ORBi: Inhibiteurs des SGLT2 et risque d'amputations des membres inférieurs: plus de peur que de mal ? - 2022

Article (Scientific journals)

Inhibiteurs des SGLT2 et risque d'amputations des membres inférieurs: plus de peur que de mal ?

Scheen, André

2022 • In Médecine des Maladies Métaboliques, 16 (4), p. 336 - 342

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https://hdl.handle.net/2268/300354

DOI
10.1016/j.mmm.2022.01.015

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Keywords :

Amputation; DPP-4 inhibitor; Gliflozin; GLP-1; Peripheral arteriopathy; Type 2 diabetes; dipeptidyl peptidase IV inhibitor; glucagon like peptide 1 receptor agonist; placebo; sodium glucose cotransporter 2 inhibitor; Article; drug safety; fear; human; leg amputation; non insulin dependent diabetes mellitus; pharmacovigilance; randomized controlled trial (topic); risk; risk reduction

Abstract :

[en] For the last five years, a potential increased risk of lower-limb amputation (LLA) among patients with type 2 diabetes treated with sodium-glucose cotransporter type 2 inhibitors (SGLT2is) has been a matter of debate. The present article traces the history of this controversy since the landmark publication of CANVAS until the last observational studies in real life. Despite the warnings that emerged from pharmacovigilance reports, neither prospective randomized placebo-controlled trials nor large cohort retrospective observational studies vs. dipeptidyl peptidase-4 inhibitors were able to demonstrate a significant increased risk of LLA among new SGLT2i users. The higher incidence of LLA when compared to glucagon-like peptide-1 receptor agonists (GLP-1 RAs), which is commonly interpreted as an increased risk associated with SGLT2is, might rather reflect a reduction of the risk of LLA with GLP-1 ARs. Overall, available data regarding the risk of LLA with SGLT2is should reassure clinicians, even if some circumstances should call for caution. © 2022 Elsevier Masson SAS

Disciplines :

Endocrinology, metabolism & nutrition
Pharmacy, pharmacology & toxicology

Author, co-author :

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

Language :

English

Title :

Inhibiteurs des SGLT2 et risque d'amputations des membres inférieurs: plus de peur que de mal ?

Alternative titles :

[en] SGLT2 inhibitors and risk of lower-limb amputations: More fear than harm?

Publication date :

2022

Journal title :

Médecine des Maladies Métaboliques

ISSN :

1957-2557

eISSN :

2214-8477

Publisher :

Elsevier Masson s.r.l.

Volume :

16

Issue :

4

Pages :

336 - 342

Peer reviewed :

Peer Reviewed verified by ORBi

Available on ORBi :

