{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,14]],"date-time":"2026-07-14T12:12:55Z","timestamp":1784031175595,"version":"3.55.0"},"reference-count":31,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2024,3,21]],"date-time":"2024-03-21T00:00:00Z","timestamp":1710979200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100008792","name":"Novartis Pharma","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008792","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100017559","name":"Recordati Rare Diseases","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100017559","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Endocrinol."],"abstract":"<jats:sec><jats:title>Introduction<\/jats:title><jats:p>Pasireotide, a somatostatin receptor ligand, is approved for treating acromegaly and Cushing\u2019s disease (CD). Hyperglycemia during treatment can occur because of the drug\u2019s mechanism of action, although treatment discontinuation is rarely required. The prospective, randomized, Phase IV SOM230B2219 (NCT02060383) trial was designed to assess optimal management of pasireotide-associated hyperglycemia. Here, we investigated predictive factors for requiring antihyperglycemic medication during pasireotide treatment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Participants with acromegaly or CD initiated long-acting pasireotide 40 mg\/28 days intramuscularly (acromegaly) or pasireotide 600 \u03bcg subcutaneously twice daily during pre-randomization (\u226416 weeks). Those who did not need antihyperglycemic medication, were managed with metformin, or received insulin from baseline entered an observational arm ending at 16 weeks. Those who required additional\/alternative antihyperglycemic medication to metformin were randomized to incretin-based therapy or insulin for an additional 16 weeks. Logistic-regression analyses evaluated quantitative and qualitative factors for requiring antihyperglycemic medication during pre-randomization.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 190 participants with acromegaly and 59 with CD, 88 and 15, respectively, did not need antihyperglycemic medication; most were aged &amp;lt;40 years (acromegaly 62.5%, CD 86.7%), with baseline glycated hemoglobin (HbA<jats:sub>1c<\/jats:sub>) &amp;lt;6.5% (&amp;lt;48 mmol\/mol; acromegaly 98.9%, CD 100%) and fasting plasma glucose (FPG) &amp;lt;100 mg\/dL (&amp;lt;5.6 mmol\/L; acromegaly 76.1%, CD 100%). By logistic regression, increasing baseline HbA<jats:sub>1c<\/jats:sub> (odds ratio [OR] 3.6; <jats:italic>P<\/jats:italic>=0.0162) and FPG (OR 1.0; <jats:italic>P<\/jats:italic>=0.0472) and history of diabetes\/pre-diabetes (OR 3.0; <jats:italic>P<\/jats:italic>=0.0221) predicted receipt of antihyperglycemic medication in acromegaly participants; increasing baseline HbA<jats:sub>1c<\/jats:sub> (OR 12.6; <jats:italic>P<\/jats:italic>=0.0276) was also predictive in CD participants. Investigator-reported hyperglycemia-related adverse events were recorded in 47.9% and 54.2% of acromegaly and CD participants, respectively, mainly those with diabetes\/pre-diabetes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Increasing age, HbA<jats:sub>1c<\/jats:sub>, and FPG and pre-diabetes\/diabetes were associated with increased likelihood of requiring antihyperglycemic medication during pasireotide treatment. These risk factors may be used to identify those who need more vigilant monitoring to optimize outcomes during pasireotide treatment.<\/jats:p><\/jats:sec>","DOI":"10.3389\/fendo.2024.1250822","type":"journal-article","created":{"date-parts":[[2024,3,21]],"date-time":"2024-03-21T10:13:53Z","timestamp":1711016033000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":11,"title":["Predictive factors and the management of hyperglycemia in patients with acromegaly and Cushing\u2019s disease receiving pasireotide treatment: post hoc analyses from the SOM230B2219 study"],"prefix":"10.3389","volume":"15","author":[{"given":"Ulla","family":"Feldt-Rasmussen","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marek","family":"Bolanowski","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shao-Ling","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yerong","family":"Yu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Przemys\u0142aw","family":"Witek","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pramila","family":"Kalra","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Noppadol","family":"Kietsiriroje","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Piacentini","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alberto M.","family":"Pedroncelli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan L.","family":"Samson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2024,3,21]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","DOI":"10.1016\/S2213-8587(22)00244-3","article-title":"Acromegaly: pathogenesis, diagnosis, and management","volume":"10","author":"Fleseriu","year":"2022","journal-title":"Lancet Diabetes Endocrinol"},{"key":"B2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(14)61375-1","article-title":"Cushing's syndrome","volume":"386","author":"Lacroix","year":"2015","journal-title":"Lancet"},{"key":"B3","doi-asserted-by":"publisher","first-page":"25","DOI":"10.1016\/S1042-3680(02)00035-9","article-title":"Pathology of pituitary tumors","volume":"14","author":"Sanno","year":"2003","journal-title":"Neurosurg Clin N 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