Abstract

Introduction

Treatment-related quality of life (QOL) is an important aspect of diabetes management. We evaluated the influence of a sodium-glucose cotransporter 2 (SGLT2) inhibitor, tofogliflozin, on treatment-related QOL in Japanese patients with type 2 diabetes mellitus (T2DM).

Methods

This is the prespecified subanalysis study of the “Using TOfogliflozin for Possible better Intervention against Atherosclerosis for type 2 diabetes patients (UTOPIA)” trial. Treatment-related QOL was evaluated at baseline, week 26, week 52, and week 104 after the initiation of the study using the Diabetes Therapy-Related QOL questionnaire (DTR-QOL). Among the 340 patients in the original UTOPIA study, a total of 252 patients (127, tofogliflozin group; 125, conventional treatment group) who completed the DTR-QOL questionnaire at baseline were the study subjects of the current subanalysis.

Results

The tofogliflozin and conventional treatment groups exhibited almost comparable baseline clinical characteristics, while the use of antihypertensive drugs and lipid-lowering agents was significantly lower in the tofogliflozin treatment group than in the conventional treatment group. Tofogliflozin treatment increased the total score of DTR-QOL7 from baseline (P < 0.001), while conventional treatment did not change it. There were statistically significant differences in delta change in the total DTR-QOL7 score and DTR-QOL7 Q4, Q5, Q6, and Q7 scores from the baseline to week 104 between the treatment groups. Delta changes in HbA1c (Spearman’s correlation coefficient, ρ =  − 0.30, P < 0.001), fasting blood glucose (ρ =  − 0.16, P = 0.031), BMI (ρ =  − 0.19, P = 0.008), and waist circumference (ρ =  − 0.17, P = 0.024) at week 104 were negatively associated with delta change in the total QOL7 score.

Conclusions

Our data indicated that tofogliflozin treatment improved treatment-related QOL compared to conventional treatment in Japanese patients with T2DM, in accordance with the improvement of major cardiovascular risk factors.

Trial registration: UMIN000017607

Details

Title
The Influence of Tofogliflozin on Treatment-Related Quality of Life in Patients with Type 2 Diabetes Mellitus
Author
Katakami, Naoto 1   VIAFID ORCID Logo  ; Mita, Tomoya 2 ; Yoshii, Hidenori 3 ; Shiraiwa, Toshihiko 4 ; Yasuda, Tetsuyuki 5 ; Okada, Yosuke 6 ; Torimoto, Keiichi 6 ; Umayahara, Yutaka 7 ; Kaneto, Hideaki 8 ; Osonoi, Takeshi 9 ; Yamamoto, Tsunehiko 10 ; Kuribayashi, Nobuichi 11 ; Maeda, Kazuhisa 12 ; Yokoyama, Hiroki 13 ; Kosugi, Keisuke 14 ; Ohtoshi, Kentaro 15 ; Hayashi, Isao 16 ; Sumitani, Satoru 17 ; Tsugawa, Mamiko 18 ; Ryomoto, Kayoko 19 ; Taki, Hideki 20 ; Nakamura, Tadashi 21 ; Kawashima, Satoshi 22 ; Sato, Yasunori 23 ; Watada, Hirotaka 2 ; Shimomura, Iichiro 24 ; Hayashi, I.; Tsugawa, M.; Yokoyama, H.; Yoshii, H.; Komiyama, K.; Mita, T.; Shimizu, T.; Yamamoto, T.; Kawashima, S.; Nakamura, T.; Kamei, S.; Kinoshita, T.; Shimoda, M.; Maeda, K.; Kosugi, K.; Ishida, H.; Osonoi, T.; Saito, M.; Tamazawa, A.; Sumitani, S.; Fujiki, N.; Fujita, Y.; Shimizu, S.; Umayahara, Y.; Kato, K.; Irie, Y.; Kataoka, R.; Yasuda, T.; Kiyohara, Y.; Ohashi, M.; Ryomoto, K.; Takahi, Y.; Fujishima, Y.; Fukuhara, A.; Fukui, K.; Hosokawa, Y.; Imagawa, A.; Iwahashi, H.; Mukai, K.; Katakami, N.; Katsura, T.; Kawamori, D.; Kimura, T.; Kobayashi, S.; Kozawa, J.; Kubo, F.; Maeda, N.; Matsuoka, T.; Miyashita, K.; Nakata, S.; Ninomiya, H.; Nishizawa, H.; Okuno, Y.; Otsuki, M.; Sakamoto, F.; Sasaki, S.; Sato, I.; Shimo, N.; Shimomura, I.; Takahara, M.; Takano, T.; Tokunaga, A.; Uno, S.; Yamaoka, M.; Yoneda, S.; Ohtoshi, K.; Shiraiwa, T.; Hajime, M.; Koikawa, K.; Kuno, F.; Kurozumi, A.; Matsushita, K.; Narisawa, M.; Tanaka, K.; Sugai, K.; Okada, Y.; Torimoto, K.

