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Title: Pioglitazone Associated With Lower Cardiovascular Risk in Type 2 Diabetic Patients: Presented at ADA

"Pioglitazone Associated With Lower Cardiovascular Risk in Type 2 Diabetic Patients: Presented at ADA"

By Bruce Sylvester SAN FRANCISCO -- June 8, 2008 -- Pioglitazone treatment is associated with reduced cardiovascular risk among a general type 2 diabetes patient population, according to research presented here at the American Diabetes Association (ADA) 68th Scientific Sessions. "The results of this subgroup analysis suggest that pioglitazone not only lowered the risk for major cardiovascular events in a high-risk population of patients with established cardiovascular disease … but the potential cardiovascular benefits of pioglitazone treatment on preventing cardiovascular events may also extend to patients with less advanced disease," said Alfonso Perez, MD, Takeda Pharmaceuticals, Deerfield, Illinois, in a poster presentation on June 7. Patients with type 2 diabetes are at high risk for macrovascular ischaemic events. "We completed a meta-analysis to evaluate the effect of pioglitazone on the incidence of ischaemic cardiovascular complications using data from randomised, double-blind, comparator-controlled trials," said Dr. Perez. The researchers analysed data from 19 trials enrolling 16,390 subjects to derive composite data on all-cause death, myocardial infarction, or stroke. The largest of the trials -- The Prospective Pioglitazone Clinical Trial in Macrovascular Events (PROactive) -- enrolled 5,238 high-risk type 2 diabetic subjects with macrovascular disease. PROactive was designed as a cardiovascular-outcome study. The remaining trials generally enrolled lower-risk diabetes patients. In PROactive, the investigators previously reported a nonsignificant 10% reduction among pioglitazone subjects; however, they also reported a significant 16% relative risk reduction in the composite of death, myocardial infarction, or stroke (hazard ratio [HR]: 0.84; 95% confidence interval [CI], 0.72-0.98; P = .027). In the current meta-analysis, Dr. Perez and colleagues examined whether findings from PROactive extended to type 2 diabetes subjects who have a lower cardiovascular risk. Across all cohorts in the meta-analysis, the investigators found lower rates of death, myocardial infarction, or stroke with pioglitazone versus comparator. When PROactive data were included in the analysis, the differential was statistically significant (P = .0076) in favouring pioglitazone treatment. When PROactive data were excluded, the researchers still found a trend of benefit with pioglitazone (HR: 0.75; 95% CI, 0.5-1.02; P = .0704) for patients with a lower cardiovascular risk, showing lower rates of cardiovascular events among these patients as well. The authors concluded, "The results of this meta-analysis confirm and extend the observations of PROactive, in that pioglitazone treatment is associated with reduced cardiovascular risk in a more general, lower-risk type 2 diabetes patient population. These results are consistent with an independent meta-analysis by Lincoff (2007) of major cardiovascular events in pioglitazone-treated patients [[JAMA. 2007 Sep 12;298(10):1216-8]."

Funding for this study was provided by Takeda Pharmaceuticals.

[Presentation title: Pioglitazone Treatment Is Associated With Reduced Cardiovascular Ischemic Events in Type 2 Diabetic Patients With High or Low Cardiovascular Risk. Abstract 523-P]

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