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      Opioid therapy duration before naldemedine treatment is a significant independent risk of diarrhea: a retrospective cohort study

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          Abstract

          Background

          The most common adverse event (AE) associated with opioid analgesics is opioid-induced constipation (OIC). Naldemedine (NAL) is widely used for the treatment of OIC. However, diarrhea has been reported as the most common treatment-emergent AE of NAL, and little is known about the risk factors associated with the development of diarrhea during NAL administration. This study examined the risk factors for NAL-induced diarrhea via a retrospective chart review of hospitalized patients.

          Methods

          The data of 101 hospitalized adult patients who received NAL for the first time for the treatment of OIC at Mie University Hospital between June 2017 and December 2018 were extracted from electronic medical records. According to the inclusion and exclusion criteria, 70 of the 101 patients were enrolled in this study. Diarrhea was defined as “diarrhea” on the medical record within 2 weeks of NAL administration. Univariate and multivariate analyses were performed to identify risk factors for the development of diarrhea in patients receiving NAL.

          Results

          Twenty-two of the 70 patients enrolled (31%) developed diarrhea within 2 weeks of NAL administration. The median duration (range) of NAL treatment before diarrhea onset was 3 (1–12) days. Patients with diarrhea had a significantly longer duration of opioid therapy before NAL administration than patients without diarrhea ( P=0.002). Multivariate logistic regression analysis indicated that the independent risk factors for the development of NAL-induced diarrhea were NAL administration after more than 17 days of opioid therapy (odds ratio [OR]=7.539; P=0.016) and pancreatic cancer (OR=6.217; P=0.025). In fact, the incidence of diarrhea in patients who were administered NAL within a day of opioid therapy was significantly lower than that in patients who were administered NAL after more than 17 days of opioid therapy (13% vs. 54%, P=0.030).

          Conclusions

          These results suggested that a prolonged duration of opioid therapy prior to NAL initiation is associated with increased incidence of diarrhea.

          Supplementary Information

          The online version contains supplementary material available at 10.1186/s40780-020-00187-3.

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          FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer.

          Thierry Conroy, Françoise Desseigne, Marc Ychou … (2011)
          Data are lacking on the efficacy and safety of a combination chemotherapy regimen consisting of oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) as compared with gemcitabine as first-line therapy in patients with metastatic pancreatic cancer. We randomly assigned 342 patients with an Eastern Cooperative Oncology Group performance status score of 0 or 1 (on a scale of 0 to 5, with higher scores indicating a greater severity of illness) to receive FOLFIRINOX (oxaliplatin, 85 mg per square meter of body-surface area; irinotecan, 180 mg per square meter; leucovorin, 400 mg per square meter; and fluorouracil, 400 mg per square meter given as a bolus followed by 2400 mg per square meter given as a 46-hour continuous infusion, every 2 weeks) or gemcitabine at a dose of 1000 mg per square meter weekly for 7 of 8 weeks and then weekly for 3 of 4 weeks. Six months of chemotherapy were recommended in both groups in patients who had a response. The primary end point was overall survival. The median overall survival was 11.1 months in the FOLFIRINOX group as compared with 6.8 months in the gemcitabine group (hazard ratio for death, 0.57; 95% confidence interval [CI], 0.45 to 0.73; P<0.001). Median progression-free survival was 6.4 months in the FOLFIRINOX group and 3.3 months in the gemcitabine group (hazard ratio for disease progression, 0.47; 95% CI, 0.37 to 0.59; P<0.001). The objective response rate was 31.6% in the FOLFIRINOX group versus 9.4% in the gemcitabine group (P<0.001). More adverse events were noted in the FOLFIRINOX group; 5.4% of patients in this group had febrile neutropenia. At 6 months, 31% of the patients in the FOLFIRINOX group had a definitive degradation of the quality of life versus 66% in the gemcitabine group (hazard ratio, 0.47; 95% CI, 0.30 to 0.70; P<0.001). As compared with gemcitabine, FOLFIRINOX was associated with a survival advantage and had increased toxicity. FOLFIRINOX is an option for the treatment of patients with metastatic pancreatic cancer and good performance status. (Funded by the French government and others; ClinicalTrials.gov number, NCT00112658.).
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            Use of opioid analgesics in the treatment of cancer pain: evidence-based recommendations from the EAPC.