1  Osaka University Graduate School of Medicine, Department of Metabolic Medicine, Suita, Japan (GRID:grid.136593.b) (ISNI:0000 0004 0373 3971); Osaka University Graduate School of Medicine, Department of Metabolism and Atherosclerosis, Suita, Japan (GRID:grid.136593.b) (ISNI:0000 0004 0373 3971) 
2  Juntendo University Graduate School of Medicine, Department of Metabolism and Endocrinology, Tokyo, Japan (GRID:grid.258269.2) (ISNI:0000 0004 1762 2738) 
3  Juntendo Tokyo Koto Geriatric Medical Center, Department of Medicine, Diabetology and Endocrinology, Tokyo, Japan (GRID:grid.258269.2) 
4  Shiraiwa Medical Clinic, Kashiwara, Japan (GRID:grid.258269.2) 
5  Osaka Police Hospital, Department of Diabetes and Endocrinology, Osaka, Japan (GRID:grid.416980.2) (ISNI:0000 0004 1774 8373) 
6  University of Occupational and Environmental Health, First Department of Internal Medicine, School of Medicine, Kitakyushu, Japan (GRID:grid.271052.3) (ISNI:0000 0004 0374 5913) 
7  Osaka General Medical Center, Department of Diabetes and Endocrinology, Osaka, Japan (GRID:grid.416985.7) (ISNI:0000 0004 0378 3952) 
8  Department of Diabetes, Endocrinology and Metabolism, Kawasaki Medical School, Kurashiki, Japan (GRID:grid.415086.e) (ISNI:0000 0001 1014 2000) 
9  Nakakinen Clinic, Naka, Japan (GRID:grid.415086.e) 
10  Kansai Rosai Hospital, Diabetes and Endocrinology, Amagasaki, Japan (GRID:grid.414976.9) (ISNI:0000 0004 0546 3696) 
11  Misaki Naika Clinic, Funabashi, Japan (GRID:grid.414976.9) 
12  Kitasenri Maeda Clinic, Suita, Japan (GRID:grid.414976.9) 
13  Jiyugaoka Medical Clinic, Obihiro, Japan (GRID:grid.414976.9) 
14  Kosugi Medical Clinic, Osaka, Japan (GRID:grid.414976.9) 
15  Otoshi Medical Clinic, Osaka, Japan (GRID:grid.414976.9) 
16  Hayashi Clinic, Nishinomiya, Japan (GRID:grid.414976.9) 
17  Nippon Life Hospital, Center for Diabetes and Endocrinology, Osaka, Japan (GRID:grid.414976.9) 
18  Ikeda Municipal Hospital, Department of Endocrinology and Metabolism, Osaka, Japan (GRID:grid.414568.a) (ISNI:0000 0004 0604 707X) 
19  Osaka Rosai Hospital, Center for Diabetes Mellitus, Sakai, Japan (GRID:grid.417001.3) (ISNI:0000 0004 0378 5245) 
20  National Hospital Organization Osaka National Hospital, Diabetes Center, Osaka, Japan (GRID:grid.416803.8) (ISNI:0000 0004 0377 7966) 
21  Kawasaki Hospital, Department of Internal Medicine, Kobe, Japan (GRID:grid.415097.e) (ISNI:0000 0004 0642 2597) 
22  Kanda Naika Clinic, Osaka, Japan (GRID:grid.415097.e) 
23  Keio University School of Medicine, Department of Preventive Medicine and Public Health, Tokyo, Japan (GRID:grid.26091.3c) (ISNI:0000 0004 1936 9959) 
24  Osaka University Graduate School of Medicine, Department of Metabolic Medicine, Suita, Japan (GRID:grid.136593.b) (ISNI:0000 0004 0373 3971) 
Pages
2499-2515
Publication year
2021
Publication date
Sep 2021
Publisher
Springer Nature B.V.
ISSN
18696953
e-ISSN
18696961
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1007/s13300-021-01125-8
ProQuest document ID
2938142125
Copyright
© The Author(s) 2021. This work is published under http://creativecommons.org/licenses/by-nc/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.