Effect of preceding drug therapy on the renal and cardiovascular outcomes of combined sodium-glucose cotransporter-2 inhibitor and glucagon-like peptide-1 receptor agonist treatment in patients with type 2 diabetes and chronic kidney disease.
combination treatment
glucagon‐like peptide 1 receptor agonist
preceding drug
renal outcome
sodium‐glucose cotransporter 2 inhibitors
Journal
Diabetes, obesity & metabolism
ISSN: 1463-1326
Titre abrégé: Diabetes Obes Metab
Pays: England
ID NLM: 100883645
Informations de publication
Date de publication:
19 May 2024
19 May 2024
Historique:
revised:
27
04
2024
received:
11
03
2024
accepted:
28
04
2024
medline:
20
5
2024
pubmed:
20
5
2024
entrez:
20
5
2024
Statut:
aheadofprint
Résumé
To conduct a post hoc subgroup analysis of patients with type 2 diabetes (T2D) from the RECAP study, who were treated with sodium-glucose cotransporter-2 (SGLT2) inhibitor and glucagon-like peptide 1 receptor agonist (GLP-1RA) combination therapy, focusing only on those patients who had chronic kidney disease (CKD), to examine whether the composite renal outcome differed between those who received SGLT2 inhibitor treatment first and those who received a GLP-1RA first. We included 438 patients with CKD (GLP-1RA-first group, n = 223; SGLT2 inhibitor-first group, n = 215) from the 643 T2D patients in the RECAP study. The incidence of the composite renal outcome, defined as progression to macroalbuminuria and/or a ≥50% decrease in estimated glomerular filtration rate (eGFR), was analysed using a propensity score (PS)-matched model. Furthermore, we calculated the win ratio for these composite renal outcomes, which were weighted in the following order: (1) both a ≥50% decrease in eGFR and progression to macroalbuminuria; (2) a decrease in eGFR of ≥50% only; and (3) progression to macroalbuminuria only. Using the PS-matched model, 132 patients from each group were paired. The incidence of renal composite outcomes did not differ between the two groups (GLP-1RA-first group, 10%; SGLT2 inhibitor-first group, 17%; odds ratio 1.80; 95% confidence interval [CI] 0.85 to 4.26; p = 0.12). The win ratio of the GLP-1RA-first group versus the SGLT2 inhibitor-first group was 1.83 (95% CI 1.71 to 1.95; p < 0.001). Although the renal composite outcome did not differ between the two groups, the win ratio of the GLP-1RA-first group versus the SGLT2 inhibitor-first group was significant. These results suggest that, in GLP-1RA and SGLT2 inhibitor combination therapy, the addition of an SGLT2 inhibitor to baseline GLP-1RA treatment may lead to more favourable renal outcomes.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2024 John Wiley & Sons Ltd.
Références
Hahr AJ, Molitch ME. Management of Diabetes Mellitus in patients with CKD: Core curriculum 2022. Am J Kidney Dis. 2022;79(5):728‐736.
Aart‐van der Beek AB, de Boer RA, Heerspink HJL. Kidney and heart failure outcomes associated with SGLT2 inhibitor use. Nat Rev Nephrol. 2022;18(5):294‐306.
Perkovic V, Jardine MJ, Neal B, et al. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy. N Engl J Med. 2019;380(24):2295‐2306.
Heerspink HJL, Stefánsson BV, Correa‐Rotter R, et al. Dapagliflozin in patients with chronic kidney disease. N Engl J Med. 2020;383(15):1436‐1446.
Herrington WG, Staplin N, Wanner C, et al. Empagliflozin in patients with chronic kidney disease. N Engl J Med. 2023;388(2):117‐127.
Mann JFE, Ørsted DD, Brown‐Frandsen K, et al. Liraglutide and renal outcomes in type 2 diabetes. N Engl J Med. 2017;377(9):839‐848.
Holman RR, Bethel MA, Mentz RJ, et al. Effects of once‐weekly Exenatide on cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2017;377(13):1228‐1239.
Gerstein HC, Sattar N, Rosenstock J, et al. Cardiovascular and renal outcomes with Efpeglenatide in type 2 diabetes. N Engl J Med. 2021;385(10):896‐907.
Gerstein HC, Colhoun HM, Dagenais GR. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double‐blind, randomised placebo‐controlled trial. Lancet. 2019;394(10193):121‐130.
Frías JP, Guja C, Hardy E, et al. Exenatide once weekly plus dapagliflozin once daily versus exenatide or dapagliflozin alone in patients with type 2 diabetes inadequately controlled with metformin monotherapy (DURATION‐8): a 28 week, multicentre, double‐blind, phase 3, randomised controlled trial. Lancet Diabetes Endocrinol. 2016;4(12):1004‐1016.
Zinman B, Bhosekar V, Busch R, et al. Semaglutide once weekly as add‐on to SGLT‐2 inhibitor therapy in type 2 diabetes (SUSTAIN 9): a randomised, placebo‐controlled trial. Lancet Diabetes Endocrinol. 2019;7(5):356‐367.
