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Multicenter, open label, randomized controlled superiority trial for availability to reduce nocturnal urination frequency: The TOP-STAR study.
Nakajima, Hanako; Okada, Hiroshi; Kogure, Akinori; Osaka, Takafumi; Tsutsumi, Takeshi; Onishi, Masayoshi; Mitsuhashi, Kazuteru; Kitagawa, Noriyuki; Mogami, Shinichi; Kitamura, Akane; Ishii, Michiyo; Nakamura, Naoto; Kishi, Akio; Eiko, Sato; Hamaguchi, Masahide; Fukui, Michiaki.
Afiliación
  • Nakajima H; Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.
  • Okada H; Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.
  • Kogure A; Department of Diabetes and Endocrinology, Matsushita Memorial Hospital, Moriguchi, Japan.
  • Osaka T; Department of Diabetes and Metabolic Medicine, Kyoto City Hospital, Kyoto, Japan.
  • Tsutsumi T; Department of Endocrinology and Diabetology, Ayabe City Hospital, Ayabe, Japan.
  • Onishi M; Department of Endocrinology and Metabolism, Kyoto Yamashiro General Medical Center, Kidugawa, Japan.
  • Mitsuhashi K; Department of Diabetes and Metabolism, Osaka General Hospital of West Japan Railway Company, Osaka, Japan.
  • Kitagawa N; Department of Diabetes and Internal Medicine, Fukuchiyama City Hospital, Fukuchiyama, Japan.
  • Mogami S; Department of Diabetology, Kameoka Municipal Hospital, Kameoka, Japan.
  • Kitamura A; Department of Endocrinology, Metabolism, and Diabetes, Saiseikai Suita Hospital, Osaka, Japan.
  • Ishii M; Department of Diabetology, Nagitsuji Hospital, Kyoto, Japan.
  • Nakamura N; Department of Internal Medicine, Otsu City Hospital, Otsu, Japan.
  • Kishi A; Division of Diabetes, Saiseikai Kyoto Hospital, Kyoto, Japan.
  • Eiko S; Department of Diabetes, Kyoto Okamoto Memorial Hospital, Kyoto, Japan.
  • Hamaguchi M; Ashikaga University, Tochigi, Japan.
  • Fukui M; Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.
J Diabetes Investig ; 2024 Sep 18.
Article en En | MEDLINE | ID: mdl-39292166
ABSTRACT

AIM:

Nocturia impairs the quality of life in patients with type 2 diabetes mellitus. Although sodium glucose co-transporter 2 inhibitors (SGLT2i) such as tofogliflozin increase urine volume, their impact on nocturia, in conjunction with dietary salt restriction, is less clear. MATERIALS AND

METHODS:

This multicenter, open-label, randomized, parallel-group trial included 80 subjects with type 2 diabetes and nocturia. The patients were divided into two groups one receiving tofogliflozin, the shortest half-life, without salt restriction, and the other receiving both tofogliflozin and dietary salt restriction. The primary endpoint was nocturia frequency at 12 weeks. The secondary outcomes included changes in daytime urination frequency, urine volume, and home blood pressure.

RESULTS:

At 12 weeks, there were no significant differences in nocturia changes between both groups. Nocturia frequency did not change in the tofogliflozin without salt restriction group from 1.5 ± 0.8 to 1.3 ± 1.1 times per night (P = 0.297), and significantly decreased from 1.6 ± 1.0 to 1.3 ± 0.7 times per night in the tofogliflozin and dietary salt restriction group (P = 0.049). There was a trend toward increased urine volume and frequency during the daytime in the group with salt restriction, indicating a time-shift effect of the short half-life tofogliflozin and salt restriction on urinary time.

CONCLUSIONS:

The frequency of nocturia after tofogliflozin did not increase. Tofogliflozin reduced nocturia when combined with salt restriction. Furthermore, daytime urine volume and frequency showed an increasing trend, suggesting a shift in urine production to daytime hours due to the short half-life of tofogliflozin. Dietary modifications can enhance the therapeutic benefits of tofogliflozin in managing nocturia in people with type 2 diabetes.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: J Diabetes Investig Año: 2024 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Japón
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: J Diabetes Investig Año: 2024 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Japón