SGLT-2 inhibitors and euglycemic diabetic ketoacidosis/diabetic ketoacidosis in FAERS: a pharmacovigilance assessment

He, Ziwen; Lam, Kakei; Zhao, Wenxia; Yang, Shan; Yu, Li; Mo, Jiayao; Gao, Siyuan; Liang, Dan; Qiu, Kaifu; Huang, Min; Wu, Junyan

doi:10.1007/s00592-022-02015-6

Cited by 11 publications

(13 citation statements)

References 34 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…A population-based pharmacovigilance study utilizing a case/noncase approach was employed to investigate the potential association between GLP-1RA and reports of suicidal tendencies and/or self-injury. This method is a prevalent technique employed in pharmacovigilance research to detect safety signals [16][17][18]. From a mathematical perspective, the concept behind the case/non-case approach involves contrasting the reporting rate of a specific AE in patients who have been exposed to a particular drug with the reporting rate of the same AE in patients who haven't been exposed to that drug [19,20].…”

Section: Discussionmentioning

confidence: 99%

Postmarket safety profile of suicide/self-injury for GLP-1 receptor agonist: a real-world pharmacovigilance analysis

Chen,

Zhou,

et al. 2023

Eur. Psychiatr.

View full text Add to dashboard Cite

Background Recent reports of individuals experiencing suicidal and/or self-injurious behaviors while using liraglutide and semaglutide have heightened the concerns regarding neuropsychiatric safety of Glucagon-like peptide-1 agonists (GLP-1RAs). As real-world evidence is very limited, we explored the association between GLP-1RA and suicide/self-injury by mining the FDA Adverse Event Reporting System (FAERS) database. Methods The FAERS database was queried from 2005 Q2 to 2023 Q2. The Reporting Odds Ratio (ROR) and Empirical Bayes Geometric Mean (EBGM) were used to conduct the disproportionality analysis. Results A total of 534 GLP-1RA-associated suicide/self-injury cases were reported in the FAERS during the study period. GLP-1RA did not cause a disproportionate increase in overall suicidal and self-injurious cases (ROR: 0.16, 95%CI 0.15-0.18, P < 0.001; EBGM05: 0.15). Stratified analyses found no safety signal of suicide/injury for GLP-1RA in both females and males. The ROR for suicide/self-injury with GLP-1RA was slightly elevated (ROR: 2.50, 95%CI 1.02-6.13, P = 0.05) in children, while the EBGM05 was < 2 in this population. No significant signal value was observed in other age groups. No over-reporting of suicide/self-injury was identified for GLP-1RA before or after the COVID-19 pandemic outbreak. Conclusions The cases of suicide or self-injury reported to FAERS do not indicate any overall safety signal attributable to GLP-1RA at this time. Subgroup analysis revealed a marginal elevation of ROR for suicide and self-injury with GLP-1RA in children, but no safety signal was detected by EBGM05 in this population. Further large-scale prospective investigations are still warranted to further confirm this finding.

show abstract

Section: Discussionmentioning

confidence: 99%

Postmarket safety profile of suicide/self-injury for GLP-1 receptor agonist: a real-world pharmacovigilance analysis

Chen,

Zhou,

et al. 2023

Eur. Psychiatr.

View full text Add to dashboard Cite

show abstract

“…A large number of patients discontinued the treatment (95.5% for euDKA and 93.9% for DKA), and nearly 49.0% (n = 3658) of patients had a remission of symptoms after the discontinuation of the SGLT2-i; 2.3% (n = 173) had no remission. Hospitalization was necessary for 75.6% (n = 6126) of patients after euDKA/DKA [50].…”

Section: Epidemiologymentioning

confidence: 99%

Ketoacidosis and SGLT2 Inhibitors: A Narrative Review

Morace,

Lorello,

Bellone

et al. 2024

Metabolites

View full text Add to dashboard Cite

An acute metabolic complication of diabetes mellitus, especially type 1, is diabetic ketoacidosis (DKA), which is due to an increase in blood ketone concentrations. Sodium/glucose co-transporter-2 inhibitor (SGLT2-i) drugs have been associated with the occurrence of a particular type of DKA defined as euglycemic (euDKA), characterized by glycemic levels below 300 mg/dL. A fair number of euDKA cases in SGLT2-i-treated patients have been described, especially in the last few years when there has been a significant increased use of these drugs. This form of euDKA is particularly insidious because of its latent onset, associated with unspecific symptomatology, until it evolves (progressing) to severe systemic forms. In addition, its atypical presentation can delay diagnosis and treatment. However, the risk of euDKA associated with SGLT2-i drugs remains relatively low, but it is essential to promptly diagnose and manage it to prevent its serious life-threatening complications. In this narrative review, we intended to gather current research evidence on SGLT2i-associated euDKA from randomized controlled trials and real-world evidence studies, its diagnostic criteria and precipitating factors.

show abstract

“…Euglycaemic DKA can be caused by a variety of factors, including exogenous insulin injection, reduced food intake, pregnancy, or impaired gluconeogenesis due to alcohol use, liver failure and/or SGLT2 inhibitor therapy [103,104]. In recent years, the use of SGLT2 inhibitors in those with type 1 diabetes and type 2 diabetes has accounted for the majority of cases of euglycaemic DKA [105][106][107]. In recognition of the wider range of glucose levels at presentation with DKA, the criteria for diagnosis of DKA have been changed to encompass a The key diagnostic feature in DKA is the elevation of the circulating total ketone body concentration.…”

Section: Section 3 What Are the Diagnostic Criteria Of Dka And Hhs?mentioning

confidence: 99%

Hyperglycaemic crises in adults with diabetes: a consensus report

Umpierrez,

Davis,

ElSayed

et al. 2024

Diabetologia

View full text Add to dashboard Cite

The American Diabetes Association (ADA), European Association for the Study of Diabetes (EASD), Joint British Diabetes Societies for Inpatient Care (JBDS), American Association of Clinical Endocrinology (AACE) and Diabetes Technology Society (DTS) convened a panel of internists and diabetologists to update the ADA consensus statement on hyperglycaemic crises in adults with diabetes, published in 2001 and last updated in 2009. The objective of this consensus report is to provide up-to-date knowledge about the epidemiology, pathophysiology, clinical presentation, and recommendations for the diagnosis, treatment and prevention of diabetic ketoacidosis (DKA) and hyperglycaemic hyperosmolar state (HHS) in adults. A systematic examination of publications since 2009 informed new recommendations. The target audience is the full spectrum of diabetes healthcare professionals and individuals with diabetes.

show abstract

SGLT-2 inhibitors and euglycemic diabetic ketoacidosis/diabetic ketoacidosis in FAERS: a pharmacovigilance assessment

Cited by 11 publications

References 34 publications

Postmarket safety profile of suicide/self-injury for GLP-1 receptor agonist: a real-world pharmacovigilance analysis

Postmarket safety profile of suicide/self-injury for GLP-1 receptor agonist: a real-world pharmacovigilance analysis

Ketoacidosis and SGLT2 Inhibitors: A Narrative Review

Hyperglycaemic crises in adults with diabetes: a consensus report

Contact Info

Product

Resources

About