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Therapy with pioglitazone (Actos, Takeda) appears to slow the progression of atherosclerosis in people with type 2 diabetes, according to late-breaking clinical research presented at the American Heart Association Scientific Sessions, held November 12–15 in Chicago.
People who remained on pioglitazone therapy for 18 months showed greater improvement in carotid intima-media thickness (CIMT) than those receiving the sulfonylurea drug glimepiride (Amaryl, Sanofi-Aventis), according to the results of the Carotid Intima-Media Thickness in Atherosclerosis Using Pioglitazone (CHICAGO) study.
CIMT is an important marker for cardiovascular disease and an early step in the atherosclerotic process, according to endocrinologist Theodore Mazzone, MD, of University of Illinois at Chicago, who presented the findings at the sessions.
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The study "adds to the understanding that pioglitazone may confer benefits beyond glycemic control," Mazzone says.
STUDY DESIGN
CHICAGO, funded by Takeda, is a randomized, double-blind trial of 462 adults with type 2 diabetes who were followed at 28 medical centers in the Chicago area during 2003–2006. Participants were an average 60 years of age, with a mean body mass index of 32, duration of diabetes averaging 7.7 years, and average glycated hemoglobin (A1C) of 7.4%.
Participants were randomized to receive 15–45 mg/day pioglitazone or
1–4 mg/day glimepiride. The drugs were titrated to achieve a fasting
plasma glucose level 
140 mg/dl. CIMT was measured by ultrasound at
baseline and at the end of the 18-month treatment period.
At the end of the treatment period, the average CIMT among those on pioglitazone was reduced by 0.001 mm, while among those taking glimepiride the average CIMT increased by 0.012 mm.
Although the study did not look at cardiovascular outcomes, Mazzone says that the differences in CIMT between the two treatment groups widened over time, suggesting that the progression of atherosclerosis had been significantly slowed or halted in the pioglitazone group.
CLASS EFFECT
The results, which were simultaneously published in JAMA,1 add to the growing evidence that thiazolidinediones (TZDs) offer therapeutic benefit in reducing cardiometabolic risk. Research shows that TZDs have a favorable effect on lipid levels and are linked to lower levels of inflammatory markers.
Mazzone says that, in the CHICAGO trial, those who took pioglitazone had a 13% increase in HDL cholesterol. "For HDL cholesterol, that's a pretty substantial change."
It is likely that rosiglitazone (Avandia, GlaxoSmithKline) has similar cardiometabolic effects, but that would not be known until a head-to-head study of the drugs is conducted, Mazzone says.
"As a class, the [TZDs] have a number of similar effects on multiple end points," he says.
Despite concerns that TZDs cause fluid retention and increase the risk of heart failure, no untoward effects were seen in the CHICAGO study. One new case of congestive heart failure occurred in the pioglitazone group and none in the glimepiride group, and there was one case each of heart attack and stroke in the glimepiride group and none among those taking pioglitazone.
The CHICAGO findings are another factor to consider when choosing medications for patients with diabetes, Mazzone says.
"When a person with diabetes walks in, you have six or seven oral
medications to use now," he says. "Heart disease kills 80% of
people with diabetes. If you can do something to prevent heart disease in
those patients, that's a big advance." 
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