ArticlePharmaceuticals (Basel, Switzerland)2024
Real-Life Data on the Safety of Pasireotide in Acromegaly: Insights from EudraVigilance.
Article in Pharmaceuticals (Basel, Switzerland), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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Who cites it
11 citing papers in PubMed.
- Acromegaly and cardiovascular disease: mechanisms, clinical impact, and evolving management.Endocrine reviews · 2026Review
- Comparative Pharmacovigilance Analysis of Selected Cardiotoxicity Signals Associated with Doxorubicin and Epirubicin Based on EudraVigilance Data.Journal of clinical medicine · 2026Article
- Digoxin Dosing Errors, Drug Interactions and Off-Label Risks: Insights from an EudraVigilance Disproportionality Analysis.Journal of clinical medicine · 2026Article
- Metabolic and Inflammatory Adverse Drug Reactions Associated with Amlodipine: A Descriptive and Disproportionality Analysis of EudraVigilance Reports.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Metabolic Disturbances Associated with Beta-Blocker Therapy: New Insights from a Large-Scale Pharmacovigilance Study.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Current Insights into Pasireotide Therapy for Uncontrolled Acromegaly: Biochemical Response, Tumor Reduction, and Glycemic Safety in a Real-World Latin American Cohort.Life (Basel, Switzerland) · 2026Article
- Incretin-Based Drugs for Obesity: Common and Drug-Specific Reporting Patterns of Adverse Drug Reactions-A Comparative Disproportionality Analysis Using EudraVigilance Reports Integrating SmPC Data.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Therapeutic Potential of Somatostatin and Its Analogues in Alzheimer's Disease: From Molecular Mechanisms to Preclinical Studies.Molecular neurobiology · 2026Review
- Pharmacovigilance Insights into Ibuprofen's Neuropsychiatric Safety: A Retrospective Analysis of EudraVigilance Reports.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Exploring the Cardiovascular Safety Profile of Ibuprofen: Insights from EudraVigilance Database.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Protective Effects of Pasireotide in LPS-Induced Acute Lung Injury.Pharmaceuticals (Basel, Switzerland) · 2025Article
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9 authors.
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Abstract
BACKGROUND/
objectivesPasireotide (PAS) is a somatostatin receptor ligand (SRL) used to treat acromegaly, a chronic condition caused by excess growth hormone. While it offers significant benefits as a second-line treatment for uncontrolled acromegaly, its use raises major concerns due to hyperglycemic side effects and gastrointestinal issues, the latter being similar to those seen with first-generation SRLs. The aim of this study is to evaluate the real-world evidence on adverse drug reactions (ADRs) reported for PAS in the EudraVigilance database, in comparison to other established drug-based therapies for acromegaly.
methodsA descriptive analysis and a disproportionality analysis were conducted.
resultsThe fewest individual case safety reports (ICSRs) and adverse drug reactions (ADRs) were reported for PAS, with 698 (4%) ICSRs and 1,647 (4%) ADRs, which is even lower than for pegvisomant (PEG), which had 1765 (11%) ICSRs and 4842 (10%) ADRs. Both PAS and lanreotide (LAN) exhibited the lowest proportion of cases classified as serious. Among the total reported ADRs, those categorized as "Metabolic and nutrition disorders" were most frequent and severe for PAS (PAS-17.5% vs. OCT-4.6%, LAN-4.5%, and PEG-2.7%). Additionally, PAS demonstrated a higher likelihood of reporting endocrine disorders, which were frequently classified as serious, as well as stones affecting the hepatobiliary system compared to other drugs.
conclusionsAlthough PAS had the fewest ICSRs and ADRs, and less frequent serious ADRs, it had more reports frequently classified as serious in the "Metabolism and Nutrition Disorders" category (including events such as elevated blood glucose levels or diabetes) and "Endocrine Disorders" category compared to other SRLs and PEG. Furthermore, there was a higher likelihood of reporting hepatobiliary stones with PAS compared to OCT and PEG. This highlights the importance of adequately monitoring glycemic control and the biliary tract through ultrasound at the initiation and during follow-up of PAS therapy. Improved monitoring and reporting of these ADRs could enhance care for patients with acromegaly.
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