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Effectiveness and tolerability of transdermal buprenorphine patches: a multicenter, prospective, open-label study in Asian patients with moderate to severe chronic musculoskeletal pain

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      Abstract

      Background

      We examined the effectiveness and tolerability of transdermal buprenorphine (TDB) treatment in real-world setting in Asian patients with musculoskeletal pain.

      Methods

      This was an open-label study conducted in Hong Kong, Korea, and the Philippines between June 2013 and April 2015. Eligible patients fulfilled the following criteria: 18 to 80 years of age; clinical diagnosis of osteoarthritis, rheumatoid arthritis, low back pain, or joint/muscle pain; chronic non-malignant pain of moderate to severe intensity (Box-Scale-11 [BS-11] pain score ≥ 4), not adequately controlled with non-opioid analgesics and requiring an opioid for adequate analgesia; and no prior history of opioid treatment. Patients started with a 5 μg/h buprenorphine patch and were titrated as necessary to a maximum of 40 μg/h over a 6-week period to achieve optimal pain control. Patients continued treatment with the titrated dose for 11 weeks. The primary efficacy endpoint was the change in BS-11 pain scores. Other endpoints included patients’ sleep quality and quality of life as assessed by the 8-item Global Sleep Quality Assessment Scale (GSQA) questionnaire and the EuroQol Group 5-Dimension Self-Report Questionnaire-3 Level version (EQ-5D-3 L), respectively. Tolerability was assessed by collecting adverse events.

      Results

      A total of 114 eligible patients were included in the analysis. The mean BS-11 score at baseline was 6.2 (SD 1.6). Following initiation of TDB, there was a statistically significant improvement in BS-11 score from baseline to visit 3 (least squares [LS] mean change: -2.27 [95% CI -2.66 to −1.87]), which was maintained till the end of the study (visit 7) (LS mean change: −2.64 [95% -3.05 to −2.23]) ( p < 0.0001 for both). The proportion of patients who rated sleep quality as ‘good’ increased from 14.0% at baseline to 26.9% at visit 6. By visit 6, the mean EQ VAS score increased by 7.7 units (SD 17.9). There were also significant improvements in patients’ levels of functioning for all EQ-5D-3 L dimensions from baseline at visit 6 ( p < 0.05 for all). Seventy-eight percent of patients reported TEAEs and 22.8% of patients discontinued due to TEAEs. TEAEs were generally mild to moderate in intensity (96.5%).

      Conclusions

      TDB provides effective pain relief with an acceptable tolerability profile over the 11-week treatment period in Asian patients with chronic musculoskeletal pain. More studies are needed to examine the long-term efficacy and safety of TBD treatment in this patient population.

      Trial registration

      ClinicalTrials.gov NCT01961271. Registered 7 October 2013 (retrospectively registered; first patient was enrolled on 28 June 2013 and last patient last visit date was 26 Apr 2015).

      Related collections

      Most cited references 30

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      EuroQol--a new facility for the measurement of health-related quality of life.

        (1990)
      In the course of developing a standardised, non-disease-specific instrument for describing and valuing health states (based on the items in Table 1), the EuroQol Group (whose members are listed in the Appendix) conducted postal surveys in England, The Netherlands and Sweden which indicate a striking similarity in the relative valuations attached to 14 different health states. The data were collected using a visual analogue scale similar to a thermometer. The EuroQol instrument is intended to complement other quality-of-life measures and to facilitate the collection of a common data set for reference purposes. Others interested in participating in the extension of this work are invited to contact the EuroQol Group.
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        Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale.

        Pain intensity is frequently measured on an 11-point pain intensity numerical rating scale (PI-NRS), where 0=no pain and 10=worst possible pain. However, it is difficult to interpret the clinical importance of changes from baseline on this scale (such as a 1- or 2-point change). To date, there are no data driven estimates for clinically important differences in pain intensity scales used for chronic pain studies. We have estimated a clinically important difference on this scale by relating it to global assessments of change in multiple studies of chronic pain. Data on 2724 subjects from 10 recently completed placebo-controlled clinical trials of pregabalin in diabetic neuropathy, postherpetic neuralgia, chronic low back pain, fibromyalgia, and osteoarthritis were used. The studies had similar designs and measurement instruments, including the PI-NRS, collected in a daily diary, and the standard seven-point patient global impression of change (PGIC), collected at the endpoint. The changes in the PI-NRS from baseline to the endpoint were compared to the PGIC for each subject. Categories of "much improved" and "very much improved" were used as determinants of a clinically important difference and the relationship to the PI-NRS was explored using graphs, box plots, and sensitivity/specificity analyses. A consistent relationship between the change in PI-NRS and the PGIC was demonstrated regardless of study, disease type, age, sex, study result, or treatment group. On average, a reduction of approximately two points or a reduction of approximately 30% in the PI-NRS represented a clinically important difference. The relationship between percent change and the PGIC was also consistent regardless of baseline pain, while higher baseline scores required larger raw changes to represent a clinically important difference. The application of these results to future studies may provide a standard definition of clinically important improvement in clinical trials of chronic pain therapies. Use of a standard outcome across chronic pain studies would greatly enhance the comparability, validity, and clinical applicability of these studies.
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          OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines.

