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.
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.
Jayaram
S
S
Glenmark Pharmaceuticals Ltd, Mumbai 400026.
Jain
M M
MM
Naikawadi
Akram A
AA
Gawde
Ashish
A
Desai
Anish
A
D001055:Apolipoproteins B / Q000097:blood; D000069059:Atorvastatin; D002784:Cholesterol / Q000097:blood; D005260:Female; D005464:Fluorobenzenes / Q000627:therapeutic use*; D006538:Heptanoic Acids / Q000627:therapeutic use*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D006937:Hypercholesterolemia / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011743:Pyrimidines / Q000627:therapeutic use*; D011758:Pyrroles / Q000627:therapeutic use*; D000068718:Rosuvastatin Calcium; D013449:Sulfonamides / Q000627:therapeutic use*
D001055:Apolipoproteins B; D005464:Fluorobenzenes; D006538:Heptanoic Acids; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011743:Pyrimidines; D011758:Pyrroles; D013449:Sulfonamides; D000068718:Rosuvastatin Calcium; D002784:Cholesterol; D000069059:Atorvastatin