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Comparison of efficacy and tolerability of original and generic drugs of simvastatin in patients with hyperlipidaemia and high risk of ischemic heart disease complications

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Author(s): S.N. Tolpygina | S.Y. Martsevich

Journal: Racionalʹnaâ Farmakoterapiâ v Kardiologii
ISSN 1819-6446

Volume: 4;
Issue: 5;
Start page: 21;
Date: 2008;
Original page

Keywords: hyperlipidaemia | simvastatin | original and generic drug | clinical trial.

ABSTRACT
Aim. To assess efficacy and safety of generic simvastatin, Simvahexal, in comparison with original drug of simvastatin, Zocor, in patients with hyperlipidaemia in short-term study.Material and methods. 30 patients (19 men and 11 women, 64,0Ѓ}1,8 y.o.) with low density lipoprotein (LDL) cholesterol ≥3,0 mmol/l and high cardiovascular risk were involved into the study. During 5 weeks before study including patients kept the hypolipidaemic diet and did not receive any hypolipidaemic drug. 28 patients completed study, 2 patients drop out: one patient because of nettle rash on Zocor therapy, another one – because of personal reason. Efficacy was assessed by dynamic of lipid profile and a number of patients who reached target level of LDL cholesterol (
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