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

Aim: To assess efficacy and safety of a generic preparation of simvastatin Vasilip (KRKA) in ischemic heart disease patients with hypercholesterolemia or combined hyperlipidemia.

Material: 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.

Conclusion: 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.