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A Prospective, Real-World, Multinational Study of Naloxegol for Patients with Cancer Pain Diagnosed with Opioid-Induced Constipation-The NACASY Study
- Source :
- Scientia, Cancers; Volume 14; Issue 5; Pages: 1128
- Publication Year :
- 2022
-
Abstract
- 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.
- Subjects :
- Cancer Research
cancer pain
real-world
IMPACT
afecciones patológicas, signos y síntomas::signos y síntomas::signos y síntomas digestivos::estreñimiento [ENFERMEDADES]
Narcòtics - Ús terapèutic
afecciones patológicas, signos y síntomas::signos y síntomas::manifestaciones neurológicas::dolor [ENFERMEDADES]
MOVANTIK
Pathological Conditions, Signs and Symptoms::Signs and Symptoms::Neurologic Manifestations::Pain [DISEASES]
neoplasias [ENFERMEDADES]
QUALITY-OF-LIFE
MANAGEMENT
PAMORA
naloxegol
Càncer
Pathological Conditions, Signs and Symptoms::Signs and Symptoms::Signs and Symptoms, Digestive::Constipation [DISEASES]
Science & Technology
opioid-induced constipation
PREVALENCE
Restrenyiment
acciones y usos químicos::acciones farmacológicas::efectos fisiológicos de los fármacos::depresores del sistema nervioso central::narcóticos::analgésicos opioides [COMPUESTOS QUÍMICOS Y DROGAS]
Neoplasms [DISEASES]
Chemical Actions and Uses::Pharmacologic Actions::Physiological Effects of Drugs::Central Nervous System Depressants::Narcotics::Analgesics, Opioid [CHEMICALS AND DRUGS]
Oncology
Dolor
Life Sciences & Biomedicine
Subjects
Details
- ISSN :
- 20726694
- Volume :
- 14
- Issue :
- 5
- Database :
- OpenAIRE
- Journal :
- Cancers
- Accession number :
- edsair.doi.dedup.....64e70a13aae17ff492224efa0c535a00