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      Estimating the population-level impacts of improved uptake of SGLT2 inhibitors in patients with chronic kidney disease: a cross-sectional observational study using routinely collected Australian primary care data

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          Summary

          Background

          Sodium glucose co-transporter 2 (SGLT2) inhibitors reduce the risk of kidney failure and death in patients with chronic kidney disease (CKD) but are underused. We evaluated the number of patients with CKD in Australia that would be eligible for treatment and estimated the number of cardiorenal and kidney failure events that could be averted with improved uptake of SGLT2 inhibitors.

          Methods

          This cross-sectional observational study leveraged nationally representative primary care data from 392 Australian general practices (MedicineInsight) between 1 January 2020 and 31 December 2021. We identified patients that would have met inclusion criteria of key SGLT2 inhibitor trials and applied these data to age and sex-stratified estimates of CKD prevalence for the Australian population (using national census data), estimating the number of preventable events using trial event rates. Key outcomes included cardiorenal events (CKD progression, kidney failure, or death due to cardiovascular or kidney disease) and kidney failure.

          Findings

          In MedicineInsight, 44.2% of adults with CKD would have met CKD eligibility criteria for an SGLT2 inhibitor; baseline use was 4.1%. Applying these data to the Australian population, 230,246 patients with CKD would have been eligible for treatment with an SGLT2 inhibitor. Optimal implementation of SGLT2 inhibitors (75% uptake) could reduce cardiorenal and kidney failure events annually in Australia by 3644 (95% CI 3526–3764) and 1312 (95% CI 1242–1385), respectively.

          Interpretation

          Improved uptake of SGLT2 inhibitors for patients with CKD in Australia has the potential to prevent large numbers of patients experiencing CKD progression or dying due to cardiovascular or kidney disease. Identifying strategies to increase the uptake of SGLT2 inhibitors is critical to realising the population-level benefits of this drug class.

          Funding

          doi 10.13039/501100001773, University of New South Wales; Scientia Program and doi 10.13039/100001003, Boehringer Ingelheim; Eli Lilly Alliance.

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          The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for reporting observational studies.

          Erik von Elm, Douglas G. Altman, Matthias Egger … (2014)
          Much biomedical research is observational. The reporting of such research is often inadequate, which hampers the assessment of its strengths and weaknesses and of a study's generalisability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Initiative developed recommendations on what should be included in an accurate and complete report of an observational study. We defined the scope of the recommendations to cover three main study designs: cohort, case-control, and cross-sectional studies. We convened a 2-day workshop in September 2004, with methodologists, researchers, and journal editors to draft a checklist of items. This list was subsequently revised during several meetings of the coordinating group and in e-mail discussions with the larger group of STROBE contributors, taking into account empirical evidence and methodological considerations. The workshop and the subsequent iterative process of consultation and revision resulted in a checklist of 22 items (the STROBE Statement) that relate to the title, abstract, introduction, methods, results, and discussion sections of articles. 18 items are common to all three study designs and four are specific for cohort, case-control, or cross-sectional studies. A detailed Explanation and Elaboration document is published separately and is freely available on the Web sites of PLoS Medicine, Annals of Internal Medicine, and Epidemiology. We hope that the STROBE Statement will contribute to improving the quality of reporting of observational studies.
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            Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy

            Vlado Perkovic, Meg J Jardine, Bruce Neal … (2019)
            Type 2 diabetes mellitus is the leading cause of kidney failure worldwide, but few effective long-term treatments are available. In cardiovascular trials of inhibitors of sodium-glucose cotransporter 2 (SGLT2), exploratory results have suggested that such drugs may improve renal outcomes in patients with type 2 diabetes.
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              Empagliflozin in Patients with Chronic Kidney Disease

