Risk factors for genital infections in people initiating SGLT2 inhibitors and their impact on discontinuation

McGovern, A. P. et al. (2020) Risk factors for genital infections in people initiating SGLT2 inhibitors and their impact on discontinuation. BMJ Open Diabetes Research and Care, 8(1), e001238. (doi: 10.1136/bmjdrc-2020-001238)

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Abstract

Introduction: To identify risk factors, absolute risk, and impact on treatment discontinuation of genital infections with sodium-glucose co-transporter-2 inhibitors (SGLT2i). Research design and methods: We assessed the relationship between baseline characteristics and genital infection in 21 004 people with type 2 diabetes initiating SGLT2i and 55 471 controls initiating dipeptidyl peptidase-4 inhibitors (DPP4i) in a UK primary care database. We assessed absolute risk of infection in those with key risk factors and the association between early genital infection and treatment discontinuation. Results: Genital infection was substantially more common in those treated with SGLT2i (8.1% within 1 year) than DPP4i (1.8%). Key predictors of infection with SGLT2i were female sex (HR 3.64; 95% CI 3.23 to 4.11) and history of genital infection; <1 year before initiation (HR 4.38; 3.73 to 5.13), 1–5 years (HR 3.04; 2.64 to 3.51), and >5 years (HR 1.79; 1.55 to 2.07). Baseline HbA1c was not associated with infection risk for SGLT2i, in contrast to DPP4i where risk increased with higher HbA1c. One-year absolute risk of genital infection with SGLT2i was highest for those with a history of prior infection (females 23.7%, males 12.1%), compared with those without (females 10.8%, males 2.7%). Early genital infection was associated with a similar discontinuation risk for SGLT2i (HR 1.48; 1.21–1.80) and DPP4i (HR 1.58; 1.21–2.07). Conclusions: Female sex and history of prior infection are simple features that can identify subgroups at greatly increased risk of genital infections with SGLT2i therapy. These data can be used to risk-stratify patients. High HbA1c is not a risk factor for genital infections with SGLT2i.

Item Type:Articles
Additional Information:Funding: The MASTERMIND (MRC APBI Stratification and Extreme Response Mechanism IN Diabetes) consortium is funded by the UK Medical Research Council study grant number MR/N00633X/1. BMS and ATH are supported by the NIHR Exeter Clinical Research Facility. ATH is an NIHR Senior Investigator. ATH is a Wellcome Trust Senior Investigator. AGJ is supported by an NIHR Clinician Scientist award (17/0005624). APM is an NIHR academic clinical fellow. ERP is a Wellcome Trust New Investigator (102820/Z/13/Z). JMD is supported by an Independent Fellowship funded by Research England’s Expanding Excellence in England (E3) fund. RRH is an emeritus UK National Institute for Health Research Senior Investigator.
Keywords:Emerging Technologies, Pharmacology and Therapeutics, 1506, non-insulin treated type 2 diabetes, candida, A1C, adherence to medications.
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Sattar, Professor Naveed
Authors: McGovern, A. P., Hogg, M., Shields, B. M., Sattar, N. A., Holman, R. R., Pearson, E. R., Hattersley, A. T., Jones, A. G., Dennis, J. M., MASTERMIND consortium, , Henley, W. E., Lonergan, M., Rodgers, L. R., Hamilton, W. T., Angwin, C., Cruickshank, K. J., Farmer, A. J., Gough, S. C. L., Gray, A. M., Hyde, C., Jennison, C., and Walker, M.
College/School:College of Medical Veterinary and Life Sciences > Institute of Cardiovascular and Medical Sciences
Journal Name:BMJ Open Diabetes Research and Care
Publisher:BMJ Publishing
ISSN:2052-4897
ISSN (Online):2052-4897
Copyright Holders:Copyright © 2020 The Authors
First Published:First published in BMJ Open Diabetes Research and Care 8:e001238
Publisher Policy:Reproduced under a Creative Commons License

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Project CodeAward NoProject NamePrincipal InvestigatorFunder's NameFunder RefLead Dept
172300MRC APBI STratification and Extreme Response Mechanism IN Diabetes - MASTERMIND (MRC Stratifying Medicine Pilot)Naveed SattarMedical Research Council (MRC)MR/N00633X/1Institute of Cardiovascular & Medical Sciences