LDL Cholesterol Reduction Beneficial
For Diabetic Without Coronary Disease
Statin therapy recommended for all patients
with diabetes, regardless of cholesterol levels.
Cholesterol-lowering therapy (statins) reduce
the risk of macrovascular events for people with
diabetes, even if they do not have manifest coronary
disease or elevated cholesterol levels, researchers
report.
Myocardial infarction and stroke are common causes
of major morbidity and mortality in people with
diabetes. However, blood concentrations of total
and LDL cholesterol in these patients are similar
to the general population, so most do not receive
cholesterol-lowering therapy despite their elevated
risk.
The Heart Protection Study Collaborative Group,
Oxford, United Kingdom, has conducted a study
to address whether diabetics without symptomatic
coronary diseases may benefit from LDL cholesterol
reduction.
In a randomized trial, 5963 diabetics patients
(mean age, 62.1; males, 70%) and 14,573 high-risk
patients without diagnosed diabetes (mean age,
64.7, males, 78%) received either 40 mg simvastatin
or placebo daily over a five-year period. At baseline,
the mean total LDL cholesterol was 3.2 mmol/L
for the diabetes group and 3.4 mmol/L for the
non-diabetes group. The simvastatin-allocated
participants (both diabetic and non-diabetic)
showed a 1.0-mmol/L average reduction in LDL cholesterol
compared to those receiving the placebo during
the treatment period.
Among the participants with diabetes, allocation
to simvastatin produced a 22% (95% CI 13-39, p<0.0001)
proportional reduction in the first occurrence
of any major vascular event, including major coronary
events, strokes and revascularizations. This reduction
was similar to that observed for the other high-risk
participants (24%, 95% CI 19-28, p<0.0001).
The researchers also report a highly significant
33% (95% CI 17-46, p=0.0003) proportional reduction
in first major vascular events among the 2912
diabetic patients who did not have any diagnosed
coronary or other occlusive arterial disease at
study entry, and a 27% (95% CI 13-40, p=0.0007)
proportional reduction among the 2426 diabetic
participants whose pre-treatment measurements
of LDL cholesterol were below 3.0 mmol/L.
The proportional risk reductions among all diabetic
participants appeared to be approximately a quarter
irrespective of sex, age, blood creatinine concentration,
treatment for hypertension, or body size at study
entry.
The researchers conclude these results represent
"definitive evidence that cholesterol-lowering
statin therapy can produce substantial reductions
in the risk of heart attacks, of strokes, and
of revascularizations in people with diabetes,
even if they do not already have diagnosed coronary
or other occlusive arterial disease."
They recommend that, "statin therapy should
now be considered routinely for all diabetic patients
at sufficiently high risk of such major vascular
event, irrespective of their initial cholesterol
concentrations." Lancet 2003 Jun 14;361:9374:2005-2016.
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