This double-blind study to evaluate long-term efficacy and safety of
atorvastatin was performed in 31 community- and university-based research centers in the USA to directly compare a new
3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitor (
reductase inhibitor) to an accepted
drug of this class in patients with moderate
hypercholesterolemia. Participants remained on a
cholesterol-lowering diet throughout the study. One thousand forty-nine patients were randomized to receive
atorvastatin 10 mg,
lovastatin 20 mg, or placebo. At 16 weeks the placebo group was randomized to either
atorvastatin or
lovastatin treatment. At 22 weeks, patients who had not met
low-density lipoprotein (
LDL) cholesterol 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, and reporting of adverse events were similar for the 2
reductase inhibitors. After 52 weeks, the
atorvastatin group maintained a significantly 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 cholesterol target levels than did
lovastatin patients (78% vs 63%, respectively), particularly those with
coronary heart disease (37% vs 11%, respectively).
Atorvastatin is highly effective and well tolerated in patients with primary
hypercholesterolemia with no increased risk of adverse events.