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A study shows that ACTOS® reduces the risk of cardiovascular events
by an extra 16% on top of standard medication.
A study published in The Lancet shows that Takeda's ACTOS?
(pioglitazone HCl), an oral glucose lowering medication,
significantly reduces the combined risk of non-fatal heart
attacks, strokes and deaths by an additional 16% on top of
standard medication, such as statins, fibrates, ACE
inhibitors, beta blockers, other glucose-lowering
medications and anti-platelet drugs, in patients with type-2
diabetes with high risk of cardiovascular disease.
This means that for every 48 patients treated with ACTOS over
three years one major cardiovascular event or death can be
"Seeing pioglitazone improve these cardiovascular outcomes (16%
relative risk reduction) is an impressive result especially as these
patients were already receiving standard treatments including the
use of lipid-modifying drugs, anti-hypertensives, aspirin and other
glucose-lowering agents," said Professor Ian Campbell, Consultant
Physician at Victoria Hospital, Edinburgh, Scotland. He further
commented, "We look forward to further analyses that I understand
are being submitted to scientific meetings and to reviews of the
results in the medical press during the coming year."
Dr Michael George, Managing Director of the Takeda European
Research and Development Center commented, "In light of these
excellent results Takeda is working on preparations for a label
change for ACTOS."
Study design and results as presented at the 41st EASD meeting in
Athens on September 12th 2005 PROactive (PROspective PioglitAzone
Clinical Trial In MacroVascular Events) was a randomised,
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 their standard
treatment. Standard treatment included the use of anti-hypertensives
such as ACE inhibitors and beta blockers; glucose lowering agents
such as metformin, sulphonylureas and insulin; antiplatelet drugs
such as aspirin and lipid-modifying medicines such as statins and
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The PROactive 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 non-fatal heart
attacks, strokes and deaths.
The primary endpoint was reduced by 10% but had not reached
statistical significance by the end of the study (p=0.095). However,
the principal secondary endpoint of life-threatening events showed
that ACTOS significantly reduced the combined risk of non-fatal
heart attacks, strokes and deaths by 16% (p=0.027).
Data from the PROactive Study were presented at the European
Association for the Study of Diabetes in Athens last month.
Additional PROactive study results of ACTOS showed:
HbA1c levels (a measurement of blood glucose control) were
significantly reduced by 0.5% 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 as compared to placebo.
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, oedema, non-serious hypoglycaemia and
heart failure, were observed more frequently in the ACTOS group
compared to placebo group.
The PROactive Study was funded by Takeda Pharmaceutical Company
Limited, the makers of pioglitazone (marketed under the trade name
ACTOS) and Eli Lilly and Company.
The PROactive Study involved 5,238 patients in 19 European
countries who had experienced one or more cardiovascular events such
as a heart attack, coronary artery bypass surgery or stroke. Each
patient was randomly assigned to either ACTOS or placebo in addition
to the best standard of usual care and treatments.