Efficacy and Safety of Prolonged Treatment with Pemafibrate plus an
                    HMG-CoA Reductase Inhibitor in Japanese Patients with Type 2 Diabetes
                    Mellitus

Masataka Kusunoki; Fumiya Hisano; Shin-ichi Matsuda; Akiko Kusunoki; Kazuhiko Tsutsumi; Tetsuro Miyata

doi:10.1055/a-2560-9750

Drug Research, Table of Contents

Drug Res (Stuttg)
DOI: 10.1055/a-2560-9750

Original Article

Efficacy and Safety of Prolonged Treatment with Pemafibrate plus an HMG-CoA Reductase Inhibitor in Japanese Patients with Type 2 Diabetes Mellitus

Masataka Kusunoki

¹Department of Diabetes, Motor Function and Metabolism, Research Center of Health, Physical Fitness and Sports, Nagoya University, Chikusa-ku, Nagoya City, Aichi, Japan

,

Fumiya Hisano

²Graduate School of Medicine, Department of Integrated Health Sciences, Nagoya University, Higashi-ku, Nagoya City, Aichi, Japan

,

Shin-ichi Matsuda

³Department of Data Science, Faculty of Science and Technology, Nanzan University, Showa-ku, Nagoya City, Aichi, Japan

,

Akiko Kusunoki

⁴Akishima Clinic, Naka-ku, Nagoya City, Japan

,

Kazuhiko Tsutsumi

⁵Okinaka Memorial Institute for Medical Research, Minato-ku, Tokyo, Japan

,

Tetsuro Miyata

⁶Office of Medical Education, School of Medicine, International University of Health and Welfare, Kozunomori, Narita City, Chiba, Japan

› Author Affiliations

Abstract

It has been suggested that caution should be exercised when using HMG-CoA reductase inhibitor (statin) in combination with a drug of the fibrate family because of the potentially elevated risk of development of hepatic function impairment and myopathy. We conducted this present study to evaluate the efficacy and safety of treatment with a statin plus pemafibrate (a new fibrate) versus treatment with pemafibrate alone in Japanese patients with type 2 diabetes mellitus.

In this study, a total of 23 Japanese patients with type 2 diabetes mellitus were divided into two groups: a group that received pemafibrate alone and a group that received pemafibrate+a statin for a period of 3 years, respectively. Blood levels of lipids and hepatic and renal function parameters were measured before and one and three years after the start of treatment.

The pemafibrate-alone group showed reduction of the blood lipid levels, but no adverse changes of the hepatic or renal function parameters were observed. Similarly, the combined pemafibrate+statin treatment group also showed lowering of the blood lipid levels without any adverse changes of the parameters.

Improvement of the blood lipid profile was observed in patients who received prolonged treatment with pemafibrate. Similarly, improvement of the blood lipid profile without any adverse changes of the hepatic or renal function parameters was also observed in patients who received prolonged combined pemafibrate+statin treatment. Thus, our findings confirm the safety and efficacy of pemafibrate administered either alone or in combination with a statin.

Keywords

pemafibrate - statin - combined treatment - type 2 diabetes mellitus

Full Text

References

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