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

 Hae-Young Lee  ;  Ki-Hoon Han  ;  Woo-Baek Chung  ;  Sung-Ho Her  ;  Tae-Ho Park  ;  Seung-Woon Rha  ;  So-Yeon Choi  ;  Kyung-Tae Jung  ;  Jong-Seon Park  ;  Pum-Joon Kim  ;  Jong-Min Lee  ;  Myung-Ho Jeong  ;  Eun-Seok Shin  ;  Hyeon-Cheol Gwon  ;  Kyoo-Rok Han  ;  Jei-Keon Chae  ;  Woo-Shik Kim  ;  Dong-Ju Choi  ;  Bum-Kee Hong  ;  Si-Wan Choi  ;  Namsik Chung 
 CLINICAL THERAPEUTICS, Vol.42(10) : 2036-2048, 2020-10 
Journal Title
Issue Date
Aged ; Apolipoprotein A-I / blood ; Apolipoproteins B / blood ; Blood Glucose / drug effects ; Cholesterol / blood ; Fasting ; Female ; Glycated Hemoglobin A / metabolism ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors / therapeutic use* ; Hypercholesterolemia / drug therapy* ; Hyperlipidemias / drug therapy* ; Lipids / blood ; Male ; Middle Aged ; Quinolines / administration & dosage*
hyperlipidemia ; impaired fasting glucose ; new-onset diabetes mellitus ; pitavastatin
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 (HbA1c) 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 HbA1c 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).

Implications: The high-dose pitavastatin therapy did not aggravate glucose metabolism compared with the usual dose therapy. Moreover, it had a better effect on cholesterol-lowering and apolipoprotein distribution in the patients with hyperlipidemia and IFG.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Obstetrics and Gynecology (산부인과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Jae Hoon(김재훈) ORCID logo https://orcid.org/0000-0001-6599-7065
Hong, Bum Kee(홍범기) ORCID logo https://orcid.org/0000-0002-6456-0184
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