Christos Rizos, Evangelos Liberopoulos, Eleni Mpilianou, Vasileios Kotsis, Nikolaos Tentolouris, Christina Antza, Ioanna Eleftheriadou, Vasileios Tsimihodimos, Moses Elisaf
Abstract
Introduction: The effective management of high-risk patients requires treatment with high-intensity statins, such as high-dose atorvastatin. However, intensive hypolipidemic treatment is associated with increased incidence of adverse effects, higher financial costs and higher rates of treatment discontinuation. In our country, a novel atorvastatin dosage formulation (30 mg) has been introduced. However, there are no data available on efficacy and safety of this formulation.
Aim: To compare atorvastatin 30 mg/day with atorvastatin 40 mg/day on lipid profile and metabolic parameters in an observational, open label study.
Methods: In this multicenter study, high-risk patients whose low-density lipoprotein cholesterol (LDL-C) levels were above treatment thresholds were included. Patients were randomized to receive atorvastatin 30 mg/day (Α30) or atorvastatin 40 mg/day (Α40). After 3 months of treatment subjects were re-evaluated.
Results: Patients (n=141, 75 males, age 56 years) had a comparable lipid profile at baseline (p = NS between groups). Similar changes in serum lipid parameters were observed in the two study groups. Specifically, LDL-C decreased by 42.1% in the A30 group compared with 44.1% in the A40 group (p=NS). There were no significant changes in carbohydrate homeostasis parameters in any group. Treatment was equally well tolerated in both groups.
Conclusions: Atorvastatin 30 mg resulted in a similar reduction of LDL-C compared with atorvastatin 40 mg.
Keywords: Atorvastatin, lipidemic profile, carbohydrate metabolism, side effects