since 24 February 2023

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Bibliography

Gourdy, P., Mise au point sur le profil de tolérance de la classe des inhibiteurs de SGLT2. Med Mal Metab 13:Suppl. 1 (2019), S31–S39.
Scheen, A.J., An update on the safety of SGLT2 inhibitors. Expert Opin Drug Saf 18 (2019), 295–311.
Scheen, A.J., Sodium-glucose cotransporter type 2 inhibitors for the treatment of type 2 diabetes mellitus. Nat Rev Endocrinol 16 (2020), 556–577.
Neal, B., Perkovic, V., Mahaffey, K.W., et al. Canagliflozin and cardiovascular and renal events in type 2 diabetes. N Engl J Med 377 (2017), 644–657.
Paul, S.K., Bhatt, D.L., Montvida, O., The association of amputations and peripheral artery disease in patients with type 2 diabetes mellitus receiving sodium-glucose cotransporter type-2 inhibitors: real-world study. Eur Heart J 42 (2021), 1728–1738.
Matthews, D.R., Li, Q., Perkovic, V., et al. Effects of canagliflozin on amputation risk in type 2 diabetes: the CANVAS Program. Diabetologia 62 (2019), 926–938.
Fadini, G.P., Avogaro, A., SGTL2 inhibitors and amputations in the US FDA Adverse Event Reporting System. Lancet Diabetes Endocrinol 5 (2017), 680–681 [Erratum in: Lancet Diabetes Endocrinol 2018;6:e5].
US Food & Drug Administration (FDA), FDA Drug Safety Communication: FDA confirms increased risk of leg and foot amputations with the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR). 2017 https://wwwfdagov/downloads/Drugs/DrugSafety/UCM558427pdf.
Khouri, C., Cracowski, J.L., Roustit, M., SGLT-2 inhibitors and the risk of lower-limb amputation: is this a class effect?. Diabetes Obes Metab 20 (2018), 1531–1534.
Scheen, A.J., Does lower-limb amputation concern all SGLT-2 inhibitors?. Nat Rev Endocrinol 14 (2018), 326–328.
Alkabbani, W., Gamble, J.M., Active comparator restricted disproportionality analysis for pharmacovigilance signal detection studies of chronic disease medications: an example using sodium/glucose cotransporter 2 (SGLT2) inhibitors. Br J Clin Pharmacol, 2021, 10.1111/bcp.15178 [Online ahead of print].
Raschi, E., Poluzzi, E., Salvo, F., et al. Pharmacovigilance of sodium-glucose co-transporter-2 inhibitors: what a clinician should know on disproportionality analysis of spontaneous reporting systems. Nutr Metab Cardiovasc Dis 28 (2018), 533–542.
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; eCollection 2020].
Elashoff, M., Matveyenko, A.V., Gier, B., et al. Pancreatitis, pancreatic, and thyroid cancer with glucagon-like peptide-1-based therapies. Gastroenterology 141 (2011), 150–156.
Perkovic, V., Jardine, M., Vijapurkar, U., Meininger, G., Renal effects of canagliflozin in type 2 diabetes mellitus. Curr Med Res Opin 31 (2015), 2219–2231.
Miyashita, S., Kuno, T., Takagi, H., et al. Risk of amputation associated with sodium-glucose co-transporter 2 inhibitors: a meta-analysis of five randomized controlled trials. Diabetes Res Clin Pract, 163, 2020, 108136.
Heyward, J., Mansour, O., Olson, L., et al. Association between sodium-glucose cotransporter 2 (SGLT2) inhibitors and lower extremity amputation: a systematic review and meta-analysis. PLoS One, 15, 2020, e0234065.
Qiu, M., Ding, L.L., Zhang, M., Zhou, H.R., Comparison of the risk of SGLT2is and NonSGLT2is in leading to amputation: a network meta-analysis. J Diabetes Complications, 35, 2021, 107803.
Patoulias, D., Papadopoulos, C., Doumas, M., Updated meta-analysis assessing the risk of amputation with sodium-glucose co-transporter-2 inhibitors in the hallmark cardiovascular and renal outcome trials. Diabetes Obesity Metab 23 (2021), 1063–1065.
Inzucchi, S.E., Iliev, H., Pfarr, E., Zinman, B., Empagliflozin and assessment of lower-limb amputations in the EMPA-REG OUTCOME trial. Diabetes Care 41 (2018), e4–e5.
Huang, C.Y., Lee, J.K., Sodium-glucose co-transporter-2 inhibitors and major adverse limb events: a trial-level meta-analysis including 51,713 individuals. Diabetes Obes Metab 22 (2020), 2348–2355.
