Real‐world risk of lower‐limb amputation associated with sodium–glucose cotransporter 2 inhibitors versus metformin: A propensity score‐matched model analysis in Japan
ABSTRACT Aims/Introduction We aimed to clarify the real‐world risk of lower‐limb amputation and identify factors related to increased risk in Japanese patients with type 2 diabetes using sodium–glucose cotransporter 2 inhibitors (SGLT2is). Materials and Methods We carried out a retrospective observa...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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Wiley
2022-12-01
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| Series: | Journal of Diabetes Investigation |
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| Online Access: | https://doi.org/10.1111/jdi.13906 |
| _version_ | 1797807118076608512 |
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| author | Gen Mizutani Takeshi Horii Yoichi Oikawa Koichiro Atsuda Akira Shimada |
| author_facet | Gen Mizutani Takeshi Horii Yoichi Oikawa Koichiro Atsuda Akira Shimada |
| author_sort | Gen Mizutani |
| collection | DOAJ |
| description | ABSTRACT Aims/Introduction We aimed to clarify the real‐world risk of lower‐limb amputation and identify factors related to increased risk in Japanese patients with type 2 diabetes using sodium–glucose cotransporter 2 inhibitors (SGLT2is). Materials and Methods We carried out a retrospective observational cohort study utilizing the Japanese Medical Data Vision, a diagnosis procedure combination database. We identified 107,296 patients with type 2 diabetes who were initiated on SGLT2is or metformin (control; n = 53,648 per group) using 1:1 propensity score matching from April 2014 to October 2019. The hazard ratio (HR) for the risk of lower‐limb amputation was analyzed using a Cox proportional hazards model adjusted for patients' baseline characteristics and use of concomitant medical agents. Results Of the 107,296 patients, 66 (0.06%); that is, 41 (0.08%) in the SGLT2is group and 25 (0.05%) in the metformin group, underwent amputation, with no significant difference in the proportions between the groups. There was no significant difference in the risk of amputation between the SGLT2is and metformin groups (HR 1.34, 95% confidence interval [CI] 0.80–2.24). However, female sex (HR 2.78, 95% CI 1.12–6.94) and use of strong statins (HR 2.68; 95% CI 1.18–8.20) were significantly associated with a higher risk of amputation in the SGLT2is group than in the metformin group. Conclusions SGLT2is might not be related to an increased risk of lower‐limb amputation in patients with type 2 diabetes in real‐world clinical practice. The possible increased risk of SGLT2is‐associated amputation in female patients with type 2 diabetes and patients with type 2 diabetes requiring strong statins is notable. |
| first_indexed | 2024-03-13T06:17:44Z |
| format | Article |
| id | doaj.art-7b7485b63a9f49ed81e04a7630bafebc |
| institution | Directory Open Access Journal |
| issn | 2040-1116 2040-1124 |
| language | English |
| last_indexed | 2024-03-13T06:17:44Z |
| publishDate | 2022-12-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Diabetes Investigation |
| spelling | doaj.art-7b7485b63a9f49ed81e04a7630bafebc2023-06-10T05:22:03ZengWileyJournal of Diabetes Investigation2040-11162040-11242022-12-0113122000200910.1111/jdi.13906Real‐world risk of lower‐limb amputation associated with sodium–glucose cotransporter 2 inhibitors versus metformin: A propensity score‐matched model analysis in JapanGen Mizutani0Takeshi Horii1Yoichi Oikawa2Koichiro Atsuda3Akira Shimada4Department of Endocrinology and Diabetes, School of Medicine Saitama Medical University Saitama JapanResearch and Education Center for Clinical Pharmacy, Division of Clinical Pharmacy, Laboratory of Pharmacy Practice and Science 1 Kitasato University School of Pharmacy Kanagawa JapanDepartment of Endocrinology and Diabetes, School of Medicine Saitama Medical University Saitama JapanResearch and Education Center for Clinical Pharmacy, Division of Clinical Pharmacy, Laboratory of Pharmacy Practice and Science 1 Kitasato University School of Pharmacy Kanagawa JapanDepartment of Endocrinology and Diabetes, School of Medicine Saitama Medical University Saitama JapanABSTRACT Aims/Introduction We aimed to clarify the real‐world risk of lower‐limb amputation and identify factors related to increased risk in Japanese patients with type 2 diabetes using sodium–glucose cotransporter 2 inhibitors (SGLT2is). Materials and Methods We carried out a retrospective observational cohort study utilizing the Japanese Medical Data Vision, a diagnosis procedure combination database. We identified 107,296 patients with type 2 diabetes who were initiated on SGLT2is or metformin (control; n = 53,648 per group) using 1:1 propensity score matching from April 2014 to October 2019. The hazard ratio (HR) for the risk of lower‐limb amputation was analyzed using a Cox proportional hazards model adjusted for patients' baseline characteristics and use of concomitant medical agents. Results Of the 107,296 patients, 66 (0.06%); that is, 41 (0.08%) in the SGLT2is group and 25 (0.05%) in the metformin group, underwent amputation, with no significant difference in the proportions between the groups. There was no significant difference in the risk of amputation between the SGLT2is and metformin groups (HR 1.34, 95% confidence interval [CI] 0.80–2.24). However, female sex (HR 2.78, 95% CI 1.12–6.94) and use of strong statins (HR 2.68; 95% CI 1.18–8.20) were significantly associated with a higher risk of amputation in the SGLT2is group than in the metformin group. Conclusions SGLT2is might not be related to an increased risk of lower‐limb amputation in patients with type 2 diabetes in real‐world clinical practice. The possible increased risk of SGLT2is‐associated amputation in female patients with type 2 diabetes and patients with type 2 diabetes requiring strong statins is notable.https://doi.org/10.1111/jdi.13906Lower‐limb amputationSodium–glucose cotransporter 2 inhibitorType 2 diabetes |
| spellingShingle | Gen Mizutani Takeshi Horii Yoichi Oikawa Koichiro Atsuda Akira Shimada Real‐world risk of lower‐limb amputation associated with sodium–glucose cotransporter 2 inhibitors versus metformin: A propensity score‐matched model analysis in Japan Journal of Diabetes Investigation Lower‐limb amputation Sodium–glucose cotransporter 2 inhibitor Type 2 diabetes |
| title | Real‐world risk of lower‐limb amputation associated with sodium–glucose cotransporter 2 inhibitors versus metformin: A propensity score‐matched model analysis in Japan |
| title_full | Real‐world risk of lower‐limb amputation associated with sodium–glucose cotransporter 2 inhibitors versus metformin: A propensity score‐matched model analysis in Japan |
| title_fullStr | Real‐world risk of lower‐limb amputation associated with sodium–glucose cotransporter 2 inhibitors versus metformin: A propensity score‐matched model analysis in Japan |
| title_full_unstemmed | Real‐world risk of lower‐limb amputation associated with sodium–glucose cotransporter 2 inhibitors versus metformin: A propensity score‐matched model analysis in Japan |
| title_short | Real‐world risk of lower‐limb amputation associated with sodium–glucose cotransporter 2 inhibitors versus metformin: A propensity score‐matched model analysis in Japan |
| title_sort | real world risk of lower limb amputation associated with sodium glucose cotransporter 2 inhibitors versus metformin a propensity score matched model analysis in japan |
| topic | Lower‐limb amputation Sodium–glucose cotransporter 2 inhibitor Type 2 diabetes |
| url | https://doi.org/10.1111/jdi.13906 |
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