Real-world Observational Study on Patient Outcomes in Diabetes (RESPOND): study design and baseline characteristics of patients with type 2 diabetes newly initiating oral antidiabetic drug monotherapy in Japan
Introduction To investigate factors affecting glycemic control, oral antidiabetic drug (OAD) treatment distribution and self-care activities among patients with type 2 diabetes mellitus (T2DM) who newly initiate OAD monotherapy in a real-world setting in Japan.Research design and methods A Real-worl...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2020-12-01
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| Series: | BMJ Open Diabetes Research & Care |
| Online Access: | https://drc.bmj.com/content/8/2/e001361.full |
| _version_ | 1819283182195834880 |
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| author | Daisuke Yabe Hideki Origasa Hirotaka Watada Takashi Kadowaki Iichiro Shimomura Hiroko Higashiyama Keisuke Tobe Kristy Iglay Shigeru Tokita Yutaka Seino |
| author_facet | Daisuke Yabe Hideki Origasa Hirotaka Watada Takashi Kadowaki Iichiro Shimomura Hiroko Higashiyama Keisuke Tobe Kristy Iglay Shigeru Tokita Yutaka Seino |
| author_sort | Daisuke Yabe |
| collection | DOAJ |
| description | Introduction To investigate factors affecting glycemic control, oral antidiabetic drug (OAD) treatment distribution and self-care activities among patients with type 2 diabetes mellitus (T2DM) who newly initiate OAD monotherapy in a real-world setting in Japan.Research design and methods A Real-world Observational Study on Patient Outcomes in Diabetes (RESPOND) is an ongoing, prospective, observational cohort study with follow-up at 6, 12, 18 and 24 months. Primary objectives include OAD treatment patterns (cross-sectional and longitudinal) among diabetes specialists versus non-specialists; adherence to diabetes self-care activities; quality of life; treatment satisfaction among patients and target attainment rates of parameters, including glycated hemoglobin. Here, we present the study design and baseline data.Results Of 1506 patients enrolled (June 2016–May 2017; 174 sites in Japan), 1485 were included in the baseline analysis (617 treated by specialists, 868 by non-specialists). Most patients were prescribed dipeptidyl peptidase-4 inhibitors (DPP-4Is) (specialist vs non-specialist, 54.1% vs 57.1%), then sodium-glucose cotransporter 2 inhibitors (13.9% vs 22.2%), metformin (20.3% vs 12.9%) and other OADs (<5% individually in both groups). Regardless of age, body mass index and glycated hemoglobin, DPP-4Is were the most commonly prescribed OADs by both specialists and non-specialists. About one-fifth and one-third of patients visiting specialists and non-specialists, respectively, received no advice on diet and exercise. The proportion of patients following self-care recommendations for diet and exercise (2/5 items on the Summary of Diabetes Self-Care Activities) was significantly higher among those visiting specialists than non-specialists.Conclusion The use of newer OAD was common across a broad range of clinical characteristics in patients with T2DM who newly initiated monotherapy in Japan. However, patient-related and physician-related factors could affect the treatment changes during the following course of treatment. In addition, treatment outcome could vary with the observed difference in the level of patient education provided by diabetes specialists versus non-specialists. |
| first_indexed | 2024-12-24T01:27:25Z |
| format | Article |
| id | doaj.art-aa5bfb67ed5e48eabdfbdccbf452ff96 |
| institution | Directory Open Access Journal |
| issn | 2052-4897 |
| language | English |
| last_indexed | 2024-12-24T01:27:25Z |
| publishDate | 2020-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open Diabetes Research & Care |
| spelling | doaj.art-aa5bfb67ed5e48eabdfbdccbf452ff962022-12-21T17:22:28ZengBMJ Publishing GroupBMJ Open Diabetes Research & Care2052-48972020-12-018210.1136/bmjdrc-2020-001361Real-world Observational Study on Patient Outcomes in Diabetes (RESPOND): study design and baseline characteristics of patients with type 2 diabetes newly initiating oral antidiabetic drug monotherapy in JapanDaisuke Yabe0Hideki Origasa1Hirotaka Watada2Takashi Kadowaki3Iichiro Shimomura4Hiroko Higashiyama5Keisuke Tobe6Kristy Iglay7Shigeru Tokita8Yutaka Seino9Kansai Electric Power Medical Research Institute, Kobe, JapanDepartment of Biostatistics and Clinical Epidemiology, The University of Toyama School of Medicine, Toyama, JapanDepartment of Metabolism and Endocrinology, Juntendo University, Bunkyo-ku, Tokyo, JapanDepartment