Safety profile of tirzepatide: A real-world pharmacovigilance analysis of EudraVigilance database
Background: Tirzepatide has demonstrated superior efficacy in glycemic control and weight reduction compared to existing GLP-1 receptor agonists. However, its safety profile remains to be fully elucidated in real-world settings. This study examines its safety profile using the EudraVigilance databas...
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| Format: | Article |
| Language: | English |
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Elsevier
2024-11-01
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| Series: | Clinical Epidemiology and Global Health |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2213398424003026 |
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| author | Atul Khurana Syed Arman Rabbani Mohamed El-Tanani Mandeep Kumar Arora Shrestha Sharma Harikesh Dubey Alaa A. Aljabali Murtaza M. Tambuwala |
| author_facet | Atul Khurana Syed Arman Rabbani Mohamed El-Tanani Mandeep Kumar Arora Shrestha Sharma Harikesh Dubey Alaa A. Aljabali Murtaza M. Tambuwala |
| author_sort | Atul Khurana |
| collection | DOAJ |
| description | Background: Tirzepatide has demonstrated superior efficacy in glycemic control and weight reduction compared to existing GLP-1 receptor agonists. However, its safety profile remains to be fully elucidated in real-world settings. This study examines its safety profile using the EudraVigilance database. Methods: We conducted a pharmacovigilance analysis of individual case safety reports (ICSRs) with tirzepatide as the suspected drug using EudraVigilance database. A descriptive analysis was carried out to explore the characteristics of these ICSRs. Disproportionality analysis was performed using reporting odds ratio (ROR) and proportional reporting ratio (PRR) metrics. Results: We evaluated 2102 ICSRs where tirzepatide was implicated as the suspected drug. Majority of the ICSRs were reported by healthcare professionals (1299, 61.8 %). A total of 5774 AEs associated with tirzepatide were reported with majority being classified as serious (4914, 85.1 %). The outcome for most AEs (47.7 %, 2754 AEs) was reported as unknown, whereas 30.9 % (1784 AEs) were reported as recovered/resolved. AEs associated with the ‘Gastrointestinal Disorders’ SOC (1873, 32.4 %) were the most frequently reported, followed by those related to ‘Injury, poisoning and procedural complications’ SOC (641 AEs). Pancreatitis (363) and vomiting (274) emerged as the most commonly reported AEs. The disproportionality analysis indicated a higher reporting frequency of gastrointestinal AEs for tirzepatide (ROR: 1.35, 95 % CI: 1.47-1.23; PRR: 1.16, 95 % CI: 1.26-1.06) compared to semaglutide, dulaglutide, liraglutide and exenatide. Conclusion: This study underscores tirzepatide's safety profile in real-world settings. It highlights the need for ongoing monitoring, especially considering tirzepatide's recent introduction to the market. |
| format | Article |
| id | doaj-art-c7be2d7654984122a6fcce9dac0f04f9 |
| institution | Kabale University |
| issn | 2213-3984 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Clinical Epidemiology and Global Health |
| spelling | doaj-art-c7be2d7654984122a6fcce9dac0f04f92024-12-28T05:21:59ZengElsevierClinical Epidemiology and Global Health2213-39842024-11-0130101805Safety profile of tirzepatide: A real-world pharmacovigilance analysis of EudraVigilance databaseAtul Khurana0Syed Arman Rabbani1Mohamed El-Tanani2Mandeep Kumar Arora3Shrestha Sharma4Harikesh Dubey5Alaa A. Aljabali6Murtaza M. Tambuwala7School of Pharmaceutical and Population Health Informatics, DIT University, Dehradun, IndiaRAK College of Pharmacy, RAK Medical and Health Sciences University, United Arab EmiratesRAK College of Pharmacy, RAK Medical and Health Sciences University, United Arab EmiratesSchool of Pharmaceutical and Population Health Informatics, DIT University, Dehradun, India; Corresponding author.Amity Institute of Pharmacy (AIP), Amity University, Gurgaon, Haryana, IndiaThe Institute for Quantitative Health Science and Engineering, Michigan State University, East Lansing, USADepartment of Pharmaceutics and Pharmaceutical Technology, Yarmouk University, Irbid, JordanRAK College of Pharmacy, RAK Medical and Health Sciences University, United Arab EmiratesBackground: Tirzepatide has demonstrated superior efficacy in glycemic control and weight reduction compared to existing GLP-1 receptor agonists. However, its safety profile remains to be fully elucidated in real-world settings. This study examines its safety profile using the EudraVigilance database. Methods: We conducted a pharmacovigilance analysis of individual case safety reports (ICSRs) with tirzepatide as the suspected drug using EudraVigilance database. A descriptive analysis was carried out to explore the characteristics of these ICSRs. Disproportionality analysis was performed using reporting odds ratio (ROR) and proportional reporting ratio (PRR) metrics. Results: We evaluated 2102 ICSRs where tirzepatide was implicated as the suspected drug. Majority of the ICSRs were reported by healthcare professionals (1299, 61.8 %). A total of 5774 AEs associated with tirzepatide were reported with majority being classified as serious (4914, 85.1 %). The outcome for most AEs (47.7 %, 2754 AEs) was reported as unknown, whereas 30.9 % (1784 AEs) were reported as recovered/resolved. AEs associated with the ‘Gastrointestinal Disorders’ SOC (1873, 32.4 %) were the most frequently reported, followed by those related to ‘Injury, poisoning and procedural complications’ SOC (641 AEs). Pancreatitis (363) and vomiting (274) emerged as the most commonly reported AEs. The disproportionality analysis indicated a higher reporting frequency of gastrointestinal AEs for tirzepatide (ROR: 1.35, 95 % CI: 1.47-1.23; PRR: 1.16, 95 % CI: 1.26-1.06) compared to semaglutide, dulaglutide, liraglutide and exenatide. Conclusion: This study underscores tirzepatide's safety profile in real-world settings. It highlights the need for ongoing monitoring, especially considering tirzepatide's recent introduction to the market.http://www.sciencedirect.com/science/article/pii/S2213398424003026TirzepatideSafetyPharmacovigilanceAdverse eventEudraVigilanceReal-world |
| spellingShingle | Atul Khurana Syed Arman Rabbani Mohamed El-Tanani Mandeep Kumar Arora Shrestha Sharma Harikesh Dubey Alaa A. Aljabali Murtaza M. Tambuwala Safety profile of tirzepatide: A real-world pharmacovigilance analysis of EudraVigilance database Clinical Epidemiology and Global Health Tirzepatide Safety Pharmacovigilance Adverse event EudraVigilance Real-world |
| title | Safety profile of tirzepatide: A real-world pharmacovigilance analysis of EudraVigilance database |
| title_full | Safety profile of tirzepatide: A real-world pharmacovigilance analysis of EudraVigilance database |
| title_fullStr | Safety profile of tirzepatide: A real-world pharmacovigilance analysis of EudraVigilance database |
| title_full_unstemmed | Safety profile of tirzepatide: A real-world pharmacovigilance analysis of EudraVigilance database |
| title_short | Safety profile of tirzepatide: A real-world pharmacovigilance analysis of EudraVigilance database |
| title_sort | safety profile of tirzepatide a real world pharmacovigilance analysis of eudravigilance database |
| topic | Tirzepatide Safety Pharmacovigilance Adverse event EudraVigilance Real-world |
| url | http://www.sciencedirect.com/science/article/pii/S2213398424003026 |
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