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oai:recercat.cat:11351/129632025-05-03T03:19:16Zcom_2072_378070com_2072_378040col_2072_378092

Naloxegol for the Treatment of Opioid-Induced Constipation in Patients with Cancer Pain: A Pooled Analysis of Real-World Data SABATE, Jean-Marc Beato-Zambrano, Carmen lemaire, antoine Montesarchio, Vincenzo Serna Mont-Ros, Judith cobo, manuel Institut Català de la Salut [Sabaté JM] Gastroenterology and Gastrointestinal Oncology, Hôpital Avicenne, AP-HP, Sorbonne University, Bobigny, France. INSERM U987, Pathophysiology and Clinical Pharmacology of Pain, Boulogne Billancourt, France. [Beato-Zambrano C] Medical Oncology, Hospital Universitario Virgen Macarena, Sevilla, Spain. [Cobo M] Medical Oncology, Instituto de Investigación Biomédica de Málaga-Plataforma BIONAND (IBIMA-BIONAND), Hospital Regional Universitario Malaga, Malaga, Spain. [Lemaire A] Oncology & Medical Specialties Department, Valenciennes General Hospital, Valenciennes, France. [Montesarchio V] Pneumology and Oncology, A.O.R.N. dei Colli-Monaldi Hospital, Napoli, Italy. [Serna-Montros J] Unitat de Cures Pal·liatives, Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO),Barcelona, Spain Vall d'Hebron Barcelona Hospital Campus Dolor oncològic Restrenyiment - Tractament Narcòtics - Antagonistes - Ús terapèutic - Eficàcia Pèptids opioides - Ús terapèutic - Efectes secundaris DISEASES::Pathological Conditions, Signs and Symptoms::Signs and Symptoms::Signs and Symptoms, Digestive::Constipation Other subheadings::Other subheadings::Other subheadings::/chemically induced DISEASES::Pathological Conditions, Signs and Symptoms::Signs and Symptoms::Signs and Symptoms, Digestive::Constipation Other subheadings::Other subheadings::Other subheadings::/drug therapy CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Physiological Effects of Drugs::Central Nervous System Depressants::Narcotics::Analgesics, Opioid Other subheadings::Other subheadings::Other subheadings::/adverse effects DISEASES::Pathological Conditions, Signs and Symptoms::Signs and Symptoms::Neurologic Manifestations::Pain::Cancer Pain CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Physiological Effects of Drugs::Narcotic Antagonists Other subheadings::Other subheadings::/therapeutic use ENFERMEDADES::afecciones patológicas, signos y síntomas::signos y síntomas::signos y síntomas digestivos::estreñimiento Otros calificadores::Otros calificadores::Otros calificadores::/inducido químicamente ENFERMEDADES::afecciones patológicas, signos y síntomas::signos y síntomas::signos y síntomas digestivos::estreñimiento Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::efectos fisiológicos de los fármacos::depresores del sistema nervioso central::narcóticos::analgésicos opioides Otros calificadores::Otros calificadores::Otros calificadores::/efectos adversos ENFERMEDADES::afecciones patológicas, signos y síntomas::signos y síntomas::manifestaciones neurológicas::dolor::dolor oncológico COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::efectos fisiológicos de los fármacos::antagonistas de narcóticos Otros calificadores::Otros calificadores::/uso terapéutico Cancer pain; Naloxegol; Opioid-induced constipation Dolor per càncer; Naloxegol; Restrenyiment induït per opioides Dolor por cáncer; Naloxegol; Estreñimiento inducido por opioides Objective: The aim of the NALOPOOL project was to assess the efficacy and safety of naloxegol in patients with cancer pain who exhibited opioid-induced constipation (OIC) and were treated under real-world conditions. Methods: We pooled individual patient data from three multicenter observational studies conducted with naloxegol in patients with cancer who exhibited OIC and were prescribed naloxegol under real-world conditions. Efficacy outcomes were evaluated after 4 weeks of treatment. All analyses were performed via a visit-wise approach. Heterogeneity was assessed via Cochran’s Q-test or Levene’s test. Results: Spontaneous bowel movements (SBM) response (≥3 SBM per week and an increase of ≥1 from baseline; three studies) was reported in 223 of 314 evaluable patients (71%, 95% CI 66–76); clinically relevant improvement in the Patient Assessment of Constipation Quality-of-Life Questionnaire (>0.5 points; three studies) occurred in 179 of 299 evaluable patients (60%, 95% CI 56–74) and in the Patient Assessment of Constipation Symptoms (>0.5 points; two studies) was reported in 131 of 190 evaluable patients (69%, 95% CI 62–76); and clinically relevant improvement in the Bowel Function Index (score ≥ 12 points at the endpoint; two studies;) was reported in 133 of 195 evaluable patients (68%, 95% CI 62–75). No significant heterogeneity was found for any efficacy outcome. The pooled proportion of patients who discontinued the drug owing to adverse reactions was 6.1% (95% CI 3.8% to 8.4%). Conclusions: Our results support the u This project was funded by Kyowa Kirin International. 2025-04-17T06:55:02Z 2025-04-17T06:55:02Z 2025-03 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Sabaté JM, Beato-Zambrano C, Cobo M, Lemaire A, Montesarchio V, Serna-Montros J, et al. Naloxegol for the Treatment of Opioid-Induced Constipation in Patients with Cancer Pain: A Pooled Analysis of Real-World Data. Cancers (Basel). 2025 Mar;17(5):865. 2072-6694 http://hdl.handle.net/11351/12963 10.3390/cancers17050865 40075711 001442541500001 http://hdl.handle.net/11351/12963 eng Cancers;17(5) https://doi.org/10.3390/cancers17050865 Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ info:eu-repo/semantics/openAccess application/pdf MDPI Scientia