{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T04:23:31Z","timestamp":1790915011644,"version":"4.1.0"},"reference-count":82,"publisher":"MDPI AG","issue":"12","license":[{"start":{"date-parts":[[2024,12,4]],"date-time":"2024-12-04T00:00:00Z","timestamp":1733270400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"\u201cIuliu Ha\u021bieganu\u201d University of Medicine and Pharmacy, Cluj-Napoca"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceuticals"],"abstract":"<jats:p>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 \u201cMetabolic and nutrition disorders\u201d were most frequent and severe for PAS (PAS\u201417.5% vs. OCT\u20144.6%, LAN\u20144.5%, and PEG\u20142.7%). 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 \u201cMetabolism and Nutrition Disorders\u201d category (including events such as elevated blood glucose levels or diabetes) and \u201cEndocrine Disorders\u201d 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.<\/jats:p>","DOI":"10.3390\/ph17121631","type":"journal-article","created":{"date-parts":[[2024,12,4]],"date-time":"2024-12-04T11:03:08Z","timestamp":1733310188000},"page":"1631","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Real-Life Data on the Safety of Pasireotide in Acromegaly: Insights from EudraVigilance"],"prefix":"10.3390","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5281-5004","authenticated-orcid":false,"given":"Ioana Rada","family":"Popa Ilie","sequence":"first","affiliation":[{"name":"Department of Endocrinology, Faculty of Medicine, \u201cIuliu Ha\u0163ieganu\u201d University of Medicine and Pharmacy, 3-5 Louis Pasteur Street, 400349 Cluj-Napoca, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9913-1750","authenticated-orcid":false,"given":"Carmen Maximiliana","family":"Dobrea","sequence":"additional","affiliation":[{"name":"Preclinical Department, Faculty of Medicine, \u201cLucian Blaga\u201d University of Sibiu, 550169 Sibiu, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1540-641X","authenticated-orcid":false,"given":"Anca","family":"Butuca","sequence":"additional","affiliation":[{"name":"Preclinical Department, Faculty of Medicine, \u201cLucian Blaga\u201d University of Sibiu, 550169 Sibiu, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Calin","family":"Homorodean","sequence":"additional","affiliation":[{"name":"Medical Clinic No. 1, Internal Medicine Department, University of Medicine and Pharmacy \u201cIuliu Hatieganu\u201d, 400006 Cluj-Napoca, Romania"},{"name":"Interventional Cardiology Department, Cluj County Emergency Hospital, 400006 Cluj-Napoca, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2730-8729","authenticated-orcid":false,"given":"Claudiu","family":"Morgovan","sequence":"additional","affiliation":[{"name":"Preclinical Department, Faculty of Medicine, \u201cLucian Blaga\u201d University of Sibiu, 550169 Sibiu, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6362-4302","authenticated-orcid":false,"given":"Andreea Loredana","family":"Vonica-Tincu","sequence":"additional","affiliation":[{"name":"Preclinical Department, Faculty of Medicine, \u201cLucian Blaga\u201d University of Sibiu, 550169 Sibiu, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3167-9864","authenticated-orcid":false,"given":"Felicia Gabriela","family":"Gligor","sequence":"additional","affiliation":[{"name":"Preclinical Department, Faculty of Medicine, \u201cLucian Blaga\u201d University of Sibiu, 550169 Sibiu, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2247-4613","authenticated-orcid":false,"given":"Steliana","family":"Ghibu","sequence":"additional","affiliation":[{"name":"Department of Pharmacology, Physiology and Pathophysiology, Faculty of Pharmacy, \u201cIuliu Ha\u0163ieganu\u201d University of Medicine and Pharmacy, 6A Louis Pasteur Street, 400349 Cluj-Napoca, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4874-0430","authenticated-orcid":false,"given":"Adina","family":"Frum","sequence":"additional","affiliation":[{"name":"Preclinical Department, Faculty of Medicine, \u201cLucian Blaga\u201d University of Sibiu, 550169 Sibiu, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2024,12,4]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"491","DOI":"10.1016\/j.nec.2019.05.009","article-title":"Endocrine Outcomes After Pituitary Surgery","volume":"30","author":"Buttan","year":"2019","journal-title":"Neurosurg. 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