Dapagliflozin Utilization in Chronic Kidney Disease and Its Real-World Effectiveness Among Patients with Lower Levels of Albuminuria in the USA and Japan.

Chronic kidney disease Dapagliflozin Effectiveness Epidemiology SGLT2i

Journal

Advances in therapy
ISSN: 1865-8652
Titre abrégé: Adv Ther
Pays: United States
ID NLM: 8611864

Informations de publication

Date de publication:
19 Jan 2024
Historique:
received: 29 09 2023
accepted: 14 12 2023
medline: 19 1 2024
pubmed: 19 1 2024
entrez: 19 1 2024
Statut: aheadofprint

Résumé

Sodium-glucose cotransporter 2 inhibitors such as dapagliflozin have been proven effective for slowing chronic kidney disease (CKD) progression in large outcomes trials that mainly included patients with higher levels of albuminuria. Understanding the real-world utilization and effectiveness of these drugs among patients with CKD with lower levels of albuminuria can inform clinical decision-making in this population. Claims data from the USA and Japan were used to describe patients with CKD and urinary albumin-to-creatinine ratio (UACR) < 200 mg/g who were eligible for dapagliflozin 10 mg treatment (initiators and untreated) following its approval for CKD. A quantile regression analysis was performed to evaluate the effect of dapagliflozin 10 mg initiation versus no initiation on estimated glomerular filtration rate (eGFR) slope in a propensity score-matched cohort, using a prevalent new-user design. Dapagliflozin initiators (n = 20,407) mostly had stage 3-4 CKD (69-81% across databases). The most common comorbidities were type 2 diabetes, hypertension and cardiovascular disease. At baseline, a renin-angiotensin system inhibitor was prescribed in 53-81% of patients. Eligible but untreated patients were older and had a higher eGFR and lower comorbidity burden than initiators. Following dapagliflozin initiation, the differences in median eGFR slope between initiators and matched non-initiators were 1.07 mL/min/1.73 m Dapagliflozin 10 mg was prescribed to a broad range of patients with CKD. In patients with UACR < 200 mg/g, dapagliflozin initiation was associated with a clinically meaningful attenuation of eGFR slope compared with non-initiation. These findings supplement available clinical efficacy evidence and suggest that dapagliflozin effectiveness may extend to patients with CKD and UACR < 200 mg/g. Graphical Abstract and Video Abstract available for this article. (Video Abstract 245964 kb).

Identifiants

pubmed: 38240949
doi: 10.1007/s12325-023-02773-x
pii: 10.1007/s12325-023-02773-x
doi:

Types de publication

Journal Article

Langues

eng

Informations de copyright

© 2024. The Author(s).

