Adverse events with sodium-glucose co-transporter-2 inhibitors: A global analysis of international spontaneous reporting systems

Raschi, Emanuel; Parisotto, Matteo; Forcesi, Emanuele; Plaça, M. La; Marchesini, Giulio; Ponti, Fabrizio De; Poluzzi, Elisabetta

doi:10.1016/j.numecd.2017.10.008

Cited by 38 publications

(29 citation statements)

References 28 publications

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“…Cases defined as AEs reports in which the reporter mentioned DPP-4is as suspect ("Primary Suspect", "Secondary Suspect" or "Concomitant") were selected. To control for major reporting and confounders, non-cases were selected by restricting the analysis to AEs reports in which at least one antidiabetic agent (excluding insulins) was recorded (ATC code: A10B), the so-called analysis by therapeutic area [15,16].…”

Section: Disproportionality Analysesmentioning

confidence: 99%

Adverse event profiles of dipeptidyl peptidase-4 inhibitors: data mining of the public version of the FDA adverse event reporting system

Huang

Jia²,

Sun

et al. 2020

BMC Pharmacol Toxicol

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Background To describe and analyze the patterns of adverse events associated with dipeptidyl peptidase-4 inhibitors (DPP-4is) (sitagliptin, saxagliptin, linagliptin, vildagliptin, and alogliptin) from the FDA Adverse Event Reporting System (FAERS) and to highlight areas of safety concerns. Methods Adverse events spontaneously submitted to the FAERS between 2004 Q1 to 2019 Q2 were included. The online tool OpenVigil 2.1 was used to query the database. The research relied on definitions of preferred terms (PTs) specified by the Medical Dictionary for Regulatory Activities (MedDRA) and the standardized MedDRA Queries (SMQ). The reporting odds ratio (ROR), with 95% confidence intervals (CIs) was calculated for disproportionality analysis. Results Over 16 years, a total of 9706 adverse event reports were identified. Alogliptin was excluded from further analysis due to insufficient sample size. Compared with the non-insulin antidiabetic drugs, the four DPP-4is were all disproportionately associated with four SMQs: “gastrointestinal nonspecific inflammation and dysfunctional conditions,” “hypersensitivity,” “severe cutaneous adverse reactions,” and “noninfectious diarrhoea”. As for PT level analyses, DPP-4is are associated with higher reporting of the gastrointestinal tract, pancreas, malignancies, infection, musculoskeletal disorders, general disorders, hypersensitivity, and skin AEs. Conclusions Data mining of the FAERS is useful for examining DPP-4 inhibitors-associated adverse events. The findings of the present study are compatible with clinical experience, and it provides valuable information to decision-makers and healthcare providers in clinical practice.

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Section: Disproportionality Analysesmentioning

confidence: 99%

Adverse event profiles of dipeptidyl peptidase-4 inhibitors: data mining of the public version of the FDA adverse event reporting system

Huang

Jia²,

Sun

et al. 2020

BMC Pharmacol Toxicol

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“…Genital and urinary tract infections were associated with all members of the class and predictable on the basis of the mechanism of action; although the true rate in clinical practice is still uncertain, the high reporting frequency in the postmarketing phase calls for real-time pharmacovigilance monitoring. 50 The overall evidence suggests that SGLT2-Is increase the risk of genital mycotic infections by four to five times according to the largest MA, 51 although they are usually mild to moderate, can be adequately treated with standard medical therapy, and drug discontinuation is not required. Conversely, gathered evidence is not consistent for an increased risk of urinary infections, with MAs showing mixed results.…”

Section: Debated Safety Issuesmentioning

confidence: 99%

Observational research on sodium glucose co‐transporter‐2 inhibitors: A real breakthrough?

Raschi

Poluzzi

Fadini

et al. 2018

Diabetes Obesity Metabolism

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Sodium glucose co‐transporter‐2 inhibitors have attracted the interest of the scientific community following the results from dedicated cardiovascular outcome trials, which demonstrated remarkable reduction in all‐cause mortality and other cardiovascular (CV) endpoints with empagliflozin and canagliflozin. These impressive results raised further expectations on real world data from large observational cohort studies. They were designed to address the possible existence of a class effect, and the uncertainty on whether this benefit can be extended from secondary to primary CV prevention of patients with type 2 diabetes. In this review, we collated data from existing observational studies (including the celebrated CVD‐REAL cohorts) and critically appraised results and methodological issues with the aim of providing clinical insight, including unsettled aspects, and proposing a research agenda for future investigations.

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“…In fact, data mining could virtually provide as many associations as possible between drug and effect, but without consensus among experts on the methodological steps and confirmation of pathophysiological pathways, the association can easily conduct to interpret errors. Modified and updated from [32,113]. ADR: adverse drug reaction; MedDRA: Medical Dictionary for Regulatory Activities.…”

Section: The Appropriate Choice Of Data Source According To the Reseamentioning

confidence: 99%

“…The choice of comparator group is pivotal in signal detection, especially in terms of clinical implications. For instance, a novel antidiabetic drug should be compared with other antidiabetic drugs through the so-called analysis by therapeutic area (i.e., comparing the reporting of a given drug with other agents belonging to the same therapeutic class), in order to identify patients that are likely to share the common risk factors, mitigate the confounding by indication bias, and investigate the potential intraclass variations of risk [28][29][30][31][32]. As a matter of fact, a suspected risk for a drug can be interpreted by a clinical point of view only if compared to the same risk of therapeutic alternatives, especially for severe disorders (e.g., diabetes) because patient cannot be left without treatment.…”

Section: There Is Increasing Availability Of Publicly Accessible Srssmentioning

confidence: 99%

Evolving Roles of Spontaneous Reporting Systems to Assess and Monitor Drug Safety

Raschi¹,

Moretti²,

Salvo³

et al. 2019

Pharmacovigilance

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This chapter aims to describe current and emerging roles of spontaneous reporting systems (SRSs) for assessing and monitoring drug safety. Moreover, it offers a perspective on the near future, which entails the so-called era of Big Data, keeping in mind both regulator and researcher viewpoints. After a panorama on key data sources and analyses of post-marketing data of adverse drug reactions, a critical appraisal of methodological issues and debated future applications of SRSs will be presented, including the exploitation and challenges in evidence integration (i.e., merging and combining heterogeneous sources of data into a unique indicator of risk) and patient's reporting via social media. Finally, a call for a responsible use of these studies is offered, with a proposal on a set of minimum requirements to assess the quality of disproportionality analysis in terms of study conception, performing and reporting.

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Adverse events with sodium-glucose co-transporter-2 inhibitors: A global analysis of international spontaneous reporting systems

Cited by 38 publications

References 28 publications

Adverse event profiles of dipeptidyl peptidase-4 inhibitors: data mining of the public version of the FDA adverse event reporting system

Adverse event profiles of dipeptidyl peptidase-4 inhibitors: data mining of the public version of the FDA adverse event reporting system

Observational research on sodium glucose co‐transporter‐2 inhibitors: A real breakthrough?

Evolving Roles of Spontaneous Reporting Systems to Assess and Monitor Drug Safety

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