The potential antidepressant effect of antidiabetic agents: New insights from a pharmacovigilance study based on data from the reporting system databases FAERS and VigiBase
Background: Growing evidence supports a bidirectional association between diabetes and depression; promising but limited and conflicting data from human studies support the intriguing possibility that antidiabetic agents may be used to relieve effectively depressive symptoms in diabetic patients. We...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2023-02-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2023.1128387/full |
| _version_ | 1828013117750116352 |
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| author | Vera Battini Robbert P. Van Manen Michele Gringeri Giulia Mosini Greta Guarnieri Anna Bombelli Marco Pozzi Maria Nobile Sonia Radice Emilio Clementi Emilio Clementi Carla Carnovale |
| author_facet | Vera Battini Robbert P. Van Manen Michele Gringeri Giulia Mosini Greta Guarnieri Anna Bombelli Marco Pozzi Maria Nobile Sonia Radice Emilio Clementi Emilio Clementi Carla Carnovale |
| author_sort | Vera Battini |
| collection | DOAJ |
| description | Background: Growing evidence supports a bidirectional association between diabetes and depression; promising but limited and conflicting data from human studies support the intriguing possibility that antidiabetic agents may be used to relieve effectively depressive symptoms in diabetic patients. We investigated the potential antidepressant effects of antidiabetic drugs in a high-scale population data from the two most important pharmacovigilance databases, i.e., the FDA Adverse Event Reporting System (FAERS) and the VigiBase.Material and methods: From the two primary cohorts of patients treated with antidepressants retrieved from FDA Adverse Event Reporting System and VigiBase we identified cases (depressed patients experiencing therapy failure) and non-cases (depressed patients experiencing any other adverse event). We then calculated the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Empirical Bayes Geometric Mean (EBGM), and Empirical Bayes Regression-Adjusted Mean (ERAM) for cases versus non-cases in relation with the concurrent exposure to at least one of the following antidiabetic agent: A10BA Biguanides; A10BB Sulfonylureas; A10BG Thiazolidinediones; A10BH DPP4-inhibitors; A10BJ GLP-1 analogues; A10BK SGLT2 inhibitors (i.e., those agents for which preliminary evidence from literature supports our pharmacological hypothesis).Results: For GLP-1 analogues, all the disproportionality scores showed values <1, i.e., statistically significant, in both analyses [from the FAERS: ROR confidence interval of 0.546 (0.450–0.662); PRR (p-value) of 0.596 (0.000); EBGM (CI) of 0.488 (0.407–0.582); ERAM (CI) of 0.480 (0.398–0.569) and VigiBase: ROR (CI) of 0.717 (0.559–0.921); PRR (p-value) of 0.745 (0.033); EBGM (CI) of 0.586 (0.464–0.733); ERAM of (CI): 0.515 (0.403–0.639)]. Alongside GLP-1 analogues, DPP-4 Inhibitors and Sulfonylureas showed the greatest potential protective effect. With regard to specific antidiabetic agents, liraglutide and gliclazide were associated with a statistically significant decrease in all disproportionality scores, in both analyses.Conclusion: The findings of this study provide encouraging results, albeit preliminary, supporting the need for further clinical research for investigating repurposing of antidiabetic drugs for neuropsychiatric disorders. |
| first_indexed | 2024-04-10T09:42:03Z |
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| id | doaj.art-66353f6e2011458e8a4a14c04d79d8e6 |
| institution | Directory Open Access Journal |
| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-04-10T09:42:03Z |
| publishDate | 2023-02-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Pharmacology |
| spelling | doaj.art-66353f6e2011458e8a4a14c04d79d8e62023-02-17T07:54:43ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122023-02-011410.3389/fphar.2023.11283871128387The potential antidepressant effect of antidiabetic agents: New insights from a pharmacovigilance study based on data from the reporting system databases FAERS and VigiBaseVera Battini0Robbert P. Van Manen1Michele Gringeri2Giulia Mosini3Greta Guarnieri4Anna Bombelli5Marco Pozzi6Maria Nobile7Sonia Radice8Emilio Clementi9Emilio Clementi10Carla Carnovale11Unit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences, University Hospital, Università degli Studi di Milano, Milan, ItalyOracle Health Sciences Global Business Unit, Kattendijke, NetherlandsUnit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences, University Hospital, Università degli Studi di Milano, Milan, ItalyUnit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences, University Hospital, Università degli Studi di Milano, Milan, ItalyUnit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences, University Hospital, Università degli Studi di Milano, Milan, ItalyUnit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences, University