Maintenance of response to oral octreotide compared with injectable somatostatin receptor ligands in patients with acromegaly: a phase 3, multicentre, randomised controlled trial

Autor: Fleseriu, M., Dreval, A., Bondar, I., Vagapova, G., Macut, D., Pokramovich, Y.G., Molitch, M.E., Leonova, N., Raverot, G., Grineva, E., Poteshkin, Y.E., Gilgun-Sherki, Y., Ludlam, W.H., Patou, G., Haviv, A., Gordon, M.B., Biermasz, N.R., Melmed, S., Strasburger, C.J.
Rok vydání: 2021
Předmět:
Zdroj: The Lancet Diabetes and Endocrinology, 10(2), 102-111. ELSEVIER SCIENCE INC
ISSN: 2213-8595
Popis: Background Despite biochemically responding to injectable somatostatin receptor ligands (iSRLs), many patients with acromegaly experience treatment burdens. We aimed to assess maintenance of biochemical response and symptomatic control with oral octreotide capsules versus iSRLs in patients with acromegaly who previously tolerated and responded to both. Methods This global, open-label, randomised controlled phase 3 trial was done in 29 clinical sites in Austria, France, Germany, Hungary, Italy, Lithuania, Russia, Serbia, Spain, and the USA. Eligible patients were adults aged 18-75 years with acromegaly who were receiving iSRLs (long-acting octreotide or lanreotide autogel) for at least 6 months before baseline with a stable dose for at least 4 months, and were deemed to be biochemically responding (insulin-like growth factor I [IGF-I]
Databáze: OpenAIRE