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

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.

• Authors: 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
• Journal: Clinical therapeutics (Clin Ther) Vol. 42 Issue 10 Pg. 2036-2048 (10 2020) ISSN: 1879-114X [Electronic] United States
• PMID: 32921501 (Publication Type: Clinical Trial, Phase IV, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2020. Published by Elsevier Inc.

Chemical References

• Apolipoprotein A-I
• Apolipoproteins B
• Blood Glucose
• Glycated Hemoglobin A
• Hydroxymethylglutaryl-CoA Reductase Inhibitors
• Lipids
• Quinolines
• Cholesterol
• pitavastatin

Topics

• Aged
• Apolipoprotein A-I (blood)
• Apolipoproteins B (blood)
• Blood Glucose (drug effects)
• Cholesterol (blood)
• Fasting
• Female
• Glycated Hemoglobin (metabolism)
• Humans
• Hydroxymethylglutaryl-CoA Reductase Inhibitors (therapeutic use)
• Hypercholesterolemia (drug therapy)
• Hyperlipidemias (drug therapy)
• Lipids (blood)
• Male
• Middle Aged
• Quinolines (administration & dosage)