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 ChoiNamsik Chung

Research output: Contribution to journalArticle

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 (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.

Original languageEnglish
JournalClinical Therapeutics
DOIs
Publication statusAccepted/In press - 2020

Keywords

  • hyperlipidemia
  • impaired fasting glucose
  • new-onset diabetes mellitus
  • pitavastatin

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

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    Lee, H. Y., Han, K. H., Chung, W. B., Her, S. H., Park, T. H., Rha, S. W., Choi, S. Y., Jung, K. T., Park, J. S., Kim, P. J., Lee, J. M., Jeong, M. H., Shin, E. S., Gwon, H. C., Han, K. R., Chae, J. K., Kim, W. S., Choi, D. J., Hong, B. K., ... Chung, N. (Accepted/In press). Safety and Efficacy of Pitavastatin in Patients With Impaired Fasting Glucose and Hyperlipidemia: A Randomized, Open-Labeled, Multicentered, Phase IV Study. Clinical Therapeutics. https://doi.org/10.1016/j.clinthera.2020.07.013