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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, Sang HakChung, NamsikKwan, JunKim, Doo-IlKim, Won HoKim, Chee JeongKim, Hyun SeungPark, Si HoonSeo, Hong SeogShin, Dong GuShin, Yung WooShim, Wan-JooAhn, Tae HoonYun, Kyeong HoYoon, Myeong-HoCha, Kwang-SooChoi, Si-WanHan, Seong WookHyon, Min Su
Issue Date
Nov-2007
Publisher
ELSEVIER
Keywords
statins; hypercholesterolemia; pitavastatin; atorvastatin
Citation
CLINICAL THERAPEUTICS, v.29, no.11, pp 2365 - 2373
Pages
9
Indexed
SCIE
SCOPUS
Journal Title
CLINICAL THERAPEUTICS
Volume
29
Number
11
Start Page
2365
End Page
2373
URI
https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/17649
DOI
10.1016/j.clinthera.2007.11.002
ISSN
0149-2918
1879-114X
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 highsensitivity 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. (Clin Ther. 2007;29:2365-2373) Copyright (c) 2007 Excerpta Medica, Inc.
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