[Efficacy and safety of simvastatin in patients with hypercholesterolemia (results of a Multicenter Clinical Study)].
OBJECTIVE
To assess efficacy and safety of a generic preparation of simvastatin Vasilip (KRKA) in ischemic heart disease patients with hypercholesterolemia or combined hyperlipidemia.


METHODS
Patients (n=167, age 36-73 years) with ischemic heart disease and moderate hypercholesterolemia or combined hyperlipidemia.


METHODS
Duration of simvastatin administration was 12 weeks. All patients received 20 mg/day for 6 weeks. Then those patients who did not achieve target low density lipoprotein (LDL) cholesterol level (3.0 mmol/l) were given 40 mg/day for 6 more weeks. Other patients continued to take 20 mg/day.


RESULTS
The use of Vasilip was associated with lowering of total, LDL cholesterol and triglycerides (by 28, 39 and 10%, respectively) and 18% elevation of high density lipoprotein cholesterol. Target LDL CH level was achieved in 107 patients (66.9%). In 47 patients (29.4%) LDL CH concentration remained higher than target level but decrease of LDL CH exceeded 10%. Six patients (3.8%) did not respond to therapy. Treatment was stopped because of adverse effects in 2.4% of patients.


CONCLUSIONS
A generic preparation of simvastatin Vasilip in a 12-week open noncomparative study demonstrated substantial lipid lowering activity and did not induce serious adverse reactions.
Kukharchuk
V V
VV
Bubnova
M G
MG
Katel'nitskaia
L I
LI
Nikitin
Iu P
IuP
Ol'binskaia
L I
LI
D002784:Cholesterol / Q000097:blood; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D005260:Female; D006801:Humans; D006937:Hypercholesterolemia / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D006949:Hyperlipidemias / Q000097:blood / Q000150:complications / Q000188:drug therapy; D000960:Hypolipidemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000097:blood / Q000150:complications; D012449:Safety; D019821:Simvastatin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D014280:Triglycerides / Q000097:blood
D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D000960:Hypolipidemic Agents; D014280:Triglycerides; D002784:Cholesterol; D019821:Simvastatin