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Odkazy a zdroje - Studie - ASPEN



ASPEN

The Atorvastatin Study for Prevention of Coronary Heart Disease Endpoints in Non-Insulin-Dependent Diabetes Mellitus

Author(s)
(a) Knopp RH, d'Emden M, Smilde JG, Pocock SJ.

Title(s)
(a) Efficacy and Safety of Atorvastatin in the Prevention of Cardiovascular End Points in Subjects With Type 2 Diabetes

Reference(s)
(a) Diabetes Care 29:1478–1485, 2006

Disease
Diabetes mellitus (both primary and secondary prevention)

Purpose
To assess the effect of 10 mg of atorvastatin versus placebo on CVD prevention in subjects with type 2 diabetes and LDL cholesterol levels below contemporary guideline targets

Study design
Randomised, double-blind, placebo-controlled

Follow-up
4 years

Patients
2410 male and female patients with type 2 diabetes (1905 primary prevention, 505 secondary prevention), LDL cholesterol levels below contemporary guideline targets (LDL cholesterol <140 mg/dl (3.6 mmol/l) for primary prevention or <160 mg/dl (4.1 mmol/l) for secondary prevention), and triglyceride levels <600 mg/dl (6.8 mmol/l)

Treatment regimen
Atorvastatin 10 mg per day, or placebo

Concomitant therapy
-

Results
Mean LDL cholesterol reduction in the atorvastatin group over 4 years was 29% versus placebo (P < 0.0001). When we compared atorvastatin versus placebo, composite primary end point rates were 13.7 and 15.0%, respectively (hazard ratio 0.90 [95% CI 0.73–1.12]). In the subset of 1,905 subjects without prior myocardial infarction or interventional procedure, 10.4% of atorvastatin- and 10.8% of placebo-treated subjects experienced a primary end point (0.97 [0.74– 1.28]). In the 505 subjects with prior myocardial infarction or interventional procedure, 26.2% of atorvastatin- and 30.8% of placebo-treated subjects experienced a primary end point (0.82 [0.59 –1.15]). Relative risk reductions in fatal and nonfatal myocardial infarction were 27% overall (P = 0.10) and 19% (P = 0.41) and 36% (P = 0.11) for subjects without and with prior myocardial infarction or interventional procedure, respectively.
Conclusions: Composite end point reductions were not statistically significant. The results of the ASPEN trial did not confirm the benefit of statin therapy in diabetic patients bellow the above specified, recommended targets.