scholarly journals Sodium-glucose cotransporter-2 inhibitors and risk for genitourinary infections in older adults with type 2 diabetes

2021 ◽  
Vol 12 ◽  
pp. 204209862199770
Author(s):  
Navya Varshney ◽  
Sarah J. Billups ◽  
Joseph J. Saseen ◽  
Cy W. Fixen
Keyword(s):  
Type 2 Diabetes ◽  
Older Adults ◽  
Urinary Tract ◽  
Real World ◽  
Fungal Infections ◽  
Sodium Glucose Cotransporter ◽  
Increased Risk ◽  
Significant Difference ◽  
Tract Infections

Background and aims: Although landmark clinical trials have demonstrated an increased risk for genitourinary infection (GUI) after initiation of sodium-glucose cotransporter-2 inhibitor (SGLT2i) therapy that led to an FDA label warning, real world findings have been inconsistent and evidence specifically in older adults is lacking. The objective of the study was to examine the incidence of GUI in patients aged 65 years or older initiated on SGLT2i compared with glucagon-like peptide-1 receptor agonist (GLP1-RA) therapy at a large academic health system. Methods: A retrospective population-based cohort study was conducted using electronic health records of patients aged 65 years and older with a diagnosis of type 2 diabetes mellitus. Patients newly initiated on SGLT2i or GLP1-RA therapy with estimated glomerular filtration rate (eGFR) ⩾30 mL/min per 1.73 m² and active within the health system for at least 1 year prior to initiation were included. We compared the incidence of inpatient, emergency room, or outpatient diagnosis of GUI (bacterial and mycotic) within 6 months of SGLT2i or GLP1-RA initiation. A chi-square or Fisher’s exact test were used to analyze between-group differences for categorical variables, while a t-test was used for continuous variables. A Cox proportional hazards model was used to estimate the impact of confounding variables on the primary outcome. Results: One hundred and thirty-three patients were initiated on SGLT2i therapy and 341 patients newly initiated on GLP1-RA therapy. After adjusting for differences in age, A1c, body mass index, eGFR, race and sex, there was no statistically significant difference in GUI incidence within 6 months of SGLT2i versus GLP1-RA initiation (3.8% versus 6.5%, adjusted hazard ratio: 0.784, 95% confidence interval 0.260–2.367). Conclusion: We found no increased risk of composite GUI within 6 months of initiating SGLT2i compared with GLP1-RA therapy. These real-world data in older adults add to previous findings, which suggest no increased risk of urinary tract infection with SGLT2i initiation. Plain language summary A class of antidiabetic medications and risk for genitourinary infections in older adults with type 2 diabetes Older adults with type 2 diabetes often benefit from a class of antidiabetic medications known as sodium-glucose cotransporter-2 inhibitors (SGLT2is) which help to lower blood glucose, decrease risk for cardiovascular disease and prevent kidney disease progression. However, there is concern that these medications may increase risk for urinary tract infections and/or genital fungal infections in older adults based on clinical trial evidence. Our study evaluated the real-world occurrence of these safety events in patients aged 65 years or older who were newly started on these medications. We compared these patients with a group of patients newly started on an alternative class of antidiabetic agents which are not expected to increase risk for infections, known as glucagon-like peptide-1 receptor agonists (GLP1-RA). In our study, we included 133 patients who started an SGLT2i and 341 patients who started a GLP1-RA at a large teaching hospital. We evaluated the occurrence of infection up to 6 months after initiation of these mediations. We found no significant difference in infection rate between these two groups. We conclude in the study that the use of SGLT2i in older adults was not associated with increased risk for urinary tract infections or genital fungal infections when compared with GLP1-RA use.

scholarly journals Use of sodium-glucose cotransporter-2 inhibitors and urinary tract infections in type 2 diabetes patients: a systematic review

2019 ◽  
Vol 65 (2) ◽  
pp. 246-252 ◽  
Author(s):  
Izabela Rodrigues Figueiredo ◽  
Sara Cardoso Paes Rose ◽  
Nathália Bandeira Freire ◽  
Marina Stabile Patrocínio ◽  
Natália Pierdoná ◽  
...  
Keyword(s):  
Systematic Review ◽  
Type 2 Diabetes ◽  
Urinary Tract ◽  
Urinary Tract Infections ◽  
Randomized Clinical Trials ◽  
Oral Antidiabetic Agents ◽  
Sodium Glucose Cotransporter ◽  
Increased Risk ◽  
Tract Infections

