New Data Showed ACTOS(R) (pioglitazone HCl) Prevented Progression of Atherosclerotic Plaque Volume in Patients With Type 2 Diabetes

Chicago (ots/PRNewswire) -

- Data Expands Body of Evidence in High Risk Population Using
IVUS, a Unique Marker for Coronary Atherosclerosis

New data from a clinical trial using intravascular ultrasound
(IVUS) technology found that in patients living with type 2 diabetes,
ACTOS(R) (pioglitazone HCl) reduced the atherosclerotic burden in the
coronary arteries compared to the sulphonylurea glimepiride, and
prevented progression compared to baseline.

Results from the PERISCOPE (Pioglitazone Effect on Regression of
Intravascular Sonographic Coronary Obstruction Prospective
Evaluation) trial have today been simultaneously presented as a late
breaker at the 57th Annual Scientific Session of the American College
of Cardiology and published on-line by the Journal of the American
Medical Association (JAMA).

PERISCOPE is the first clinical trial to examine the effects of
an oral antidiabetic medication on the development of coronary
atherosclerosis in patients with type 2 diabetes using IVUS
technology. IVUS measures the volume of plaque build-up in the
coronary arteries, a marker of coronary atherosclerosis. The 18-month
trial, involving 543 patients, was conducted in 97 centres in the
USA, Canada and Latin America.

The analysis demonstrated a statistically significant difference
in percent change in coronary artery atheroma volume (PAV) in favour
of ACTOS treatment compared to glimepiride treatment. The data showed
that patients treated with glimepiride exhibited progression of
coronary atherosclerosis, whilst in contrast the ACTOS arm showed no
progression of coronary atherosclerosis over the 18-month period from
the initial baseline measurement.

"The findings of PERISCOPE represent a fundamental observation
demonstrating that pioglitazone, in addition to controlling blood
sugar, favourably influences the development of coronary artery
atherosclerosis, the process that is responsible for the premature
death of 80 percent of type 2 diabetic patients," commented Mark
Kearney, Professor of Cardiology, University of Leeds, UK.

"This is further robust evidence that pioglitazone has a
beneficial effect on coronary atherosclerosis in patients with
diabetes. Importantly, this effect is seen on top of good treatment
with statins and other cardiovascular drugs," added Martin Cowie,
Professor of Cardiology, National Heart & Lung Institute, Imperial
College London.

Cardiovascular safety data was collected by looking at
macrovascular events and episodes of congestive heart failure (CHF).
The number of episodes of a common cardiovascular endpoint of
cardiovascular mortality, non-fatal MI, or non-fatal stroke was 6
(2.2 percent) in glimepiride patients and 5 (1.9 percent) in
ACTOS-treated patients. The number of hospitalisations due to CHF
were equivalent in both arms. In the ACTOS-treated group, eight
patients experienced a bone fracture, none involving the hip or
spine.

This trial adds to the body of cardiovascular data for ACTOS.
ACTOS studies, conducted over the past 10 years in more than 16,000
patients, including short- and long-term trials, as well as
prospective and observational studies, have shown no evidence that
ACTOS is associated with an increased risk of heart attack, stroke,
or death.

The data are consistent with the findings of the CHICAGO (Carotid
intima-media tHICkness in Atherosclerosis using pioGlitazOne) trial.
Both PERISCOPE and CHICAGO support the findings of the PROactive
(PROspective PioglitAzone Clinical Trial In MacroVascular Events)
trial, which showed that ACTOS was not associated with an increased
risk of heart attack, stroke or death.

Atherosclerosis is a condition that leads to reduced or blocked
blood flow, and is accelerated in patients with type 2 diabetes.
Atherosclerosis-related cardiovascular disease is the leading cause
of death and disability in people with type 2 diabetes. Published
data shows that slowed progression and reductions in atheroma volume
lessens the incidence of a second heart attack.

Note to Editors

CHICAGO

The CHICAGO (Carotid intima-media tHICkness in Atherosclerosis
using pioGlitazOne) trial, published in JAMA in 20061, demonstrated
that ACTOS significantly slowed progression of carotid intima-media
thickness (CIMT) in patients with type 2 diabetes, compared with the
sulphonylurea glimepiride, over an 18-month period. CIMT is a marker
of coronary atheroscelerosis and independently predicts subsequent
cardiovascular events.

