The Influence of Tofogliflozin on Treatment-Related Quality of Life in Patients with Type 2 Diabetes Mellitus

Naoto Katakami; Tomoya Mita; Hidenori Yoshii; Toshihiko Shiraiwa; Tetsuyuki Yasuda; Yosuke Okada; Keiichi Torimoto; Yutaka Umayahara; Hideaki Kaneto; Takeshi Osonoi; Tsunehiko Yamamoto; Nobuichi Kuribayashi; Kazuhisa Maeda; Hiroki Yokoyama; Keisuke Kosugi; Kentaro Ohtoshi; Isao Hayashi; Satoru Sumitani; Mamiko Tsugawa; Kayoko Ryomoto; Hideki Taki; Tadashi Nakamura; Satoshi Kawashima; Yasunori Sato; Hirotaka Watada; Iichiro Shimomura; UTOPIA study investigators

doi:10.1007/s13300-021-01125-8

The Influence of Tofogliflozin on Treatment-Related Quality of Life in Patients with Type 2 Diabetes Mellitus

Diabetes Ther. 2021 Sep;12(9):2499-2515. doi: 10.1007/s13300-021-01125-8. Epub 2021 Aug 6.

Authors

Naoto Katakami^{1

2}, Tomoya Mita³, Hidenori Yoshii⁴, Toshihiko Shiraiwa⁵, Tetsuyuki Yasuda⁶, Yosuke Okada⁷, Keiichi Torimoto⁷, Yutaka Umayahara⁸, Hideaki Kaneto⁹, Takeshi Osonoi¹⁰, Tsunehiko Yamamoto¹¹, Nobuichi Kuribayashi¹², Kazuhisa Maeda¹³, Hiroki Yokoyama¹⁴, Keisuke Kosugi¹⁵, Kentaro Ohtoshi¹⁶, Isao Hayashi¹⁷, Satoru Sumitani¹⁸, Mamiko Tsugawa¹⁹, Kayoko Ryomoto²⁰, Hideki Taki²¹, Tadashi Nakamura²², Satoshi Kawashima²³, Yasunori Sato²⁴, Hirotaka Watada³, Iichiro Shimomura²⁵; UTOPIA study investigators

Collaborators

UTOPIA study investigators:
I Hayashi, M Tsugawa, H Yokoyama, H Yoshii, K Komiyama, T Mita, T Shimizu, T Yamamoto, S Kawashima, T Nakamura, S Kamei, T Kinoshita, M Shimoda, K Maeda, K Kosugi, H Yoshii, H Ishida, T Osonoi, M Saito, A Tamazawa, S Sumitani, N Fujiki, Y Fujita, S Shimizu, Y Umayahara, K Kato, Y Irie, R Kataoka, T Yasuda, Y Kiyohara, M Ohashi, K Ryomoto, Y Takahi, Y Fujishima, Y Fujita, A Fukuhara, K Fukui, Y Hosokawa, A Imagawa, H Iwahashi, K Mukai, N Katakami, T Katsura, D Kawamori, T Kimura, S Kobayashi, J Kozawa, F Kubo, N Maeda, T Matsuoka, K Miyashita, S Nakata, H Ninomiya, H Nishizawa, Y Okuno, M Otsuki, F Sakamoto, S Sasaki, I Sato, N Shimo, I Shimomura, M Takahara, T Takano, A Tokunaga, S Uno, M Yamaoka, S Yoneda, K Ohtoshi, T Shiraiwa, M Hajime, K Koikawa, F Kuno, A Kurozumi, K Matsushita, M Narisawa, K Tanaka, K Sugai, Y Okada, K Torimoto

Affiliations

¹ Department of Metabolic Medicine, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan. katakami@endmet.med.osaka-u.ac.jp.
² Department of Metabolism and Atherosclerosis, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan. katakami@endmet.med.osaka-u.ac.jp.
³ Department of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, Hongo 2-1-1, Bunkyo-ku, Tokyo, 113-8421, Japan.
⁴ Department of Medicine, Diabetology and Endocrinology, Juntendo Tokyo Koto Geriatric Medical Center, Koto-ku, Tokyo, 136-0075, Japan.
⁵ Shiraiwa Medical Clinic, 4-10-24 Hozenji, Kashiwara, Osaka, 582-0005, Japan.
⁶ Department of Diabetes and Endocrinology, Osaka Police Hospital, 10-31, Kitayama-cho, Tennoji-ku, Osaka, 543-0035, Japan.
⁷ First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, 1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu, 807-8555, Japan.
⁸ Department of Diabetes and Endocrinology, Osaka General Medical Center, 3-1-56, Bandai-Higashi, Sumiyoshi-ku, Osaka, 558-8558, Japan.
⁹ Department of Diabetes, Endocrinology and Metabolism, Kawasaki Medical School, 577 Matsushima, Kurashiki, Okayama, 701-0192, Japan.
¹⁰ Nakakinen Clinic, 745-5, Nakadai, Naka, Ibaraki, 311-0113, Japan.
¹¹ Diabetes and Endocrinology, Kansai Rosai Hospital, 3-1-69, Inabaso, Amagasaki, Hyogo, Japan.
¹² Misaki Naika Clinic, 6-44-9, Futawa-higashi, Funabashi, Chiba, 274-0805, Japan.
¹³ Kitasenri Maeda Clinic, 4-119, Furuedai, Suita, Osaka, 565-0874, Japan.
¹⁴ Jiyugaoka Medical Clinic, West 6, South 6-4-3, Obihiro, Hokkaido, 080-0016, Japan.
¹⁵ Kosugi Medical Clinic, 3-9, Tamatsukurimoto-cho, Tennoji-ku, Osaka, 543-0014, Japan.
¹⁶ Otoshi Medical Clinic, 8-47, Kakudacho, Osaka Kita-ku, Osaka, 530-0017, Japan.
¹⁷ Hayashi Clinic, 3-9-23, Koshienguchi, Nishinomiya, Hyogo, 663-8113, Japan.
¹⁸ Center for Diabetes and Endocrinology, Nippon Life Hospital, 2-1-54 Enokojima, Nishi-ku, Osaka, 550-0006, Japan.
¹⁹ Department of Endocrinology and Metabolism, Ikeda Municipal Hospital, 3-1-18, Jonan, Ikeda, Osaka, 563-8510, Japan.
²⁰ Center for Diabetes Mellitus, Osaka Rosai Hospital, 1179-3 Nagasone-cho, Kita-ku, Sakai, Osaka, 591-8025, Japan.
²¹ Diabetes Center, National Hospital Organization Osaka National Hospital, 2-1-14, Hoenzaka, Chuo-ku, Osaka, 540-0006, Japan.
²² Department of Internal Medicine, Kawasaki Hospital, 3-3-1, Higashiyamacho, Hyogo-ku, Kobe, Hyogo, 652-0042, Japan.
²³ Kanda Naika Clinic, 5-21-3, Hannancho, Osaka Abeno-ku, Osaka, 545-0021, Japan.
²⁴ Department of Preventive Medicine and Public Health, Keio University School of Medicine, 45 Shinanomachi Shinjuku-ku, Tokyo, 160-8582, Japan.
²⁵ Department of Metabolic Medicine, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan.

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.

Keywords: Quality of life (QOL); Sodium-glucose cotransporter 2 (SGLT2) inhibitor; Tofogliflozin; Type 2 diabetes mellitus.