New Research Shows ACTOS(R) (pioglitazone HCI) is Associated With a 38% Lower Risk of Heart Attack in Type 2 Diabetes

Amsterdam (ots/PRNewswire) -

- For Non-US Media Only

New research, including two studies presented this week at the
43rd Annual Meeting of the European Association for the Study of
Diabetes (EASD), further support the cardiovascular safety of
ACTOS(R) (pioglitazone HCI) and its benefits regarding improved blood
glucose and blood lipid levels for patients with type 2 diabetes. The
unique outcomes, including some clinical practice results, reinforce
the consistency of pioglitazone data and underscore that ACTOS(R) has
different effects from the other thiazolidinedione rosiglitazone due
to differences in molecular structure.

New research(1) presented at EASD has shown that therapies which
include pioglitazone are associated with significant reductions in
the risk of stroke or myocardial infarction (MI) compared to
non-thiazolidinedione therapies. This retrospective analysis of case
records from a large managed care database of diabetes patients have
shown that the adjusted relative risk of stroke for the pioglitazone
group was 20 percent lower than the group not receiving pioglitazone.
Likewise, the risk of heart attack over the study period was 38
percent lower in patients receiving pioglitazone than in those taking
an anti-diabetes drug regimen that did not include pioglitazone. John
Betteridge, Professor of Endocrinology and Metabolism at University
College, London said: "The results of this analysis are very welcome
and support the findings from the PROactive study of pioglitazone for
secondary prevention of vascular events which showed a reduction in
stroke and heart attack in this high risk population."

In addition, the GLAI study(2), also presented at EASD, further
reflects the cardioprotective strength of pioglitazone. A new
analysis of data from the first three months of this six-month
head-to-head study of pioglitazone and rosiglitazone, in which the
endpoint was the change in serum lipids, demonstrated that initial
treatment with a starting dose of pioglitazone (30 mg) was more
effective than a starting dose of rosiglitazone (4 mg) in improving
blood glucose (HbA1c) levels and lipid levels. Also, researchers
found that in addition to lowering HbA1c significantly more than
rosiglitazone, pioglitazone also significantly decreased triglyceride
levels and non-HDL cholesterol (a predictor of cardiovascular death),
and markedly improved HDL-C levels ("good" cholesterol) versus
rosiglitazone. "A likely explanation for the different effects on
heart attack and strokes between the two drugs could be the
favourable effect of pioglitazone in increasing HDL cholesterol
without adverse effects on LDL as demonstrated in the GLAI study,"
said Professor Betteridge.

The data presented at EASD add weight to a growing body of
evidence including newly published findings from a large
retrospective cohort trial published recently in the journal of
Pharmacoepidemiology and Drug Safety(3), which showed that
pioglitazone is associated with a 22 percent relative risk reduction
of hospitalization for acute myocardial infarction in patients with
type 2 diabetes compared to rosiglitazone. In addition, they
correlate with findings from a meta analysis published in the Journal
of the American Medical Association(4) which demonstrated that
pioglitazone reduces the risk of heart attack, stroke or death by 18
percent in patients with type 2 diabetes.

Notes to Editors

About pioglitazone

Pioglitazone was approved by the European Medicines Agency for the
treatment of type-2 diabetes in October 2000. The original label was
most recently extended in January 2007. 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

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 contains 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.

About PROactive

PROactive (5) was a prospective, randomized, placebo-controlled
outcomes trial. The PROactive study included 5,238 patients with type
2 diabetes and a history of macrovascular disease, who were force
titrated up to 45 mg daily of either ACTOS or placebo. (5) In this
study, there was no difference in the number of macrovascular events
between standard of care and ACTOS, and standard of care alone.
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.

The ACTOS Summary of Product Characteristics was recently revised
by the EMEA to include this reassuring cardiovascular safety data.
ACTOS is the only thiazolidinedione (TZD) with safety data from a
cardiovascular outcomes trial in its label.

About Takeda in Europe

Takeda Pharmaceuticals Europe Ltd, based in London, UK, supervises
the overall business activities of Takeda's subsidiaries in Europe
through promoting pan-European strategies.

Takeda Global Research & Development Center, Inc., based in
Deerfield, Ill., USA, and London, U.K., is a wholly owned subsidiary
of Takeda Pharmaceutical Company Limited and is responsible for
Takeda's clinical research and development in the U.S. and Europe.

Takeda Pharmaceutical Company Limited, 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,
http://www.takeda.com

ACTOS(R) (pioglitazone HCl) is a registered trademark of Takeda
Pharmaceutical Company Limited.

(1) Y. Xu et al Risk of Stroke and Myocardial Infarction Are
Reduced in Patients with Type 2 Diabetes Treated with Pioglitazone:
Results of a Retrospective, Claims-Based Study. PS130 / Abstract
#1257. Presented at EASD on 18 September, 2007.

(2) T McCall et al. Effects of 30 mg of Pioglitazone vs 4 mg of
Rosiglitazone on Hyperglycemia and Dyslipidemia: Results from a
Head-to-Head Trial. PS80 / Abstract #0865. Presented at EASD on 19
September, 2007.

(3) Gerrits et al. A comparison of pioglitazone and rosiglitazone
for hospitalization for acute myocardial infarction in type 2
diabetes. Pharmacoepidemiology and drug safety. 2007. Available
online at http://www.interscience.wiley.com. [Last accessed 6
September 2007].

(4) Lincoff et al. Pioglitazone and the risk of cardiovascular
events in patients with type 2 diabetes mellitus. JAMA. 2007; 298
(10):1216-1218

(5) JA Dormandy 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. 366:1279-89.

Contacts:
Alison Wright
Ketchum London
+44-20-7611-3662 (office)
+44-78-3573-4143 (mobile)
Charlotte James
Ketchum London
+44-20-7611-3866 (office)
+44-7771-568-915 (mobile)

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

Contact:
Contacts: Alison Wright, Ketchum London, +44-20-7611-3662 (office),
+44-78-3573-4143 (mobile); Charlotte James, Ketchum London,
+44-20-7611-3866 (office), +44-7771-568-915 (mobile)


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