Welcome to the official results website of PROactive, the landmark clinical trial investigating the effect of pioglitazone on CV morbidity and mortality in type 2 diabetes patients.

2007 was another busy year for the PROactive Executive Committee. Publication in peer-review journals of the important data presented at earlier congresses became a priority for us and we have now published a number of papers from subgroups of patients enrolled in PROactive. In particular, the prespecified subgroup analysis showing a significant 28% risk reduction of recurrent MI with pioglitazone (presented at AHA 2005) has been published in JACC and the previous stroke analysis showing a significant 47% reduced risk of recurrent fatal/non-fatal stroke (presented at WCC 2006) has been published in Stroke. Our detailed analysis of the HF cases in PROactive that has been published in Diabetes Care highlights that, although the incidence of serious HF was increased with pioglitazone compared with placebo in our high CV-risk patient population, subsequent mortality or morbidity was not. Other important publications include MACE and chronic kidney disease subgroup analyses. A number of our publications are available to download from this website. Please click here. We would like to thank our National Principal Investigators for their enthusiasm and contributions to the development of these papers.

Important data from PROactive were again presented at ADA and EASD in 2007, with a particular focus on cost-effectiveness analyses using the CORE model. Health economics data from the USA, Germany and Switzerland were presented during poster sessions and build upon the UK data that were published in Diabetic Medicine last year. The abstracts and posters can be viewed by clicking here.

The importance of PROactive has been highlighted by the recent controversy surrounding the possible increased risk of ischaemic myocardial events with rosiglitazone, as reported in several meta-analyses, resulting in a subsequent label changes for all products containing rosiglitazone. In contrast, data from PROactive show that pioglitazone was associated with a significant reduction in the hard macrovascular events and, as such, PROactive provides the only robust CV outcomes data for a TZD to date.

Since this website went live on 18 July 2005, these pages have been viewed over 6.5 million times by visitors from 133 countries. My colleagues and I hope that you will continue to find this resource useful for your work and studies and would gladly accept your proposals for improvement of this website.  Please do return here regularly as we update the information and analyses continually.

Professor Erland Erdmann
Study Chairman
Köln (Cologne), Germany, 31st March 2008