Références

Sundström J, Bodegard J, Bollmann A, et al. Prevalence, outcomes, and cost of chronic kidney disease in a contemporary population of 24 million patients from 11 countries: the CaReMe CKD study. Lancet Reg Health Eur. 2022;20:100438.
doi: 10.1016/j.lanepe.2022.100438 pubmed: 36090671 pmcid: 9459126
Jager KJ, Kovesdy C, Langham R, Rosenberg M, Jha V, Zoccali C. A single number for advocacy and communication-worldwide more than 850 million individuals have kidney diseases. Kidney Int. 2019;96(5):1048–50.
doi: 10.1016/j.kint.2019.07.012 pubmed: 31582227
Carney EF. The impact of chronic kidney disease on global health. Nat Rev Nephrol. 2020;16(5):251.
doi: 10.1038/s41581-020-0268-7 pubmed: 32144399
Gansevoort RT, Correa-Rotter R, Hemmelgarn BR, et al. Chronic kidney disease and cardiovascular risk: epidemiology, mechanisms, and prevention. Lancet. 2013;382(9889):339–52.
doi: 10.1016/S0140-6736(13)60595-4 pubmed: 23727170
Verberne WR, Das-Gupta Z, Allegretti AS, et al. Development of an international standard set of value-based outcome measures for patients with chronic kidney disease: a report of the International Consortium for Health Outcomes Measurement (ICHOM) CKD Working Group. Am J Kidney Dis. 2019;73(3):372–84.
doi: 10.1053/j.ajkd.2018.10.007 pubmed: 30579710
Centers for Disease Control and Prevention (CDC), 2023. Chronic kidney disease in the United States. 2023. https://www.cdc.gov/kidneydisease/publications-resources/ckd-national-facts.html . Accessed 29 Nov 2023.
Wang V, Vilme H, Maciejewski ML, Boulware LE. The economic burden of chronic kidney disease and end-stage renal disease. Semin Nephrol. 2016;36(4):319–30.
doi: 10.1016/j.semnephrol.2016.05.008 pubmed: 27475662
US Department of Health and Human Services, 2023. 2023 Annual Data Report: healthcare expenditures for persons with CKD. 2023. https://usrds-adr.niddk.nih.gov/2023/chronic-kidney-disease/6-healthcare-expenditures-for-persons-with-ckd . Accessed 29 Nov 2023.
US Department of Health and Human Services, 2023. 2023 Annual Data Report: healthcare expenditures for persons with ESRD. 2023. https://usrds-adr.niddk.nih.gov/2023/end-stage-renal-disease/9-healthcare-expenditures-for-persons-with-esrd . Accessed 29 Nov 2023.
Imai E, Horio M, Watanabe T, et al. Prevalence of chronic kidney disease in the Japanese general population. Clin Exp Nephrol. 2009;13(6):621–30.
doi: 10.1007/s10157-009-0199-x pubmed: 19513802
Nawata K. Risk factors for heart, cerebrovascular, and kidney diseases: evaluation of potential side effects of medications to control hypertension, hyperglycemia, and hypercholesterolemia. Front Cardiovasc Med. 2023;10:1103250.
doi: 10.3389/fcvm.2023.1103250 pubmed: 37332577 pmcid: 10272769
Hanafusa N, Fukagawa M. Global dialysis perspective: Japan. Kidney 360. 2020;1(5):416–9.
doi: 10.34067/KID.0000162020 pubmed: 35369370 pmcid: 8809283
Nangaku M, Kashihara N. Committee report on measures against hiding disease. Nihon Jinzo Gakkai Shi. 2019;61(2):62–7.
American Society of Nephrology, 2019. Advancing American kidney health initiative: a primer. 2023. https://www.asn-online.org/policy/webdocs/page.aspx?code=220 . Accessed 15 Sep 2023.
Yau K, Dharia A, Alrowiyti I, Cherney DZI. Prescribing SGLT2 inhibitors in patients with CKD: expanding indications and practical considerations. Kidney Int Rep. 2022;7(7):1463–76.
doi: 10.1016/j.ekir.2022.04.094 pubmed: 35812300 pmcid: 9263228
McGuire DK, Shih WJ, Cosentino F, et al. Association of SGLT2 inhibitors with cardiovascular and kidney outcomes in patients with type 2 diabetes: a meta-analysis. JAMA Cardiol. 2021;6(2):148–58.
doi: 10.1001/jamacardio.2020.4511 pubmed: 33031522
Heerspink HJL, Stefánsson BV, Correa-Rotter R, et al. Dapagliflozin in patients with chronic kidney disease. N Engl J Med. 2020;383(15):1436–46.
doi: 10.1056/NEJMoa2024816 pubmed: 32970396
Herrington WG, Staplin N, Wanner C, et al. Empagliflozin in patients with chronic kidney disease. N Engl J Med. 2023;388(2):117–27.
doi: 10.1056/NEJMoa2204233 pubmed: 36331190
US Food and Drug Administration, 2021. FDA approves treatment for chronic kidney disease. 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-treatment-chronic-kidney-disease . Accessed 28 Feb 2023.
Kumamaru H, Togo K, Kimura T, et al. Inventory of real-world data sources in Japan: annual survey conducted by the Japanese Society for Pharmacoepidemiology Task Force. Pharmacoepidemiol Drug Saf. 2023. https://doi.org/10.1002/pds.5680 .
Sumida K, Nadkarni GN, Grams ME, et al. Conversion of urine protein-creatinine ratio or urine dipstick protein to urine albumin-creatinine ratio for use in chronic kidney disease screening and prognosis: an individual participant-based meta-analysis. Ann Intern Med. 2020;173(6):426–35.
