Elevated levels of serum lipids and lipoproteins are known to play a major
role in the development of atherosclerosis and subsequent coronary heart di
sease (CHD). In controlled clinical studies, atorvastatin (Sortis(R)), a ne
w 3-hydroxy-3-methyl-glutaryl-coenzyme-A (HMG-CoA)-reductase inhibitor, pro
ved to be a very effective and safe lipid-lowering agent. The aim of this o
pen-label, multicentre study (without a control group) was to confirm the e
fficacy and safety of atorvastatin in a private practice group, including 1
81 Swiss cardiologists, internists, and general practitioners. A total of 8
77 hyperlipidaemic patients requiring treatment participated in this study.
To evaluate the effectiveness of the treatment with atorvastatin over a pe
riod of 12 weeks, total plasma cholesterol (TC), HDL cholesterol, LDL chole
sterol and triglycerides (TG) were determined every 4 weeks.
The initial atorvastatin dose was 10 mg in 78% of patients and 20 mg in 22%
. The dose was doubled every 4 weeks until the target values of TC less tha
n or equal to 5.2 mmol/l and TC/HDL less than or equal to 5 were reached. A
fter 12 weeks of treatment with atorvastatin the mean reduction in TC, TC/H
DL, LDL and TG compared to baseline levels was 33, 37, 42, and 25% respecti
vely. At the same time the HDL concentration was increased by 9%. These res
ults were evidenced in patients with existing coronary heart disease, in hi
gh risk patients without manifest coronary heart disease and in patients wi
th significantly elevated lipid levels (TC >7.8 mmol/l, TC/HDL >6.5). After
treatment with atorvastatin for 12 weeks, 59% of patients had reached the
therapeutic target of TC less than or equal to 5.2 mmol/l. The target of TC
/HDL less than or equal to 5 was reached by 79%. Atorvastatin was almost wi
thout exception well tolerated, the most frequently reported side effects b
eing nausea, myalgia, and headache.
In this open-label multicentre study atorvastatin was found to be effective
and well tolerated. The observed reduction in the lipid and lipoprotein co
ncentration is in accordance with the results of published controlled studi
es. The lipid and lipoprotein concentrations were decreased significantly i
n patients with slight to moderate elevation of lipid levels as well as in
those with significantly raised values.