Hospital, Università degli Studi di Milano, Milan, ItalyScientific Institute, IRCCS E Medea, Bosisio Parini, ItalyScientific Institute, IRCCS E Medea, Bosisio Parini, ItalyUnit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences, University Hospital, Università degli Studi di Milano, Milan, ItalyUnit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences, University Hospital, Università degli Studi di Milano, Milan, ItalyScientific Institute, IRCCS E Medea, Bosisio Parini, ItalyUnit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences, University Hospital, Università degli Studi di Milano, Milan, ItalyBackground: Growing evidence supports a bidirectional association between diabetes and depression; promising but limited and conflicting data from human studies support the intriguing possibility that antidiabetic agents may be used to relieve effectively depressive symptoms in diabetic patients. We investigated the potential antidepressant effects of antidiabetic drugs in a high-scale population data from the two most important pharmacovigilance databases, i.e., the FDA Adverse Event Reporting System (FAERS) and the VigiBase.Material and methods: From the two primary cohorts of patients treated with antidepressants retrieved from FDA Adverse Event Reporting System and VigiBase we identified cases (depressed patients experiencing therapy failure) and non-cases (depressed patients experiencing any other adverse event). We then calculated the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Empirical Bayes Geometric Mean (EBGM), and Empirical Bayes Regression-Adjusted Mean (ERAM) for cases versus non-cases in relation with the concurrent exposure to at least one of the following antidiabetic agent: A10BA Biguanides; A10BB Sulfonylureas; A10BG Thiazolidinediones; A10BH DPP4-inhibitors; A10BJ GLP-1 analogues; A10BK SGLT2 inhibitors (i.e., those agents for which preliminary evidence from literature supports our pharmacological hypothesis).Results: For GLP-1 analogues, all the disproportionality scores showed values <1, i.e., statistically significant, in both analyses [from the FAERS: ROR confidence interval of 0.546 (0.450–0.662); PRR (p-value) of 0.596 (0.000); EBGM (CI) of 0.488 (0.407–0.582); ERAM (CI) of 0.480 (0.398–0.569) and VigiBase: ROR (CI) of 0.717 (0.559–0.921); PRR (p-value) of 0.745 (0.033); EBGM (CI) of 0.586 (0.464–0.733); ERAM of (CI): 0.515 (0.403–0.639)]. Alongside GLP-1 analogues, DPP-4 Inhibitors and Sulfonylureas showed the greatest potential protective effect. With regard to specific antidiabetic agents, liraglutide and gliclazide were associated with a statistically significant decrease in all disproportionality scores, in both analyses.Conclusion: The findings of this study provide encouraging results, albeit preliminary, supporting the need for further clinical research for investigating repurposing of antidiabetic drugs for neuropsychiatric disorders.https://www.frontiersin.org/articles/10.3389/fphar.2023.1128387/fulldiabetespharmacovigilancedepressionantidiabetic agentsdrug repurposingreal-world data |
| spellingShingle | Vera Battini Robbert P. Van Manen Michele Gringeri Giulia Mosini Greta Guarnieri Anna Bombelli Marco Pozzi Maria Nobile Sonia Radice Emilio Clementi Emilio Clementi Carla Carnovale The potential antidepressant effect of antidiabetic agents: New insights from a pharmacovigilance study based on data from the reporting system databases FAERS and VigiBase Frontiers in Pharmacology diabetes pharmacovigilance depression antidiabetic agents drug repurposing real-world data |
| title | The potential antidepressant effect of antidiabetic agents: New insights from a pharmacovigilance study based on data from the reporting system databases FAERS and VigiBase |
| title_full | The potential antidepressant effect of antidiabetic agents: New insights from a pharmacovigilance study based on data from the reporting system databases FAERS and VigiBase |
| title_fullStr | The potential antidepressant effect of antidiabetic agents: New insights from a pharmacovigilance study based on data from the reporting system databases FAERS and VigiBase |
| title_full_unstemmed | The potential antidepressant effect of antidiabetic agents: New insights from a pharmacovigilance study based on data from the reporting system databases FAERS and VigiBase |
| title_short | The potential antidepressant effect of antidiabetic agents: New insights from a pharmacovigilance study based on data from the reporting system databases FAERS and VigiBase |
| title_sort | potential antidepressant effect of antidiabetic agents new insights from a pharmacovigilance study based on data from the reporting system databases faers and vigibase |
| topic | diabetes pharmacovigilance depression antidiabetic agents drug repurposing real-world data |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2023.1128387/full |
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