SUMMARY Sodium-glucose cotransporter-2 inhibitors (SGLT2i) are drugs that act by maintaining glycosuria. Recent studies have shown promising effects of these in the treatment of type 2 diabetes mellitus (DM2). However, there may be an increased risk of developing urinary tract infections (UTIs) in patients treated with these. Our study aims to analyze the association between the risk of UTI in patients treated with SGLT2i. A systematic review of the literature was carried out by randomized clinical trials, totalizing at the end of the selection 23 articles that were statistically evaluated. The incidence of UTI was generally demonstrated in articles and in different subgroups: patients on SGLT2i monotherapy or on combination therapy; according to specific comorbidities of each sample or according to the drug used. They noticed an increase in the chance of UTI in the SGLT2i groups compared to the control groups on placebo or other oral antidiabetic agents. This increased chance was found predominantly with the use of Dapagliflozin, Canagliflozin, and Tofogliflozin, regardless of the dosing. Lastly, stands out that the dimension of UTI chances for DM2 patients who use SGLT2i remains to be more strictly determined.

scholarly journals The risk for urinary tract infections with sodium-glucose cotransporter 2 inhibitors: no longer a cause of concern?

2019 ◽  
Vol 13 (1) ◽  
pp. 24-26 ◽  
Author(s):  
Pantelis A Sarafidis ◽  
Alberto Ortiz
Keyword(s):  
Type 2 Diabetes ◽  
Urinary Tract ◽  
Case Reports ◽  
European Medicines Agency ◽  
Sodium Glucose Cotransporter ◽  
Increased Risk ◽  
The Us ◽  
Post Marketing ◽  
Tract Infections

Abstract Sodium–glucose co-transporter-2 (SGLT2) inhibitors improve cardiovascular and renal outcomes in patients with type 2 diabetes, including those with diabetic kidney disease. However, the US Food and Drug Administration and European Medicines Agency warnings about potential adverse effects, such as urosepsis and pyelonephritis, based on post-marketing case reports, may deter physicians from prescribing these drugs. A recent evaluation of two large US-based databases of commercial claims failed to find evidence for an increased risk of urinary tract infection (UTI) or severe UTI in type 2 diabetes patients who were prescribed an SGLT2.

scholarly journals Urinary tract infections in patients with type 2 diabetes mellitus with pharmacological glucosuria

2020 ◽  
Vol 92 (11) ◽  
pp. 106-109
Author(s):  
N. V. Sturov ◽  
S. V. Popov ◽  
N. K. Mamporia ◽  
A. A. Mager
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Urinary Tract ◽  
Urinary Tract Infections ◽  
Renal Tubules ◽  
Sodium Glucose Cotransporter ◽  
Glucose Reabsorption ◽  
Tract Infections

Selective inhibitors of sodium-glucose cotransporter belong to a new class of drugs for the treatment of type 2 diabetes mellitus. The mechanism of their action is based on insulin-independent reduction of glucose reabsorption in the proximal renal tubules, which leads to stimulation of its excretion in the urine and, accordingly, to a decrease in the concentration of glucose in the blood plasma. Drugs of this group demonstrate effectiveness in the treatment of type 2 diabetes, but their use may be associated with an increased frequency of urinary tract infections. Pharmacological glucosuria, which leads to a decrease in the concentration of glucose in the blood, creates the preconditions for the occurrence of urinary tract infections. Urinary tract and genital infections are the most common adverse events associated with the use of sodium-glucose cotransporter inhibitors. In the presented literature review for 20162019, the relationship between urinary tract infections in patients with type 2 diabetes mellitus and therapy with sodium-glucose cotransporter inhibitors was analyzed.

scholarly journals Undesirable effects and persistence of gliflozine treatment in patients with type 2 diabetes mellitus

