This weeks Lancet contains no less than four letters that question the validity of the conclusions of the PROactive Study1.
All four letters2 raise concerns about several aspects of the study including the non-significance of the primary end-point, basing conclusions on a secondary end-point, potential harms and differences in other established markers of cardiovascular risk.
The first two letters (Gaede et al and Guillausseau) question whether the conclusion that pioglitazone reduces cardiovascular events is valid or accurate. The last (Holman et al) of these letters concludes "Metformin is the only antidiabetic agent that has been shown definitively to reduce macrovascular risk in overweight type 2 diabetic patients".
Action: The recommendations made earlier are still valid. Metformin is still the first line choice for diabetes.
- Dormandy JA, Charbonnel B, Eckland DJ, et al, for the PROactive investigators. 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
- Correspondence. Lancet 2006;367:23-26
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