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In a head-to-head study comparing two medications that improve insulin sensitivity, researchers found that pioglitazone (Actos, Takeda) had greater influence on the lipid levels of patients with type 2 diabetes than rosiglitazone (Avandia, Glaxo-SmithKline).
"Pioglitazone is associated with significant improvements versus rosiglitazone in triglycerides, HDL cholesterol, non-HDL cholesterol, and LDL particle concentration and size, despite similar effects on glycemic control," according to lead investigator Ronald Goldberg, MD, of the University of Miami School of Medicine. "Whether these differences in lipid measures translate into differences for the future risk of cardiovascular disease has not been determined."
The results of the study were presented at the American Heart Association's 2004 Scientific Sessions in New Orleans. The research has been submitted for publication in a peer-reviewed journal, according to co-investigator Mehmood Kahn, MD, senior vice president of medical and scientific affairs at Takeda Pharmaceuticals North America, Lincolnshire, Ill.
Both glitazone therapies lower blood glucose levels in patients with type 2 diabetes. While the study showed pioglitazone and rosiglitazone had similar effects on blood glucose control, it found that pioglitazone lowered triglycerides and raised HDL to a greater degree.
After 24 weeks of treatment, the 400 patients who took pioglitazone showed a 14.9% increase in their HDL levels, or almost double the 7.8% increase seen in the 402 patients who took rosiglitazone. The pioglitazone patients also experienced a 12% decrease in triglyceride levels, while the rosiglitazone branch had a 14% increase.
"Having an agent that improves the lipid profile at the same time that it improves blood sugar control in type 2 diabetes would clearly add a potentially beneficial component, and therefore, physicians may wish to choose to use an agent with multiple effects rather than one that does not cause any improvement in the profile," says Goldberg.
Although the study demonstrates a difference in laboratory values, whether such an effect alters a patient's clinical course remains unknown. "We really need outcomes data to be sure about what that clinical impact is," he says. "And until we have that clinical evidence, physicians are going to have to make judgments in their decision on how to treat patients."
Regarding questions about the methodology of the study, "[w]e're showing a difference between two agents, and people are going to look hard at those differences," says Goldberg. "I think that the study is very clear, that the groups were well matched, that there were no significant differences between the baseline values in either group. So we really, I think, have a pretty impressive and convincing difference at the end of the study."
The study was funded by Takeda, developer of pioglitazone. Eli Lilly, which is co-promotional partner for the drug with Takeda, did not support the research, according to Goldberg.
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REDUCED RESTENOSIS
In related news, a case-controlled trial recently reported in the November 2004 issue of Diabetes Care suggests that rosiglitazone can reduce the rate of restenosis following placement of a stent to treat coronary artery disease (CAD). Patients with type 2 diabetes have a much greater risk of restenosis, affecting nearly 50% of patients receiving stents.1
Donghood Choi, MD, PhD, of Yonsei University College of Medicine in Seoul, South Korea, and colleagues conducted a prospective trial of 95 patients with CAD undergoing stent placement. Thirty-eight patients with a total of 51 lesions were randomized to receive rosiglitazone, while the remainder served as a control group.
After 6 months, 17.6% of those who received rosiglitazone experienced restenosis, compared to 38.2% in the control group. In addition, the degree of diameter stenosis was smaller among those receiving the drug; 23.0%, compared to 40.9% among control subjects.
The researchers speculate that the rate of restenosis may be lower in the
treatment group because rosiglitazone reduces inflammation. Patients who
received the drug had a significantly reduced concentration of C-reactive
protein. 
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