Frontiers in medicine · 2025
A study on the pharmacovigilance of various SGLT-2 inhibitors.
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Dong Yanwen, Wang Yangyang, Lan Xiaomei, Zeng Huiyan
Аннотация
BACKGROUND: Sodium-glucose co-transporter two inhibitors (SGLT2is) are widely used in clinical practice due to their proven cardiovascular and renal benefits. However, various adverse drug reactions (ADRs) have been reported. This study aims to systematically update the ADRs associated with SGLT2is and identify the differences among various SGLT2is acovigilance of various SGLT-2 inhibitors.
METHODS: Data from the FAERS database covering Q1 2013 to Q2 2024 were selected for disproportionality analysis. ADRs were defined using the System Organ Classes (SOC) and Preferred Terms (PT) from the MedDRA 27.0 dictionary. Four signal detection metrics-reporting odds ratio (ROR), proportional reporting ratios (PRRs), Bayesian Confidence Propagation Neural Network (BCPNN), and empirical Bayesian geometric mean (EBGM)-were utilized to infer ADRs and assess differences among specific SGLT2i drugs through intersection analysis.
RESULTS: Except for canagliflozin, both dapagliflozin and empagliflozin showed a general increase in ADRs. Specifically, canagliflozin had 93 ADRs, dapagliflozin had 173, and empagliflozin had 214. Most of these were related to Infections and Infestations, Investigations, and Reproductive System and Breast Disorders, notably manifesting as inflammatory conditions of the urinary and reproductive systems, such as orchitis and testicular abscess, consistent with FDA labeling. Additionally, overlooked ADRs were identified, including bladder cancer, cholangiocarcinoma, and thrombotic strokes, none of which were reported for canagliflozin.
DISCUSSION: While shared ADRs for SGLT2is are noted in FDA labeling, monitoring for high-risk populations, such as those with cancers or strokes, remains crucial to prevent deterioration. Medication regimens may need adjustment, including selecting canagliflozin or non-SGLT2i alternatives when necessary.
METHODS: Data from the FAERS database covering Q1 2013 to Q2 2024 were selected for disproportionality analysis. ADRs were defined using the System Organ Classes (SOC) and Preferred Terms (PT) from the MedDRA 27.0 dictionary. Four signal detection metrics-reporting odds ratio (ROR), proportional reporting ratios (PRRs), Bayesian Confidence Propagation Neural Network (BCPNN), and empirical Bayesian geometric mean (EBGM)-were utilized to infer ADRs and assess differences among specific SGLT2i drugs through intersection analysis.
RESULTS: Except for canagliflozin, both dapagliflozin and empagliflozin showed a general increase in ADRs. Specifically, canagliflozin had 93 ADRs, dapagliflozin had 173, and empagliflozin had 214. Most of these were related to Infections and Infestations, Investigations, and Reproductive System and Breast Disorders, notably manifesting as inflammatory conditions of the urinary and reproductive systems, such as orchitis and testicular abscess, consistent with FDA labeling. Additionally, overlooked ADRs were identified, including bladder cancer, cholangiocarcinoma, and thrombotic strokes, none of which were reported for canagliflozin.
DISCUSSION: While shared ADRs for SGLT2is are noted in FDA labeling, monitoring for high-risk populations, such as those with cancers or strokes, remains crucial to prevent deterioration. Medication regimens may need adjustment, including selecting canagliflozin or non-SGLT2i alternatives when necessary.