Epidemiology of acute kidney injury adverse events with SGLT2 inhibitors: A meta-analysis of observational cohort studies

Delanaye, Pierre; Scheen, André

doi:10.1016/j.deman.2021.100021

Article (Scientific journals)

Epidemiology of acute kidney injury adverse events with SGLT2 inhibitors: A meta-analysis of observational cohort studies

Delanaye, Pierre; Scheen, André

2021 • In Diabetes Epidemiology and Management, 3, p. 100021

Peer Reviewed verified by ORBi

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https://hdl.handle.net/2268/312594

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10.1016/j.deman.2021.100021

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Keywords :

Acute kidney injury; Meta-analysis; Nephrotoxicity; RAAS inhibitors; Real-life; SGLT2 inhibitors

Abstract :

[en] Sodium-glucose cotransporter type 2 inhibitors (SGLT2is) have proven long-term nephroprotective effects in large prospective cardiovascular and renal outcome placebo-controlled trials, which follow a initial transient dip of estimated glomerular filtration rate. Nevertheless, case reports of acute kidney injury (AKI) associated with SGLT2i therapy were reported, leading the US Food and Drug Administration to publish a warning in 2016. Of note, the incidence of AKI events was not increased and often reduced in outcome trials that compared SGLT2i treatment with placebo. However, patients in real-life might be at higher risk because of a more frailty profile and a less strict supervision. In a meta-analysis of 9 cohorts from 8 observational studies worldwide, the relative risk of AKI was significantly reduced (HR 0.61, 95% CI 0.55–0.67, I² = 70%) in SGLT2i users (725 AKI events/68,802 patients) compared with non-users (treated with other glucose-lowering agents, including incretin-based compounds: 977 AKI events/67,458 patients). In conclusion, observational studies in real-world conditions confirm the results reported in placebo-controlled outcome trials and show a reduction in AKI episodes in patients with type 2 diabetes treated with SGLT2is compared with those treated with other glucose-lowering agents. Overall, the renal safety of SGLT2is should be acknowledged by physicians, even if dehydration should be avoided.

Disciplines :

Endocrinology, metabolism & nutrition
Urology & nephrology
Pharmacy, pharmacology & toxicology

Author, co-author :

Delanaye, Pierre ; Centre Hospitalier Universitaire de Liège - CHU > > Service de néphrologie

Scheen, André ; Centre Hospitalier Universitaire de Liège - CHU > > Service de diabétologie, nutrition, maladies métaboliques

Language :

English

Title :

Epidemiology of acute kidney injury adverse events with SGLT2 inhibitors: A meta-analysis of observational cohort studies

Publication date :

2021

Journal title :

Diabetes Epidemiology and Management

eISSN :

2666-9706

Volume :

Pages :

100021

Peer reviewed :

Peer Reviewed verified by ORBi

Additional URL :

https://www.sciencedirect.com/science/article/pii/S2666970621000214

Available on ORBi :

