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PROactive study (PROspective pioglitAzone Clinical Trial In macroVascular Events)

Study design: - 5238 patients with type 2 diabetes - mean age, 62; 99% white - hemoglobin A1c >6.5% despite treatment - advanced macrovascular disease Treatment groups - pioglitazone (maximum, 45 mg daily) vs placebo - all patients received other oral hypoglycemic agents & insulin as needed to reduce HbA1c below 6.5% - optimal antihypertensive, antiplatelet, & antihyperlipidemic therapies were provided - ACE inhibitor, beta blocker, aspirin, statins Results: - mean follow-up of 35 months - median decrease in HbA1c was significantly greater with pioglitazone than with placebo (-0.8% vs. -0.3%) - significantly fewer pioglitazone patients started chronic insulin therapy - pioglitazone group had a significantly lower median triglyceride level & LDL/HDL ratio than did placebo group - median LDL level had risen significantly more with pioglitazone - incidence of the composite endpoint of death, nonfatal myocardial infarction, or stroke was significantly lower with pioglitazone than with placebo (12% vs. 14%) - incidence of heart failure was significantly higher with pioglitazone (11% vs. 8%), but heart failure-related mortality did not differ between the groups

Related

pioglitazone (Actos)

General

emergency medicine

References

  1. Prescriber's Letter 12(9): 2005 The Prospective Pioglitazone Clinical Trial in Macrovascular Events Study (PROactive Study) Detail-Document#: 211002 (subscription needed) http://www.prescribersletter.com
  2. Dormandy JA, Charbonnel B, Eckland DJ, Erdmann E, Massi-Benedetti M, Moules IK, Skene AM, Tan MH, Lefebvre PJ, Murray GD, Standl E, Wilcox RG, Wilhelmsen L, Betteridge J, Birkeland K, Golay A, Heine RJ, Koranyi L, Laakso M, Mokan M, Norkus A, Pirags V, Podar T, Scheen A, Scherbaum W, Schernthaner G, Schmitz O, Skrha J, Smith U, Taton J; 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 Oct 8;366(9493):1279-89. PMID: 16214598