Actos halted the dangerous progression of atherosclerosis and even started to reverse it, Nissen says. In contrast, plaque continued to build up in the arteries of patients who took Amaryl.
Additionally, compared with patients on Amaryl, those taking Actos experienced a 16% increase in HDL "good" cholesterol, a 15% drop in triglyceride levels, and a 45% drop in blood levels of a marker known as C-reactive protein that is associated with heart disease.
Past American Heart Association President Sidney Smith, MD, a cardiologist at the University of North Carolina at Chapel Hill, tells WebMD that the results are very encouraging.
But he says that he would not recommend that a person with diabetes switch treatments based on these results.
"The question now is whether the benefit will translate to improved outcomes," Smith says.
Nissen says that the study was not designed to determine whether Actos actually cuts the risk of heart attacks and stroke, but he thinks it "will translate into clinical benefits down the road."
Moving forward, he adds, "We can't just focus on pricking your finger and getting blood sugar down. The goal in diabetes therapy is to prevent complications. And the most feared complication is heart disease. I'm thrilled with results."
The study was funded by Takeda Pharmaceuticals, which manufactures Actos.