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Evidence-Based Medicine 2006;11:47; doi:10.1136/ebm.11.2.47
Copyright © 2006 by the BMJ Publishing Group Ltd.
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Therapeutics

Pioglitazone did not reduce macrovascular complications and increased HF in type 2 diabetes with macrovascular disease

Dormandy JA, Charbonnel B, Eckland DJ, et al. Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a randomised controlled trial. Lancet 2005;366:1279–89.[CrossRef][Medline]

Q In patients with type 2 diabetes and evidence of macrovascular disease, does pioglitazone reduce all cause mortality and macrovascular complications?

Clinical impact ratings GP/FP/Primary care ******{star} IM/Ambulatory care ******{star} Endocrine ******{star} Cardiology ******{star}

Key Words: diabetes mellitus (type 2) • coronary disease • myocardial infarction • PPAR gamma • thiazolidinediones

The first 150 words of the full text of this article appear below.

METHODS
Formula Design randomised placebo controlled trial (PROactive study).

Formula Allocation concealed.*

Formula Blinding blinded (clinicians, patients, data collectors, and outcome assessors).*

Formula Follow up period mean 34.5 months.

Formula Setting 321 centres (including communities and hospitals) in 19 European countries.

Formula Patients 5238 patients 35–75 years of age (mean age 62 y, 66% men) who had type 2 diabetes, haemoglobin A1c concentration >=6.5%, and >=1 of the following criteria: myocardial infarction (MI), stroke, percutaneous coronary intervention or coronary artery bypass surgery >=6 months previously, acute coronary syndrome >=3 months previously, or objective evidence for coronary artery disease or obstructive arterial disease in the leg. Exclusion criteria: type 1 diabetes; taking only insulin; planned coronary or peripheral revascularisation; >=class II New York Heart Association heart failure; ischaemic ulcers, gangrene, or pain at rest in the leg; haemodialysis; or alanine aminotransferase concentration >=2.5 times the upper limit of normal.

Formula Intervention oral pioglitazone, 15 mg/day for 1st month, 30 . . . [Full text of this article]

William L Isley, MD

Mayo Clinic, Rochester, Minnesota, USA


Related Article

Glossary
Evid. Based Med. 2006 11: 63a. (in Glossary) [Extract] [Full Text] [PDF]





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