since 01 February 2024

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Bibliography

Heerspink, H.J.L., Kosiborod, M., Inzucchi, S.E., Cherney, D.Z.I., Renoprotective effects of sodium-glucose cotransporter-2 inhibitors. Kidney Int 94 (2018), 26–39.
Scheen, A.J., Delanaye, P., Understanding the protective effects of SGLT2 inhibitors in type 2 diabetes patients with chronic kidney disease. Expert Rev Endocrinol Metab, 2021 In press.
Zelniker, T.A., Wiviott, S.D., Raz, I., Im, K., Goodrich, E.L., Bonaca, M.P., et al. SGLT2 inhibitors for primary and secondary prevention of cardiovascular and renal outcomes in type 2 diabetes: a systematic review and meta-analysis of cardiovascular outcome trials. Lancet 393 (2019), 31–39.
Neuen, B.L., Young, T., Heerspink, H.J.L., Neal, B., Perkovic, V., Billot, L., et al. SGLT2 inhibitors for the prevention of kidney failure in patients with type 2 diabetes: a systematic review and meta-analysis. Lancet Diabetes Endocrinol 7 (2019), 845–854.
Toyama, T., Neuen, B.L., Jun, M., Ohkuma, T., Neal, B., Jardine, M.J., et al. Effect of SGLT2 inhibitors on cardiovascular, renal and safety outcomes in patients with type 2 diabetes mellitus and chronic kidney disease: a systematic review and meta-analysis. Diabetes Obes Metab 21 (2019), 1237–1250.
Giugliano, D., Longo, M., Caruso, P., Maiorino, M.I., Bellastella, G., Esposito, K., Sodium-glucose co-transporter-2 inhibitors for the prevention of cardiorenal outcomes in type 2 diabetes: an updated meta-analysis. Diabetes Obes Metab 23 (2021), 1672–1676.
Phadke, G., Kaushal, A., Tolan, D.R., Hahn, K., Jensen, T., Bjornstad, P., et al. Osmotic nephrosis and acute kidney injury associated with SGLT2 inhibitor use: a case report. Am J Kidney Dis 76 (2020), 144–147.
Watanabe, S., Sawa, N., Mizuno, H., Yamanouchi, M., Suwabe, T., Hoshino, J., et al. Development of osmotic vacuolization of proximal tubular epithelial cells following treatment with sodium-glucose transport protein 2 inhibitors in type II diabetes mellitus patients-3 case reports. CEN Case Rep 10 (2021), 563–569.
Ryan, R., Choo, S., Willows, J., Walker, J., Prasad, K., Tez, D., Acute interstitial nephritis due to sodium-glucose co-transporter 2 inhibitor empagliflozin. Clin Kidney J 14 (2021), 1020–1022.
Hassani-Ardakania, K., Lipman, M.L., Laporta, D., Yu, O.H.Y., A case of severe acute kidney injury exacerbated by canagliflozin in a patient with type 2 diabetes. Case Rep Endocrinol, 2019, 2019, 8639629.
Pleros, C., Stamataki, E., Papadaki, A., Damianakis, N., Poulidaki, R., Gakiopoulou, C., et al. Dapagliflozin as a cause of acute tubular necrosis with heavy consequences: a case report. CEN Case Rep 7 (2018), 17–20.
Legrand, M., Rossignol, P., Cardiovascular consequences of acute kidney injury. N Engl J Med 382 (2020), 2238–2247.
Advani, A., Acute kidney injury: a bona fide complication of diabetes. Diabetes 69 (2020), 2229–2237.
Thakar, C.V., Christianson, A., Himmelfarb, J., Leonard, A.C., Acute kidney injury episodes and chronic kidney disease risk in diabetes mellitus. Clin J Am Soc Nephrol 6 (2011), 2567–2572.
Perlman, A., Heyman, S.N., Matok, I., Stokar, J., Muszkat, M., Szalat, A., Acute renal failure with sodium-glucose-cotransporter-2 inhibitors: analysis of the FDA adverse event report system database. Nutr Metab Cardiovasc Dis 27 (2017), 1108–1113.
US Food and Drug Administration. FDA Drug Safety Communication: FDA strengthens kidney warnings for diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR). 2016: https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-strengthens-kidney-warnings-diabetes-medicines-canagliflozin (latest accessed October 8, 2021).
