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Comparison of the efficacy and tolerability of pitavastatin and atorvastatin: an 8-week, multicenter, randomized, open-label, dose-titration study in Korean patients with hypercholesterolemia.

Authors
Lee, SH; Chung, N; Kwan, J; Kim, DI; Kim, WH; Kim, CJ; Kim, HS; Park, SH; Seo, HS; Shin, DG; Shin, YW; Shim, WJ; Ahn, TH; Ho, Yun K; Yoon, MH; Cha, KS; Choi, SW; Han, SW; Hyon, MS
Citation
Clinical therapeutics, 29(11):2365-2373, 2007
Journal Title
Clinical therapeutics
ISSN
0149-29181879-114X
Abstract
BACKGROUND: Although previous studies have examined the efficacy of pitavastatin, its tolerability and effects on lipid concentrations have not been compared with those of atorvastatin in a multicenter, randomized study.



OBJECTIVE: This trial compared the efficacy and tolerability of pitavastatin and atorvastatin in hypercholesterolemic Korean adults.



METHODS: This 8-week, multicenter, randomized, open-label, dose-titration study was conducted at 18 clinical centers in Korea between May 2005 and February 2006. After a 4-week dietary lead-in period, patients with hypercholesterolemia were randomized to receive either pitavastatin 2 mg/d or atorvastatin 10 mg/d. Patients who had not reached the low-density lipoprotein cholesterol (LDL-C) goal by week 4 received a double dose of the assigned medication for an additional 4 weeks. Efficacy was evaluated in terms of achievement of the National Cholesterol Education Program Adult Treatment Panel III LDL-C goals and changes from baseline in other lipids and high-sensitivity C-reactive protein (hs-CRP). The tolerability profile was assessed by physical and electro-cardiographic examinations, laboratory tests, and recording adverse reactions at all visits.



RESULTS: A total of 268 patients were randomized to treatment, and 222 (82.8%) completed the study (149 women, 73 men; mean age, 59 years; mean weight, 63.5 kg). At the end of the study, there was no significant difference between the pitavastatin and atorvastatin groups in the proportion of patients achieving the LDL-C goal (92.7% [102/110] vs 92.0% [103/112], respectively). In addition, there were no significant differences between groups in terms of the percent changes from baseline in LDL-C, total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), or hs-CRP. Twenty-six of 136 patients (19.1%) taking pitavastatin reported 35 treatment-emergent adverse reactions; 33 of 132 patients (25.0%) taking atorvastatin reported 39 treatment-emergent adverse reactions. Elevations in creatine kinase were observed in 6 patients (4.4%) in the pitavastatin group and 7 patients (5.3%) in the atorvastatin group. There were no serious adverse drug reactions in either group.



CONCLUSIONS: In these adult Korean patients with hypercholesterolemia, pitavastatin and atorvastatin did not differ significantly in terms of the proportions of patients achieving the LDL-C goal; reductions in LDL-C, total cholesterol, and triglycerides; or increases in HDL-C. Both drugs were well tolerated.
MeSH terms
Cholesterol/bloodCholesterol, HDL/bloodCholesterol, LDL/bloodFemaleHeptanoic Acids/administration & dosageHeptanoic Acids/adverse effectsHeptanoic Acids/therapeutic use*HumansHydroxymethylglutaryl-CoA Reductase Inhibitors/administration & dosageHydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effectsHydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use*Hypercholesterolemia/bloodHypercholesterolemia/drug therapy*KoreaMaleMiddle AgedPyrroles/administration & dosagePyrroles/adverse effectsPyrroles/therapeutic use*Quinolines/administration & dosageQuinolines/adverse effectsQuinolines/therapeutic use*Triglycerides/blood
DOI
10.1016/j.clinthera.2007.11.002
PMID
18158077
Appears in Collections:
Journal Papers > School of Medicine / Graduate School of Medicine > Cardiology
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