| Authors |
Helen
M Colhoun, D John Betteridge, Paul N Durrington, Graham A Hitman, H Andrew
W Neil, Shona J Livingstone, Margaret J Thomason, Michael I Mackness, Valentine
Charlton-Menys, John H Fuller, on behalf of the CARDS investigators |
| Abstract |
BACKGROUND:
Type 2 diabetes is associated with a substantially increased risk of cardiovascular
disease, but the role of lipid-lowering therapy with statins for the primary
prevention of cardiovascular disease in diabetes is inadequately defined.
We aimed to assess the effectiveness of atorvastatin 10 mg daily for primary
prevention of major cardiovascular events in patients with type 2 diabetes
without high concentrations of LDL-cholesterol. METHODS: 2838 patients aged
40-75 years in 132 centres in the UK and Ireland were randomised to placebo
(n=1410) or atorvastatin 10 mg daily (n=1428). Study entrants had no documented
previous history of cardiovascular disease, an LDL-cholesterol concentration
of 4.14 mmol/L or lower, a fasting triglyceride amount of 6.78 mmol/L or
less, and at least one of the following: retinopathy, albuminuria, current
smoking, or hypertension. The primary endpoint was time to first occurrence
of the following: acute coronary heart disease events, coronary revascularisation,
or stroke. Analysis was by intention to treat. FINDINGS: The trial was terminated
2 years earlier than expected because the prespecified early stopping rule
for efficacy had been met. Median duration of follow-up was 3.9 years (IQR
3.0-4.7). 127 patients allocated placebo (2.46 per 100 person-years at risk)
and 83 allocated atorvastatin (1.54 per 100 person-years at risk) had at
least one major cardiovascular event (rate reduction 37% [95% CI -52 to
-17], p=0.001). Treatment would be expected to prevent at least 37 major
vascular events per 1000 such people treated for 4 years. Assessed separately,
acute coronary heart disease events were reduced by 36% (-55 to -9), coronary
revascularisations by 31% (-59 to 16), and rate of stroke by 48% (-69 to
-11). Atorvastatin reduced the death rate by 27% (-48 to 1, p=0.059). No
excess of adverse events was noted in the atorvastatin group. INTERPRETATION:
Atorvastatin 10 mg daily is safe and efficacious in reducing the risk of
first cardiovascular disease events, including stroke, in patients with
type 2 diabetes without high LDL-cholesterol. No justification is available
for having a particular threshold level of LDL-cholesterol as the sole arbiter
of which patients with type 2 diabetes should receive statins. The debate
about whether all people with this disorder warrant statin treatment should
now focus on whether any patients are at sufficiently low risk for this
treatment to be withheld. |
