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Rosiglitazone was non-inferior to metformin plus sulphonylurea for CV events but increased risk of HF and fractures in type 2 diabetes

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Study design

Design:

randomised controlled trial (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of glycaemia in Diabetes [RECORD]). ClinicalTrials.gov NCT00379769.

Allocation:

concealed.*

Blinding:

blinded (outcome adjudication committee).*

Study question

Setting:

364 centres in 25 countries in Europe and Australasia.

Patients:

4458 patients 40–75 years of age (mean age 58 y, 52% men) who had type 2 diabetes, body mass index >25 (mean 31) kg/m2, and haemoglobin (Hb) A1c concentration >7.0% to 9.0% (mean 7.9%) on maximum doses of metformin (MFN) or sulphonylurea (SFU). Exclusion criteria included hospital admission for a major cardiovascular (CV) event in ⩽3 months, planned CV intervention, and heart failure (HF).

Intervention:

rosiglitazone (RGZ), 4 mg/day, plus MFN or SFU, with starting doses determined by local practice (n = 2220); or MFN plus SFU (control) (n = 2227). Drug doses …

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