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Cardiovascular Diabetology

, 10:18

First Online: 11 February 2011Received: 04 January 2011Accepted: 11 February 2011


BackgroundType 2 diabetes T2D is strongly associated with cardiovascular risk and requires medications that improve glycemic control and other cardiovascular risk factors. The authors aimed to assess the relative effectiveness of pioglitazone Pio, metformin Met and any sulfonylurea SU combinations in non-insulin-treated T2D patients who were failing previous hypoglycemic therapy.

MethodsOver a 1-year period, two multicenter, open-labeled, controlled, 1-year, prospective, observational studies evaluated patients with T2D n = 4585 from routine clinical practice in Spain and Greece with the same protocol. Patients were eligible if they had been prescribed Pio + SU, Pio + Met or SU + Met serving as a control cohort, once they had failed with previous therapy. Anthropometric measurements, lipid and glycemic profiles, blood pressure, and the proportions of patients at microvascular and macrovascular risk were assessed.

ResultsAll study treatment combinations rendered progressive 6-month and 12-month lipid, glycemic, and blood pressure improvements. Pio combinations, especially Pio + Met, were associated with increases in HDL-cholesterol and decreases in triglycerides and in the atherogenic index of plasma. The proportion of patients at high risk decreased after 12 months in all study cohorts. Minor weight changes gain or loss and no treatment-related fractures occurred during the study. The safety profile was good and proved similar among treatments, except for more hypoglycemic episodes in patients receiving SU and for the occurrence of edema in patients using Pio combinations. Serious cardiovascular events were rarely reported.

ConclusionsIn patients with T2D failing prior hypoglycemic therapies, Pio combinations with SU or Met especially Pio + Met improved blood lipid and glycemic profiles, decreasing the proportion of patients with a high microvascular or macrovascular risk. The combination of Pio with SU or Met may therefore be recommended for T2D second-line therapy in the routine clinical practice, particularly in patients with dyslipidemia.

AbbreviationsAEadverse event

AIPatherogenic index of plasma

ALTalanine transaminase

ANOVAone-way analysis of variance

BMIbody mass index

CVDcardiovascular disease

DBPdiastolic blood pressure

EDPGEuropean Diabetes Policy Group

CIconfidence interval

FPGfasting plasma glucose

HbA1cglycosylated hemoglobin

HDL-Chigh-density lipoprotein cholesterol

IDFInternational Diabetes Federation

LDL-Clow-density lipoprotein cholesterol

LOCFlast observation carried forward

MedDRAMedical Dictionary for Regulatory Activities


ORodds ratio


PPARperoxisome proliferator-activated receptor

PROactiveProspective Pioglitazone Clinical Trial in Macrovascular Events

SBPsystolic blood pressure

SDstandard deviation

SEEDOSpanish Society for the Study of Obesity


T2Dtype 2 diabetes

total-Ctotal cholesterol


Electronic supplementary materialThe online version of this article doi:10.1186-1475-2840-10-18 contains supplementary material, which is available to authorized users.

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Author: Ángel Rodríguez - Jesús Reviriego - Vasilios Karamanos - Francisco J del Cañizo - Nikolaos Vlachogiannis - Vangelis Dro


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