doi: 10.7326/M20-0529 pubmed: 32658569 pmcid: 7780415
Suissa S, Moodie EE, Dell’Aniello S. Prevalent new-user cohort designs for comparative drug effect studies by time-conditional propensity scores. Pharmacoepidemiol Drug Saf. 2017;26(4):459–68.
doi: 10.1002/pds.4107 pubmed: 27610604
Inker LA, Eneanya ND, Coresh J, et al. New creatinine- and cystatin C-based equations to estimate GFR without race. N Engl J Med. 2021;385(19):1737–49.
doi: 10.1056/NEJMoa2102953 pubmed: 34554658 pmcid: 8822996
Ho D, Imai K, King G, Stuart EA. MatchIt: nonparametric preprocessing for parametric causal inference. J Stat Softw. 2011;42(8):1–28.
doi: 10.18637/jss.v042.i08
Koenker R, 2023. quantreg: Quantile Regression. R package version 5.95. 2023. https://cran.r-project.org/package=quantreg . Accessed 15 Sep 2023.
Best N, Price RG, Pouliquen IJ, Keene ON. Assessing efficacy in important subgroups in confirmatory trials: an example using Bayesian dynamic borrowing. Pharm Stat. 2021;20(3):551–62.
doi: 10.1002/pst.2093 pubmed: 33475231 pmcid: 8247867
Heerspink HJL, Jongs N, Chertow GM, et al. Effect of dapagliflozin on the rate of decline in kidney function in patients with chronic kidney disease with and without type 2 diabetes: a prespecified analysis from the DAPA-CKD trial. Lancet Diabetes Endocrinol. 2021;9(11):743–54.
doi: 10.1016/S2213-8587(21)00242-4 pubmed: 34619108
Heerspink HJ, Chertow GM, Jongs N, et al. Effects of dapagliflozin in patients without diabetes and with microalbuminuria: an exploratory analysis from the DAPA-CKD trial [poster]. Presented at the ASN Kidney Week 2022, 3–6 November 2022, Orlando, FL, USA.
Inker LA, Heerspink HJL, Tighiouart H, et al. GFR slope as a surrogate end point for kidney disease progression in clinical trials: a meta-analysis of treatment effects of randomized controlled trials. J Am Soc Nephrol. 2019;30(9):1735–45.
doi: 10.1681/ASN.2019010007 pubmed: 31292197 pmcid: 6727261
Levey AS, Gansevoort RT, Coresh J, et al. Change in albuminuria and GFR as end points for clinical trials in early stages of CKD: a scientific workshop sponsored by the National Kidney Foundation in collaboration with the US Food and Drug Administration and European Medicines Agency. Am J Kidney Dis. 2020;75(1):84–104.
doi: 10.1053/j.ajkd.2019.06.009 pubmed: 31473020
Grams ME, Sang Y, Ballew SH, et al. Evaluating glomerular filtration rate slope as a surrogate end point for ESKD in clinical trials: an individual participant meta-analysis of observational data. J Am Soc Nephrol. 2019;30(9):1746–55.
doi: 10.1681/ASN.2019010008 pubmed: 31292199 pmcid: 6727262
James G, Garcia Sanchez JJ, Carrero JJ, et al. Low adherence to Kidney Disease: Improving Global Outcomes 2012 CKD clinical practice guidelines despite clear evidence of utility. Kidney Int Rep. 2022;7(9):2059–70.
doi: 10.1016/j.ekir.2022.05.033 pubmed: 36090504 pmcid: 9458998
Sultan AA, Barone S, Kumar S, et al. REVEAL-CKD: prevalence of and patient characteristics associated with undiagnosed stage 3 chronic kidney disease [poster]. Presented at the American Diabetes Association 81st Scientific Sessions, 25–29 June 2021, [virtual].
Chu CD, Xia F, Du Y, et al. Estimated prevalence and testing for albuminuria in US adults at risk for chronic kidney disease. JAMA Netw Open. 2023;6(7): e2326230.
doi: 10.1001/jamanetworkopen.2023.26230 pubmed: 37498594 pmcid: 10375308
Svangård N, Hildeman A, Greasley P, Ambery P. #4519 Can we replace urine testing and deliver a step change in access to renoprotective medications? Nephrol Dial Transpl. 2023. https://doi.org/10.1093/ndt/gfad063c_4519 .
doi: 10.1093/ndt/gfad063c_4519
Anderson SL. Dapagliflozin efficacy and safety: a perspective review. Ther Adv Drug Saf. 2014;5(6):242–54.
doi: 10.1177/2042098614551938 pubmed: 25436106 pmcid: 4232499

Auteurs

Navdeep Tangri (N)

Department of Internal Medicine, University of Manitoba, Winnipeg, MB, Canada. ntangri@sogh.mb.ca.
Seven Oaks General Hospital, 2LB19-2300, McPhillips Street, Winnipeg, MB, R2V 3M3, Canada. ntangri@sogh.mb.ca.

Anjay Rastogi (A)

David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.

Cassandra Nekeman-Nan (C)

Epidemiology, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Medical, AstraZeneca, Gothenburg, Sweden.

Lai San Hong (LS)

Redsen Limited, Bournemouth, UK.

Asuka Ozaki (A)

Medical Affairs, AstraZeneca K. K., Osaka, Japan.

Stefan Franzén (S)

Medical and Payer Evidence Statistics, BioPharmaceuticals Medical, AstraZeneca, Gothenburg, Sweden.

Tadashi Sofue (T)

Department of Cardiorenal and Cerebrovascular Medicine, Faculty of Medicine, Kagawa University, Miki, Japan.

Classifications MeSH