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September 5, 2002 — Pioglitazone, a thiazolidinedione insulin sensitiser, significantly reduces the concentration of dense low-density lipoprotein (dLDL) particles in non-diabetic, hypertensive patients. This new finding was presented September 4th at the 38th Annual Meeting of the European Association for the Study of Diabetes (EASD). The research was conducted by investigators from University of Freiburg, University of Frankfurt, and Takeda Pharma GmbH, in Germany.
The researchers, lead by Dr. Karl Winkler of the University of Freiburg, enrolled 55 non-diabetic patients with moderate arterial hypertension in a randomised, double blind, phase II clinical trial. Patients in the experimental group (n=26) were treated with 45 mg/day of pioglitazone, while subjects in the control group (n=29) were given matching placebo for a period of 16 weeks.
The aim of the study was to investigate the effects of pioglitazone on dLDL particles, since they have an important role in promoting atherogenic plaques and increase cardiovascular disease risk.
Statistical analysis of the results revealed significant differences between the pioglitazone and the placebo groups regarding changes in serum dLDL concentration. Specifically, the apolipoprotein B (apoB) concentration in dLDL decreased by 22.5 percent in the pioglitazone group and by 5.7 percent in the control group during the course of the trial (p=0.035, Mann-Whitney U-test). Furthermore, there was a 9 percent decrease in triglycerides and a 5 percent increase in high-density lipoprotein (HDL) cholesterol in the pioglitazone group; however, these changes did not reach statistical significance when compared to the placebo group.
Based on these results, the researchers concluded that pioglitazone favourably influences lipoprotein metabolism and reduces the preponderance of atherogenic dense LDL in patients with arterial hypertension. They also suggested that the effects of pioglitazone may generally translate into a reduced risk for the development of atherosclerotic complications in patients with insulin resistance or type 2 diabetes.
"In type 2 diabetes there is an extremely high risk for cardiovascular diseases," said Dr. Winkler. This is in part due to increased blood levels of dLDL in these patients, since dLDL molecules have a low affinity for the LDL receptor and are easily oxidized, thus promoting the generation of atherogenic plaques, he explained. "So pioglitazone might not only improve insulin sensitivity but may also reduce cardiovascular risk in type 2 diabetes," Dr. Winkler added. The study was funded by Takeda Pharma GmbH, of Aachen, Germany, the manufacturers of pioglitazone.