Thesis (M.Sc. in Pharm.)--Chulalongkorn University, 2009

Objectives: To compare the efficacy and safety of pitavastatin 1 mg once daily with atorvastatin 10 mg once daily in terms of: (1) serum lipids, hsCRP, and fibrinogen alteration, (2) the percentage of patients who achieved their LDL-C goals according to NCEP ATP III guidelines, (3) adverse event rates, and (4) annual cost of drug treatment. Methods: A randomized, open-label, parallel study was conducted during November, 2008 to May, 2009 at outpatient department, Phramongkutklao Hospital, Bangkok, Thailand. One hundred patients were randomly assigned equally into the pitavastatin 1 mg once daily group and atorvastatin 10 mg once daily group for 8 weeks. Data were assessed using laboratory data (12-hour fasting blood), physical examination, and patients’ interviews. Results: Of 100 patients enrolled, 98 patients completed the study. There was no significant difference in baseline characteristics between groups except serum AST level. Although, mean AST in pitavastatin group was statistically higher than atorvastatin group but there was no clinically significant difference between groups. Pitavastatin 1 mg once daily reduced LDL-C and TC from baseline lower than atorvastatin 10 mg once daily (37.37% vs. 45.75%, p<0.001 for LDL-C and 27.55% vs. 32.31%, p=0.005 for TC), but there was no significant difference in percent TG, HDL-C, hsCRP, and fibrinogen change between groups (p>0.05). The percentage of patients who achieved their LDL-C goals was not significantly different between pitavastatin and atorvastatin group (74% vs. 84%, p=0.220). In addition, the number of patients who experienced adverse events was not significantly different between groups (p>0.05). Annual cost of drug treatment in pitavastatin 1 mg once daily group was lower than atorvastatin 10 mg once daily group by 40.51% (5,856.00 baht vs. 14,457.00 baht, respectively). Conclusions: Although pitavastatin 1 mg once daily dose reduced TC and LDL-C lower than atorvastatin 10 mg once daily dose, but the percentage of patients who achieved their LDL-C goals was not significantly different between groups. Moreover, pitavastatin 1 mg once daily is an alternative regimen for cost saving than atorvastatin 10 mg once daily.