Dapagliflozin improves treatment satisfaction in overweight patients with type 2 diabetes mellitus: a patient reported outcome study (PRO study).

• Material Type: 博士論文
• Title: Dapagliflozin improves treatment satisfaction in overweight patients with type 2 diabetes mellitus: a patient reported outcome study (PRO study).
• Author/Editor: Nakajima, Hiroki; Okada, Sadanori; Mohri, Takako; Kanda, Eiichiro; Inaba, Naoyuki; Hirasawa, Yoko; Seino, Hiroaki; Kuroda, Hisamoto; Hiyoshi, Toru; Niiya, Tetsuji; Ishii, Hitoshi
• Author Heading: Nakajima, Hiroki; Okada, Sadanori; Mohri, Takako; Kanda, Eiichiro; Inaba, Naoyuki; Hirasawa, Yoko; Seino, Hiroaki; Kuroda, Hisamoto; Hiyoshi, Toru; Niiya, Tetsuji; Ishii, Hitoshi
• Publication, Distribution, etc.: BioMed Central
• Publication Date: 2018-03-01
• Publication Date (W3CDTF): 2018-03-01
• Alternative Title: ダパグリフロジン投与における肥満２型糖尿病患者の治療満足度への影響：a patient reported outcome study (PRO study).
• Periodical title: Diabetology and metabolic syndrome
• No. or year of volume/issue: 10
• Volume: 10
• Pages: Article No.11-
• ISSN (Periodical Title): ISSN : 1758-5996
• Degree grantor/type: 奈良県立医科大学
• Date Granted: 2019-03-15
• Dissertation Number: 甲第694号
• Degree Type: 博士（医学）
• Text Language Code: eng
• Subject Heading: Type 2 diabetes mellitus; Oral hypoglycemic agent; Sodium glucose cotransporters 2 inhibitors; SGLT2 inhibitors; Dapagliflozin; Treatment satisfaction; Oral Hypoglycemic Agent-Questionnaire; Body weight; Patient reported outcome; Quality of life
• Target Audience: 一般
• Note (General): type:Thesis; Background: The benefits of sodium glucose cotransporters 2 (SGLT2) inhibitors in patients with type 2 diabetes mellitus include plasma glucose control, reduction in body weight and blood pressure, and low risk of hypoglycemia, although they may also cause genitourinary infections, polyuria, or volume depletion. It is not clear whether dapagliflozin, an SGLT2 inhibitor, improves treatment satisfaction among patients in a comprehensive way despite the negative side effects. This study assessed the effect of dapagliflozin on glycosylated hemoglobin (HbA1c), body weight, and treatment satisfaction in overweight patients with type 2 diabetes mellitus treated with oral hypoglycemic agents. Methods: This multicenter, open-label, single-arm observational study included patients with type 2 diabetes mellitus administering dapagliflozin 5 or 10 mg per day for 14 weeks. Changes in treatment satisfaction were evaluated using a new version of the Oral Hypoglycemic Agent-Questionnaire (OHA-Q ver. 2) consisting of 23 items. Correlation between treatment satisfaction and HbA1c levels and body weight were analyzed using the Spearman's rank-correlation coefficient. Results: Of the 221 patients enrolled, 188 completed the study. Mean HbA1c decreased from 7.8 ± 0.7% (62.1 ± 7.5 mmol/mol) to 7.3 ± 0.8% (55.9 ± 8.7 mmol/mol) (change - 0.6 ± 0.7%, P < 0.001) and body weight decreased from 82.5 ± 14.6 to 80.7 ± 14.8 kg (change - 2.3 ± 2.8 kg, P < 0.001). OHA-Q ver. 2 was validated as well, the mean OHA-Q ver. 2 total score increased from 44.3 ± 9.4 to 46.6 ± 9.8 (best score 69, worst score 0; change 2.3 ± 6.6, P < 0.001). The change in body weight significantly correlated with the OHA-Q ver. 2 total score (Spearman's ρ = - 0.17, P = 0.035). The change in HbA1c levels significantly correlated with the satisfaction subscale score (Spearman's ρ = - 0.19, P = 0.011). Conclusions: Dapagliflozin significantly improved treatment satisfaction among patients with type 2 diabetes mellitus for 14 weeks. Body weight loss significantly correlated with treatment satisfaction.Trial registration UMIN-CTR: UMIN000016304.; 博士（医学）・甲第694号・平成31年3月15日; © The Author(s) 2018. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/ publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.; identifier:Diabetology and metabolic syndrome Vol.10 Article No.11 (2018 Mar); identifier:17585996; identifier:http://ginmu.naramed-u.ac.jp/dspace/handle/10564/3542; identifier:Diabetology and metabolic syndrome, 10: Article No.11
• Access Restrictions: インターネット公開
• Related Material (DOI): 10.1186/s13098-018-0313-x
• Data Provider (Database): 国立情報学研究所 : 学術機関リポジトリデータベース（IRDB）（機関リポジトリ）; https://irdb.nii.ac.jp
• Original Data Provider (Database): 奈良県立医科大学 : 奈良県立医科大学機関リポジトリ GINMU

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