IRIS Trial design: Patients without diabetes with a history of stroke or TIA within 6 months, with objective evidence of insulin resistance (HOMA-IR value.

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Presentation transcript:

IRIS Trial design: Patients without diabetes with a history of stroke or TIA within 6 months, with objective evidence of insulin resistance (HOMA-IR value >3.0), were randomized to either pioglitazone 45 mg or placebo. They were followed for 4.8 years. Results (p = 0.007) The primary outcome, stroke or MI, for pioglitazone vs. placebo: 9.0% vs. 11.8%, HR 0.76, 95% CI 0.62-0.93, p = 0.007 All strokes: 6.5% vs. 8.0%, p = 0.19; ACS: 5.0% vs. 6.6%, p = 0.11; new-onset DM2: 3.8% vs. 7.7%, p < 0.001 Bone fracture: 5.1% vs. 3.2%, p = 0.003; weight gain >4.5 kg: 52.2% vs. 33.7%, p < 0.0001 % Conclusions Pioglitazone was superior to placebo in reducing the composite of stroke/MI in patients with recent stroke/TIA, no history of DM2, and objective evidence of insulin resistance There was an increase in previously described side effects with TZDs, including bone fractures, edema, and weight gain Primary endpoint Pioglitazone (n = 1,939) Placebo (n = 1,937) Kernan WN, et al. N Engl J Med 2016;374:1321-31