Diabetes, obesity & metabolism · 2025
Assessment of thyroid cancer risk associated with glucagon-like peptide 1 receptor agonist use.
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Vilsbøll Tina, Stellfeld Michael, Aroda Vanita R, Dandanell Sune, David Jens-Peter, Kristiansen Ceyda T P, Rasmussen Søren, Roberts Fiona L, Hegedüs Laszlo
Аннотация
AIMS: Published literature has raised concerns regarding a causal association between glucagon-like peptide 1 receptor agonist (GLP-1RA) use and thyroid cancer risk in adults. In this analysis, we evaluated the association between thyroid cancer risk and GLP-1RA use.
MATERIALS AND METHODS: Our evaluation included data from (i) 93 liraglutide or semaglutide phase 2 and 3 clinical trials, of which six were cardiovascular outcome trials (CVOTs); (ii) post-marketing surveillance from the Novo Nordisk safety database (evaluating data for liraglutide and semaglutide); and (iii) the US Merative™ MarketScan® Commercial Database. Hazard ratios (HRs) were estimated for overall thyroid cancer risk for treatment groups in the clinical trials and for individuals with type 2 diabetes treated with any GLP-1RAs versus sodium-glucose cotransporter-2 inhibitors (SGLT2is) for the real-world data.
RESULTS: Data from all clinical trials across 101 732 participants (totalling 206 950 patient-years of exposure [PYE]) reported low numbers of thyroid cancer events; across all trials, HRs were 1.70 (95% confidence interval [CI] 0.99, 3.03) and 1.83 (0.70, 6.71) for pooled GLP-1RA versus pooled placebo and active comparator, respectively. For CVOTs, the HR (95% CI) for pooled GLP-1RA versus pooled placebo was 1.41 (0.72, 2.81). Post-marketing surveillance data showed a low thyroid cancer reporting rate of 0.001 cases/100 PYE and did not support an association between liraglutide or semaglutide exposure and the number of thyroid cancer events. Analysis of the US Merative™ MarketScan® Commercial Database reported an HR of 0.87 (95% CI 0.58, 1.29) for the occurrence of thyroid cancer in individuals using any GLP-1RAs versus SGLT2is.
CONCLUSIONS: The totality of data analysed did not suggest an association between liraglutide or semaglutide use and thyroid cancer risk in adults.
MATERIALS AND METHODS: Our evaluation included data from (i) 93 liraglutide or semaglutide phase 2 and 3 clinical trials, of which six were cardiovascular outcome trials (CVOTs); (ii) post-marketing surveillance from the Novo Nordisk safety database (evaluating data for liraglutide and semaglutide); and (iii) the US Merative™ MarketScan® Commercial Database. Hazard ratios (HRs) were estimated for overall thyroid cancer risk for treatment groups in the clinical trials and for individuals with type 2 diabetes treated with any GLP-1RAs versus sodium-glucose cotransporter-2 inhibitors (SGLT2is) for the real-world data.
RESULTS: Data from all clinical trials across 101 732 participants (totalling 206 950 patient-years of exposure [PYE]) reported low numbers of thyroid cancer events; across all trials, HRs were 1.70 (95% confidence interval [CI] 0.99, 3.03) and 1.83 (0.70, 6.71) for pooled GLP-1RA versus pooled placebo and active comparator, respectively. For CVOTs, the HR (95% CI) for pooled GLP-1RA versus pooled placebo was 1.41 (0.72, 2.81). Post-marketing surveillance data showed a low thyroid cancer reporting rate of 0.001 cases/100 PYE and did not support an association between liraglutide or semaglutide exposure and the number of thyroid cancer events. Analysis of the US Merative™ MarketScan® Commercial Database reported an HR of 0.87 (95% CI 0.58, 1.29) for the occurrence of thyroid cancer in individuals using any GLP-1RAs versus SGLT2is.
CONCLUSIONS: The totality of data analysed did not suggest an association between liraglutide or semaglutide use and thyroid cancer risk in adults.
Предметные рубрики MeSH
HumansThyroid NeoplasmsGlucagon-Like Peptide-1 Receptor AgonistsDiabetes Mellitus, Type 2Hypoglycemic AgentsGlucagon-Like PeptidesLiraglutideFemaleMaleMiddle AgedSodium-Glucose Transporter 2 InhibitorsAdultRisk AssessmentClinical Trials, Phase II as TopicAgedProduct Surveillance, PostmarketingRisk FactorsClinical Trials, Phase III as TopicGlucagon-Like Peptide 1Semaglutide