EASD

European Association for the Study of Diabetes

Results of PROactive

PROspective pioglitAzone Clinical Trial In macroVascular Events

 LAY PRESS RELEASE – Press Embargo Athens, 12 September, 16:00 EEST

 LANDMARK STUDY SHOWS PIOGLITAZONE REDUCES HEART ATTACKS AND STROKES IN PATIENTS WITH TYPE 2 DIABETES

 Landmark data from the PROactive Study*, presented today at the largest International scientific meeting on diabetes research, the 41 st Annual Meeting of EASD**, demonstrated that pioglitazone significantly reduces the risk of heart attacks, strokes and death in high risk patients with Type 2 Diabetes.

 This result is a breakthrough for these patients who are at high risk from heart attacks, strokes or premature death, as it is the first time that an oral diabetes medication has shown significant reductions in these cardiovascular events.

“The PROactive Study found that pioglitazone has the potential to save lives and help delay or reduce the risk of cardiovascular events such as heart attacks or strokes in people with Type 2 Diabetes said Professor Dormandy M.D., Professor of Vascular Sciences at St. George’s Hospital, London, UK, and chairman of the PROactive Study steering committee.

John Dormandy further explained,  “The PROactive Study is the first study in the world to show that a specific diabetes medication, namely pioglitazone, normally used to control blood glucose, can also significantly improve patient outcomes associated with cardiovascular disease in patients with Type 2 Diabetes, which means that people with Type 2 Diabetes can potentially benefit from longer and healthier lives if they are prescribed pioglitazone” said Professor Dormandy M.D., Professor of Vascular Sciences at St. George’s Hospital, London, UK, and chairman of the PROactive Study steering committee.

According to the websites of the International Diabetes Federation (IDF) and the World Health Organisation (WHO), Type 2 Diabetes affects over 150 million people worldwide with the prevalence predicted to nearly double within the next 15 years.

The IDF further highlights that Type 2 Diabetes is associated with an increased risk of coronary heart disease, heart attacks, strokes and premature death, and that life expectancy for patients with Type 2 Diabetes is as much as 10 years shorter than in the general population, mainly because of increased cardiovascular mortality.

About the PROactive Study.

The full name of the PROactive Study is  “PROspective PioglitAzone Clinical Trial In MacroVascular Events Study”.

• The PROactive Study involved 5,238 patients in 19 European countries who had experienced one or more cardiovascular events such as a heart attack, coronary artery bypass surgery or stroke.
• The PROactive Study was funded by Takeda Pharmaceutical Company Limited, the makers of pioglitazone (marketed under the trade name ACTOS ® ) and Eli Lilly and Company.
• **The results from the landmark three year PROactive Study were presented at the 41 st European Association for the Study of Diabetes (EASD) Annual Meeting, by Professor John Dormandy and other members of the PROactive Executive Steering Committee.
• These results are expected be published in The Lancet on September 17 th 2005. The Lancet paper will be on-line on September 12 th 2005.
• There were no unexpected adverse events.

For more information from the EASD please contact
Dr. Monika Grüßer Email: monikagruesser@easd.org