E Erdmann

Dr E Erdmann, Universität zu Köln, Köln, Germany; erland.erdmann@uni-koeln.de

STUDY DESIGN

Design:

subgroup analysis of a randomised controlled trial (PROspective pioglitAzone Clinical Trial In macroVascular Events [PROactive]).

Allocation:

{concealed}*.†

Blinding:

blinded {patients, investigators, and study personnel}*.†

STUDY QUESTION

Setting:

19 European countries.

Patients:

subgroup of 2445 patients with type 2 diabetes (age range 35–75 y, 74% men, 99% white), myocardial infarction (MI) ⩾6 months before randomisation, {and a haemoglobin A_1c concentration >6.5% (or local equivalent)}*.

Intervention:

pioglitazone (n = 1230), increased in 15 mg steps from 15 mg to 45 mg over 2 months to maximum tolerable dose, or matching placebo (n = 1215).

Outcomes:

composite end points for the subgroup analysis were fatal or non-fatal MI, cardiovascular (CV) death or non-fatal MI, and CV death or non-fatal MI …