Saly, D.L., Perazella, M.A., Harnessing basic and clinic tools to evaluate SGLT2 inhibitor nephrotoxicity. Am J Physiol Renal Physiol 313 (2017), F951–F9F4.
Katsuhara, Y., Ogawa, T., Acute renal failure, ketoacidosis, and urogenital tract infections with SGLT2 inhibitors: signal detection using a Japanese spontaneous reporting database. Clin Drug Investig 40 (2020), 645–652.
Gilbert, R.E., Thorpe, K.E., Acute kidney injury with sodium-glucose co-transporter-2 inhibitors: a meta-analysis of cardiovascular outcome trials. Diabetes Obes Metab 21 (2019), 1996–2000.
Qiu, M., Ding, L.L., Zhang, M., Zhou, H.R., Safety of four SGLT2 inhibitors in three chronic diseases: a meta-analysis of large randomized trials of SGLT2 inhibitors. Diab Vasc Dis Res, 18, 2021, 14791641211011016.
Bai, Y., Jin, J., Zhou, W., Zhang, S., Xu, J, The safety outcomes of sodium-glucose cotransporter 2 inhibitors in patients with different renal function: a systematic review and meta-analysis. Nutr Metab Cardiovasc Dis 31 (2021), 1365–1374.
Shao, S.C., Lin, Y.H., Chang, K.C., Chan, Y.Y., Hung, M.J., Kao, Yang YH, et al. Sodium glucose co-transporter 2 inhibitors and cardiovascular event protections: how applicable are clinical trials and observational studies to real-world patients?. BMJ Open Diabetes Res Care, 7:e000742, 2019.
Perlman, A., Heyman, S.N., Stokar, J., Darmon, D., Muszkat, M., Szalat, A., Clinical spectrum and mechanism of acute kidney injury in patients with diabetes mellitus on SGLT-2 inhibitors. Isr Med Assoc J 20 (2018), 513–516.
Fralick, M., Schneeweiss, S., Redelmeier, D.A., Razak, F., Gomes, T., Patorno, E., Comparative effectiveness and safety of sodium-glucose cotransporter-2 inhibitors versus metformin in patients with type 2 diabetes: an observational study using data from routine care. Diabetes Obes Metab 23 (2021), 950–960.
Shen, L., Yang, H., Fang, X., Huang, H., Yao, W., Chen, D., et al. A clinical study on the association of sodium-glucose cotransporter 2 inhibitors and acute kidney injury among diabetic Chinese population. Diabetes Metab Syndr Obes 14 (2021), 1621–1630.
Rampersad, C., Kraut, E., Whitlock, R.H., Komenda, P., Woo, V., Rigatto, C., et al. Acute kidney injury events in patients with type 2 diabetes using SGLT2 inhibitors versus other glucose-lowering drugs: a retrospective cohort study. Am J Kidney Dis, 76, 2020 471-9 e1.
Iskander, C., Cherney, D.Z., Clemens, K.K., Dixon, S.N., Harel, Z., Jeyakumar, N., et al. Use of sodium-glucose cotransporter-2 inhibitors and risk of acute kidney injury in older adults with diabetes: a population-based cohort study. CMAJ 192 (2020), E351–EE60.
Nadkarni, G.N., Ferrandino, R., Chang, A., Surapaneni, A., Chauhan, K., Poojary, P., et al. Acute kidney injury in patients on SGLT2 inhibitors: a propensity-matched analysis. Diabetes Care 40 (2017), 1479–1485.
Lin, Y.H., Huang, Y.Y., Hsieh, S.H., Sun, J.H., Chen, S.T., Lin, C.H., Renal and glucose-lowering effects of empagliflozin and dapagliflozin in different chronic kidney disease stages. Front Endocrinol (Lausanne), 10, 2019, 820.
Ueda, P., Svanstrom, H., Melbye, M., Eliasson, B., Svensson, A.M., Franzen, S., et al. Sodium glucose cotransporter 2 inhibitors and risk of serious adverse events: nationwide register based cohort study. BMJ, 363, 2018, k4365.
Cahn, A., Melzer-Cohen, C., Pollack, R., Chodick, G., Shalev, V., Acute renal outcomes with sodium-glucose co-transporter-2 inhibitors: real-world data analysis. Diabetes Obes Metab 21 (2019), 340–348.
