4 225

Cited 32 times in

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

 Sang Hak Lee  ;  Namsik Chung  ;  Min Su Hyon  ;  Seong Wook Han  ;  Si-Wan Choi  ;  Kwang-Soo Cha  ;  Myeong-Ho Yoon  ;  Kyeong Ho Yun  ;  Tae Hoon Ahn  ;  Wan-Joo Shim  ;  Yung Woo Shin  ;  Dong Gu Shin  ;  Hong Seog Seo  ;  Si Hoon Park  ;  Hyun Seung Kim  ;  Chee Jeong Kim  ;  Won Ho Kim  ;  Doo-Il Kim  ;  Jun Kwan 
 CLINICAL THERAPEUTICS, Vol.29(11) : 2365-2373, 2007 
Journal Title
Issue Date
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 achievi
Full Text
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Lee, Sang Hak(이상학) ORCID logo https://orcid.org/0000-0002-4535-3745
Chung, Nam Sik(정남식)
사서에게 알리기


Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.