M. Davidson et al., COMPARISON OF ONE-YEAR EFFICACY AND SAFET Y OF ATORVASTATIN VERSUS LOVASTATIN IN PRIMARY HYPERCHOLESTEROLEMIA, Perfusion, 10(10), 1997, pp. 344-352
This double-blind study to evaluate long-term efficacy and safety of a
torvastatin was performed in 31 community-and university-based researc
h centers in the USA to directly compare a new 3-hydroxy-3-methylgluta
ryl-coenzyme A reductase inhibitor (reductase inhibitor) to an accepte
d drug of this class in patients with moderate hypercholesterolemia. P
articipants remained on a cholesterol-lowering diet throughout the stu
dy, One thousand forty-nine patients were randomized to receive atorva
statin 10 mg, lovastatin 20 mg, or placebo, At 16 weeks the placebo gr
oup was randomized to either atorvastatin or lovastatin treatment, At
22 weeks, patients who had not met low-density lipoprotein (LDL) chole
sterol target levels doubled the dose of reductase inhibitor, Efficacy
evaluation was mean percent change from baseline in LDL cholesterol,
triglycerides, total cholesterol, high-density-lipoprotein cholesterol
, and apolipoprotein B (apoB), Safety profiles as determined by change
from baseline in laboratory evaluations, ophthalmologic parameters, a
nd reporting of adverse events were similar for the 2 reductase inhibi
tors, After 52 weeks, the atorvastatin group maintained a significantl
y greater reduction in LDL cholesterol (-37% vs -29%), triglyceride (-
16% vs -8%), total cholesterol (-27% vs -21%), and apoB (-30% vs -22%)
(p < 0.05), More patients receiving atorvastatin achieved LDL cholest
erol target levels than did lovastatin patients (78% vs 63%, respectiv
ely), particularly those with coronary heart disease (37% vs 11%, resp
ectively), Atorvastatin is highly effective and well tolerated in pati
ents with primary hypercholesterolemia with no increased risk of adver
se events.