Fadini, G.P., Solini, A., Manca, M.L., Penno, G., Gatti, A., Anichini, R., et al. Effectiveness of dapagliflozin versus comparators on renal endpoints in the real world: a multicentre retrospective study. Diabetes Obes Metab 21 (2019), 252–260.
Kidney Disease: Improving Global Outcomes (KDIGO) Acute Kidney Injury Work Group. KDIGO clinical practice guideline for acute kidney injury. Kidney Int 2 (2012), 1–138.
Heerspink, H.J.L., Karasik, A., Thuresson, M., Melzer-Cohen, C., Chodick, G., Khunti, K., et al. Kidney outcomes associated with use of SGLT2 inhibitors in real-world clinical practice (CVD-REAL 3): a multinational observational cohort study. Lancet Diabetes Endocrinol 8 (2020), 27–35.
Pasternak, B., Wintzell, V., Melbye, M., Eliasson, B., Svensson, A.M., Franzen, S., et al. Use of sodium-glucose co-transporter 2 inhibitors and risk of serious renal events: scandinavian cohort study. BMJ, 369, 2020, m1186.
Lameire, N.H., Levin, A., Kellum, J.A., Cheung, M., Jadoul, M., Winkelmayer, W.C., et al. Harmonizing acute and chronic kidney disease definition and classification: report of a Kidney Disease: improving Global Outcomes (KDIGO) Consensus Conference. Kidney Int 100 (2021), 516–526.
Desai, M., Yavin, Y., Balis, D., Sun, D., Xie, J., Canovatchel, W., et al. Renal safety of canagliflozin, a sodium glucose co-transporter 2 inhibitor, in patients with type 2 diabetes mellitus. Diabetes Obes Metab 19 (2017), 897–900.
Delanaye, P., Scheen, A.J., Preventing and treating kidney disease in patients with type 2 diabetes. Expert Opin Pharmacother 20 (2019), 277–294.
Alomar, M., Tawfiq, A.M., Hassan, N., Palaian, S., Post marketing surveillance of suspected adverse drug reactions through spontaneous reporting: current status, challenges and the future. Ther Adv Drug Saf, 11, 2020, 2042098620938595.
Katsuhara, Y., Ikeda, S., Correlations between SGLT-2 inhibitors and acute renal failure by signal detection using FAERS: stratified analysis for reporting country and concomitant drugs. Clin Drug Investig 41 (2021), 235–243.
Caparrotta, T.M., Greenhalgh, A.M., Osinski, K., Gifford, R.M., Moser, S., Wild, S.H., et al. Sodium-glucose co-transporter 2 inhibitors (SGLT2i) exposure and outcomes in type 2 diabetes: a systematic review of population-based observational studies. Diabetes Ther 12 (2021), 991–1028.
Menne, J., Dumann, E., Haller, H., Schmidt, B.M.W., Acute kidney injury and adverse renal events in patients receiving SGLT2-inhibitors: a systematic review and meta-analysis. PLoS Med, 16, 2019, e1002983.
Donnan, J.R., Grandy, C.A., Chibrikov, E., Marra, C.A., Aubrey-Bassler, K., Johnston, K., et al. Comparative safety of the sodium glucose co-transporter 2 (SGLT2) inhibitors: a systematic review and meta-analysis. BMJ Open, 9, 2019, e022577.
Cahn, A., Mosenzon, O., Wiviott, S.D., Rozenberg, A., Yanuv, I., Goodrich, E.L., et al. Efficacy and safety of dapagliflozin in the elderly: analysis from the DECLARE-TIMI 58 study. Diabetes Care 43 (2020), 468–475.
Heerspink, H.J.L., Oshima, M., Zhang, H., Li, J., Agarwal, R., Capuano, G., et al. Canagliflozin and kidney-related adverse events in type 2 diabetes and CKD: findings from the randomized CREDENCE trial. Am J Kidney Dis, 2021, 10.1053/j.ajkd.2021.05.005 May 23;S0272-6386(21)00626-0.
Heerspink, H.J., Cherney, D., Postmus, D., Stefansson, B.V., Chertow, G.M., Dwyer, J.P., et al. A pre-specified analysis of the Dapagliflozin and Prevention of Adverse Outcomes in Chronic Kidney Disease (DAPA-CKD) randomized controlled trial on the incidence of abrupt declines in kidney function. Kidney Int, 2021, 10.1016/j.kint.2021.09.005 Sep 21;S0085-2538(21)00865-6.
