Safety profile of lanreotide: a retrospective post-marketing pharmacovigilance study based on the real-world data from FAERS database

A. Periferakis, G. Tsigas, A.T. Periferakis, C.M. Tone, D.A. Hemes, K. Periferakis et al. Agonists, antagonists and receptors of somatostatin: pathophysiological and therapeutical implications in neoplasias. Curr. Issues Mol. Biol. 46(9), 9721–9759 (2024)

Article  CAS  PubMed  PubMed Central  Google Scholar 

U. Rai, T.R. Thrimawithana, C. Valery, S.A. Young, Therapeutic uses of somatostatin and its analogues: current view and potential applications. Pharmacol. Ther. 152, 98–110 (2015)

Article  CAS  PubMed  Google Scholar 

A. Angelousi, A. Koumarianou, E. Chatzellis, G. Kaltsas, Resistance of neuroendocrine tumours to somatostatin analogs. Expert Rev. Endocrinol. Metab. 18(1), 33–52 (2023)

Article  CAS  PubMed  Google Scholar 

A. Colao, R.S. Auriemma, R. Pivonello, L. Kasuki, M.R. Gadelha, Interpreting biochemical control response rates with first-generation somatostatin analogues in acromegaly. Pituitary 19(3), 235–247 (2016)

Article  CAS  PubMed  Google Scholar 

B. Kiesewetter, F.F. Pflüger, P. Melhorn, P. Mazal, M. Raderer, Long-term experience with octreotide and lanreotide for the treatment of gastroenteropancreatic neuroendocrine tumors. Clin. Transl. Oncol. 27(4), 1642–1652 (2025)

Article  CAS  PubMed  Google Scholar 

L.B. Anthony, T.M. O’Dorisio, Opportunities to improve symptom control with somatostatin congeners in GEP-NETs: a review of key issues. Oncologist 26(7), e1171–e1178 (2021)

Article  PubMed  PubMed Central  Google Scholar 

N. Brighi, F. Panzuto, R. Modica, F. Gelsomino, M. Albertelli, S. Pusceddu et al. Biliary stone disease in patients with neuroendocrine tumors treated with somatostatin analogs: a multicenter study. Oncologist 25(3), 259–265 (2020)

Article  CAS  PubMed  Google Scholar 

A.T. Scott, J.R. Howe, Evaluation and management of neuroendocrine tumors of the pancreas. Surg. Clin. North. Am. 99(4), 793–814 (2019)

Article  PubMed  PubMed Central  Google Scholar 

E. Liu, K.D. Hoffman, G. Murfin, H. Eccard, Breakthrough symptoms remain an unmet need in symptomatic patients with neuroendocrine tumors and carcinoid syndrome. Pancreas 52(1), e70–e74 (2023)

Article  CAS  PubMed  Google Scholar 

P. Ryan, A. McBride, D. Ray, S. Pulgar, R.A. Ramirez, E. Elquza et al. Lanreotide vs octreotide LAR for patients with advanced gastroenteropancreatic neuroendocrine tumors: an observational time and motion analysis. J. Oncol. Pharm. Pract. 25(6), 1425–1433 (2019)

Article  CAS  PubMed  PubMed Central  Google Scholar 

C. Chen, B. Wu, C. Zhang, T. Xu, Immune-related adverse events associated with immune checkpoint inhibitors: an updated comprehensive disproportionality analysis of the FDA adverse event reporting system. Int. Immunopharmacol. 95, 107498 (2021)

Article  CAS  PubMed  Google Scholar 

Y. Wang, B. Zhao, H. Yang, Z. Wan, A real-world pharmacovigilance study of FDA adverse event reporting system events for sildenafil. Andrology 12(4), 785–792 (2024)

Article  CAS  PubMed  Google Scholar 

L. Wang, G. Jiang, D. Li, H. Liu, Standardizing adverse drug event reporting data. J. Biomed. Semantics. 5, 36 (2014)

Article  PubMed  PubMed Central  Google Scholar 

E.P. van Puijenbroek, A. Bate, H.G. Leufkens, M. Lindquist, R. Orre, A.C. Egberts, A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions. Pharmacoepidemiol. Drug. Saf. 11(1), 3–10 (2002)

Article  PubMed  Google Scholar 

K. Kubota, D. Koide, T. Hirai, Comparison of data mining methodologies using Japanese spontaneous reports. Pharmacoepidemiol. Drug. Saf. 13(6), 387–394 (2004)

Article  PubMed  Google Scholar 

S.T. de Vries, P. Denig, C. Ekhart, P.G.M. Mol, E.P. van Puijenbroek, Sex differences in adverse drug reactions of metformin: a longitudinal survey study. Drug. Saf. 43(5), 489–495 (2020)