2020 ◽  
Vol 23 (2) ◽  
pp. 102
Author(s):  
De Mori, v.
Keyword(s):  
Type 2 Diabetes ◽  
Urinary Tract ◽  
Urinary Tract Infections ◽  
Plasma Glucose ◽  
Real World ◽  
Sglt2 Inhibitors ◽  
Tract Infections ◽  
Demographic Features

OBJECTIVE OF THE STUDY SIDECAR (SGLT2-Inhibitors in Diabetes: Evaluation of metabolic Control and Adverse events in the Real-world), is a monocentric prospective observational study performed to monitoring in clinical practice patients with type 2 diabetes (T2D) treated with SGLT2-i to evaluate metabolic and anthropometric evolution during time, as well as the onset of adverse effects (AEs). Design and methods. Demographic features, T2D duration, and clinical parameters at baseline have been recorded as mean ± Standard Deviation (SD) for continuous variables, and frequency distribution for discrete variables. A repeated measures regression model was utilized for the evolution during time of parameters. AEs prevalence were recorded with stratification for main clinical and demographic features at baseline. RESULTS N=220 patients, with 18 months available follow-up, treated with SGLT2-i (N= 19 canagliflozin, 8.6%; N=91 dapagliflozin, 41.4%; N=110 empagliflozin, 50%) monotherapy or in combination according to AIFA indications). Really effective was the action of SGLT2-i on glucose  metabolism, with rapid reduction in HbA1c and fasting plasma glucose after 6 months, as well as after 12 and 18 months (HbA1c: -1,0%; fasting plasma glucose: -34,8mg/dL). Weight and BMI showed a satisfying improvement, while waist circumference was statistically significant only after 12 months. Blood pressure, total cholesterol, and renal function were not modified by the treatment. But, apart from the valuable effects on metabolic parameters, 86 patients (39%) suspended SGLT2-i treatment mainly because ineffectiveness (15,7%) or for Genito-Urinary Tract Infections (GUTIs) appearance (14,3%). CONCLUSIONS Median term follow-up confirms the efficacy of SGLT2-i, but a significant percentage of patients is forced to suspend these drugs especially for GUTIs appearance. Such high prevalence of non-serious AEs limits the potential nephro-cardiovascular benefits related to SGLT2-i utilization. A possible chance to reduce GUTIs should come from single tablet association of SGLT2-i and DPP4-i actually available on the market. KEY WORDS type 2 diabetes; SGLT2 inhibitors; genito-urinary tract infections; real world evaluation; health education

scholarly journals Pharmacovigilance of Sodium-Glucose Cotransporter-2 Inhibitors for Genital Fungal Infections and Urinary Tract Infections: A Review of the Food and Drug Administration Adverse Event Reporting System Database

2018 ◽  
Vol 34 (4) ◽  
pp. 144-148
Author(s):  
Hannah Mohammad ◽  
Nancy Borja-Hart
Keyword(s):  
Urinary Tract ◽  
Tract Infection ◽  
Adverse Events ◽  
Fungal Infections ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Sglt2 Inhibitors ◽  
Postmarketing Surveillance ◽  
Sodium Glucose Cotransporter ◽  
Tract Infections

Background: Postmarketing surveillance had previously identified the need for revisions in the labeling of the sodium-glucose cotransporter-2 (SGLT2) inhibitors drug class related to the risk of diabetic ketoacidosis. Other adverse events have been reported. Objective: To examine postmarketing surveillance data of the SGLT2 inhibitors, using the Food and Drug Administration Adverse Event Reporting System (FAERS) database, specifically to assess prevalence of urinary tract infections (UTIs) and genital fungal infections. Methods: FAERS case reports submitted between March 2013 and November 2015 were reviewed for 6 SGLT2 inhibitors (mono and combo therapies). The Medical Dictionary for Regulatory Activities (MedDRA) was used to define preferred terms (genital fungal infections: vulvovaginal mycotic infection, vulvovaginal candidiasis, urinary tract infection fungal, and genital candidiasis; UTI: urinary tract infection, genitourinary tract infection, kidney infection, cystitis, and pyelonephritis). Word frequencies were queried using the qualitative data analysis software NVivo 11 (QSR International), and results were then individually reviewed. Results: A total of 12 581 cases were received, but 466 were excluded (total n = 12 115). A total of 348 cases related to genital fungal infections were reported (2.9% of reports submitted): dapagliflozin = 53, empagliflozin/linagliptin = 6, canagliflozin = 267, canagliflozin/metformin = 3, empagliflozin = 17, and dapagliflozin/metformin HCl ER = 2. A total of 727 cases related to UTIs were reported (6% of reports submitted): dapagliflozin = 168, empagliflozin/linagliptin = 5, canagliflozin/metformin = 8, canagliflozin = 503, empagliflozin = 38, and dapagliflozin/metformin HCl ER = 5. Conclusions: A causal relationship between SGLT2 inhibitors and the adverse events reported cannot be established due to the nature of postmarketing surveillance. However, health care providers should counsel patients about these potential adverse events.

