Sistema de Salut de Catalunya
Institut Català de la Salut
[Davies A] Trinity College Dublin, University College Dublin, Our Lady’s Hospice Dublin’, Dublin, Ireland. [Cinieri S] Medical Oncology, ASL Brindisi–P.O. “A. Perrino”, Brindisi, Italy. [Dupoiron D] Département d’Anesthésie–Douleur, Institut de Cancerologie de l’Ouest–Site Paul Papin, Angers, France. [España Fernandez S] Medical Oncology Department, Institut Català d’Oncologia-Badalona, Barcelona, Spain. [Leclerc J] Doleur, CHU Amiens Picardie, Amiens, France. [Montesarchio V] UOC Ongologia, A.O.R.N. dei Colli–Monaldi–Coutgno–C.T.O. Hospitals, Napoli, Italy. [Serna J] Vall d’Hebron Hospital Universitari, Barcelona, Spain
Vall d'Hebron Barcelona Hospital Campus
2023-01-12T12:52:19Z
2023-01-12T12:52:19Z
2022-02-23
Cancer pain; Naloxegol; Ppioid-induced constipation
Dolor por cáncer; Naloxegol; Estreñimiento inducido por opioides
Dolor per càncer; Naloxegol; Restrenyiment induït per opioides
The Naloxegol Cancer Study (NACASY) was a multinational European study aimed to evaluate the 4-week safety and efficacy of naloxegol in a real-world setting in patients with cancer pain diagnosed with opioid-induced constipation. The primary safety endpoint was the incidence of adverse events leading to study discontinuation. We recruited 170 patients who received at least one dose of naloxegol (i.e., safety population). Out of 170 patients, 20 (11.8%, 95%CI 6.9–16.6) discontinued the study due to adverse events, and, of them, 12 (7.1%, 95%CI 3.2–10.9%) were study discontinuations due to naloxegol-related adverse events. From 76 patients subjects who had completed both 4 weeks of treatment and 28 days of the diary, 55 patients (72.4%, 95% CI 62.3–82.4%) were regarded as responders (i.e., showed ≥3 bowel-movements per week and an increase of ≥1 bowel-movement over baseline) to naloxegol treatment. The Patient Assessment of Constipation—Quality of Life Questionnaire total score and all its subscales improved from baseline to 4 weeks of follow up. Our findings support and provide new evidence about the beneficial effect of naloxegol in terms of improvement of constipation and quality-of-life in patients with cancer-related pain and opioid-induced constipation and show a safety profile consistent with previous pivotal and real-world studies.
This project was funded by Kyowa Kirin International. Role of the funding source: The funder of the study and its employees and assignees were involved in study design, data collection, data analysis, data interpretation, and writing of all related reports and publications.
Article
Published version
English
Càncer; Dolor; Narcòtics - Ús terapèutic; Restrenyiment; CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Physiological Effects of Drugs::Central Nervous System Depressants::Narcotics::Analgesics, Opioid; DISEASES::Pathological Conditions, Signs and Symptoms::Signs and Symptoms::Signs and Symptoms, Digestive::Constipation; DISEASES::Pathological Conditions, Signs and Symptoms::Signs and Symptoms::Neurologic Manifestations::Pain; DISEASES::Neoplasms; COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::efectos fisiológicos de los fármacos::depresores del sistema nervioso central::narcóticos::analgésicos opioides; ENFERMEDADES::afecciones patológicas, signos y síntomas::signos y síntomas::signos y síntomas digestivos::estreñimiento; ENFERMEDADES::afecciones patológicas, signos y síntomas::signos y síntomas::manifestaciones neurológicas::dolor; ENFERMEDADES::neoplasias
MDPI
Cancers;14(5)
https://doi.org/10.3390/cancers14051128
Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
Articles científics - HVH [3440]