Article  PubMed  PubMed Central  Google Scholar 

C. Álvarez-Escolá, E.M. Venegas-Moreno, J.A. García-Arnés, C. Blanco-Carrera, M. Marazuela-Azpiroz, M. Gálvez-Moreno et al. ACROSTART: a retrospective study of the time to achieve hormonal control with lanreotide Autogel treatment in Spanish patients with acromegaly. Endocrinol. Diabetes Nutr. 66(5), 320–329 (2019)

Article  Google Scholar 

P. Caron, [Somatuline(R) Autogel(R), a new formulation of lanreotide for the treatment of acromegalic patients]. Ann. Endocrinol. 63(2 Pt 3), 2s19–24s19 (2002)

CAS  Google Scholar 

A. Dasari, C. Shen, D. Halperin, B. Zhao, S. Zhou, Y. Xu et al. Trends in the incidence, prevalence, and survival outcomes in patients with neuroendocrine tumors in the United States. JAMA Oncol. 3(10), 1335–1342 (2017)

Article  PubMed  PubMed Central  Google Scholar 

D.L. Chan, D. Ferone, M. Albertelli, N. Pavlakis, E. Segelov, S. Singh, Escalated-dose somatostatin analogues for antiproliferative effect in GEPNETS: a systematic review. Endocrine 57(3), 366–375 (2017)

Article  CAS  PubMed  Google Scholar 

M. Pavel, D. O’Toole, F. Costa, J. Capdevila, D. Gross, R. Kianmanesh et al. ENETS consensus guidelines update for the management of distant metastatic disease of intestinal, pancreatic, bronchial neuroendocrine neoplasms (NEN) and NEN of unknown primary site. Neuroendocrinology 103(2), 172–185 (2016)

Article  CAS  PubMed  Google Scholar 

S. Singh, D. Granberg, E. Wolin, R. Warner, M. Sissons, T. Kolarova et al. Patient-reported burden of a neuroendocrine tumor (NET) diagnosis: results from the first global survey of patients with NETs. J. Glob. Oncol. 3(1), 43–53 (2017)

Article  PubMed  Google Scholar 

S. Das, T. Al-Toubah, G. El-Haddad, J. Strosberg, (177)Lu-DOTATATE for the treatment of gastroenteropancreatic neuroendocrine tumors. Expert. Rev. Gastroenterol. Hepatol. 13(11), 1023–1031 (2019)

Article  CAS  PubMed  PubMed Central  Google Scholar 

E.S. Mittra, Neuroendocrine Tumor Therapy: (177)Lu-DOTATATE. AJR Am. J. Roentgenol. 211(2), 278–285 (2018)

Article  PubMed  Google Scholar 

A. Godara, N.S. Siddiqui, M.M. Byrne, M.W. Saif, The safety of lanreotide for neuroendocrine tumor. Expert. Opin. Drug. Saf. 18(1), 1–10 (2019)

Article  CAS  PubMed  Google Scholar 

E.B. Geer, J. Sisco, D.T. Adelman, W.H. Ludlam, A. Haviv, S. Liu et al. Patient reported outcome data from acromegaly patients treated with injectable somatostatin receptor ligands (SRLs) in routine clinical practice. BMC Endocr. Disord. 20(1), 117 (2020)

Article  CAS  PubMed  PubMed Central  Google Scholar 

T. Ito, Y. Honma, S. Hijioka, A. Kudo, A. Fukutomi, A. Nozaki et al. Phase II study of lanreotide autogel in Japanese patients with unresectable or metastatic well-differentiated neuroendocrine tumors. Invest. N. Drugs 35(4), 499–508 (2017)

Article  CAS  Google Scholar 

P. Burman, J. Besjakov, T. Svensjö, Large fat and skin necroses after deep subcutaneous injections of a slow-release somatostatin analogue in a woman with acromegaly. Growth Horm. IGF Res. 20(6), 438–440 (2010)

Article  CAS  PubMed  Google Scholar 

D. O’Toole, P.L. Kunz, S.M. Webb, G. Goldstein, S. Khawaja, M. McDonnell et al. PRESTO 2: an international survey to evaluate patients’ injection experiences with the latest devices/formulations of long-acting somatostatin analog therapies for neuroendocrine tumors or acromegaly. Adv. Ther. 40(2), 671–690 (2023)

Article  PubMed  Google Scholar 

D.T. Adelman, D. Van Genechten, C.M. Megret, X.T. Truong Thanh, P. Hand, W.A. Martin, Co-creation of a lanreotide autogel/depot syringe for the treatment of acromegaly and neuroendocrine tumours through collaborative human factor studies. Adv. Ther. 36(12), 3409–3423 (2019)

Article  PubMed  PubMed Central  Google Scholar 

S.E. Aapkes, R.J. de Haas, L.H.P. Bernts, C.J. Blijdorp, S.E.I. Dekker, M.D.A. van Gastel et al. Incident gallstones during somatostatin analog treatment are associated with acute biliary complications especially after discontinuation. Drugs R. D. 21(2), 179–188 (2021)

Article 

Comments (0)

No login
gif