Evidence mapPaperPMID 39285057Full record

ArticleEuropean journal of clinical pharmacology2024

Sodium-glucose cotransporter 2 inhibitors and renal cancer in the US FDA adverse event reporting system.

Bo Xu, Jiecan Zhou

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Article in European journal of clinical pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

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0cells of the map it votes in
4citing papers in PubMed
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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

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Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

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4 · The record

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5 · Who and what money

Authors and funding

2 authors.

Bo XuSchool of Pharmaceutical Science, Hengyang Medical School, University of South China, Hengyang, 421001, Hunan, China.ORCID http://orcid.org/0000-0003-0594-9103
Jiecan ZhouSchool of Pharmaceutical Science, Hengyang Medical School, University of South China, Hengyang, 421001, Hunan, China. zhoujiecan@fsyy.usc.edu.cn.ORCID http://orcid.org/0000-0002-3037-3997

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRecent evidence suggests an association between sodium-glucose cotransporter 2 (SGLT2) inhibitors and a higher risk of renal cancer.

objectiveWe conducted a pharmacovigilance analysis using the US FDA Adverse Event Reporting System (FAERS) to investigate the disproportionate association between SGLT2 inhibitors and renal cancer.

methodsWe used AERSMine to mine data from FAERS, covering the period from 2014 Q1 to 2023 Q3. The control group was treated with other glucose-lowering medications (ATC-A10B). Disproportionality analysis results were performed using a proportional reporting ratio (PRR) with a 95% confidence interval (CI) and an information component (IC) with 95% credible interval.

resultsCompared to the control group, the SGLT2 inhibitor group had a higher disproportionate renal cancer reporting frequency (0.92 vs 0.27/1000 reports; PRR 3.38; 95% CI 2.68-4.25; p < 0.001) with an IC of 1.36 (0.60-2.06), comprising dapagliflozin (PRR 4.14; 2.95-5.80; p < 0.001), empagliflozin (PRR 2.74; 1.94-3.89; p < 0.001), and canagliflozin (PRR 3.56; 2.48-5.12; p < 0.001). Consistent results were obtained in the diabetes indication with the primary outcomes only for the SGLT2 inhibitors group (not individual molecule). The results of the sensitivity analysis (excluding hypertension indication or antihypertensive drugs, obesity, smoking, alpha-1 blockers, or anti-renal cancer drugs) were highly consistent with the main outcomes, indicating good robustness of the results. The results from 2004 Q1 to 2023 Q3 were similar to those from 2014 Q1 to 2023 Q3, with the exception of empagliflozin.

conclusionThere was a disproportionate association between SGLT2 inhibitors and renal cancer, which supports the current meta-analysis results indicating an increased risk of renal cancer associated with SGLT2 inhibitors.

Indexed as

Adverse Drug Reaction Reporting SystemsKidney NeoplasmsPharmacovigilanceSodium-Glucose Transporter 2 InhibitorsUnited States Food and Drug AdministrationBenzhydryl CompoundsCanagliflozinGlucosidesHumansHypoglycemic AgentsUnited StatesBenzhydryl CompoundsCanagliflozindapagliflozinGlucosidesHypoglycemic AgentsSodium-Glucose Transporter 2 InhibitorsFAERSPharmacovigilanceRenal cancerSodium-glucose cotransporter 2 inhibitors

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.