On the occasion of the 2nd International Congress on Prediabetes and the Metabolic Syndrome held in Barcelona, Spain, April 25-28, 2007, the initiation of the Acarbose Cardiovascular Evaluation (ACE) was announced. This new trial, sponsored by Bayer Schering Pharma, will investigate the effects of Bayer's oral antidiabetes drug containing acarbose, Glucobay®*, on preventing recurrent cardiovascular disease (CVD) and type 2 diabetes in individuals with CVD and prediabetes.

Trial to measure secondary prevention of CVD

ACE will have a randomised, placebo-controlled design, recruiting approximately 7,500 individuals with CVD, who also have pre-diabetes, from approximately 150 specialist centers in China and Hong Kong. Patients will receive acarbose or matching placebo for a minimum of 4 years in addition to optimised CVD management. The trial will assess, as the primary endpoint, the effect of acarbose on the occurrence of new cardiovascular events (secondary CVD prevention). It will also assess the occurrence of new-onset type 2 diabetes (primary diabetes prevention) as a secondary endpoint. Final trial results are expected in 2013.

The ACE trial will be co-chaired by Professor Rury Holman, University of Oxford Diabetes Trials Unit, United Kingdom, and Professor Pan Chang-Yu, University of Beijing, China. It will be coordinated by the University of Oxford Diabetes Trials Unit, which will set up a project office in China.

"This-trial, an academic collaboration with Bayer HealthCare, provides an important opportunity to confirm the cardiovascular findings of STOP-NIDDM. ACE will be conducted in China and Hong Kong, but its findings will be of relevance worldwide," said Professor Holman, who represented the independent research group in Barcelona.

"We hope to expand our knowledge of acarbose as an important treatment for the primary prevention of type 2 diabetes and a possible option for the secondary prevention of CVD through ACE," said Dr. Thorsten Petruschke, Bayer Schering Pharma, Head Global Scientific Affairs Management Metabolism, Business Unit Primary Care. "Acarbose is currently the only oral antidiabetes drug approved for the treatment of prediabetes."

It is anticipated that ACE will support and extend the findings of the Study to Prevent Non-Insulin Dependent Diabetes Mellitus (STOP-NIDDM) a randomised, placebocontrolled trial was carried out in Europe and North America. It was found that acarbose significantly reduced the risk of progressing from pre-diabetes to type 2 diabetes by 36% (primary diabetes prevention), and significantly lowered the risk of a first cardiovascular event by 49% (primary CVD prevention), including a 91% reduction in the risk of myocardial infarction (MI).

Experts note that the Euro Heart Survey 1 and the China Heart Survey2 have established the close relationship between coronary heart disease and dysglycaemia. As a result of these and other data, the recent joint European Society of Cardiology (ESC) and European Association for the Study of Diabetes (EASD) guideline on dysglycaemia and CVD encourages closer collaboration between diabetologists and cardiologists to improve the diagnosis and management of both diseases. The guideline recommends early and direct intervention to prevent CVD and diabetes once pre-diabetes has been confirmed by an oral glucose tolerance test.

Patient selection for ACE

Individuals must be at least 50 years old, have confirmed CVD (MI, as well as stable and unstable angina) and be shown to have impaired glucose tolerance (IGT) to be included in ACE. Patients will be excluded from the trial if they have a previous history of type 2 diabetes, have suffered a cardiovascular event within the previous 3 months, or have undergone or plan to have cardiovascular surgery. Patients will receive international standard-of-care therapy for their existing CVD during the trial, and will attend regular visits at which physiological and safety parameters will be checked.

A typical 'start low, go slow' dose titration regimen will be used in the trial to optimize acarbose treatment. Patients will initially receive acarbose 50 mg or matching placebo once daily, with the dosage increasing gradually to a maximum of 50 mg three times daily.

Bayer HealthCare

Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma and as Bayer HealthCare Pharmaceuticals in the US and Canada. Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide.
www.bayerhealthcare.com

Bayer Schering Pharma

Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, Specialized Therapeutics and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life.
www.bayerscheringpharma.de

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