A study on the pharmacovigilance of various SGLT-2 inhibitors
BackgroundSodium-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 an...
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Frontiers Media S.A.
2025-01-01
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| Series: | Frontiers in Medicine |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fmed.2024.1515847/full |
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| author | Yanwen Dong Yangyang Wang Yangyang Wang Xiaomei Lan Xiaomei Lan Huiyan Zeng Huiyan Zeng |
| author_facet | Yanwen Dong Yangyang Wang Yangyang Wang Xiaomei Lan Xiaomei Lan Huiyan Zeng Huiyan Zeng |
| author_sort | Yanwen Dong |
| collection | DOAJ |
| description | BackgroundSodium-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.MethodsData 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.ResultsExcept 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.DiscussionWhile 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. |
| format | Article |
| id | doaj-art-a404fa3b852443daa5897c978f2f306e |
| institution | Kabale University |
| issn | 2296-858X |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Medicine |
| spelling | doaj-art-a404fa3b852443daa5897c978f2f306e2025-01-15T06:10:51ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2025-01-011110.3389/fmed.2024.15158471515847A study on the pharmacovigilance of various SGLT-2 inhibitorsYanwen Dong0Yangyang Wang1Yangyang Wang2Xiaomei Lan3Xiaomei Lan4Huiyan Zeng5Huiyan Zeng6Guangzhou University of Chinese Medicine, Guangzhou, ChinaThe Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou, ChinaThe Affiliated Huizhou Hospital, Guangzhou Medical University, Guangzhou, ChinaGuangzhou University of Chinese Medicine, Guangzhou, ChinaGuangzhou Development District Hospital, Guangzhou, ChinaThe Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou, ChinaThe Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, ChinaBackgroundSodium-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.MethodsData 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.ResultsExcept 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.DiscussionWhile 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.https://www.frontiersin.org/articles/10.3389/fmed.2024.1515847/fullSGLT2iadverse reactionssafe medicationpharmacovigilancedisproportionality analysis |
| spellingShingle | Yanwen Dong Yangyang Wang Yangyang Wang Xiaomei Lan Xiaomei Lan Huiyan Zeng Huiyan Zeng A study on the pharmacovigilance of various SGLT-2 inhibitors Frontiers in Medicine SGLT2i adverse reactions safe medication pharmacovigilance disproportionality analysis |
| title | A study on the pharmacovigilance of various SGLT-2 inhibitors |
| title_full | A study on the pharmacovigilance of various SGLT-2 inhibitors |
| title_fullStr | A study on the pharmacovigilance of various SGLT-2 inhibitors |
| title_full_unstemmed | A study on the pharmacovigilance of various SGLT-2 inhibitors |
| title_short | A study on the pharmacovigilance of various SGLT-2 inhibitors |
| title_sort | study on the pharmacovigilance of various sglt 2 inhibitors |
| topic | SGLT2i adverse reactions safe medication pharmacovigilance disproportionality analysis |
| url | https://www.frontiersin.org/articles/10.3389/fmed.2024.1515847/full |
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