Finally: Clinical outcome-based data in favor of thiazolidinediones

On September 12 at the 41st European Association for the Study of Diabetes meeting the results of the Prospective Pioglitazone Clinical Trial in Macrovascular Events (PROactive) were announced. As reported by Medscape the study of over 5000 type 2 diabetic patients showed a decrease in macrovascular complications in patients treated with pioglitazone (Actose). The 10% relative risk reduction for the primary composite endpoint of seven macrovascular events did not reach statistical significance. However for the composite of stroke, MI and death the 16% reduction was statistically significant.

Other findings included a highly statistically significant >50% reduction in patients needing to add long term insulin. In addition to a significant fall in HbA1C the pioglitazone group experienced a statistically significant rise in HDL and fall in triglyceride levels confirming a beneficial effect on the “metabolic syndrome”, the principal dyslipidemia of type 2 diabetes. No new safety concerns were noted in the study.

This is a significant advance because it has previously been difficult to demonstrate a beneficial effect on macrovascular disease with insulin or oral agents, with the exception of metformin. Pioglitazone and rosiglitazone were reviewed last year in NEJM.

Now will the Public Citizen Health Research Group finally remove Actose from its black list?