W. Insull et al., Translated Paper: Comparison of efficacy and safety of atorvastatin (10 mg) and simvastatin (10 mg) at six weeks., PERFUSION, 14(6), 2001, pp. 244-250
The 6-week efficacy and safety of atorvastatin versus simvastatin was deter
mined during a 54-week, open-label, multicenter, parallel-arm, treat-to-tar
get study. In all, 1,424 patients with mixed dyslipidemia (triglyceride 200
to 600 mg/dl [2.26 to 6.77 mmol/L]) were stratified to 1 of 2 groups (diab
etes or no diabetes). Patients were then randomized to receive either atorv
astatin 10 mg/day (n = 730) or simvastatin 10 mg/day (n = 694), Efficacy wa
s determined by measuring changes from baseline in lipid parameters includi
ng low-density lipoprotein (LDL) cholesterol, total cholesterol, triglyceri
des, and apolipoprotein B, Compared with simvastatin, atorvastatin produced
significantly greater (p < 0.0001) reductions from baseline in LDL cholest
erol (37.2 % vs 29.6 %), total cholesterol (27.6 % vs 21.5 %), triglyceride
s (22.1 % vs 16.0 %), the ratio of LDL cholesterol to high-density Lipoprot
ein (HDL) cholesterol (41.1% vs 33.7 %), and apolipoprotein B (28.3 % vs 21
.2 %), and a comparable increase from baseline in HDL cholesterol (7.4 % vs
6.9 %), Atorvastatin was also significantly (p < 0.0001) more effective th
an simvastatin at treating the overall patient population to LDL cholestero
l goals (55.6 % vs 38.4 %), Fewer than 6 % of patients in either treatment
group experienced drug-attributable adverse events, which were mostly mild
to moderate in nature. Diabetic patients treated with either statin had saf
ety characteristics similar to nondiabetics, with atorvastatin exhibiting s
uperior efficacy to simvastatin. In conclusion, atorvastatin, at a dose of
10 mg/day, is more effective than simvastatin 10 mg/day at lowering lipids
and reaching LDL cholesterol goals in patients with mixed dyslipidemia. Bot
h statins are well tolerated with safety profiles similar to other members
of the statin class.