Efficacy and safety of simvastatin in patients with hypercholesterolemia (results of a Multicenter Clinical Study)

• Published in: Kardiologiia Vol. 43; no. 5; p. 42
• Main Authors: Kukharchuk, V V, Bubnova, M G, Katel'nitskaia, L I, Nikitin, Iu P, Ol'binskaia, L I
• Format: Journal Article
• Language: Russian
• Published: Russia (Federation) 2003
• Subjects: Cholesterol - blood; Cholesterol, HDL - blood; Cholesterol, LDL - blood; Female; Humans; Hypercholesterolemia - blood; Hypercholesterolemia - complications; Hypercholesterolemia - drug therapy; Hyperlipidemias - blood; Hyperlipidemias - complications; Hyperlipidemias - drug therapy; Hypolipidemic Agents - administration & dosage; Hypolipidemic Agents - adverse effects; Hypolipidemic Agents - therapeutic use; Male; Middle Aged; Myocardial Ischemia - blood; Myocardial Ischemia - complications; Safety; Simvastatin - administration & dosage; Simvastatin - adverse effects; Simvastatin - therapeutic use; Time Factors; Triglycerides - blood
• ISSN: 0022-9040

To assess efficacy and safety of a generic preparation of simvastatin Vasilip (KRKA) in ischemic heart disease patients with hypercholesterolemia or combined hyperlipidemia.
Patients (n=167, age 36-73 years) with ischemic heart disease and moderate hypercholesterolemia or combined hyperlipidemia.
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.
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.
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.