Singh AK, Singh R. Metabolic and cardiovascular benefits with combination therapy of SGLT‐2 inhibitors and GLP‐1 receptor agonists in type 2 diabetes. World J Cardiol. 2022;14(6):329‐342.
Clegg LE, Penland RC, Bachina S, et al. Effects of exenatide and open‐label SGLT2 inhibitor treatment, given in parallel or sequentially, on mortality and cardiovascular and renal outcomes in type 2 diabetes: insights from the EXSCEL trial. Cardiovasc Diabetol. 2019;18(1):138.
Cahn A, Wiviott SD, Mosenzon O, et al. Cardiorenal outcomes with dapagliflozin by baseline glucose‐lowering agents: post hoc analyses from DECLARE‐TIMI 58. Diabetes Obes Metab. 2021;23(1):29‐38.
Wright AK, Carr MJ, Kontopantelis E, et al. Primary prevention of cardiovascular and heart failure events with SGLT2 inhibitors, GLP‐1 receptor agonists, and their combination in type 2 diabetes. Diabetes Care. 2022;45(4):909‐918.
Lam CSP, Ramasundarahettige C, Branch KRH, et al. Efpeglenatide and clinical outcomes with and without concomitant sodium‐glucose Cotransporter‐2 inhibition use in type 2 diabetes: exploratory analysis of the AMPLITUDE‐O trial. Circulation. 2022;145(8):565‐574.
KDIGO. 2022 clinical practice guideline for diabetes Management in Chronic Kidney Disease. Kidney Int. 2022;102(suppl 5):S1‐S127.
Davies MJ, Aroda VR, Collins BS, et al. Management of Hyperglycemia in type 2 diabetes, 2022. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of diabetes (EASD). Diabetes Care. 2022;45(11):2753‐2786.
Kobayashi K, Toyoda M, Tone A, Kawanami D, Suzuki D, Tsuriya D, Machimura H, Shimura H, Takeda H, Yokomizo H, Takeshita K, Chin K, Kanasaki K, Miyauchi M, Saburi M, Morita M, Yomota M, Kimura M, Hatori N, Nakajima S, Ito S, Tsukamoto S, Murata T, Matsushita T, Furuki T, Hashimoto T, Umezono T, Muta Y, Takashi Y, Tamura K Renoprotective effects of combination treatment with sodium‐glucose cotransporter inhibitors and GLP‐1 receptor agonists in patients with type 2 diabetes mellitus according to preceding medication. Diab Vasc Dis Res 2023;20(6):14791641231222837.
Matsuo S, Imai E, Horio M, et al. Revised equations for estimated GFR from serum creatinine in Japan. Am J Kidney Dis. 2009;53(6):982‐992.
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):426‐435.
Kobayashi K, Toyoda M, Kimura M, et al. Renal effects of sodium glucose co‐transporter 2 inhibitors in Japanese type 2 diabetes mellitus patients with home blood pressure monitoring. Clin Exp Hypertens. 2019;41(7):637‐644.
Shimamoto K, Ando K, Fujita T, et al. The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2014). Hypertens Res. 2014;37(4):253‐390.
Rubin DB. Multiple Imputation for Nonresponse in Surveys. John Wiley & Sons; 1987.
Rubin DB, Schenker N. Multiple imputation in health‐care databases: an overview and some applications. Stat Med. 1991;10(4):585‐598.
Enders CK. Applied missing data analysis. Guilford Press; 2010.
Aloisio KM, Swanson SA, Micali N, Field A, Horton NJ. Analysis of partially observed clustered data using generalized estimating equations and multiple imputation. Stata J. 2014;14(4):863‐883.
Hershberger SL, Fisher DG. A note on determining the number of imputations for missing data. Struct Equ Model Multidiscip J. 2003;10(4):648‐650.
Furukawa K, Preston DL, Misumi M, Cullings HM. Handling incomplete smoking history data in survival analysis. Stat Methods Med Res. 2017;26(2):707‐723.
Austin PC. Optimal caliper widths for propensity‐score matching when estimating differences in means and differences in proportions in observational studies. Pharm Stat. 2011;10(2):150‐161.
Pocock SJ, Ariti CA, Collier TJ, Wang D. The win ratio: a new approach to the analysis of composite endpoints in clinical trials based on clinical priorities. Eur Heart J. 2011;33(2):176‐182.
Finkelstein DM, Schoenfeld DA. Combining mortality and longitudinal measures in clinical trials. Stat Med. 1999;18(11):1341‐1354.
Tuttle KR. Digging deep into cells to find mechanisms of kidney protection by SGLT2 inhibitors. J Clin Invest. 2023;133(5):e167700.
Meier JJ. GLP‐1 receptor agonists for individualized treatment of type 2 diabetes mellitus. Nat Rev Endocrinol. 2012;8(12):728‐742.
