S. Bertolini et al., EFFICACY AND SAFETY OF ATORVASTATIN COMPA RED TO PRAVASTATIN IN PATIENTS WITH HYPERCHOLESTEROLEMIA, Perfusion, 10(11), 1997, pp. 407-413
Plasma cholesterol and other lipoproteins play a significant role in t
he development of atherosclerosis and subsequent coronary heart diseas
e (CHD), This one year study was designed to confirm the efficacy and
safety of atorvastatin compared to pravastatin, a marketed agent for l
ow density lipoprotein cholesterol (LDL-C) reduction in hypercholester
olemic patients, Patients were recruited at 26 centers in six European
countries, After a 6 week placebo baseline phase, patients were rando
mized to receive atorvastatin 10 mg or pravastatin 20 mg daily. The do
se could be doubled at week 16, if LDL-C levels remained greater than
or equal to 3.4mmol/l (135 mg/dl). Atorvastatin significantly lowered
LDL-C from baseline by 35% compared with 23% for pravastatin (p < 0.05
). A total of 72% of atorvastatin patients attained the LDL-C target l
evel of <3.4 mmol/l, compared to 26% of pravastatin patients. Atorvast
atin also significantly reduced TC, TG and apo B (p < 0.05). Safety wa
s assessed by recording adverse events and measuring clinical laborato
ry parameters. The adverse event profile was similar for both treatmen
t groups and neither treatment caused clinically relevant laboratory a
bnormalities. Atorvastatin 10 and 20 mg once daily is superior to prav
astatin 20 and 40 mg once daily in treating patients with hypercholest
erolemia.