Safety and Efficacy of Pitavastatin in Patients With Impaired Fasting Glucose and Hyperlipidemia: A Randomized, Open-labeled, Multicentered, Phase IV Study
- Authors
- Lee, Hae-Young; Han, Ki-Hoon; Chung, Woo-Baek; Her, Sung-Ho; Park, Tae-Ho; Rha, Seung-Woon; Choi, So-Yeon; Jung, Kyung-Tae; Park, Jong-Seon; Kim, Pum-Joon; Lee, Jong-Min; Jeong, Myung-Ho; Shin, Eun-Seok; Gwon, Hyeon-Cheol; Han, Kyoo-Rok; Chae, Jei-Keon; Kim, Woo-Shik; Choi, Dong-Ju; Hong, Bum-Kee; Choi, Si-Wan; Chung, Namsik
- Issue Date
- 10월-2020
- Publisher
- ELSEVIER
- Keywords
- hyperlipidemia; impaired fasting glucose; new-onset diabetes mellitus; pitavastatin
- Citation
- CLINICAL THERAPEUTICS, v.42, no.10, pp.2036 - 2048
- Indexed
- SCIE
SCOPUS
- Journal Title
- CLINICAL THERAPEUTICS
- Volume
- 42
- Number
- 10
- Start Page
- 2036
- End Page
- 2048
- URI
- https://scholar.korea.ac.kr/handle/2021.sw.korea/53017
- DOI
- 10.1016/j.clinthera.2020.07.013
- ISSN
- 0149-2918
- Abstract
- Purpose: Although the role of high-intensity lipid lowering therapy in cardiovascular protection has broadened, concerns still exist about new-onset diabetes mellitus (NODM), especially in vulnerable patients. This study aimed to compare the effect high-dose (4 mg/d) and usual dose (2 mg/d) pitavastatin on glucose metabolism in patients with hyperlipidemia and impaired fasting glucose (IFG). Methods: In this 12-month study, glucose tolerance and lipid-lowering efficacy of high-dose pitavastatin (4 mg [study group]) was compared with that of usual dose pitavastatin (2 mg [control group]) in patients with hyperlipidemia and IFG. The primary end point was the change of glycosylated hemoglobin (HbA(1c)) after 24 weeks of treatment. The secondary end points were as follows: (1) NODM within 1 year after treatment, (2) change of lipid parameters, (3) changes of adiponectin, and (4) change of blood glucose and insulin levels. Findings: Of the total 417 patients screened, 313 patients with hypercholesterolemia and IFG were randomly assigned into groups. The mean (SD) change in HbA(1c) was 0.06% (0.20%) in the study group and 0.03% (0.22%) in the control group (P = 0.27). Within 1 year, 27 patients (12.3%) developed NODM, including 12 (10.6%) of 113 patients in the study group and 15 (14.2%) of 106 in the control group (P = 0.43). The study group had a significantly higher reduction of total cholesterol and LDL-C levels and a higher increase in apolipoprotein A1/apolipoprotein B ratio (0.68 [0.40] vs 0.51 [0.35], P < 0.01). (C) 2020 Pub-lished by Elsevier Inc.
- Files in This Item
- There are no files associated with this item.
- Appears in
Collections - Graduate School > Department of Biomedical Sciences > 1. Journal Articles
Items in ScholarWorks are protected by copyright, with all rights reserved, unless otherwise indicated.