One-year efficacy and safety of naloxegol on symptoms and quality of life related to opioid-induced constipation in patients with cancer: KYONAL study

Autor: Rodolfo Chicas-Sett, Gala Serrano Bermúdez, Anna Librán Oriol, Francisco Javier García Navalón, Oliver Higuera Gómez, Manuel Cobo Dols, Pedro Sánchez Mauriño, Alexandra Giraldo Marín, Pilar Torres, Ibone Huerta González, Almudena Sanz-Yagüe, Ignacio Delgado Mingorance, Jose L. Perez, Luis Cabezón-Gutiérrez, María Isabel Blancas López-Barajas, Carmen Beato Zambrano, Diana Moreno Muñoz, Begoña Soler López, Alfredo Paredes Lario
Rok vydání: 2021
Předmět:
Zdroj: BMJ Supportive & Palliative Care. :bmjspcare-2020
ISSN: 2045-4368
2045-435X
DOI: 10.1136/bmjspcare-2020-002816
Popis: ObjectivesNaloxegol is a peripherally acting µ-opioid receptor antagonist (PAMORA) for treatment of opioid-induced constipation (OIC). The main objective was to analyse the long-term efficacy, quality of life (QOL) and safety of naloxegol in patients with cancer in a real-world study.MethodsThis one-year prospective study included patients older than 18 years, with active oncological disease who were under treatment with opioids for pain control and Karnofsky≥50 and OIC with inadequate response to treatment with laxative (s). All the patients received treatment with naloxegol according to clinical criteria. The main efficacy objectives were measured by the patient assessment of constipation QOL questionnaire (PAC-QOL), the PAC symptoms (PAC-SYM), the response rate at day 15, and months 1-3-6-12, and global QOL (EuroQoL-5D-5L).ResultsA total of 126 patients (58.7% males) with a mean age of 61.5 years (95% CI 59.4 to 63.7) were included. PAC-SYM and PAC-QOL total score and all their dimensions improved from baseline (pConclusionThe results of this first long-term and real-world-data study in patients with cancer, showed the sustained efficacy and safety of naloxegol for the treatment of OIC in this group of patients.
Databáze: OpenAIRE