Comparative evaluation of the efficacy, safety, and tolerability of rosuvastatin 10 mg with atorvastatin 10 mg in adult patients with hypercholesterolaemia: the first Indian study.

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2004-01-16
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To compare the efficacy, safety and tolerability of rosuvastatin 10mg with atorvastatin 10 mg in adult Indian patients with hypercholesterolaemia, a prospective, open-label, comparative, phase III study was conducted. A total of 45 patients of either sex, between 18 and 80 years of age with hypercholesterolaemia, having LDL cholesterol (LDL-C) of 160 and < 250 mg/dl and triglyceride < 400 mg/dl, were included in this trial. After a dietary run-in period of 2 weeks, patients received either rosuvastatin 10 mg once daily or atorvastatin 10 mg once daily, for 6 weeks. The fall in the mean LDL-C levels after 6 weeks of treatment in rosuvastatin group (40.1%) was significantly more as compared to the fall in atorvastatin group (29.8%). Other secondary lipid parameters like total cholesterol (TC), HDL cholesterol (HDL-C), triglycerides, apo-B, apo-AI, and TC/HDL-C ratio also showed more beneficial changes from the baseline in rosuvastatin group than in atorvastatin group. Rosuvastatin 10 mg shows significantly better efficacy than atorvastatin 10 mg in reducing LDL-C levels and produces greater improvements in other elements of the lipid profile.
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Jayaram S, Jain MM, Naikawadi AA, Gawde A, Desai A. Comparative evaluation of the efficacy, safety, and tolerability of rosuvastatin 10 mg with atorvastatin 10 mg in adult patients with hypercholesterolaemia: the first Indian study. Journal of the Indian Medical Association. 2004 Jan; 102(1): 48-50, 52