The safety and effectiveness of naldemedine for opioid-induced constipation in patients with advanced cancer in real-world palliative care settings: a multicenter prospective observational study.
Support Care Cancer
; 32(8): 504, 2024 Jul 10.
Article
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| MEDLINE
| ID: mdl-38985364
ABSTRACT
PURPOSE:
In this study, we aimed to evaluate the safety and effectiveness of naldemedine for treating opioid-induced constipation (OIC) in patients with advanced cancer, who are receiving palliative care, and particularly explored its early effects.METHODS:
Palliative care teams and inpatient palliative care units across 14 institutions in Japan were included in this multicenter, prospective, observational study. Patients who were newly prescribed a daily oral dose of 0.2 mg naldemedine were enrolled. The spontaneous bowel movement (SBM) within 24 h after the first dose of naldemedine was considered the primary outcome, whereas, the secondary outcomes included weekly changes in SBM frequency and adverse events.RESULTS:
A total of 204 patients were enrolled and 184 completed the 7-day study. The average age of the participants (103 males, 101 females) was 63 ± 14 years. The primary cancer was detected in the lungs (23.5%), gastrointestinal tract (13.7%), and urological organs (9.3%). A considerable proportion of patients (34.8%) had ECOG performance status of 3-4. Most patients were undergoing active cancer treatment, however, 40.7% of the patients were receiving the best supportive care. Within 24 h of the first naldemedine dose, 146 patients (71.6%, 95% CI 65.4-77.8%) experienced SBMs. The weekly SBM counts increased in 62.7% of the participants. The major adverse events included diarrhea and abdominal pain, detected in 17.6% and 5.4% of the patients, respectively. However, no serious adverse events were observed.CONCLUSION:
Conclusively, naldemedine is effective and safe for OIC treatments in real-world palliative care settings. TRIAL REGISTRATION NUMBER UMIN000031381, registered 20/02/2018.Palabras clave
Texto completo:
1
Base de datos:
MEDLINE
Asunto principal:
Cuidados Paliativos
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Estreñimiento Inducido por Opioides
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Analgésicos Opioides
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Naltrexona
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Antagonistas de Narcóticos
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Neoplasias
País/Región como asunto:
Asia
Idioma:
En
Revista:
Support Care Cancer
Asunto de la revista:
NEOPLASIAS
/
SERVICOS DE SAUDE
Año:
2024
Tipo del documento:
Article