Ueda, P., Svanström, H., Melbye, M., et al. Sodium glucose cotransporter 2 inhibitors and risk of serious adverse events: nationwide register based cohort study. BMJ, 363, 2018, k4365.
Scheen, A.J., Inhibiteurs des SGLT2 et « perte de chance »: une interprétation diamétralement opposée de la Commission de transparence de la Haute Autorité de santé (HAS) et de la Société francophone du diabète (SFD). Med Mal Metab 13 (2019), 309–312.
Scheen, A.J., Darmon, P., Hanaire, H., writing committee of the position statement by the French-Speaking Society of Diabetes (SFD). Assessment of the benefit-risk balance of SGLT2 inhibitors: commentary on a new ‘French paradox’. Diabetes Metab 45 (2019), 319–321.
Bauduceau, B., Bordier, L., Bringer, J., et al. Prise de position de la Société francophone du diabète (SFD): évaluation du rapport bénéfices-risques des inhibiteurs de SGLT2. Med Mal Metab 13 (2019), 195–209.
Li, C.X., Liang, S., Gao, L., Liu, H., Cardiovascular outcomes associated with SGLT-2 inhibitors versus other glucose-lowering drugs in patients with type 2 diabetes: a real-world systematic review and meta-analysis. PLoS One, 16, 2021, e0244689.
Scheen, A.J., Lower-limb amputations in patients treated with SGLT2 inhibitors versus DPP-4 inhibitors: a meta-analysis of observational studies. Diabetes Epidemiol Manage, 2022, 100054, 10.1016/j.deman.2022.100054 [In Press, Journal Pre-proof].
Scheen, A.J., The safety of gliptins: updated data in 2018. Expert Opin Drug Saf 17 (2018), 387–405.
Scheen, A.J., Lower limb amputations: protection with GLP-1 receptor agonists rather than increased risk with SGLT2 inhibitors?. Diabetes Metab, 48, 2022, 101325, 10.1016/j.diabet.2022.101325 [Online ahead of print].
US Food & Drug Administration (FDA), FDA Drug Safety Communication: FDA removes Boxed Warning about risk of leg and foot amputations for the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR). 2020 https://www.fda.gov/drugs/drug-safety-and-availability/fda-removes-boxed-warning-about-risk-leg-and-foot-amputations-diabetes-medicine-canagliflozin.
Scheen, A.J., À propos de l'expérience belge avec les inhibiteurs des SGLT2. Med Mal Metab 14 (2020), 320–330.
Lin, D.S., Lee, J.K., Chen, W.J., Major adverse cardiovascular and limb events in patients with diabetes treated with GLP-1 receptor agonists vs DPP-4 inhibitors. Diabetologia 64 (2021), 1949–1962.
Scheen, A.J., Cardiovascular outcome studies with incretin-based therapies: comparison between DPP-4 inhibitors and GLP-1 receptor agonists. Diabetes Res Clin Pract 127 (2017), 224–237.
Lugner, M., Sattar, N., Miftaraj, M., et al. Cardiorenal and other diabetes related outcomes with SGLT-2 inhibitors compared to GLP-1 receptor agonists in type 2 diabetes: nationwide observational study. Cardiovasc Diabetol, 20, 2021, 67.
Badjatiya, A., Merrill, P., Buse, J.B., et al. Clinical outcomes in patients with type 2 diabetes mellitus and peripheral artery disease: results from the EXSCEL trial. Circ Cardiovasc Interv, 12, 2019, e008018.
Dhatariya, K., Bain, S.C., Buse, J.B., et al. The impact of liraglutide on diabetes-related foot ulceration and associated complications in patients with type 2 diabetes at high risk for cardiovascular events: results from the LEADER trial. Diabetes Care 41 (2018), 2229–2235.
Helmstädter, J., Keppeler, K., Küster, L., et al. Glucagon-like peptide-1 (GLP-1) receptor agonists and their cardiovascular benefits—The role of the GLP-1 receptor. Br J Pharmacol 179 (2022), 659–676.
Almutairi, M., Al Batran, R., Ussher, J.R., Glucagon-like peptide-1 receptor action in the vasculature. Peptides 111 (2019), 26–32.
Gallego-Colon, E., Wojakowski, W., Francuz, T., Incretin drugs as modulators of atherosclerosis. Atherosclerosis 278 (2018), 29–38.

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