Lancet publishes proactive study: Diabetes treatment reduces risk of heart attacks & strokes

October 06, 2005

London, UK, October 7, 2005 - A study published in The Lancet today shows that Takeda's ACTOS® (pioglitazone HCl), an oral glucose lowering medication, significantly reduces the combined risk of non-fatal heart attacks, strokes and deaths by an additional 16% on top of standard medication, such as statins, fibrates, ACE inhibitors, beta blockers, other glucose-lowering medications and anti-platelet drugs, in patients with type-2 diabetes with high risk of cardiovascular disease.

This means that for every 48 patients treated with ACTOS over three years one major cardiovascular event or death can be prevented.

"Seeing pioglitazone improve these cardiovascular outcomes (16% relative risk reduction) is an impressive result especially as these patients were already receiving standard treatments including the use of lipid-modifying drugs, anti-hypertensives, aspirin and other glucose-lowering agents," said Professor Ian Campbell, Consultant Physician at Victoria Hospital, Edinburgh, Scotland. He further commented, "We look forward to further analyses that I understand are being submitted to scientific meetings and to reviews of the results in the medical press during the coming year."

Dr Michael George, Managing Director of the Takeda European Research and Development Center commented, "In light of these excellent results Takeda is working on preparations for a label change for ACTOS."

Study design and results as presented at the 41st EASD meeting in Athens on September 12th 2005 PROactive (PROspective PioglitAzone Clinical Trial In MacroVascular Events) was a randomised, double-blind, placebo-controlled outcome study to determine the effects of ACTOS on mortality and morbidity associated with cardiovascular disease progression in more than 5,000 high-risk patients with type-2 diabetes when added to their standard treatment. Standard treatment included the use of anti-hypertensives such as ACE inhibitors and beta blockers; glucose lowering agents such as metformin, sulphonylureas and insulin; antiplatelet drugs such as aspirin and lipid-modifying medicines such as statins and fibrates.

The PROactive study focused on two key endpoints: a primary combination endpoint of seven different macrovascular events of varying clinical importance and a principal secondary combination endpoint of life-threatening events including non-fatal heart attacks, strokes and deaths.

The primary endpoint was reduced by 10% but had not reached statistical significance by the end of the study (p=0.095). However, the principal secondary endpoint of life-threatening events showed that ACTOS significantly reduced the combined risk of non-fatal heart attacks, strokes and deaths by 16% (p=0.027).

Data from the PROactive Study were presented at the European Association for the Study of Diabetes in Athens last month.

Additional PROactive study results of ACTOS showed:
  • HbA1c levels (a measurement of blood glucose control) were significantly reduced by 0.5% as compared to placebo (p<0.001).
  • Lipid profiles significantly improved by increasing HDL cholesterol ("good" cholesterol) by 9% more than placebo (p<0.001) and reducing triglycerides (a known cardiovascular risk factor) by 13% more than placebo (p<0.001).
  • The LDL/HDL cholesterol ratio ("bad" to "good" cholesterol) was significantly improved (p<0.001). A 2% increase in LDL cholesterol ("bad" cholesterol) was observed compared to placebo (p=0.003).
  • Systolic blood pressure was significantly decreased (p=0.03); median change of 3 mmHg as compared to placebo.

    The PROactive study was also designed to further examine the safety of ACTOS in this high-risk patient group. The results demonstrated that adverse events reported in this study were consistent with the known safety profile. Known side effects of ACTOS, including weight gain, oedema, non-serious hypoglycaemia and heart failure, were observed more frequently in the ACTOS group compared to placebo group.
    -end-
    Editors Notes
  • 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 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. Each patient was randomly assigned to either ACTOS or placebo in addition to the best standard of usual care and treatments.

  • The results on the PROactive Study are available on the PROactive website, www.proactive-results.com. This website is supported by an unrestricted educational grant by Takeda Pharmaceutical Company and Eli Lilly and Company.

    About ACTOS
    Takeda is the originator of thiazolidinedione derivatives, and ACTOS (pioglitazone HCl) is a member of the thiazolidinedione class of "insulin-sensitising" agents. Insulin sensitisers help improve the body's ability to effectively use its own insulin by reducing insulin resistance - a defect identified as a possible cause of type-2 diabetes.

    ACTOS received its first regulatory approval in July 1999 in the United States. By April 2004, more than 32 million prescriptions for ACTOS had been filled for over 4.5 million patients in the United States alone. ACTOS was originally approved by the European Medicines Agency for the treatment of type-2 diabetes in October 2000 and the label was extended in 2003. In Europe, ACTOS is indicated for use as:

  • oral monotherapy treatment at doses up to 45 mg in type-2 diabetes mellitus patients, particularly overweight patients, inadequately controlled by diet and exercise for whom metformin is inappropriate.

  • oral combination treatment at doses up to 45 mg in patients with insufficient glycaemic control despite maximum tolerated doses with either metformin (particularly in overweight patients) or sulphonylurea (in patients for whom metformin is not tolerated or is contraindicated).

    About Eli Lilly & Company
    Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organisations. Headquartered in Indianapolis, USA. Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs.

    About Takeda
    Takeda, located in Osaka, Japan, is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. Additional information about Takeda is available through its corporate website, www.takeda.com.

    Ketchum UK

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