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      Efficacy And Safety Of Controlled-Release Oxycodone For The Management Of Moderate-To-Severe Chronic Non-Cancer Pain In Japanese Patients: Results From An Open-Label Study

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          Abstract

          Purpose

          To assess the efficacy and safety of S-8117, an oral, controlled-release formulation of oxycodone hydrochloride, in Japanese patients with chronic non-cancer pain (CNCP).

          Patients and methods

          In this multicenter, non-randomized, open-label, 2-part (part 1, dose-titration followed by maintenance period; part 2, long-term administration period) study at 38 centers in Japan (2013–2015), adult patients with CNCP for ≥12 weeks were administered S-8117. The primary endpoint was proportion of patients with successful maintenance of pain control in part 1 and long-term safety in part 2. Secondary endpoints included time to inadequate analgesia, rate of transition to the maintenance period, and discontinuation due to inadequate analgesia/adverse events (AEs), Brief Pain Inventory (BPI) pain severity, BPI pain interference, 36-item Short Form Health Survey (SF-36) score, and Western Ontario and McMaster Universities (WOMAC) index, Subjective Opioid Withdrawal Scale (SOWS), Clinical Opioid Withdrawal Scale (COWS), Dependency-2-A (D-2-A), and Dependency-2-B (D-2-B) questionnaires.

          Results

          Of 130 patients (mean age, 63.6 years; women, 62.3%) in the dose-titration period, 95 entered the maintenance period; 60 of 83 who entered the long-term administration period completed it. The proportion of patients (95% confidence interval) with successful maintenance of pain control, transition to maintenance period, and discontinuation due to inadequate analgesia/AEs was 78.9% (69.4–86.6), 73.1% (64.6–80.5), and 21.1% (13.4–30.6), respectively. Time to inadequate analgesia could not be estimated. Changes from baseline in BPI, SF-36, and WOMAC index scores suggested improvements in pain relief and quality of life. Based on the SOWS, COWS, D-2-A and D-2-B questionnaires, no patient developed clinically relevant withdrawal syndrome or was ascertained to have developed drug dependence. Overall, the incidence of treatment-emergent AEs (TEAEs) was 93.8%; most common TEAEs were constipation (49.2%), nausea (42.3%), nasopharyngitis (34.6%), and somnolence (32.3%).

          Conclusion

          These results demonstrate the efficacy and safety of S-8117 in Japanese patients with CNCP.

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          Most cited references 30

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          Two new rating scales for opiate withdrawal.

          Two new rating scales for measuring the signs and symptoms of opiate withdrawal are presented. The Subjective Opiate Withdrawal Scale (SOWS) contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely). The Objective Opiate Withdrawal Scale (OOWS) contains 13 physically observable signs, rated present or absent, based on a timed period of observation of the patient by a rater. Opiate abusers admitted to a detoxification ward had significantly higher scores on the SOWS and OOWS before receiving methadone as compared to after receiving methadone for 2 days. Opiate abusers seeking treatment were challenged either with placebo or with 0.4 mg naloxone. Postchallenge SOWS and OOWS scores were significantly higher than prechallenge scores in the naloxone but not the placebo group. We have demonstrated good interrater reliability for the OOWS and good intrasubject reliability over time for both scales in controls and in patients on a methadone maintenance program. These scales are demonstrated to be valid and reliable indicators of the severity of the opiate withdrawal syndrome over a wide range of common signs and symptoms.
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            The role of opioid prescription in incident opioid abuse and dependence among individuals with chronic noncancer pain: the role of opioid prescription.

            Increasing rates of opioid use disorders (OUDs) (abuse and dependence) among patients prescribed opioids are a significant public health concern. We investigated the association between exposure to prescription opioids and incident OUDs among individuals with a new episode of a chronic noncancer pain (CNCP) condition.
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              Risk Factors for Opioid-Use Disorder and Overdose

               Lynn Webster (2017)
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                Author and article information

                Journal
                J Pain Res
                J Pain Res
                JPR
                jpainres
                Journal of Pain Research
                Dove
                1178-7090
                23 December 2019
                2019
                : 12
                : 3423-3436
                Affiliations
                [1 ]Department of Anesthesiology and Resuscitology, Shinshu University School of Medicine , Matsumoto, Japan
                [2 ]Department of Anesthesiology and Pain Medicine, Juntendo University Faculty of Medicine , Tokyo, Japan
                [3 ]Spine Care Center, Wakayama Medical University Kihoku Hospital , Wakayama, Japan
                [4 ]Department of Orthopaedic Surgery, Fukushima Medical University School of Medicine , Fukushima, Japan
                [5 ]Clinical Development Department, Shionogi & Co., Ltd ., Osaka, Japan
                [6 ]Biostatistics Center, Shionogi & Co., Ltd ., Osaka, Japan
                Author notes
                Correspondence: Takuma Sasaki Clinical Development Department, Shionogi & Co., Ltd ., 12F, Hankyu Terminal Bld., 1-4, Shibata 1-chome, Kita-ku, Osaka530-0012, JapanTel +81-6-6485-5090Fax +81-6-6375-5780 Email Takuma.sasaki@shionogi.co.jp
                Article
                210502
                10.2147/JPR.S210502
                6934115
                © 2019 Kawamata et al.

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                Page count
                Figures: 3, Tables: 5, References: 44, Pages: 14
                Funding
                Funded by: Shionogi & Co., Ltd
                This study was funded by Shionogi & Co., Ltd., Japan.
                Categories
                Original Research

                Anesthesiology & Pain management

                analgesics, chronic pain, japan, opioids

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