Nauck MA, Quast DR, Wefers J, Pfeiffer AFH. The evolving story of incretins (GIP and GLP‐1) in metabolic and cardiovascular disease: a pathophysiological update. Diabetes Obes Metab. 2021;23(Suppl 3):5‐29.
Meier JJ, Rosenstock J, Hincelin‐Méry A, et al. Contrasting effects of Lixisenatide and Liraglutide on postprandial glycemic control, gastric emptying, and safety parameters in patients with type 2 diabetes on optimized insulin glargine with or without metformin: a randomized, open‐label trial. Diabetes Care. 2015;38(7):1263‐1273.
Madsbad S, Holst JJ. Cardiovascular effects of incretins: focus on glucagon‐like peptide‐1 receptor agonists. Cardiovasc Res. 2023;119(4):886‐904.
Ceriello A, Novials A, Ortega E, et al. Glucagon‐like peptide 1 reduces endothelial dysfunction, inflammation, and oxidative stress induced by both hyperglycemia and hypoglycemia in type 1 diabetes. Diabetes Care. 2013;36(8):2346‐2350.
Drucker DJ. The cardiovascular biology of glucagon‐like Peptide‐1. Cell Metab. 2016;24(1):15‐30.
Hogan AE, Gaoatswe G, Lynch L, et al. Glucagon‐like peptide 1 analogue therapy directly modulates innate immune‐mediated inflammation in individuals with type 2 diabetes mellitus. Diabetologia. 2014;57(4):781‐784.
Rakipovski G, Rolin B, Nøhr J, et al. The GLP‐1 analogs Liraglutide and Semaglutide reduce atherosclerosis in ApoE(−/−) and LDLr(−/−) mice by a mechanism that includes inflammatory pathways. JACC Basic Transl Sci. 2018;3(6):844‐857.
Arakawa M, Mita T, Azuma K, et al. Inhibition of monocyte adhesion to endothelial cells and attenuation of atherosclerotic lesion by a glucagon‐like peptide‐1 receptor agonist, exendin‐4. Diabetes. 2010;59(4):1030‐1037.
Redfors B, Gregson J, Crowley A, et al. The win ratio approach for composite endpoints: practical guidance based on previous experience. Eur Heart J. 2020;41(46):4391‐4399.
Rizzo M, Rizvi AA, Patti AM, et al. Liraglutide improves metabolic parameters and carotid intima‐media thickness in diabetic patients with the metabolic syndrome: an 18‐month prospective study. Cardiovasc Diabetol. 2016;15(1):162.
Jensen JK, Zobel EH, von Scholten BJ, et al. Effect of 26 weeks of Liraglutide treatment on coronary artery inflammation in type 2 diabetes quantified by [(64)Cu]Cu‐DOTATATE PET/CT: results from the LIRAFLAME trial. Front Endocrinol (Lausanne). 2021;12:790405.
Devenny JJ, Godonis HE, Harvey SJ, Rooney S, Cullen MJ, Pelleymounter MA. Weight loss induced by chronic dapagliflozin treatment is attenuated by compensatory hyperphagia in diet‐induced obese (DIO) rats. Obesity (Silver Spring). 2012;20:1645‐1652.
Pasternak M, Liu P, Quinn R, et al. Association of Albuminuria and Regression of chronic kidney disease in adults with newly diagnosed moderate to severe chronic kidney disease. JAMA Netw Open. 2022;5:e2225821.
Knežević T, Gellineo L, Jelaković A, et al. Treatment of hypertension induced albuminuria. Curr Pharm des. 2018;24:4404‐4412.
Mennuni S, Rubattu S, Pierelli G, Tocci G, Fofi C, Volpe M. Hypertension and kidneys: unraveling complex molecular mechanisms underlying hypertensive renal damage. J Hum Hypertens. 2014;28:74‐79.
Sarafidis PA, Stafylas PC, Georgianos PI, Saratzis AN, Lasaridis AN. Effect of thiazolidinediones on albuminuria and proteinuria in diabetes: a meta‐analysis. Am J Kidney Dis. 2010;55:835‐847.
Sun L, Xu T, Chen Y, et al. Pioglitazone attenuates kidney fibrosis via miR‐21‐5p modulation. Life Sci. 2019;232:116609.
Suzuki Y, Kaneko H, Okada A, et al. Comparison of cardiovascular outcomes between SGLT2 inhibitors in diabetes mellitus. Cardiovasc Diabetol. 2022;21:67.
Kobayashi K, Toyoda M, Hatori N, et al. Comparison of renal outcomes between sodium glucose co‐transporter 2 inhibitors and glucagon‐like peptide 1 receptor agonists. Diabetes Res Clin Pract. 2022;185:109231.
Yamada T, Wakabayashi M, Bhalla A, et al. Cardiovascular and renal outcomes with SGLT‐2 inhibitors versus GLP‐1 receptor agonists in patients with type 2 diabetes mellitus and chronic kidney disease: a systematic review and network meta‐analysis. Cardiovasc Diabetol. 2021;20(1):14.