Alle Storys
Keine Story von Takeda mehr verpassen.


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
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
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 (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.
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
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.


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)

Weitere Storys: Takeda
Weitere Storys: Takeda