Safety and Efficacy of Pitavastatin in Patients With Impaired Fasting Glucose and Hyperlipidemia: A Randomized, Open-labeled, Multicentered, Phase IV Study.

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
Clinical therapeutics
2020Sep ; 17 ( 18 ) :.
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Lee, Hae-Young - Seoul National University Hospital, Seoul, South Korea.
Han, Ki-Hoon - Asan Medical Center, Seoul, South Korea.
Chung, Woo-Baek - Seoul St. Mary's Hospital, Seoul, South Korea.
Her, Sung-Ho - Daejeon St. Mary's Hospital, Daejeon, South Korea.
Park, Tae-Ho - Dong-A University Hospital, Busan, South Korea.
Rha, Seung-Woon - Korea University Guro Hospital, Seoul, South Korea.
Choi, So-Yeon - Ajou University Hospital, Suwan, South Korea.
Jung, Kyung-Tae - Eulji University Hospital, Daejeon, South Korea.
Park, Jong-Seon - Yeungnam University Hospital, Daegu, South Korea.
Kim, Pum-Joon - St. Mary's Hospital Eunpyeong, Seoul, South Korea.
Lee, Jong-Min - St. Mary's Hospital Uijeongbu, Seoul, South Korea.
Jeong, Myung-Ho - Chonnam National University Hospital, Gwangju, South Korea.
Shin, Eun-Seok - Ulsan University Hospital, Ulsan, South Korea.
Gwon, Hyeon-Cheol - Samsung Medical Center, Seoul, South Korea.
Han, Kyoo-Rok - Kangdong Sacred Heart Hospital, Gangdong-gu, South Korea.
Chae, Jei-Keon - Chonbuk National University Hospital, Jeollabuk-do, South Korea.
Kim, Woo-Shik - Kyung Hee University Hospital, Gangdong, South Korea.
Choi, Dong-Ju - Seoul National University Bundang Hospital, Seoul, South Korea.
Hong, Bum-Kee - Gangnam Severance Hospital, Seoul, South Korea.
Choi, Si-Wan - Chungnam National University Hospital, Daejeon, South Korea.
Chung, Namsik - Yonsei University Severance Hospital, Seoul, South Korea. Electronic address:
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 of 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?
keyword
hyperlipidemia; impaired fasting glucose; new-onset diabetes mellitus; pitavastatin
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High-dose pitavastatin does not aggravate glucose metabolism compared with usual dose pitavastatin in patients with hyperlipidemia and IFG. In patients with hyperlipidemia and IFG, pitavastatin therapy did not improve glucose metabolism.
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DOI
10.1016/j.clinthera.2020.07.013
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ICD 03
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