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Rosiglitazone increased heart failure but did not differ from metformin plus sulphonylurea for other CV outcomes at interim analysis

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In patients with type 2 diabetes, is rosiglitazone (RGZ) as add on therapy non-inferior to metformin (MFN) plus sulphonylurea (SFU) for cardiovascular (CV) outcomes?

Home PD, Pocock SJ, Beck-Nielsen H, et al. Rosiglitazone evaluated for cardiovascular outcomes—an interim analysis. N Engl J Med 2007;357:28–38.

Clinical impact ratings GP/FP/Primary care ★★★★★★⋆ Cardiology ★★★★★★⋆ Endocrine ★★★★★★⋆ Internal medicine ★★★★★⋆⋆

METHODS

Embedded ImageDesign:

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

Embedded ImageAllocation:

unclear allocation concealment.*

Embedded ImageBlinding:

blinded (outcome assessors).*

Embedded ImageFollow-up period:

mean 3.75 …

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Footnotes

  • Source of funding: GlaxoSmithKline.