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

https://doi.org/10.1136/ebm.11.2.47

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    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.
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 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 ★★★★★★☆ IM/Ambulatory care ★★★★★★☆ Endocrine ★★★★★★☆ Cardiology ★★★★★★☆

    METHODS

    Embedded ImageDesign

    randomised placebo controlled trial (PROactive study).

    Embedded ImageAllocation

    concealed.*

    Embedded ImageBlinding

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

    Embedded ImageFollow up period

    mean 34.5 months.

    Embedded ImageSetting

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

    Embedded ImagePatients

    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 …

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    Footnotes

    • ↵* See glossary.

    • For correspondence: Dr J A Dormandy, St. George’s Hospital, UK. john.dormandy{at}btinternet.com

    • Sources of funding: Takeda Pharmaceutical Company and Eli Lily and Company.

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      BMJ Publishing Group Ltd
      BMJ Evidence-Based Medicine 2006; 11 63a-63a Published Online First: 30 Mar 2006. doi: 10.1136/ebm.11.2.63a