Message from
the chairman,
Prof Erland
Erdmann |
|
|
2008 and 2009 have seen a number of publications of the PROactive safety and efficacy data in peer-reviewed journals. A number of our publications are available to download from this website. Please click here for reference citations and papers.
Of particular note is our recent detailed safety and tolerability analysis that was published in Drug Safety. In this paper, we reported that safety and tolerability of pioglitazone was predictable, and adverse events were not treatment-limiting. These results suggest that any beneficial effects of pioglitazone on macrovascular outcomes are accompanied by good long-term tolerability in this population of very high-risk patients with Type 2 diabetes and established CVD.
During the initial analysis of PROactive data (published in The Lancet in 2005), we found that, among the individual components within the primary composite endpoint, only the event rate of leg revascularisation (i.e. surgical bypass, atherectomy, angioplasty, or thrombolysis) was higher in the pioglitazone group than the placebo group. We investigated this further (paper published in Athersoclerosis) by comparing the outcome of patients with and without peripheral arterial disease (PAD) at baseline and showed that those without PAD at baseline seemed to benefit more from pioglitazone treatment than the overall PROactive population. Pioglitazone did not alter the macrovascular event rate in patients with PAD at baseline. Leg revascularisations occurred more commonly in the pioglitazone group than in the placebo group, but all of the difference in leg revascularisations occurred in patients with PAD at baseline, with no difference in leg revascularisations between the pioglitazone and placebo groups in patients who did not have PAD at entry. Moreover, the difference in leg revascularisation occurred entirely in the first year.
Important health economics data from the USA, Italy, Germany, and Switzerland have been published in local journals or are in press. These add to the UK data that were published in Diabetic Medicine in 2007.
Other important publications include an in press paper highlighting the sustained improvements in glycaemic control and reduced progression to insulin therapy using triple therapy of pioglitazone addition to the classical metformin-sulfonylurea combination in patients not receiving insulin at baseline and a recently published paper (American Journal of Cardiology) on the long-term lipid benefits of pioglitazone (stratified by baseline glucose-lowering regimen and statin use).
Once again, we would like to thank our National Principal Investigators for their enthusiasm and contributions to the development of these papers.
Since this website went live on 18 July 2005, these pages have been viewed over 7.5 million times by visitors from 138 countries. My colleagues and I hope that you will continue to find this resource useful for your work and studies.
Professor Erland Erdmann
Study Chairman
Köln (Cologne), Germany, August 2009 |
