London (ots/PRNewswire) -
Following a joint meeting today of the U.S. Food and Drug
Administration (FDA) Endocrinologic and Metabolic Drugs Advisory
Committee and the Drug Safety and Risk Management Advisory
Committee, Takeda Global Research & Development (TGRD) underscores
its position that ACTOS(R) (pioglitazone HCl) offers a proven safety
profile regarding the risk of cardiovascular disease.
"The breadth and depth of ACTOS data - encompassing more than
16,000 patients over the past 10 years-is consistent: Short- and
long-term studies have shown no evidence that ACTOS is associated
with an increased risk of heart attack or stroke," said Dr. Nico
Bruyniks, Director Medical and Scientific Affairs at Takeda
Pharmaceuticals Europe LTD. "Critical in this body of data is the
PROactive (PROspective PioglitAzone Clinical Trial In MacroVascular
Events) study, since the only scientific way to determine a
medication's safety is a prospective, long-term trial."
About the PROactive Study
PROactive 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. 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.
"Although drugs may be in the same class, they also can have
different clinical effects due to differences in molecular structure,
said Dr. Bruyniks. "ACTOS is an effective and appropriate treatment
option for people with type 2 diabetes. Since the introduction of
ACTOS in August 1999, almost 70 million prescriptions have been
written, covering more than 8 million patients and 4.5 million
Takeda has consistently emphasized the importance of physician
education and patient safety in all communications involving ACTOS
and has prioritized communicating the appropriate use of ACTOS in
patients with type 2 diabetes.
Advisory Committee meetings are discussions of pending
applications and other public health matters. The FDA frequently
convenes its panel of outside experts to provide guidance and
recommendations; however, the agency is not bound to follow the
recommendations. This joint committee meeting reviewed the
cardiovascular ischemic/thrombotic risks of the thiazolidinediones,
with focus on rosiglitazone, as presented by FDA and GlaxoSmithKline.
ACTOS received its first regulatory approval in July 1999 in the
United States. ACTOS was originally 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, ACTOS is indicated in the treatment of type 2 diabetes
@@start.t1@@ as monotherapy
-- in patients (particularly overweight patients) inadequately controlled
by diet and exercise for whom metformin is inappropriate because of
contraindications or intolerance
as 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
as triple oral therapy in combination with
-- metformin and a sulphonylurea, in patients (particularly overweight
patients) with insufficient glycaemic control despite dual oral
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
COMPETACT was first launched in Europe in October 2006.
Competact 15mg/850mg tablets containing 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 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,
ACTOS(R) (pioglitazone HCl) is a registered trademark of Takeda
Pharmaceutical Company Limited.
ots Originaltext: Takeda Pharmaceuticals Europe Ltd
Im Internet recherchierbar: http://www.presseportal.ch
Jocelyn M. Gerst of Takeda Global Research & Development,
+1-224-554-5542, or Alexander Watson, Ketchum, +44-(0)-20-7611-3663 &