{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,27]],"date-time":"2026-04-27T01:33:33Z","timestamp":1777253613287,"version":"3.51.4"},"reference-count":23,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2026,4,13]],"date-time":"2026-04-13T00:00:00Z","timestamp":1776038400000},"content-version":"vor","delay-in-days":12,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,4,1]],"date-time":"2026-04-01T00:00:00Z","timestamp":1775001600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J Neuroendocrinology"],"published-print":{"date-parts":[[2026,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    A post\u2010authorisation safety study (PASS) was conducted to assess the impact of LysaKare (2.5% Lysine\u2010Arginine solution) on serum potassium concentrations and its safety\/tolerability profile in patients with gastroenteropancreatic neuroendocrine tumours (GEP\u2010NET) eligible for\n                    <jats:sup>177<\/jats:sup>\n                    Lu\u2010DOTATATE treatment. In a phase IV, multicentre, single\u2010arm, open\u2010label PASS, adults with somatostatin receptor\u2010positive GEP\u2010NET who were eligible for\n                    <jats:sup>177<\/jats:sup>\n                    Lu\u2010DOTATATE treatment received 1000\u2009mL of LysaKare (monotherapy) intravenously over 4\u2009h. The primary endpoint was the change in serum potassium levels over the course of 24\u2009h. Secondary endpoints included the incidence of LysaKare\u2010related adverse events (AEs) and changes in laboratory parameters. Forty\u2010one patients were treated (median age, 57\u2009years; 92.7% White and 7.3% Black; 53.7% male) and 40 completed post\u2010treatment follow\u2010up. Mean (standard deviation [SD]) serum potassium was 4.33 (0.397) mmol\/L pre\u2010dose, increasing by 0.60 (0.666) mmol\/L after 4\u2009h (time to maximum change, range, 2\u201324\u2009h) before decreasing to around the pre\u2010dose level: the mean (SD) increase after 24\u2009h was 0.07 (0.396) mmol\/L. Other electrolytes and blood gas components mostly showed transient changes that lasted ~24\u2009h. A general trend of transient metabolic acidosis was also observed based on laboratory values. Serum potassium grade increased from baseline in 41.5% of patients. By comparison, five patients (12.2%) had a treatment\u2010related AE of hyperkalaemia (grade 3,\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u20091); all resolved within 24\u2009h, either without treatment (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u20093) or following intravenous furosemide (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u20092). There were no serious AEs and no AEs leading to treatment discontinuation\/interruption. This PASS identified no new safety signals attributable to LysaKare.\n                  <\/jats:p>\n                  <jats:p>Trial registration: EudraCT, 2019\u2010004073\u201076. Registered 20\/08\/2020.<\/jats:p>","DOI":"10.1111\/jne.70172","type":"journal-article","created":{"date-parts":[[2026,4,14]],"date-time":"2026-04-14T05:00:56Z","timestamp":1776142856000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["The effect of\n                    <scp>LysaKare<\/scp>\n                    infusion on serum potassium levels in patients with gastroenteropancreatic neuroendocrine tumours eligible for treatment with [\n                    <scp>\n                      <sup>177<\/sup>\n                      Lu\n                    <\/scp>\n                    ]Lu\u2010\n                    <scp>DOTA<\/scp>\n                    \u2010\n                    <scp>TATE<\/scp>\n                    : A post\u2010authorisation safety study"],"prefix":"10.1111","volume":"38","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0679-6209","authenticated-orcid":false,"given":"Johannes","family":"Hofland","sequence":"first","affiliation":[{"name":"Department of Internal Medicine, Section of Endocrinology, ENETS Center of Excellence Erasmus MC Cancer Institute  Rotterdam The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3808-2174","authenticated-orcid":false,"given":"Chiara Maria","family":"Grana","sequence":"additional","affiliation":[{"name":"Radiometabolic Therapy Unit, Division of Nuclear Medicine European Institute of Oncology (IEO), IRCCS  Milan Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4070-8164","authenticated-orcid":false,"given":"Martin O.","family":"Weickert","sequence":"additional","affiliation":[{"name":"The ARDEN NET Centre, ENETS Centre of Excellence University Hospitals Coventry and Warwickshire NHS Trust  Coventry UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7680-998X","authenticated-orcid":false,"given":"Andrew R.","family":"Moore","sequence":"additional","affiliation":[{"name":"Liverpool University Hospitals NHS Foundation Trust  Liverpool UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0420-0304","authenticated-orcid":false,"given":"Tahir","family":"Shah","sequence":"additional","affiliation":[{"name":"University Hospital Birmingham NHS Foundation Trust  Birmingham UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-9438-1666","authenticated-orcid":false,"given":"Vineet","family":"Prakash","sequence":"additional","affiliation":[{"name":"Royal Surrey County NHS Foundation Trust  Surrey UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4034-0267","authenticated-orcid":false,"given":"Agnieszka","family":"Kolasi\u0144ska\u2010\u0106wik\u0142a","sequence":"additional","affiliation":[{"name":"Maria Sklodowska\u2010Curie National Research Institute of Oncology  Warsaw Poland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1463-5165","authenticated-orcid":false,"given":"Wouter W.","family":"de Herder","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Section of Endocrinology, ENETS Center of Excellence Erasmus MC Cancer Institute  Rotterdam The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3642-0798","authenticated-orcid":false,"given":"Francesca","family":"Spada","sequence":"additional","affiliation":[{"name":"Division of Gastrointestinal Medical Oncology and Neuroendocrine Tumors European Institute of Oncology (IEO), IRCCS  Milan Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lingfei","family":"Xu","sequence":"additional","affiliation":[{"name":"Novartis Pharmaceuticals Corp, East Hanover  New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ramon","family":"Fite","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG  Barcelona Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-3340-6554","authenticated-orcid":false,"given":"Yuan","family":"Wu","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG  Basel Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5147-4167","authenticated-orcid":false,"given":"Jaros\u0142aw B.","family":"\u0106wik\u0142a","sequence":"additional","affiliation":[{"name":"University of Warmia and Mazury  Olsztyn Poland"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2026,4,13]]},"reference":[{"key":"e_1_2_12_2_1","unstructured":"European Medicines Agency.Lutathera: EPAR \u2010 Product information.https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/lutathera-epar-product-information_en.pdfAccessed 10 Feb 2025."},{"key":"e_1_2_12_3_1","unstructured":"US Food and Drug Administration.FDA approves lutetium Lu 177 dotatate for pediatric patients 12\u2009years and older with GEP\u2010NETS.https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-approves-lutetium-lu-177-dotatate-pediatric-patients-12-years-and-older-gep-netsAccessed 10 Feb 2025."},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00259\u2010025\u201007246\u20107"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140\u20106736(24)00701\u20103"},{"key":"e_1_2_12_6_1","unstructured":"European Medicines 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