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

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Název: One-year efficacy and safety of naloxegol on symptoms and quality of life related to opioid-induced constipation in patients with cancer: KYONAL study
Autoři: Manuel Cobo Dols, Carmen Beato Zambrano, Luis Cabezón-Gutiérrez, Rodolfo Chicas-Sett, María Isabel Blancas López-Barajas, Francisco Javier García Navalón, José Luis Fírvida Pérez, Gala Serrano Bermúdez, Pilar Togores Torres, Ignacio Delgado Mingorance, Alexandra Giraldo Marín, Anna Librán Oriol, Alfredo Paredes Lario, Pedro Sánchez Mauriño, Oliver Higuera Gómez, Diana Moreno Muñoz, Ibone Huerta González, Almudena Sanz-Yagüe, Begoña Soler López
Přispěvatelé: Institut Català de la Salut, [Cobo Dols M] Medical Oncology Department, Hospital Regional Universitario de Málaga, Málaga, Spain. IBIMA, Málaga, Spain. [Beato Zambrano] Medical Oncology Department, Complejo Hospitalario Virgen de la Macarena, Sevilla, Spain. [Cabezón-Gutiérrez L] Medical Oncology Department, Hospital Universitario de Torrejón, Torrejón de Ardoz, Madrid, Spain. [Chicas-Sett R] Radiation Oncology Department, Hospital Universitario de Gran Canaria Dr Negrin, Las Palmas de Gran Canaria, Spain. [Blancas López-Barajas MI] Medical Oncology Department, Hospital Universitario San Cecilio, Granada, Spain. [García Navalón FJ] Medical Oncology Department, Hospital Son Llatzer, Palma de Mallorca, Illes Balears, Spain. [Giraldo Marín A] Servei d’Oncologia Radioteràpica, Vall d’Hebron Hospital Universitari, Barcelona, Spain, Vall d'Hebron Barcelona Hospital Campus, [Cobo Dols, Manuel] Hosp Reg Univ Malaga, Med Oncol Dept, Malaga, Spain, [Cobo Dols, Manuel] IBIMA, Malaga, Spain, [Beato Zambrano, Carmen] Complejo Hosp Virgen Macarena, Med Oncol Dept, Seville, Spain, [Cabezon-Gutierrez, Luis] Hosp Univ Torrejon, Med Oncol Dept, Madrid, Spain, [Chicas-Sett, Rodolfo] Hosp Univ Gran Canaria Dr Negrin, Radiat Oncol Dept, Las Palmas Gran Canaria, Spain, [Blancas Lopez-Barajas, Maria Isabel] Hosp Univ San Cecilio, Med Oncol Dept, Granada, Spain, [Garcia Navalon, Francisco Javier] Hosp Son Llatzer, Med Oncol Dept, Palma De Mallorca, Illes Balears, Spain, [Firvida Perez, Jose Luis] COSAGA, Med Oncol Dept, Orense, Spain, [Serrano Bermudez, Gala] Inst Catala Oncol, Palliat Care Serv, Barcelona, Spain, [Togores Torres, Pilar] Ctr Oncol Galicia, Med Oncol Dept, La Coruna, Spain, [Delgado Mingorance, Ignacio] Hosp Univ Infanta Cristina, Med Oncol Dept, Badajoz, Spain, [Giraldo Marin, Alexandra] Hosp Univ Vall dHebron, Radiat Oncol Dept, Barcelona, Spain, [Libran Oriol, Anna] Consorci Sanit Terrassa, Palliat Care Dept, Barcelona, Spain, [Paredes Lario, Alfredo] Hosp Univ Donostia, Med Oncol Dept, San Sebastian, Guipuzcoa, Spain, [Sanchez Maurino, Pedro] Hosp Univ Reina Sofia, Med Oncol Dept, Cordoba, Spain, [Higuera Gomez, Oliver] Hosp Gen Univ La Paz, Med Oncol Dept, Madrid, Spain, [Moreno Munoz, Diana] Hosp Univ Fdn Alcorcon, Med Oncol Dept, Madrid, Spain, [Huerta Gonzalez, Ibone] Kyowa Kirin Farmaceut SL, Med Dept, Madrid, Spain, [Sanz-Yague, Almudena] Kyowa Kirin Farmaceut SL, Med Dept, Madrid, Spain, [Soler Lopez, Begona] EC BIO SL, Med Dept, Madrid, Spain, Kyowa Kirin Farmaceutica S.L., Spain
Zdroj: BMJ Support Palliat Care
Repositorio Institucional de la Consejería de Sanidad de la Comunidad de Madrid
Consejería de Sanidad de la Comunidad de Madrid
Scientia
Scientia. Dipòsit d'Informació Digital del Departament de Salut
instname
RISalud-ANDALUCIA. Repositorio Institucional de Salud de Andalucía
Docusalut
Conselleria de Salut i Consum del Govern de les Illes Balears
Informace o vydavateli: BMJ, 2021.
