If all of the patients were treated with statins, would there still be an effect of pioglitazone?
At baseline, statin use or non-use did not predict beneficial response to pioglitazone. Use of statins at baseline was not different between pioglitazone and placebo groups. The majority of patients in PROactive were treated with statins. The protocol specified that patients were to receive best standard of care treatment. The variability between the 25 predefined subgroups of baseline characteristics in terms of CV outcomes, including the use or non-use of statins at baseline, was not more than expected by chance alone. Therefore, the best estimate of treatment effect for any and all subgroups is the same as that for the entire PROactive cohort as a whole.