PROactive

In PROactive, a cardiovascular outcome study, 5238 patients with
type 2 diabetes mellitus and preexisting major macrovascular disease
were randomised to pioglitazone or placebo in addition to existing
antidiabetic and cardiovascular therapy, for up to 3.5 years2.
Although the study failed regarding its primary endpoint, which was a
composite of all-cause mortality, non-fatal myocardial infarction,
stroke, acute coronary syndrome, major leg amputation, coronary
revascularisation and leg revascularisation, the results suggest that
there are no long-term cardiovascular concerns regarding use of
pioglitazone. However, the incidences of oedema, weight gain and
heart failure were increased. No increase in mortality from heart
failure was observed.

ACTOS(R) (pioglitazone HCl)

In Europe, pioglitazone is indicated in the treatment of type 2
diabetes mellitus as: Monotherapy

- in patients (particularly overweight patients) inadequately
controlled by diet and exercise for whom metformin is inappropriate
because of contraindications or intolerance

Dual oral therapy in combination with

- Metformin, in patients (particularly overweight patients) with
insufficient glycaemic control despite maximal tolerated dose of
monotherapy with metformin

- A sulphonylurea, only in patients who show intolerance to
metformin or for whom metformin is contraindicated, with insufficient
glycaemic control despite maximal tolerated dose of monotherapy with
a sulphonylurea.

Triple oral therapy in combination with

- metformin and a sulphonylurea, in patients (particularly
overweight patients) with insufficient glycaemic control despite dual
oral therapy.

Pioglitazone is also indicated for combination with insulin in
type 2 diabetes mellitus patients with insufficient glycaemic control
on insulin for whom metformin is inappropriate because of
contraindications or intolerance.

Pioglitazone is contraindicated in patients with:

- Hypersensitivity to the active substance or to any of the
excipients

- Cardiac failure or history of cardiac failure (NYHA stages I to
IV)

- Hepatic impairment

- Diabetic ketoacidosis.

Some patients with long-standing type 2 diabetes mellitus and
heart disease or previous stroke who were treated with Actos and
insulin experienced the development of heart failure. Patients should
consult their doctor as soon as possible if they experience signs of
heart failure such as unusual shortness of breath or rapid increase
in weight or localised swelling (oedema).

Takeda also manufactures Competact(R), which combines two widely
used diabetes treatments (metformin and pioglitazone) in a convenient
single tablet, to be taken twice daily. COMPETACT(R) was first
launched in Europe in October 2006. Competact(R) 15mg/850mg tablets
contain 15mg pioglitazone as hydrochloride and 850mg of metformin
hydrochloride.

Indication: Treatment of type 2 diabetes mellitus patients,
particularly overweight patients, who are unable to achieve
sufficient glycaemic control at their maximally tolerated dose of
oral metformin alone.

Takeda Global Research & Development Center

Based in Deerfield, USA, and London, Takeda Global Research &
Development Center, Inc. is a wholly owned subsidiary of Takeda
Pharmaceutical Company Limited, the largest pharmaceutical company in
Japan. Takeda Global Research & Development was established in 2004
and is responsible for Takeda's clinical research and development in
the U.S. and Europe, supporting clinical and product development
activity for Takeda commercial organizations in the U.S. - Takeda
Pharmaceuticals North America, Inc, and in Europe: six sales and
marketing companies, respectively. With a robust pipeline of
compounds in development for diabetes, cardiovascular disease and
other conditions, Takeda rapidly brings innovative products to market
to improve patient health and enhance the practice of medicine. To
learn more about the company, visit http://www.tgrd.com.

References

1) Mazzone T, Meyer P, Feinstein SB et al. Effect of Pioglitazone
Compared with Glimepiride on Carotid Intima-Media Thickness in Type 2
Diabetes. JAMA 2006; 296: 2572-2581

2) Dormandy JA, Charbonnel B, Eckland DJA et al. Secondary
Prevention of Macrovascular Events in Patients with Type 2 Diabetes
in the PROactive Study (PROspective pioglitAzone Clinical Trial In
macroVascular Events): A Randomised Controlled Trial. Lancet 2005;
336:1279-89

ots Originaltext: Takeda Pharmaceuticals Europe Ltd
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Contacts: Richard Kenyon Takeda Pharmaceuticals Europe
+44-207-632-9351 (E.U. office); Helen Crow Ketchum +44-207-611-3654
helen.crow@ketchum.com


	hier anmelden...