계명대학교 의학도서관 Repository

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

Metadata Downloads
Author(s)
Sang Hak LeeNamsik ChungJun KwanDoo-II KimWon Ho KimChee Jeong KimHyun Seung KimSi Hoon ParkHong Seog SeoDong Gu ShinYung Woo ShinWan-Joo ShimTae Hoon AhnKyeong Ho YunMyeong-Ho YoonKwang-Soo ChaSi-Wan ChoiSeong Wook HanMin Su Hyon
Keimyung Author(s)
Han, Seong Wook
Department
Dept. of Internal Medicine (내과학)
Journal Title
Clinical Therapeutics
Issued Date
2007
Volume
29
Issue
11
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.

Key words
statins;
hypercholesterolemia;
pitavastatin;
atorvastatin
Keimyung Author(s)(Kor)
한성욱
Publisher
School of Medicine
Citation
Sang Hak Lee et al. (2007). 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. Clinical Therapeutics, 29(11), 2365–2373. doi: 10.1016/j.clinthera.2007.11.002
Type
Article
ISSN
0149-2918
Source
https://www.sciencedirect.com/science/article/pii/S0149291807003517?via%3Dihub
DOI
10.1016/j.clinthera.2007.11.002
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/35524
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
공개 및 라이선스
  • 공개 구분공개
  • 엠바고Forever
파일 목록

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