scholarly journals Prevalence of osteoporosis and osteoporotic fractures in postmenopausal women with type 2 diabetes mellitus

2021 ◽  
Vol 3 (3) ◽  
Author(s):  
Lamia Oulkadi ◽  
Bouchra Amine ◽  
Imane El binoune ◽  
Samira Rostom ◽  
Rachid Bahiri
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Postmenopausal Women ◽  
Mineral Density ◽  
Control Subjects ◽  
Increased Risk ◽  
Significant Difference ◽  
Prevalence Of Osteoporosis

Type 2 diabetes mellitus (T2DM) and osteoporosis are chronic diseases with increasing prevalence. The aim of this study was to determine the prevalence of osteoporosis and osteoporotic fracture in women with T2DM and to identify predictive factors of fracture occurrence. The prevalence of osteoporosis and fractures in postmenopausal women with T2DM was 23.1% and 16.9%, respectively. 46.2% of T2DM patients had normal bone mineral density (BMD) (P<0.01) and 58.5% of control subjects had osteopenia (P<0.01). Incidence of fracture in T2DM patients with osteopenia was significantly increased versus control subjects when stratified according the BMD (P=0.009). By stratifying T2DM patients according to fractures, factors that were significantly associated with occurrence included T2DM duration (P=0.038), use of insulin (P=0.017), and lower BMD (P=0.048). Our study suggests that there was a higher prevalence of fracture in T2DM patients compared to control subjects and a significant difference in BMD was found between the groups. We also showed that insulin use, low BMD, and long duration of T2DM are factors associated with an increased risk of bone fracture.

scholarly journals CRP Gene Polymorphism and Their Risk Association With Type 2 Diabetes Mellitus

2019 ◽  
Vol 7 (1) ◽  
pp. 33-37
Author(s):  
Hakim Bahlok Jebur ◽  
Mirza Masroor ◽  
Hafiz Ahmad ◽  
Naushad Ahmad Khan ◽  
Juheb Akther ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Gene Polymorphism ◽  
Inflammatory Marker ◽  
Genotype Distribution ◽  
Reactive Protein ◽  
Specific Pcr ◽  
Increased Risk ◽  
Significant Difference ◽  
Allele Specific

BACKGROUND: C-reactive protein (CRP) is an inflammatory marker associated with T2DM, obesity, insulin resistance, and cardiovascular disease. AIM: The present study evaluates the association of CRP +1059 G/C polymorphism of the CRP gene in 100 T2D cases and 100 healthy controls. METHODS: Present study was done by allele specific PCR method to study the CRP gene polymorphism in study subjects. RESULTS: Study found that CRP (+1059 G/C) genotype distribution among case and controls was found to be significant (p=0.001), Higher CRP C allele frequency (0.16) was observed compared to controls (0.04). CRP +1059 GC and CC had 2.72 (1.12-6.61), 20.56 (1.16-362.1) risk for T2D. It has been observed, HTN, Obesity, Smoking and alcoholism was found to be associated with increased risk of T2D, and a significant difference was observed in biochemical parameters. CONCLUSION: Study concluded that CRP gene polymorphism was found to be associated with risk of Type 2 Diabetes and risk was linked with heterozygosity and mutant homozygosity. Hypertension, Obesity, Smoking and alcoholism increases the risk of occurrence of Type 2 Diabetes.

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