Zhao, M., Sun, S., Huang, Z., Wang, T., Tang, H., Network meta-analysis of novel glucose-lowering drugs on risk of acute kidney injury. Clin J Am Soc Nephrol 16 (2020), 70–78.
Mansfield, K.E., Nitsch, D., Smeeth, L., Bhaskaran, K., Tomlinson, L.A., Prescription of renin-angiotensin system blockers and risk of acute kidney injury: a population-based cohort study. BMJ Open, 6, 2016, e012690.
Szalat, A., Perlman, A., Muszkat, M., Khamaisi, M., Abassi, Z., Heyman, S.N., Can SGLT2 inhibitors cause acute renal failure? Plausible role for altered glomerular hemodynamics and medullary hypoxia. Drug Saf 41 (2018), 239–252.
Mayer, G.J., Wanner, C., Weir, M.R., Inzucchi, S.E., Koitka-Weber, A., Hantel, S., et al. Analysis from the EMPA-REG OUTCOME((R)) trial indicates empagliflozin may assist in preventing the progression of chronic kidney disease in patients with type 2 diabetes irrespective of medications that alter intrarenal hemodynamics. Kidney Int 96 (2019), 489–504.
Cai, Y., Shi, W., Xu, G., The efficacy and safety of SGLT2 inhibitors combined with ACEI/ARBs in the treatment of type 2 diabetes mellitus: a meta-analysis of randomized controlled studies. Expert Opin Drug Saf 19 (2020), 1497–1504.
Tian, B., Deng, Y., Cai, Y., Han, M., Xu, G., Efficacy and safety of combination therapy with sodium-glucose transporter 2 inhibitors and renin-angiotensin system blockers in patients with type 2 diabetes: a systematic review and meta-analysis. Nephrol Dial Transplant, 2021, 10.1093/ndt/gfab048 Feb 19;gfab048.
Scheen, A.J., An update on the safety of SGLT2 inhibitors. Expert Opin Drug Safety 18 (2019), 295–311.
McGill, J.B., Subramanian, S., Safety of sodium-glucose co-transporter 2 inhibitors. Am J Cardiol 124:Suppl 1 (2019), S45–S52.
Pelletier, R., Ng, K., Alkabbani, W., Labib, Y., Mourad, N., Gamble, J.M., Adverse events associated with sodium glucose co-transporter 2 inhibitors: an overview of quantitative systematic reviews. Ther Adv Drug Saf, 12, 2021, 2042098621989134.
Delanaye, P., Scheen, A.J., The diuretic effects of SGLT2 inhibitors: a comprehensive review of their specificities and their role in renal protection. Diabetes Metab, 2021, 10.1016/j.diabet.2021.101285 Sep 28;101285.
Greenberg, A., Diuretic complications. Am J Med Sci 319 (2000), 10–24.
Scott, J., Jones, T., Redaniel, M.T., May, M.T., Ben-Shlomo, Y., Caskey, F., Estimating the risk of acute kidney injury associated with use of diuretics and renin angiotensin aldosterone system inhibitors: a population based cohort study using the clinical practice research datalink. BMC Nephrol, 20, 2019, 481.
Baker, M.L., Perazella, M.A., SGLT2 inhibitor therapy in patients with type-2 diabetes mellitus: is acute kidney injury a concern?. J Nephrol 33 (2020), 985–994.
Sridhar, V.S., Tuttle, K.R., Cherney, D.Z.I., We can finally stop worrying about SGLT2 inhibitors and acute kidney injury. Am J Kidney Dis 76 (2020), 454–456.
Scheen, A.J., Efficacy and safety profile of SGLT2 inhibitors in patients with type 2 diabetes and chronic kidney disease. Expert Opin Drug Safety 19 (2020), 243–256.
Scheen, A.J., Sodium-glucose co-transporter type 2 inhibitors for the treatment of type 2 diabetes mellitus. Nature Rev Endocrinol 16 (2020), 556–577.
Kidney Disease: improving Global Outcomes Diabetes Work G. KDIGO 2020 clinical practice guideline for diabetes management in chronic kidney disease. Kidney Int 98 (2020), S1–S115.
Fernandez-Fernandez, B., Sarafidis, P., Kanbay, M., Navarro-Gonzalez, J.F., Soler, M.J., Gorriz, J.L., et al. SGLT2 inhibitors for non-diabetic kidney disease: drugs to treat CKD that also improve glycaemia. Clin Kidney J 13 (2020), 728–733.