| アブストラクト | BACKGROUND/OBJECTIVES: Pasireotide (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. METHODS: A descriptive analysis and a disproportionality analysis were conducted. RESULTS: The 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. CONCLUSIONS: Although 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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| ジャーナル名 | Pharmaceuticals (Basel, Switzerland) |
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| Pubmed追加日 | 2025/1/8 |
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| 投稿者 | Popa Ilie, Ioana Rada; Dobrea, Carmen Maximiliana; Butuca, Anca; Homorodean, Calin; Morgovan, Claudiu; Vonica-Tincu, Andreea Loredana; Gligor, Felicia Gabriela; Ghibu, Steliana; Frum, Adina |
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| 組織名 | Department of Endocrinology, Faculty of Medicine, "Iuliu Hatieganu" University of;Medicine and Pharmacy, 3-5 Louis Pasteur Street, 400349 Cluj-Napoca, Romania.;Preclinical Department, Faculty of Medicine, "Lucian Blaga" University of Sibiu,;550169 Sibiu, Romania.;Medical Clinic No. 1, Internal Medicine Department, University of Medicine and;Pharmacy "Iuliu Hatieganu", 400006 Cluj-Napoca, Romania.;Interventional Cardiology Department, Cluj County Emergency Hospital, 400006;Cluj-Napoca, Romania.;Department of Pharmacology, Physiology and Pathophysiology, Faculty of Pharmacy,;"Iuliu Hatieganu" University of Medicine and Pharmacy, 6A Louis Pasteur Street,;400349 Cluj-Napoca, Romania. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/39770473/ |
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