of Diabetes and Metabolic Diseases, Graduate School of Medicine, The University of Tokyo, Tokyo, JapanDepartment of Metabolic Medicine, Graduate School of Medicine, Osaka University, Suita, Osaka, JapanDivision of Medical Education, Kansai Electric Medical Research Institute, Osaka, JapanMSD K.K, Tokyo, JapanMerck & Co., Inc, Kenilworth, New Jersey, USAMSD K.K, Tokyo, JapanKansai Electric Power Hospital, Osaka, JapanIntroduction To investigate factors affecting glycemic control, oral antidiabetic drug (OAD) treatment distribution and self-care activities among patients with type 2 diabetes mellitus (T2DM) who newly initiate OAD monotherapy in a real-world setting in Japan.Research design and methods A Real-world Observational Study on Patient Outcomes in Diabetes (RESPOND) is an ongoing, prospective, observational cohort study with follow-up at 6, 12, 18 and 24 months. Primary objectives include OAD treatment patterns (cross-sectional and longitudinal) among diabetes specialists versus non-specialists; adherence to diabetes self-care activities; quality of life; treatment satisfaction among patients and target attainment rates of parameters, including glycated hemoglobin. Here, we present the study design and baseline data.Results Of 1506 patients enrolled (June 2016–May 2017; 174 sites in Japan), 1485 were included in the baseline analysis (617 treated by specialists, 868 by non-specialists). Most patients were prescribed dipeptidyl peptidase-4 inhibitors (DPP-4Is) (specialist vs non-specialist, 54.1% vs 57.1%), then sodium-glucose cotransporter 2 inhibitors (13.9% vs 22.2%), metformin (20.3% vs 12.9%) and other OADs (<5% individually in both groups). Regardless of age, body mass index and glycated hemoglobin, DPP-4Is were the most commonly prescribed OADs by both specialists and non-specialists. About one-fifth and one-third of patients visiting specialists and non-specialists, respectively, received no advice on diet and exercise. The proportion of patients following self-care recommendations for diet and exercise (2/5 items on the Summary of Diabetes Self-Care Activities) was significantly higher among those visiting specialists than non-specialists.Conclusion The use of newer OAD was common across a broad range of clinical characteristics in patients with T2DM who newly initiated monotherapy in Japan. However, patient-related and physician-related factors could affect the treatment changes during the following course of treatment. In addition, treatment outcome could vary with the observed difference in the level of patient education provided by diabetes specialists versus non-specialists.https://drc.bmj.com/content/8/2/e001361.full |
| spellingShingle | Daisuke Yabe Hideki Origasa Hirotaka Watada Takashi Kadowaki Iichiro Shimomura Hiroko Higashiyama Keisuke Tobe Kristy Iglay Shigeru Tokita Yutaka Seino Real-world Observational Study on Patient Outcomes in Diabetes (RESPOND): study design and baseline characteristics of patients with type 2 diabetes newly initiating oral antidiabetic drug monotherapy in Japan BMJ Open Diabetes Research & Care |
| title | Real-world Observational Study on Patient Outcomes in Diabetes (RESPOND): study design and baseline characteristics of patients with type 2 diabetes newly initiating oral antidiabetic drug monotherapy in Japan |
| title_full | Real-world Observational Study on Patient Outcomes in Diabetes (RESPOND): study design and baseline characteristics of patients with type 2 diabetes newly initiating oral antidiabetic drug monotherapy in Japan |
| title_fullStr | Real-world Observational Study on Patient Outcomes in Diabetes (RESPOND): study design and baseline characteristics of patients with type 2 diabetes newly initiating oral antidiabetic drug monotherapy in Japan |
| title_full_unstemmed | Real-world Observational Study on Patient Outcomes in Diabetes (RESPOND): study design and baseline characteristics of patients with type 2 diabetes newly initiating oral antidiabetic drug monotherapy in Japan |
| title_short | Real-world Observational Study on Patient Outcomes in Diabetes (RESPOND): study design and baseline characteristics of patients with type 2 diabetes newly initiating oral antidiabetic drug monotherapy in Japan |
| title_sort | real world observational study on patient outcomes in diabetes respond study design and baseline characteristics of patients with type 2 diabetes newly initiating oral antidiabetic drug monotherapy in japan |
| url | https://drc.bmj.com/content/8/2/e001361.full |
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