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A comparative study of efficacy and tolerability of original and generic simvastatin in patients with hyperlipidemia

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Author(s): V.P. Voronina1 | S.N. Tolpygina | N.P. Kutishenko | N.A. Dmitrieva | Yu.V. Lukina | S.Yu. Martsevich

Journal: Racionalʹnaâ Farmakoterapiâ v Kardiologii
ISSN 1819-6446

Volume: 7;
Issue: 6;
Start page: 698;
Date: 2011;
Original page

Keywords: atherosclerosis | statins | the original drug | generics.

ABSTRACT
Aim. To study efficacy and tolerability of original and generic simvastatin in patients with hyperlipidemia.Material and methods. Patients (6 men and 24 women) aged 38 to 77 years, which needed in lipid-lowering therapy were included into the open, crossover, randomized, comparative study of efficacy and tolerability of original and generic simvastatin. The drug effects on the blood levels of total cholesterol (TC), high density cholesterol (HDC), triglycerides (TG), low density cholesterol (LDC), and tolerability of treatment were evaluated. The treatment duration (with a change of medications) was 12 weeks.Results. The target levels of LDC after 8 weeks of treatment with both generic and original simvastatin (20 mg/day) were achieved in 10 (71.4%) patients in each group. After 8 weeks of therapy with generic and original simvastatin TC decreased from 6.4±0.8 to 4.4±0.6 mmol/l (p
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