Switching Ratio from Parenteral to Oral Methadone 1:1.2 Is Safer Compared with Ratio 1:2 in Patients with Controlled Cancer Pain: A Multicenter Randomized-Controlled Trial (RATIOMTD-010810).

Autor: González-Barboteo J; Palliative Care Department, Hospital Duran i Reynals, Catalan Institute of Oncology, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain.; Bellvitge Biomedical Research Institute (IDIBELL), Bellvitge Biomedical Research Institute (IDIBELL), Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain., Porta-Sales J; Bellvitge Biomedical Research Institute (IDIBELL), Bellvitge Biomedical Research Institute (IDIBELL), Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain.; Support and Palliative Care Service, Hospital Universitari de Girona Dr. Josep Trueta, Girona, Spain.; Palliative Care Research, Institut Català d'Oncologia, Girona, Spain.; WeCare: End of Life Care Chair, Medicine and Health Sciences School, Universitat Internacional de Catalunya, Barcelona, Spain.; Girona Biomedical Research Institute (IDIBGI), Girona, Spain., Nabal-Vicuña M; Supportive Palliative Care Team, Hospital Universitari Arnau de Vilanova, Lleida, Spain., Díez-Porres L; Palliative Care Department, Hospital Universitario La Paz, Madrid, Spain., Canal-Sotelo J; Supportive Palliative Care Team, Hospital Universitari Santa Maria, Lleida, Spain., Alonso-Babarro A; Palliative Care Department, Hospital Universitario La Paz, Madrid, Spain., Vílches-Aguirre Y; Palliative Care Department, Hospital Universitario La Paz, Madrid, Spain., Pérez-Pujol S; Clinical Research and Clinical Trials Unit (UICEC), Bellvitge Biomedical Research Institute (IDIBELL), Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain., Sanllorente M; Clinical Research and Clinical Trials Unit (UICEC), Bellvitge Biomedical Research Institute (IDIBELL), Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain., Llorens-Torromé S; Palliative Care Department, Hospital Duran i Reynals, Catalan Institute of Oncology, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain.; Bellvitge Biomedical Research Institute (IDIBELL), Bellvitge Biomedical Research Institute (IDIBELL), Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain., Gómez-Batiste Alentorn X; Palliative Care Department, Hospital Duran i Reynals, Catalan Institute of Oncology, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain.; Bellvitge Biomedical Research Institute (IDIBELL), Bellvitge Biomedical Research Institute (IDIBELL), Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain.; Qualy Observatory, WHO Collaborating Center for Palliative Care Public Health Programs, Catalan Institute of Oncology, Barcelona, Spain.; Department of Palliative Care, University of Vic, Vic, Spain., Bruera E; Department of Palliative Care and Rehabilitation Medicine, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.; UT Graduate School of Biomedical Sciences at Houston, Houston, Texas, USA.
Jazyk: angličtina
Zdroj: Journal of palliative medicine [J Palliat Med] 2021 Mar; Vol. 24 (3), pp. 382-390. Date of Electronic Publication: 2020 Jul 29.
DOI: 10.1089/jpm.2020.0244
Abstrakt: Background: The most commonly used switching ratio from parenteral to oral methadone is 1:2. Methadone is highly bioavailable and a lower ratio might result in similar analgesia with less toxicity. Objective: To compare success and side effects with two ratios from parenteral to oral methadone: 1:2 versus 1:1.2 in hospitalized patients with cancer pain. Design: A multicenter double-blind randomized clinical trial. Settings/Particiants: Inpatients with well-controlled cancer pain with parenteral methadone requiring rotation to the oral route. Measurements: Outcomes included pain intensity (Brief Inventory Pain), opioid toxicity (Common Toxicology Criteria for Adverse Events), and methadone dose. Success was defined as no toxicity with good pain control at 72 hours. Results: Thirty-nine of forty-four randomized patients were evaluable: 21 in ratio 1:2 and 18 in ratio 1:1.2. Seventy-one percent male. Median age 65 years. No significant differences in basal clinical characteristics between both groups. Median methadone dose pre/post switching was 24.5 mg ±13.5 and 49 mg ±27.3 for ratio 1:2, versus 23.3 mg ±9.4 ( p : not significant) and 28 mg ±11.3 ( p  < 0.01) for ratio 1:1.2. Pain was well controlled without differences between both ratios. Drowsiness at day +1 ( p  < 0.017) and myoclonus at day +3 ( p  < 0.019) were more prevalent in group 1:2. Success was observed in 12 patients in ratio 1:2 versus 18 in ratio 1:1.2 ( p  < 0.001). Methadone side effects were observed in 12 patients in ratio 1:2 (mainly neurotoxicity symptoms) versus 2 in ratio 1:1.2 ( p  < 0.005). Conclusion: Ratio 1:1.2 when changing from parenteral to oral methadone resulted in lower toxicity and no difference in analgesia. More conservative dose adjustment during methadone route change should be considered. European Clinical Trials Register (EudraCT No. 2010-024092-39).
Databáze: MEDLINE
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