Diabetes Dateline
Summer 2010
Intensive Blood Pressure and
Combination Lipid Therapies Do Not
Reduce Combined Cardiovascular
Events in Adults with Diabetes
Lowering blood pressure to
below recommended levels
and treating blood lipids
with combination drug therapy
failed to significantly reduce cardiovascular
disease (CVD) events
in adults with type 2 diabetes,
according to new results from
the landmark Action to Control
Cardiovascular Risk in Diabetes
(ACCORD) clinical trial.
The ACCORD trial is one of the largest studies
ever conducted in adults with type 2 diabetes
with an especially high risk of CVD events, such
as heart attack, stroke, or death from CVD. The
multicenter clinical trial tested three strategies to
lower the risk of major CVD events: intensive
control of blood glucose, also called blood sugar;
intensive control of blood pressure; and treatment
of multiple blood lipids. The study’s primary
sponsor was the National Heart, Lung, and
Blood Institute (NHLBI) of the National Institutes
of Health (NIH). The National Institute
of Diabetes and Digestive and Kidney Diseases
(NIDDK) also provided support for the study.
ACCORD researchers from 77 medical centers
in the United States and Canada studied more
than 10,000 participants between the ages of
40 and 79 who had type 2 diabetes for an average
of 10 years. The participants also had pre-existing
CVD, evidence of subclinical CVD, or at
least two CVD risk factors. All the participants
were enrolled in the ACCORD
blood glucose treatment clinical
trial and maintained good control
of blood glucose levels during the
study. In addition, participants
were enrolled in either the blood
pressure trial or the lipid trial and
were treated and followed for an
average of about 5 years.
Results of the ACCORD blood
glucose clinical trial were reported in 2008.
That trial found that intensively lowering blood glucose to near-normal levels brought a higher risk of death for participants than standard blood glucose control. For more information, see “New Analysis of Data from the ACCORD Blood Glucose Trial.”
The results of the blood pressure and lipid trials appeared in the March 14, 2010, online edition of The New England Journal of Medicine.
In the blood pressure trial, researchers randomly assigned more than 4,700 participants with elevated blood pressure to a target systolic blood pressure of either below 140 millimeters of mercury (mmHg)—the standard group—or a normal level of below 120 mmHg—the intensive group. A variety of medications were used to reach blood pressure goals. The study found that lowering blood pressure to normal levels does not significantly reduce the risk of CVD events overall, although it may reduce the risk of stroke. More intensive blood pressure control was associated with a higher risk of serious adverse events.
In the lipid trial, researchers compared the cardiovascular effects of a statin (simvastatin) with combination therapy of a statin and a fibrate (fenofibrate) in more than 5,500 par-ticipants. Both statins and fibrates are used to treat abnormal levels of blood lipids. Statins lower low-density lipoprotein (LDL), or “bad,” cholesterol and are proven to lower CVD risk in people with diabetes. Fibrates primarily lower
fats in the blood known as triglycerides and raise
high-density lipoprotein (HDL), or “good,” cholesterol.
High triglycerides and low HDL levels
are common in people with diabetes.
Combination therapy appeared to be safe, but
it did not lower the risk of heart attack, stroke,
or death from CVD more than statins alone.
Henry Ginsberg, M.D., of Columbia University,
lead author of the lipid trial, said, “Although our
analysis suggests that certain patients may benefit
from combination therapy, this study provides
important information that should spare many
people with diabetes unneeded therapy with
fibrates.”
“ACCORD provides important evidence to help
guide treatment recommendations for adults with
type 2 diabetes who have had a heart attack or
stroke or who are otherwise at especially high
risk for cardiovascular disease,” said NHLBI
Acting Director Susan B. Shurin, M.D.
More information about research projects funded
by the NIH can be found by using the Research
Portfolio Online Reporting Tools (RePORT)
Expenditures and Results (RePORTER) tool
located at www.projectreporter.nih.gov/reporter.cfm.
The NIDDK has easy-to-read booklets and
fact sheets about diabetes. For more
information or to obtain copies, visit
www.diabetes.niddk.nih.gov.
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NIH Publication No. 10–4562
August 2010
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