Clinical InvestigationAcute Ischemic Heart DiseaseEffects of pioglitazone on major adverse cardiovascular events in high-risk patients with type 2 diabetes: Results from PROspective pioglitAzone Clinical Trial In macro Vascular Events (PROactive 10)☆
Section snippets
Study population
A total of 5238 adults (35-75 years of age, inclusive) with type 2 diabetes (hemoglobin A1c level above the upper limit of normal; ie, the local equivalent of 6.5% for a DCCT traceable assay) and with an established history of macrovascular disease (defined using a number of entrance criteria given below) were randomized into this prospective, double-blind, multicenter, placebo-controlled study conducted in 321 clinical sites across 19 European countries. The study was performed in accordance
Baseline demographics and characteristics
Medical history collected at baseline has been previously reported and was consistent with a study population with long-standing type 2 diabetes (mean duration of 9.5 years since diagnosis) and significant underlying cardiovascular disease (eg, 75% had hypertension, 47% had a prior MI, and 19% had a prior stroke). Importantly, nearly half had 2 or more of the cardiovascular entry criteria; and most patients were receiving at least one cardiovascular medication. There were no relevant
Main results
In this report, we provide an analysis of the risk of MACE in the patients enrolled in the 3-year PROactive study. Nearly half of all patients met at least 2 of the cardiovascular qualifying criteria, indicating that this was a seriously ill patient population that carried substantial risk for a major cardiovascular event. The outcome data revealed that pioglitazone treatment given on top of existing medication for diabetes, hypertension, and dyslipidemia resulted in statistically significant
References (17)
- et al.
Secondary prevention of macrovascular events in patients with type 2 diabetes: a randomized trial of pioglitazone. The PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events)
Lancet
(2005) - et al.
Cardiovascular morbidity and mortality in patients with diabetes in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): a randomised trial against atenolol
Lancet
(2002) - et al.
Pravastatin in elderly individuals at risk of vascular disease (PROSPER): a randomised controlled trial
Lancet
(2002) - et al.
Prevention of coronary and stroke events with atorvastatin in hypertensive patients who have average or lower-than-average cholesterol concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid-Lowering Arm (ASCOT-LLA): a multicentre randomised trial
Lancet
(2003) - et al.
Mortality from coronary heart disease in subjects with type 2 diabetes and in nondiabetic subjects with and without prior myocardial infarction
N Engl J Med
(1998) - et al.
Diabetes and glucose tolerance as risk factors for cardiovascular disease: the Framingham study
Diabetes Care
(1979) - et al.
Diabetes, other risk factors, and 12-yr cardiovascular mortality for men screened in the Multiple Risk Factor Intervention Trial
Diabetes Care
(1993) PPARγ and atherosclerosis
Curr Med Res Opin
(2005)
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The study was funded by Takeda Europe R&D Centre Ltd, London, United Kingdom, and Eli Lilly and Company, Indianapolis, IN. Conflict of interest: Prof Wilcox has served as a consultant to Takeda. Dr Kupfer is an employee of Takeda Global Research and Development. Prof Erdmann has served as a consultant to and received travel expenses and payments for speaking at meetings from Takeda.