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Kidney Outcomes Associated With SGLT2 Inhibitors Versus Other Glucose-Lowering Drugs in Real-world Clinical Practice: The Japan Chronic Kidney Disease Database.

Department of Nephrology and Hypertension, Kawasaki Medical School, Kurashiki, Japan. Center for Novel and Exploratory Clinical Trials, Yokohama City University, Kanagawa, Japan yano.yuichiro@jichi.ac.jp yyano0817@gmail.com yuichiro.yano@duke.edu. Department of Family Medicine and Community Health, Duke University, Durham, NC. Genki Plaza Medical Center for Health Care, Tokyo, Japan. The George Institute for Global Health, University of New South Wales, Sydney, Australia. Division of Nephrology and Endocrinology, University of Tokyo Graduate School of Medicine, Tokyo, Japan. Division of Cardiology, Nephrology, Pulmonology and Neurology, Department of Internal Medicine, Asahikawa Medical University, Hokkaido, Japan. Department of Medical Informatics and Hospital Management, Asahikawa Medical University, Hokkaido, Japan. Department of Nephrology, Rheumatology, Endocrinology and Metabolism, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan. Department of Human Resource Development of Dialysis Therapy for Kidney Disease, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan. Department of Nephrology, Nara Medical University, Nara, Japan. Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. Department of Nephrology, Nagoya University Graduate School of Medicine, Aichi, Japan. Department of Nephrology and Laboratory Medicine, Kanazawa University, Kanazawa, Japan. Department of Nephrology, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan. Division of Clinical Nephrology and Rheumatology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan. Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine, Kanagawa, Japan. Department of Nephrology, Graduate School of Medicine, Kyoto University, Kyoto, Japan. Department of Endocrinology, Metabolism and Nephrology, Kochi Medical School, Kochi University, Kochi, Japan. Division of Nephrology, Rinku General Medical Center, Oosaka, Japan. Division of Nephrology and Dialysis, Department of Cardiorenal and Cerebrovascular Medicine, Kagawa University, Kagawa, Japan. Division of Nephrology, Faculty of Medicine, Shimane University, Shimane, Japan. Department of Nephrology, Faculty of Medicine, Saitama Medical University, Saitama, Japan. Medical Information Center, Kyushu University Hospital, Fukuoka, Japan. Faculty of Health Science and Technology, Kawasaki University of Medical Welfare, Okayama, Japan. Department of Healthcare Information Management, The University of Tokyo Hospital, Tokyo, Japan. Institute of Health Data Infrastructure for All, Tokyo, Japan. Department of Pharmacology, Faculty of Medicine, Kagawa University, Kagawa, Japan. Department of Medical Science, Kawasaki Medical School, Kurashiki, Japan. Diabetes Research Center, National Center for Global Health and Medicine, Tokyo, Japan.

Diabetes care. 2021;(11):2542-2551
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Abstract

OBJECTIVE Randomized controlled trials have shown kidney-protective effects of sodium-glucose cotransporter 2 (SGLT2) inhibitors, and clinical practice databases have suggested that these effects translate to clinical practice. However, long-term efficacy, as well as whether the presence or absence of proteinuria and the rate of estimated glomerular filtration rates (eGFR) decline prior to SGLT2 inhibitor initiation modify treatment efficacy among type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD) patients, is unknown. RESEARCH DESIGN AND METHODS Using the Japan Chronic Kidney Disease Database (J-CKD-DB), a nationwide multicenter CKD registry, we developed propensity scores for SGLT2 inhibitor initiation, with 1:1 matching with patients who were initiated on other glucose-lowering drugs. The primary outcome included rate of eGFR decline, and the secondary outcomes included a composite outcome of 50% eGFR decline or end-stage kidney disease. RESULTS At baseline, mean age at initiation of the SGLT2 inhibitor (n = 1,033) or other glucose-lowering drug (n = 1,033) was 64.4 years, mean eGFR was 68.1 mL/min per 1.73 m2, and proteinuria was apparent in 578 (28.0%) of included patients. During follow-up, SGLT2 inhibitor initiation was associated with reduced eGFR decline (difference in slope for SGLT2 inhibitors vs. other drugs 0.75 mL/min/1.73 m2 per year [0.51 to 1.00]). During a mean follow-up of 24 months, 103 composite kidney outcomes occurred: 30 (14 events per 1,000 patient-years) among the SGLT2 inhibitors group and 73 (36 events per 1,000 patient-years) among the other drugs group (hazard ratio 0.40, 95% CI 0.26-0.61). The benefit provided by SGLT2 inhibitors was consistent irrespective of proteinuria and rate of eGFR decline before initiation of SGLT2 inhibitors (P heterogeneity ≥ 0.35). CONCLUSIONS The benefits of SGLT2 inhibitors on kidney function as observed in clinical trials translate to patients treated in clinical practice with no evidence that the effects are modified by the underlying rate of kidney function decline or the presence of proteinuria.

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Publication Type : Multicenter Study

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MeSH terms : Kidney