Cardiovascular Diseases Clinical Trial
Official title:
Double Blinded Study of the Effects of Pioglitazone in Combination With Atorvastatin in Comparison to Atorvastatin Treatment Alone on Intima-Media Thickness in Patients at Risk for Vascular Complications
The purpose of this study is to determine the effect of pioglitazone, once daily (QD), and atorvastatin combination therapy compared to atorvastatin monotherapy in patients at risk for cardiovascular disease.
Carotid intima-media thickness is a well described surrogate marker for cardiovascular risk.
A thickened carotid intima media layer correlates not only with the presence of
cardiovascular risk factors but also the risk of future macrovascular events such as
myocardial infarction and stroke. The interventional approach of cardiovascular risk factors
with angiotensin converting enzyme system blockers, calcium antagonists or beta blockers can
result in reduction of progression or even net regression of carotid intima-media thickness.
The most potent agents, however, are statins which have consistently shown effects on
carotid intima-media thickness in patients with hypercholesterolemia and/or atherosclerotic
disease.
Peroxisome proliferator activator receptor-gamma activation by thiazolidinediones is a
promising new approach which reduces insulin resistance and improves lipid profile. In
addition to their metabolic activities, peroxisome proliferator activator receptor-gamma
activators were shown to exert anti-inflammatory effects, to improve endothelial function
and to inhibit atherogenesis in diabetic and in non-diabetic atherosclerosis-prone animal
models. Treatment with peroxisome proliferator activator receptor-gamma agonists have shown
to reduce arterial pressure and carotid intima-media thickness in diabetic and non-diabetic
patients at risk for cardiovascular disease.
The aim of this study is to evaluate the effect of Pioglitazone in addition to Atorvastatin
compared to Atorvastatin alone on vascular risk markers and intima-media thickness in
patients with elevated risk for cardiovascular disease.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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