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Senior Citizen Health & Medicine
Diabetes Medication Increased Good Cholesterol, May
Slow Artery Wall Thickening
Drug pioglitazone may
have potential to protect against major cardiovascular events
November 13, 2006 - A medication given to diabetics
to improve their bodys sensitivity to insulin also appears to slow the
thickening of their artery walls, according to a study of older people
with Type 2 diabetes that was posted online today by the Journal of the American
Medical Association. The drug also increased good cholesterol and has
scientists wondering if it can help prevent cardiovascular events.
The study is being released early to coincide with
its presentation at the American Heart Association Scientific Session.
It will be published in the December 6 print issue of JAMA.
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Health & Medicine |
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Individuals with diabetes, who cannot produce
sufficient amounts of insulin or respond to the insulin needed to turn
glucose into energy, have a higher risk for myocardial infarction (heart
attack), according to background information in the article.
Controlling blood pressure and low-density
lipoprotein (LDL, or bad) cholesterol has been shown to reduce some of
this excess risk. However, even with optimal control of these potent
cardiovascular risk factors, incremental risk for cardiovascular events
remains high compared with individuals without diabetes, the authors
write.
New approaches are, therefore, needed to further
reduce cardiovascular risk in patients with diabetes.
Theodore Mazzone, M.D., of the University of
Illinois at Chicago College of Medicine, and colleagues studied the
effects of a potential new approach, using a drug known as pioglitazone,
in 462 adults with type 2 diabetes in the Chicago metropolitan area
between 2003 and 2006.
Study participants had an average age of 60 and
included 289 men and 173 women; they were randomly assigned to receive a
daily dose of either pioglitazone (15 to 45 milligrams) or of
glimepiride (1 to 4 milligrams), another diabetes medication that works
through different mechanisms.
At the beginning of the study and again 24, 48 and
72 weeks later, ultrasound was used to measure the thickness of the
middle layers of the carotid arteries (which are located in the neck and
carry blood to the brain). The measurements are called carotid artery
intima-media thickness, or CIMT.
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"The less the thickening, and the slower the rate
of thickening, the less risk of heart attack in general," said
Mazzone.
The study, Mazzone said, showed that pioglitazone
significantly slowed the thickening of the carotid artery wall
compared to the other diabetes drug.
"We showed this for both the average thickness of
the wall, as well as the maximum thickness of the wall," he
said.
The beneficial effect of pioglitazone was uniform
regardless of age, sex, duration of diabetes, blood pressure,
blood cholesterol levels or blood glucose control.
The study also monitored cardiovascular clinical
events. There were four adverse events in the pioglitazone
treated group, including three patients who required coronary
revascularization. There were 10 adverse events in the
glimepiride treated group, including eight who required coronary
revascularization.
"Additional data needs to be brought to bear,"
said Mazzone, "however this is very helpful for suggesting that
pioglitazone could be a useful, novel approach for managing
cardiovascular risk in patients with diabetes." |
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Using this measurement, other studies have
suggested that thicker artery walls, and changes in artery wall
thickness over time, are associated with a higher risk for heart events.
Glycosolated hemoglobin (HbA1c) levels, a measure of blood glucose
control over an extended period, were also monitored throughout the
study, as were blood pressure, blood cholesterol levels and adverse
events.
A total of 158 (68 percent) of the pioglitazone
group and 165 (72 percent) of the glimepiride group completed the
72-week trial; 175 (76 percent) of those in the pioglitazone group and
186 (81 percent) in the glimepiride group had at least one ultrasound of
the carotid artery and were included in the artery wall thickness
analysis.
At baseline, the average CIMT was comparable in the
pioglitazone group than among and the glimepiride group (.771
millimeters vs. .779 millimeters).
At the 72-week follow-up period, the CIMT of
patients in the glimepiride group increased by an average of .012
millimeters from the beginning of the study, while the average CIMT in
the pioglitazone group decreased by .001 millimeters.
A pre-specified subgroup analysis based on age,
sex, systolic blood pressure, duration of type 2 diabetes mellitus, body
mass index, HbA1c value and statin use showed a uniform beneficial
effect of pioglitazone treatment, the authors write.
Over the course of the study, blood pressure
changes were not significantly different between the two groups. HbA1c
levels were also similar until week 48, when those in the pioglitazone
group became significantly lower than those in the glimepiride group.
High-density lipoprotein (HDL or good)
cholesterol levels increased in those taking pioglitazone by week 24 and
remained higher through 72 weeks compared with those taking glimepiride.
These measures represent potential mechanisms by
which pioglitazone reduced artery thickness, the authors write. It also
remains possible that thiazolidinediones [the class of drug that
includes pioglitazone] can have a directly beneficial effect on the
vessel wall, they continue.
Additional data will be needed to determine the
clinical significance of these findings; specifically, whether a
strategy of routine use of pioglitazone instead of glimepiride
substantially reduces major cardiovascular events, they conclude.
Co-authors include Peter Meyer, Steven Feinstein and
Michael Davidson of Rush University Medical Center; George Kondos of UIC;
Ralph D'Agostino, Sr., of Boston University; Alfonso Perez of Takeda
Global Research and Development, Inc.; Jean-Claude Provost of Synarc;
and Steven Haffner of University of Texas Health Science Center at San
Antonio.
The study was funded by Takeda.
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