Pioglitazone therapy in patients with stroke and prediabetes: A post hoc analysis of the IRIS randomized clinical trial

Research speak so useless for survivors needing to train their doctors. Send them back to the drawing board and have them create 8th grade English so the average US citizen can understand.  

Wasn't this from Feb. 2016 good enough to write a protocol on it and prevent waste of further money on duplicate research? Once again researchers not keeping up-to-date in their field. I blame the mentors and senior researchers for such incompetency.

Pioglitazone after Ischemic Stroke or Transient Ischemic Attack - insulin resistance Feb. 2016

The latest here, was it needed?

Pioglitazone therapy in patients with stroke and prediabetes: A post hoc analysis of the IRIS randomized clinical trial

JAMA — Spence JD, et al. | February 11, 2019

Researchers assessed the impact of pioglitazone and the intention-to-treat effects of pioglitazone in prediabetes patients. In patients with stroke/transient ischemic attack and prediabetes, especially in those with good adherence, pioglitazone might be effective for secondary prevention.

Methods

• The IRIS study was a randomized multicenter clinical trial in patients with previous stroke or transient ischemic attack and insulin resistance, but not diabetes.
• From February 2005 to January 2013, patients were enrolled; median follow-up was 4.8 years.
• From June to September 2018, the post hoc analyses reported here were performed.
• Per American Diabetes Association criteria, prediabetes was characterized as having a hemoglobin A1c level of 5.7% to 6.4% or fasting plasma glucose level of 100 mg/dL to 125 mg/dL (to convert to mmol/L, multiply by 0.0555).
• Researchers defined good adherence as taking 80% or more of the protocol dose.
• Participants in the study were randomized to 15 mg of pioglitazone, with dose titrated to target of 45 mg daily, or matching placebo.
• Recurrent stroke or MI was the primary outcome; stroke, acute coronary syndrome, stroke/MI/hospitalization for heart failure, and progression to diabetes were included secondary outcomes.

Results

• Among 3,876 participants analyzed in the IRIS trial, 2,885 were involved in this analysis (1,456 in the pioglitazone cohort; 1,429 in the placebo cohort).
• It was noted that the mean (SD) age of patients was 64 (11) years, and 974 (66.9%) and 908 (63.5%) of patients were in the pioglitazone and placebo cohort, respectively.
• The hazard ratios (95% CI) were 0.57 (0.39-0.84) for stroke/MI, 0.64 (0.42-0.99) for stroke, 0.47 (0.26-0.85) for acute coronary syndrome, 0.61 (0.42-0.88) for stroke/MI/hospitalization for heart failure, and 0.18 (0.10-0.33) for progression to diabetes in the prediabetic population with good adherence (644 of 1,456 individuals [44.2%] in the pioglitazone group and 810 of 1,429 [56.7%] in the placebo group).
• The data presented in this work showed a nonsignificant reduction in overall mortality, cancer, and hospitalization, a slight increase in serious bone fractures, and an increase in weight gain and edema.
• Intention-to-treat outcomes also demonstrated significant reduction of events, though to a lesser degree.
• Investigators found that hazard ratios (95% CI) were 0.70 (0.56-0.88) for stroke/MI, 0.72 (0.56-0.92) for stroke, 0.72 (0.52-1.00) for acute coronary syndrome, 0.78 (0.63-0.96), for stroke/MI/hospitalization for heart failure, and 0.46 (0.35 to 0.61) for progression to diabetes.(Whatever the hell this means!)

Read the full article on JAMA