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).

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

Additional file 1 of Novel subgroups of obesity and their association with outcomes: a data-driven cluster analysis

Additional file 1: Supplementary Table 1A. ICD-10 codes for Cluster 1. Supplementary Table 1B. Drug codes for Cluster 1. Supplementary Table 1C. Medical procedure codes for Cluster 1. Supplementary Table 2A. ICD-10 codes for Cluster 2. Supplementary Table 2B. Drug codes for Cluster 2. Supplementary Table 2C. Medical procedure codes for Cluster 2. Supplementary Table 3A. ICD-10 codes for Cluster 3. Supplementary Table 3B. Drug codes for Cluster 3. Supplementary Table 3C. Medical procedure codes for Cluster 3. Supplementary Table 4A. ICD-10 codes for Cluster 4. Supplementary Table 4B. Drug codes for Cluster 4. Supplementary Table 4C. Medical procedure codes for Cluster 4. Supplementary Table 5A. ICD-10 codes for Cluster 5. Supplementary Table 5B. Drug codes for Cluster 5. Supplementary Table 5C. Medical procedure codes for Cluster 5. Supplementary Table 6A. ICD-10 codes for Cluster 6. Supplementary Table 6B. Drug codes for Cluster 6. Supplementary Table 6C. Medical procedure codes for Cluster 6. Supplementary Table 7A. ICD-10 codes for Cluster 7. Supplementary Table 7B. Drug codes for Cluster 7. Supplementary Table 7C. Medical procedure codes for Cluster 7. Supplementary Table 8. ICD-10, drug, and medical procedure codes indicating retinopathy in Cluster 2. Supplementary Table 9A. ICD-10 codes indicating ocular diseases in Clusters 3 and 4. Supplementary Table 9B. Drug codes indicating ocular diseases in Clusters 3 and 4. Supplementary Table 9C. Medical procedure codes indicating ocular diseases in Clusters 3 and 4. Supplementary Fig. 1. Flowchart of the study. Supplementary Fig. 2. Elbow-Plot for K-means clustering Supplementary Fig. 3. Association between BMI and the proportion of the individuals with MHO. Supplementary Fig. 4. Health care fee of each cluster. Supplementary Fig. 5. UMAP plots of all individuals with BMI 30-35. Supplementary Data 1. Python Code for UMAP Reduction and K-means Clustering. Supplementary Data 2. Hierarchical Clustering

MOESM2 of Dapagliflozin improves treatment satisfaction in overweight patients with type 2 diabetes mellitus: a patient reported outcome study (PRO study)

Additional file 2. Questions and choices in Oral Hypoglycemic Agent-Questionnaire (OHA-Q) ver.2. The data on this file consist of the questions and choices in the Oral Hypoglycemic Agent-Questionnaire (OHA-Q) ver.2

MOESM1 of Dapagliflozin improves treatment satisfaction in overweight patients with type 2 diabetes mellitus: a patient reported outcome study (PRO study)

Additional file 1. List of the 29 medical institutions participating in the study. The data on this file include the names of the 29 participating medical institutions in this multi-center study

MOESM3 of Dapagliflozin improves treatment satisfaction in overweight patients with type 2 diabetes mellitus: a patient reported outcome study (PRO study)

Additional file 3. Adverse events. The data on this file consist of all adverse events

Reproducibility and Validity of a Questionnaire Measuring Treatment Burden on Patients with Type 2 Diabetes: Diabetic Treatment Burden Questionnaire (DTBQ)

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