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Stop
Atherosclerosis
in
N
ative Diabetics
Study |
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Although
once protected from cardiovascular disease (CVD), American Indians now
have incidence rates higher than the general US
population
. The majority of CVD
cases occur in individuals with diabetes. It is therefore imperative that
intervention strategies to reduce CVD in individuals with diabetes be
developed and validated in this population.
The aim of SANDS is to
prove the effectiveness of a strategy of lowering LDL cholesterol and
blood pressure to lower targets than are currently recommended. This study will be a randomized
3-year trial to examine the effects on CVD of intensive LDL reduction
(goal <=
70 mg/dL) and
intensive blood pressure lowering (goal <=
115/75 mmHg), compared to
usual targets of <=
100 mg/dL and <=
130/85 mmHg. These cutpoints were chosen because mean LDL and blood
pressure levels are lower in this population, but there are strong
relations between LDL, blood pressure, and CVD at levels below current
targets.
The study will enroll 548 diabetic American Indian
men and women > 40 years of age and will be conducted in four
field centers involving Indian Health Service/Tribal primary care
facilities in Phoenix/Sacaton, Arizona; Chinle, Arizona; Rapid City/Pine
Ridge, South Dakota; and Lawton, Oklahoma, with input from American Indian
physicians and community members. Reports of findings will be sent to both
participants and providers. Participants will also be provided health
education. There are numerous advantages to the SANDS study design. First,
it doesn't require large numbers of participants. Second, there will only
be three years of follow-up. Third, only FDA approved drugs will be used.
Finally, endpoint tests of cardiovascular disease are safe and
painless.
Study results will provide evidence needed to develop
community-based programs to treat and prevent the epidemic of CVD among
American Indians. The data will also be valuable in understanding
the effects of intensive risk-factor reduction on atherosclerosis burden
and cardiac function in diabetic individuals in all US populations and
provide evidence for determining LDL and blood pressure treatment goals
for diabetic patients.
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