              William G. Herrington, Natalie Staplin, Christoph Wanner … (2022)
              Background This study, the EMPA-KIDNEY trial, was designed to assess the effects of empagliflozin in a broad range of patients with chronic kidney disease (CKD) at risk of progression. Methods We randomly assigned 6609 participants to empagliflozin (10mg once daily) versus matching placebo. Eligibility required an estimated glomerular filtration rate (eGFR) of ≥20 to <45 ml/minute/1.73m 2 ; or ≥45 to <90 ml/minute/1.73m 2 with a urinary albumin-to-creatinine ratio (ACR) of ≥200 mg/g. The primary outcome was a composite of kidney disease progression (end-stage kidney disease, a sustained eGFR <10 ml/minute/1.73m 2 , a sustained decline in eGFR of ≥40%, or a renal death) or death from cardiovascular causes. Results During a median of 2.0 years follow-up, a primary outcome event occurred in 432 of 3304 patients (13.1%) in the empagliflozin group and in 558 of 3305 patients (16.9%) in the placebo group (hazard ratio, 0.72; 95% CI 0.64 to 0.82; P<0.001), with consistent results in those with or without diabetes and across the range of eGFR studied. There were fewer hospitalizations from any cause in the empagliflozin group (0.86; 0.78 to 0.95, P=0.003), but no statistically significant effect on hospitalization for heart failure or cardiovascular death (4.0% vs 4.6%), or death from any cause (4.5% vs 5.1%). The rates of serious adverse events were broadly similar in the two groups. Conclusions Empagliflozin reduced the risk of the composite outcome of kidney disease progression or cardiovascular death in a wide range of patients at risk of CKD progression. (Funding:Boehringer Ingelheim, Eli Lilly and others; Clinicaltrials.gov:NCT03594110, EuDRACT: 2017-002971-24).
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                Author and article information

                Contributors
                Brendon L. Neuen
                Journal
                Journal ID (nlm-ta): Lancet Reg Health West Pac
                Journal ID (iso-abbrev): Lancet Reg Health West Pac
                Title: The Lancet Regional Health: Western Pacific
                Publisher: Elsevier
                ISSN (Electronic): 2666-6065
                Publication date PMC-release: 18 December 2023
                Publication date Collection: February 2024
                Publication date (Electronic): 18 December 2023
                Volume: 43
                Electronic Location Identifier: 100988
                Affiliations
                [a ]Faculty of Medicine and Health, The George Institute for Global Health, University of New South Wales, Sydney, Australia
                [b ]Department of Renal Medicine, Royal North Shore Hospital, Sydney, Australia
                [c ]Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
                [d ]Department of Nephrology, Prince of Wales Hospital, Sydney, Australia
                [e ]Department of Renal Medicine, St George Hospital, Sydney, Australia
                [f ]NHMRC Clinical Trials Centre, University of Sydney, New South Wales, Australia
                [g ]Department of Renal Medicine, Concord Repatriation General Hospital, Sydney, New South Wales, Australia
                [h ]Department of Renal Medicine, Liverpool Hospital, Sydney, Australia
                [i ]Faculty of Medicine, University of New South Wales, Sydney, Australia
                [j ]The George Institute for Global Health, School of Public Health, Imperial College London, London, UK
                [k ]Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
                [l ]O'Brien Institute for Public Health, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
                Author notes
                [∗ ]Corresponding author. The George Institute for Global Health, Level 5, 1 King St Newtown, New South Wales 2042, Australia. bneuen@ 123456georgeinstitute.org.au
                Article
                Publisher Item ID: S2666-6065(23)00306-1 Publisher ID: 100988
                DOI: 10.1016/j.lanwpc.2023.100988
                PMC ID: 10772282
                PubMed ID: 38192747
                SO-VID: a3d78f98-4ca1-4e4e-93da-c5d9b4d83b80
                Copyright © © 2023 The Author(s)
                License:

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                Date received : 17 August 2023
                Date revision received : 27 October 2023
                Date accepted : 28 November 2023
                Categories
                Subject: Articles

                Keywords: chronic kidney disease,end-stage kidney disease,sodium glucose cotransporter 2 inhibitors,cardiovascular disease,epidemiology
                Data availability:
                Keywords: chronic kidney disease, end-stage kidney disease, sodium glucose cotransporter 2 inhibitors, cardiovascular disease, epidemiology

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