Can the results of PROactive be extrapolated to all people with diabetes?
There are many unanswered questions that preclude the assumption that pioglitazone would be an effective CVD intervention therapy in other patients with diabetes. First, subjects who participated in PROactive had both diabetes and documented extensive macrovascular disease. They were at high risk of having another vascular event and, therefore, were an appropriate group to determine if treatment with pioglitazone reduced the probability of having a subsequent CVD event. The PROactive trial design, however, leaves uncertain the question of whether people with diabetes who do not have documented macrovascular disease would also benefit, and if so, whether the benefits would outweigh the risks. Second, in excess of 98% of the subjects who participated in the study were Caucasian. Therefore, it is not known whether the risks and benefits would be the same in other ethnic groups. Third, over 95% of the participants were taking some other form of diabetes therapy. Additional studies will be
