LINCOLNSHIRE, Ill., Sept. 12 /PRNewswire/ -- Landmark data from the
PROactive Study, presented today at the 41st meeting of the European
Association for the Study of Diabetes (EASD) demonstrated that ACTOS(R)
(pioglitazone HCl) significantly reduced the combined risk of heart attacks,
strokes and death by 16% in high-risk patients with type 2 diabetes.
"The PROactive study is the first in the world to prospectively show that
a specific oral glucose lowering medication, namely pioglitazone, can
significantly improve cardiovascular outcomes by helping to delay or reduce
heart attacks, strokes and death in high-risk patients," said John Dormandy,
M.D., professor of Vascular Sciences at St. George's Hospital, London, UK, and
chairman of the PROactive Study Steering Committee. "This groundbreaking study
gives new hope to people with type 2 diabetes who, despite their attempts to
control blood glucose and take medications, fear these life-threatening
events."
PROactive (PROspective PioglitAzone Clinical Trial In MacroVascular
Events) was a randomized, double blind, placebo-controlled outcome study to
determine the effects of ACTOS on mortality and morbidity associated with
cardiovascular disease progression in more than 5,000 high risk patients with
type 2 diabetes when added to standard of care treatment.
Standard of care included 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.
Compelling Study Results
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.
The primary endpoint was reduced by 10% 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 heart attacks, strokes and death by 16% (p=0.027).
According to Professor Dormandy, these results predict that 10 heart
attacks, strokes or deaths will be prevented for every 500 high-risk patients
treated with ACTOS(R) (pioglitazone HCl) over three years. Additional
PROactive study results of ACTOS showed:
* HbA1c levels (a measurement of long-term blood glucose control) were
significantly reduced as compared to placebo (p<0.001).
* Lipid profiles significantly improved by increasing HDL cholesterol
("good" cholesterol) by 9% more than placebo (p<0.001), and reducing
triglycerides (a known cardiovascular risk factor) by 13% more than
placebo (p<0.001).
* The LDL/HDL cholesterol ratio ("bad" to "good" cholesterol) was
significantly improved (p<0.001). A 2% increase in LDL cholesterol
("bad" cholesterol) was observed compared to placebo (p=0.003).
* Systolic blood pressure was significantly decreased (p=0.03); median
change of 3 mmHg more than produced by placebo.
* The number of patients needing to have insulin added permanently to
their treatment was 50% less than placebo (p<0.001).
The PROactive Study was also designed to further examine the safety of
ACTOS in this high-risk patient group. The results demonstrated that adverse
events reported in this study were consistent with the known safety profile.
Known side effects of ACTOS, including weight gain, edema, non-serious
hypoglycemia and heart failure were observed more frequently compared to
placebo. However, the benefits of ACTOS in the study outweighed the risks. In
addition, there were no reports of acute liver toxicity.
"ACTOS has demonstrated a unique profile in earlier comparative clinical
studies by providing benefits beyond glycemic control on markers of
cardiovascular risk," commented Dr Kitazawa, a member of the board of Takeda
Pharmaceutical Company, Osaka, Japan. "However, the clinical significance of
these effects of pioglitazone was unknown until we knew the exciting news from
the PROactive Study. Additional clinical studies are being funded by Takeda to
further improve our understanding of how ACTOS enables the results we have
seen in the PROactive study, specifically the reduction in risk of heart
attacks, strokes and deaths."
Professor Dormandy added, "Until we know how pioglitazone works to provide
these life-saving benefits, the beneficial results of PROactive should not be
generalized to any other glucose-lowering medication."
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.
The results in slide format and other information on the PROactive Study
are available on the global PROactive website, http://www.proactive-results.com.
(This independent website is supported by an unrestricted educational grant by
Takeda Pharmaceutical Company and Eli Lilly and Company.)
ACTOS, an insulin sensitizer 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 insulin, sulfonylureas
or metformin.
Important Product Information
ACTOS is not for everyone. ACTOS can cause fluid retention that may lead
to or worsen heart failure, so tell your doctor if you have a history of these
conditions. Talk to your doctor immediately if you experience rapid weight
gain, fluid retention, or shortness of breath while taking ACTOS. If you have
moderate to severe heart failure, ACTOS is not recommended. Your doctor should
perform a blood test to check for liver problems before you start ACTOS and
periodically thereafter.
Do not take ACTOS if you have active liver disease. Talk to your doctor
immediately if you experience nausea, vomiting, stomach pain, tiredness, loss
of appetite, dark urine, or yellowing of the skin. If you are of childbearing
age, talk to your doctor before taking ACTOS as it could increase your chance
of becoming pregnant. Some people taking ACTOS may experience flu-like
symptoms, mild to moderate swelling of legs and ankles, and anemia. When
taking ACTOS with insulin or sulfonylureas, you may be at risk for low blood
glucose.
Eli Lilly and 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 organizations. Headquartered in
Indianapolis, Ind., Lilly provides answers-through medicines and information-
for some of the world's most urgent medical needs. Additional information
about Lilly is available on http://www.lilly.com.
Takeda Pharmaceuticals North America, Inc.
Based in Lincolnshire, Ill., Takeda Pharmaceuticals North America, Inc. is
a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, the
largest pharmaceutical company in Japan. In the United States, Takeda
currently markets oral diabetes, insomnia and cholesterol-lowering treatments,
and through the Takeda Global Research & Development Center, Inc., the company
has a robust pipeline with compounds in development for diabetes,
cardiovascular disease and other conditions. Takeda is committed to striving
toward better health for individuals and progress in medicine by developing
superior pharmaceutical products. To learn more about the company and its
products, visit http://www.tpna.com.
ACTOS(R) (pioglitazone HCl) is a registered trademark of Takeda
Pharmaceutical Company Limited and used under license by Takeda
Pharmaceuticals North America, Inc. and Eli Lilly and Company. Please visit
the ACTOS website at http://www.actos.com for complete Prescribing Information.
SOURCE Takeda Pharmaceuticals North America, Inc.
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Related links:
http://www.tpna.com
http://www.actos.com:
CONTACT:
Jocelyn M. Gerst of Takeda Pharmaceuticals
North America +33-674-030-359 (on site cell), +1-847-383-3696
(office); or Amy Losak of Ketchum PR-New York, +1-917-865-6688
(cell), or +1-646-935-3917, (office), or Tina Parisi, Ketchum
PR-New York, +44-7801-127-412 (on site cell) +1 646 935 3959
(office)
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