            Augusto Caraceni, Geoffrey Hanks, Stein Kaasa … (2012)
            Here we provide the updated version of the guidelines of the European Association for Palliative Care (EAPC) on the use of opioids for the treatment of cancer pain. The update was undertaken by the European Palliative Care Research Collaborative. Previous EAPC guidelines were reviewed and compared with other currently available guidelines, and consensus recommendations were created by formal international expert panel. The content of the guidelines was defined according to several topics, each of which was assigned to collaborators who developed systematic literature reviews with a common methodology. The recommendations were developed by a writing committee that combined the evidence derived from the systematic reviews with the panellists' evaluations in a co-authored process, and were endorsed by the EAPC Board of Directors. The guidelines are presented as a list of 16 evidence-based recommendations developed according to the Grading of Recommendations Assessment, Development and Evaluation system. Copyright © 2012 Elsevier Ltd. All rights reserved.
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              Opioid Abuse in Chronic Pain--Misconceptions and Mitigation Strategies.

              Nora D. Volkow, A McLellan (2016)
              Article 0 comments Cited 180 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Akiharu Okamoto: okamotoa@clin.medic.mie-u.ac.jp
                Kenji Ikemura: ikemurak@hosp.med.osaka-u.ac.jp
                Eri Mizutani: emizutani@clin.medic.mie-u.ac.jp
                Takuya Iwamoto:
                ORCID: http://orcid.org/0000-0002-6445-4410
                taku-iwa@clin.medic.mie-u.ac.jp
                Masahiro Okuda: okudam@hosp.med.osaka-u.ac.jp
                Journal
                Journal ID (nlm-ta): J Pharm Health Care Sci
                Journal ID (iso-abbrev): J Pharm Health Care Sci
                Title: Journal of Pharmaceutical Health Care and Sciences
                Publisher: BioMed Central (London )
                ISSN (Electronic): 2055-0294
                Publication date (Electronic): 1 February 2021
                Publication date PMC-release: 1 February 2021
                Publication date Collection: 2021
                Volume: 7
                Electronic Location Identifier: 3
                Affiliations
                [1 ]GRID grid.412075.5, ISNI 0000 0004 1769 2015, Department of Pharmacy, , Mie University Hospital, ; 2-174 Edobashi, Tsu, Mie 514-8507 Japan
                [2 ]GRID grid.260026.0, ISNI 0000 0004 0372 555X, Department of Clinical Pharmaceutics, , Mie University Graduate School of Medicine, ; 2-174 Edobashi, Tsu, Mie 514-8507 Japan
                [3 ]GRID grid.412398.5, ISNI 0000 0004 0403 4283, Department of Pharmacy, , Osaka University Hospital, ; 2-2 Yamadaoka, Suita, Osaka 565-0871 Japan
                Author information
                http://orcid.org/0000-0002-6445-4410
                Article
                Publisher ID: 187
                DOI: 10.1186/s40780-020-00187-3
                PMC ID: 7849155
                PubMed ID: 33517900
                SO-VID: 8c529bfc-272b-44e1-a880-294273161de8
                Copyright © © The Author(s) 2021
                License:

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                Date received : 15 July 2020
                Date accepted : 21 December 2020
                Funding
                Funded by: Grant-in-Aid for Encouragement of Scientists
                Award ID: 19H00397
                Award Recipient :
                Categories
                Subject: Research Article
                Custom metadata
                issue-copyright-statement © The Author(s) 2021

                Keywords: naldemedine,diarrhea,opioid-induced constipation,peripherally acting μ-opioid receptor antagonist
                Data availability:
                Keywords: naldemedine, diarrhea, opioid-induced constipation, peripherally acting μ-opioid receptor antagonist

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