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Actos Showed Improvement in Diabetes and Macrovascular Disease

Posted: Thursday, October 11, 2007

Long-term therapy with pioglitazone in patients with cardiovascular disease and type 2 diabetes not only reduces risk of death, myocardial infarction, or stroke, but it also has favourable effects on lipid markers in patients on statin therapy.

This post-hoc analysis looked at whether statin therapy would mitigate the benefits on lipids seen in the PROspective pioglitAzone Clinical Trial In macroVascular Events (PROactive), a randomized, double-blind, placebo-controlled, multicenter trial that enrolled a total of 5,238 patients. The researchers evaluated lipid levels in the cohort of patients already on statin therapy at study entry.

Patients were randomized into a pioglitazone arm (n=2605) and a placebo arm (n=2633), and were treated for 2.5 to 3.5 years (mean exposure to study drug: 30.4 months), and were followed for approximately 34.5 months.

The patient population was separated furthermore into two cohorts per each study arm -- statin users at baseline versus non-statin users at baseline.

"The lipid effects of pioglitazone were compared within the subgroups of patients who were and who were not receiving statin therapy at baseline," explained Robert Spanheimer, MD, Senior Medical Director, Medical and Scientific Affairs, Takeda Pharmaceuticals North America, Inc., Deerfield, Illinois, United States.

The statistical analysis was performed using a Wicoxon rank sum test, which was used to compare changes in levels of triglycerides, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and LDL-C/HDL-C ratio.

The analysis showed that treatment with pioglitazone decreased triglyceride levels with -12.3% (-34.2-14.0, P <.0001) in the statin cohort (n=950) and with -10.9% (-34.9-20.7, P <.0001) in the no-statin cohort (n=1251), expressed in median (interquartile range) percent change from baseline to final visit.

In both cohorts, treatment with pioglitazone was associated with significantly larger increases in HDL-C levels compared with placebo: 20.3% (7.8-34.9, P <. 0001) in the statin cohort (n=950) and 18.4% (5.1-32.7, P <. 0001) in the no-statin cohort (n=1251), versus approximately 10% in the placebo cohorts.

Regarding changes in LDL-C levels, there was a moderate increase with pioglitazone compared with placebo in the non-statin cohort, the researchers said.

However, analysis of the LDL-C/HDL-C ratio showed significant improvement in the patients treated with pioglitazone compared with placebo in both cohorts. The ratios were -9.1% (-25.4-11.8, P <. 0001) in the pioglitazone/statin cohort (n=948) and -1.4% (-17.7-20.9) in the placebo/statin cohort (n=969), and respectively -9.7% (-29.2-9.1, P <. 01) in the pioglitazone/no-statin cohort (n=1251) versus -6.4% (-24.4-10.7) in placebo/non-statin (n=1225).

Moreover, the researchers indicated that the divergence of pioglitazone therapy effect from placebo on triglyceride and HDL-C levels was observed at the first post baseline assessment (ie, 6-months) and persisted throughout the whole study duration.

The researchers concluded that the data provide valuable insight into the long-term treatment effects of pioglitazone on lipid measures when added to standard care, but noted that further studies are needed to determine the cardiovascular benefits of these lipid changes.

Source: Diabetes In Control: Reported on Oct 6th, by lead author, John Betteridge, MD, PhD, Professor of Endocrinology and Metabolism, Department of Medicine, The Middlesex Hospital, London, United Kingdom, at the XVI International Symposium on Drugs Affecting Lipid Metabolism (DALM). [Presentation title: Effects of Pioglitazone on Lipids in Patients Receiving a Statin at Baseline in PROactive. Abstract 371]