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Comparative efficacy and safety of hypolipidemic therapy with generic and original medicinal products of simvastatin

Author(s): E.I. Tarlovskaya | Yu.A. Balandina | I.E. Sapozhnikova | N.S. Maksimchuk

Journal: Racionalʹnaâ Farmakoterapiâ v Kardiologii
ISSN 1819-6446

Volume: 7;
Issue: 5;
Start page: #;
Date: 2011;
Original page

Keywords: original drug | generic | simvastatin | hypolipidemic therapy.

Aim. To compare efficacy, safety and pharmacoeconomical characteristics of generic and original medicinal products of simvastatin in achievement of cholesterol and low density lipoprotein target levels.Material and methods. 38 patients with arterial hypertension accompanied by type 2 diabetes with dyslipidemia were included into the study. They had no clinically obvious ischemic heart disease and did not receive hypolipidemic pharmacotherapy for a month before the study start. The patients were randomized into group A or group B. Patients of group A (n=18) received original simvastatin, patients of group B (n=20) received generic simvastatin. Initial simvastatin dose was 20 mg daily. Lipid plasma profile, liver enzymes, creatine phosphokinase were evaluated every 4 weeks. Cost-effectiveness ratio was calculated.Results. 11 patients (61%) in group A and only 5 patients (25%) in group B (χ2=5.05; р
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