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Sökning: onr:"swepub:oai:lup.lub.lu.se:229a2173-d921-4a10-b0ec-29dd517d764b" > Octreotide SC depot...

  • Pavel, MarianneCharité - University Medicine Berlin,Friedrich-Alexander University Erlangen-Nürnberg (författare)

Octreotide SC depot in patients with acromegaly and functioning neuroendocrine tumors : a phase 2, multicenter study

  • Artikel/kapitelEngelska2019

Förlag, utgivningsår, omfång ...

  • 2018-12-08
  • Springer Science and Business Media LLC,2019

Nummerbeteckningar

  • LIBRIS-ID:oai:lup.lub.lu.se:229a2173-d921-4a10-b0ec-29dd517d764b
  • https://lup.lub.lu.se/record/229a2173-d921-4a10-b0ec-29dd517d764bURI
  • https://doi.org/10.1007/s00280-018-3734-1DOI

Kompletterande språkuppgifter

  • Språk:engelska
  • Sammanfattning på:engelska

Ingår i deldatabas

Klassifikation

  • Ämneskategori:art swepub-publicationtype
  • Ämneskategori:ref swepub-contenttype

Anmärkningar

  • Purpose: Octreotide SC depot is a novel, ready-to-use formulation administered via a thin needle. In a phase 1 study in healthy volunteers, this formulation provided higher bioavailability of octreotide with faster onset and stronger suppression of IGF-1 in healthy volunteers versus long-acting intramuscular (IM) octreotide. This phase 2 study evaluated the pharmacokinetics, efficacy, and safety of octreotide SC depot in patients with acromegaly and functioning NETs, previously treated with octreotide IM. Methods: Adult patients with acromegaly or functioning NETs treated for ≥ 2 months with octreotide IM [10/20/30 mg every 4 weeks (q4w)] received the last dose of octreotide IM treatment in study period 0 and were randomized 28 days later to receive octreotide SC depot 10 mg q2w, or 20 mg q4w for 3 months (period 1). The primary objective was to characterize the PK profile of octreotide SC depot after each injection vs PK for octreotide IM (period 0). Results: Twelve patients were randomized to receive octreotide SC depot 10 mg q2w (acromegaly n = 3; NET n = 1) or 20 mg q4w (acromegaly n = 4; NET n = 4). Plasma levels of octreotide were higher with octreotide SC depot as compared to octreotide IM. Adverse events were reported in 6 and 8 patients during period 0 and period 1, respectively; most common in period 1 were gastrointestinal disorders. Conclusion: Octreotide SC depot provided higher exposure (AUC) than octreotide IM, maintained biochemical control in patients with acromegaly and symptom control in patients with functioning NETs, and was well tolerated with a safety profile consistent with octreotide IM. ClinicalTrials.gov identifier: NCT02299089.

Ämnesord och genrebeteckningar

Biuppslag (personer, institutioner, konferenser, titlar ...)

  • Borson-Chazot, FrançoiseClaude Bernard University Lyon 1 (författare)
  • Cailleux, AnneHopital Charles Nicolle (författare)
  • Hörsch, DieterCentral Clinic Bad Berka (författare)
  • Lahner, HaraldUniversity Hospital Essen (författare)
  • Pivonello, RosarioUniversity of Naples Federico II (författare)
  • Tauchmanova, LibuseNovartis Pharma AG (författare)
  • Darstein, ChristelleNovartis Pharma AG (författare)
  • Olsson, HåkanCamurus AB (författare)
  • Tiberg, FredrikLund University,Lunds universitet,Fysikalisk kemi,Enheten för fysikalisk och teoretisk kemi,Kemiska institutionen,Institutioner vid LTH,Lunds Tekniska Högskola,Physical Chemistry,Physical and theoretical chemistry,Department of Chemistry,Departments at LTH,Faculty of Engineering, LTH,Camurus AB(Swepub:lu)fk1-fti (författare)
  • Ferone, DiegoUniversity of Genoa,Ospedale Policlinico San Martino (författare)
  • Charité - University Medicine BerlinFriedrich-Alexander University Erlangen-Nürnberg (creator_code:org_t)

Sammanhörande titlar

  • Ingår i:Cancer Chemotherapy and Pharmacology: Springer Science and Business Media LLC83:2, s. 375-3850344-57041432-0843

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