Rok vydání: 2021
Témata: Male, Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia, Narcòtics - Antagonistes - Ús terapèutic, Narcotic Antagonists, Pathophysiology, Pooled analysis, Severity, DISEASES::Neoplasms, 03 medical and health sciences, Noncancer pain, CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Physiological Effects of Drugs::Central Nervous System Depressants::Narcotics::Analgesics, Opioid, COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::efectos fisiológicos de los fármacos::depresores del sistema nervioso central::narcóticos::analgésicos opioides, 0302 clinical medicine, Neoplasms, Validation, Prevalence, cancer, Humans, pain, Prospective Studies, Induced bowel dysfunction, Càncer, CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Physiological Effects of Drugs::Narcotic Antagonists, Original Research, Disorders, Other subheadings::Other subheadings::Other subheadings::/drug therapy, Pèptids opioides - Ús terapèutic - Efectes secundaris, COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::efectos fisiológicos de los fármacos::antagonistas de narcóticos, constipation, Middle Aged, Management, 3. Good health, DISEASES::Pathological Conditions, Signs and Symptoms::Signs and Symptoms::Signs and Symptoms, Digestive::Constipation, Analgesics, Opioid, ENFERMEDADES::neoplasias, Quality of Life, Restrenyiment - Tractament, Female, Constipation, Opioid-Induced Constipation, ENFERMEDADES::afecciones patológicas, signos y síntomas::signos y síntomas::signos y síntomas digestivos::estreñimiento
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.
Druh dokumentu: Article
Other literature type
Popis souboru: application/pdf
Jazyk: English
ISSN: 2045-4368
2045-435X
DOI: 10.1136/bmjspcare-2020-002816
Přístupová URL adresa: https://spcare.bmj.com/content/bmjspcare/early/2021/03/10/bmjspcare-2020-002816.full.pdf
https://pubmed.ncbi.nlm.nih.gov/33707299
https://hdl.handle.net/20.500.12530/109418
https://hdl.handle.net/11351/10864
https://hdl.handle.net/10668/25895
https://hdl.handle.net/20.500.13003/19729
https://hdl.handle.net/20.500.12530/67916
https://spcare.bmj.com/content/early/2021/03/10/bmjspcare-2020-002816
https://pubmed.ncbi.nlm.nih.gov/33707299/
https://spcare.bmj.com/content/bmjspcare/early/2021/03/10/bmjspcare-2020-002816.full.pdf
https://www.ncbi.nlm.nih.gov/pubmed/33707299
Rights: CC BY NC
CC BY NC ND
Přístupové číslo: edsair.doi.dedup.....455dd69107cbbde829c26cc23896866f
Databáze: OpenAIRE
Popis
Abstrakt: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.
ISSN:20454368
2045435X
DOI:10.1136/bmjspcare-2020-002816