Clinical Profile and Treatment Adherence in Patients with Type 2 Diabetes and Chronic Kidney Disease Who Initiate an SGLT2 Inhibitor: A Multi-cohort Study

Catherine B Johannes; Ryan Ziemiecki; Manel Pladevall-Vila; Natalie Ebert; Csaba P Kovesdy; Reimar W Thomsen; Brenda N Baak; Aníbal García-Sempere; Hiroshi Kanegae; Craig I Coleman; Michael Walsh; Ina Trolle Andersen; Clara Rodríguez Bernal; Celia Robles Cabaniñas; Christian Fynbo Christiansen; Alfredo E Farjat; Alain Gay; Patrick Gee; Ron M C Herings; Isabel Hurtado; Naoki Kashihara; Frederik Pagh Bredahl Kristensen; Fangfang Liu; Suguru Okami; Jetty A Overbeek; Fernie J A Penning-van Beest; Satoshi Yamashita; Yuichiro Yano; J Bradley Layton; David Vizcaya; Nikolaus G Oberprieler

doi:10.1007/s13300-024-01671-x

Clinical Profile and Treatment Adherence in Patients with Type 2 Diabetes and Chronic Kidney Disease Who Initiate an SGLT2 Inhibitor: A Multi-cohort Study

Diabetes Ther. 2024 Dec 17. doi: 10.1007/s13300-024-01671-x. Online ahead of print.

Authors

Catherine B Johannes¹, Ryan Ziemiecki², Manel Pladevall-Vila^{3

4}, Natalie Ebert⁵, Csaba P Kovesdy⁶, Reimar W Thomsen⁷, Brenda N Baak⁸, Aníbal García-Sempere⁹, Hiroshi Kanegae¹⁰, Craig I Coleman^{11

12}, Michael Walsh¹³, Ina Trolle Andersen⁷, Clara Rodríguez Bernal⁹, Celia Robles Cabaniñas⁹, Christian Fynbo Christiansen⁷, Alfredo E Farjat¹⁴, Alain Gay¹⁴, Patrick Gee¹⁵, Ron M C Herings⁸, Isabel Hurtado⁹, Naoki Kashihara¹⁶, Frederik Pagh Bredahl Kristensen⁷, Fangfang Liu¹⁴, Suguru Okami¹⁴, Jetty A Overbeek⁸, Fernie J A Penning-van Beest⁸, Satoshi Yamashita¹⁴, Yuichiro Yano^{17

18}, J Bradley Layton², David Vizcaya¹⁴, Nikolaus G Oberprieler^{19

20}

Affiliations

¹ RTI Health Solutions, Waltham, MA, USA.
² RTI Health Solutions, Research Triangle Park, NC, USA.
³ RTI Health Solutions, Barcelona, Spain.
⁴ The Center for Health Policy and Health Services Research, Henry Ford Health System, Detroit, MI, USA.
⁵ Charité-Universitätsmedizin Berlin, Berlin, Germany.
⁶ Division of Nephrology, Department of Medicine, University of Tennessee Health Science Center, Memphis, TN, USA.
⁷ Department of Clinical Epidemiology, Aarhus University and Aarhus University Hospital, Aarhus, Denmark.
⁸ PHARMO Institute for Drug Outcomes Research, Utrecht, The Netherlands.
⁹ Valencia Health System Integrated Database, Health Services Research Unit, Valencia, Spain.
¹⁰ Genki Plaza Medical Centre for Health Care, Tokyo, Japan.
¹¹ University of Connecticut School of Pharmacy, Storrs, CT, USA.
¹² Evidence-Based Practice Center, Hartford Hospital, Hartford, CT, USA.
¹³ Division of Nephrology, Department of Medicine, McMaster University, Hamilton, ON, Canada.
¹⁴ Bayer AG, Berlin, Germany.
¹⁵ National Kidney Foundation Advocacy, Richmond, VA, USA.
¹⁶ Department of Nephrology and Hypertension, Kawasaki Medical School, Kurashiki, Japan.
¹⁷ NCD Epidemiology Research Center, Shiga University of Medical Science, Shiga, Japan.
¹⁸ Department of General Medicine, Juntendo University Faculty of Medicine, Tokyo, Japan.
¹⁹ Bayer AG, Berlin, Germany. niki.oberprieler@bayer.com.
²⁰ Bayer AS, Oslo, Norway. niki.oberprieler@bayer.com.

PMID: 39688776
DOI: 10.1007/s13300-024-01671-x

Abstract

Introduction: The clinical landscape for the treatment of patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) is rapidly evolving. As part of the FOUNTAIN platform (NCT05526157; EUPAS48148), we described and compared cohorts of adult patients with CKD and T2D initiating a sodium-glucose cotransporter 2 inhibitor (SGLT2i) before the launch of finerenone in Europe, Japan, and the United States (US).

Methods: This was a multinational, multi-cohort study of patients with T2D in five data sources: the Danish National Health Registers (DNHR) (Denmark), PHARMO Data Network (The Netherlands), Valencia Health System Integrated Database (VID) (Spain), Japan Chronic Kidney Disease Database Extension (J-CKD-DB-Ex) (Japan), and Optum's de-identified Clinformatics^® Data Mart Database (CDM) (US). Eligible patients had CKD (based on either diagnosis codes, eGFR values, and/or urine ACR) and initiated an SGLT2i between 2012 and 2021. Baseline demographic, lifestyle, and clinical characteristics were analyzed, and drug utilization patterns were described.

Results: The final cohorts included 21,739 patients in DNHR, 381 in PHARMO, 31,785 in VID, 1157 in J-CKD-DB-Ex, and 56,219 in CDM. Across data sources, approximately 41-70% had CKD stage 1 or 2 at baseline; severe CKD (stage 4) was uncommon (1.6-6.7%). The median duration of SGLT2i therapy ranged from 7.5 months in PHARMO to 17.0 months in VID. At least 50% of patients were currently receiving SGLT2i treatment at 1 year after initiation.

Conclusions: At a 1-year follow-up, at least half of the patients with CKD and T2D were receiving SGLT2i treatment across the data sources. In patients initiating SGLT2i, treatment options for T2D and CKD were heterogeneous and dynamic within and among data sources.

Keywords: CKD; Chronic kidney disease; Danish National Health Registers (DNHR); Drug utilization; FOUNTAIN; Japan Chronic Kidney Disease Database Extension (J-CKD-DB-Ex); Optum’s de-identified Clinformatics® Data Mart Database (CDM); PHARMO Data Network; SGLT2 inhibitor; T2D; Type 2 diabetes; Valencia Health System Integrated Database (VID).