Takeda

Takeda's ACTOS(R) (pioglitazone) Reduces Risk of Further Heart Attack by 28 Percent in Patients With Type-2 Diabetes

    London, November 16 (ots/PRNewswire) -

    - For Non-US Media Only

    - PROactive Study Also Shows a 37 Percent Reduction in Acute Coronary  Syndrome With ACTOS

    New results from secondary analyses of the landmark PROactive Study found that ACTOS(R) (pioglitazone) significantly reduced the occurrence of fatal and non-fatal heart attacks and of acute coronary syndrome (ACS) in high-risk patients with type-2 diabetes who had a previous non-fatal heart attack. Importantly, these benefits were above and beyond those seen with standard of care treatment.

    The findings, which were revealed today at the 2005 American Heart Association Scientific Sessions, build on previously reported results from the PROactive Study, showing that ACTOS significantly reduced the combined risk of non-fatal heart attacks, strokes and death by 16 percent in patients with type-2 diabetes and cardiovascular disease.

    "We now know that the oral antidiabetic medication ACTOS can significantly reduce the risk of a further heart attack in patients with type-2 diabetes who have already had a heart attack. PROactive is helping map uncharted waters and will enable us to provide a better standard of care for this high-risk population with type-2 diabetes and cardiovascular disease," said Dr Michael George, Managing Director of the Takeda Europe Research and Development Centre.

    These data assessed the effects of ACTOS on cardiovascular morbidity and mortality in 2,445 high-risk patients who had previously had a heart attack, a population that tends to have a very poor outcome. The results show that in patients taking ACTOS on top of standard of care treatment:

    - The occurrence of fatal or nonfatal heart attacks was reduced by 28 percent (P=0.045)

    - The risk of acute coronary syndrome or ACS (a term used to describe a potentially life-threatening acute cardiovascular event) was reduced by 37 percent (P=0.035)

    - There was a 19 percent (P=0.034) risk reduction in the combined cardiac endpoint of cardiac death, non-fatal MI, coronary revascularisation and ACS.

    "PROactive is the largest study to look at a high-risk population with type-2 diabetes and cardiovascular disease and we know that patients with type-2 diabetes are more likely than those without diabetes to die from a heart attack or to have a further heart attack", commented Dr Michael George. "Until we know how ACTOS works to provide this life-saving benefit, the beneficial results of PROactive should not be generalised to any other oral anti-diabetic medication."

    Notes to Editors:

    About the PROactive Study

    The PROactive Study was funded by Takeda Pharmaceutical Company Limited, the makers of pioglitazone (marketed under the trade name ACTOS(R)) and Eli Lilly and Company.

    PROactive (PROspective PioglitAzone Clinical Trial In MacroVascular Events) was the first study to prospectively look at the reduction in total mortality and macrovascular morbidity using an oral anti-diabetic agent. It was a randomised, double blind, placebo-controlled outcome study of 5,238 patients with type-2 diabetes and macrovascular disease. Patients were randomised to receive either ACTOS or placebo in addition to other blood-glucose medications and on top of standard of care treatment (including the routine use of anti-hypertensives such as ACE inhibitors and beta blockers; glucose-lowering agents such as metformin, sulfonylureas and insulin; antiplatelet drugs such as aspirin, and lipid-modifying medicines such as statins and fibrates).

    This 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 death, heart attack and stroke.

    As reported at the European Association for the Study of Diabetes (EASD) Annual Meeting in September 2005, the primary endpoint was reduced by 10 percent but had not reached statistical significance by study end (P=0.095). The principal secondary endpoint of life-threatening events showed that pioglitazone significantly reduced the risk of non-fatal heart attacks, strokes and death by 16 percent (P=0.027).

    For more information, visit www.proactive-results.com. (This independent website is supported by an unrestricted educational grant by Takeda Pharmaceutical Company and Eli Lilly and Company).

    The first PROactive results were published in The Lancet on 8th October 2005. The data presented at the AHA is new analyses.

    About ACTOS

    ACTOS, an insulin sensitiser belonging to the thiazolidinedione (TZD) class of oral anti-diabetic medications, directly targets insulin resistance, a condition in which the body does not efficiently use the insulin it produces to control blood glucose levels. ACTOS is taken once daily as an adjunct to diet and exercise, and is approved for use in type-2 diabetes as monotherapy to lower blood glucose and in combination therapy with sulfonylureas or metformin.

    Takeda is the originator of thiazolidinedione derivatives, and ACTOS(r) (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 Commission for the treatment of type-2 diabetes in October 2000 and the label extended in 2003. In Europe, ACTOS is indicated for use as:

    - oral monotherapy treatment at doses up to 45mg 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 45mg 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, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs.

    About Takeda

    Takeda is an R & D oriented global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the leaders in the world, Takeda is committed to strive toward better health for individuals and progress in medicine by developing superior pharmaceutical products.

ots Originaltext: Takeda
Im Internet recherchierbar: http://www.presseportal.ch

Contact:
Contacts: Peter Impey, Ketchum London ,+44-(0)-7976-734493 (mobile),
+44-(0)-20- 611-3589. David Roberts, Takeda European Marketing
Office, +44-(0)-207-484-9088 (office)



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