          To develop concise, patient-focussed, up to date, evidence-based, expert consensus recommendations for the management of hip and knee osteoarthritis (OA), which are adaptable and designed to assist physicians and allied health care professionals in general and specialist practise throughout the world. Sixteen experts from four medical disciplines (primary care, rheumatology, orthopaedics and evidence-based medicine), two continents and six countries (USA, UK, France, Netherlands, Sweden and Canada) formed the guidelines development team. A systematic review of existing guidelines for the management of hip and knee OA published between 1945 and January 2006 was undertaken using the validated appraisal of guidelines research and evaluation (AGREE) instrument. A core set of management modalities was generated based on the agreement between guidelines. Evidence before 2002 was based on a systematic review conducted by European League Against Rheumatism and evidence after 2002 was updated using MEDLINE, EMBASE, CINAHL, AMED, the Cochrane Library and HTA reports. The quality of evidence was evaluated, and where possible, effect size (ES), number needed to treat, relative risk or odds ratio and cost per quality-adjusted life years gained were estimated. Consensus recommendations were produced following a Delphi exercise and the strength of recommendation (SOR) for propositions relating to each modality was determined using a visual analogue scale. Twenty-three treatment guidelines for the management of hip and knee OA were identified from the literature search, including six opinion-based, five evidence-based and 12 based on both expert opinion and research evidence. Twenty out of 51 treatment modalities addressed by these guidelines were universally recommended. ES for pain relief varied from treatment to treatment. Overall there was no statistically significant difference between non-pharmacological therapies [0.25, 95% confidence interval (CI) 0.16, 0.34] and pharmacological therapies (ES=0.39, 95% CI 0.31, 0.47). Following feedback from Osteoarthritis Research International members on the draft guidelines and six Delphi rounds consensus was reached on 25 carefully worded recommendations. Optimal management of patients with OA hip or knee requires a combination of non-pharmacological and pharmacological modalities of therapy. Recommendations cover the use of 12 non-pharmacological modalities: education and self-management, regular telephone contact, referral to a physical therapist, aerobic, muscle strengthening and water-based exercises, weight reduction, walking aids, knee braces, footwear and insoles, thermal modalities, transcutaneous electrical nerve stimulation and acupuncture. Eight recommendations cover pharmacological modalities of treatment including acetaminophen, cyclooxygenase-2 (COX-2) non-selective and selective oral non-steroidal anti-inflammatory drugs (NSAIDs), topical NSAIDs and capsaicin, intra-articular injections of corticosteroids and hyaluronates, glucosamine and/or chondroitin sulphate for symptom relief; glucosamine sulphate, chondroitin sulphate and diacerein for possible structure-modifying effects and the use of opioid analgesics for the treatment of refractory pain. There are recommendations covering five surgical modalities: total joint replacements, unicompartmental knee replacement, osteotomy and joint preserving surgical procedures; joint lavage and arthroscopic debridement in knee OA, and joint fusion as a salvage procedure when joint replacement had failed. Strengths of recommendation and 95% CIs are provided. Twenty-five carefully worded recommendations have been generated based on a critical appraisal of existing guidelines, a systematic review of research evidence and the consensus opinions of an international, multidisciplinary group of experts. The recommendations may be adapted for use in different countries or regions according to the availability of treatment modalities and SOR for each modality of therapy. These recommendations will be revised regularly following systematic review of new research evidence as this becomes available.
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            Author and article information

            Affiliations
            [1 ]ISNI 0000 0004 0470 5454, GRID grid.15444.30, Department of Neurosurgery, , Spine and Spinal Cord Institute, Yonsei University College of Medicine, Severance Hospital, ; 134 Shinchon-dong Seodaemun-gu, Seoul, 120–752 South Korea
            [2 ]ISNI 0000 0001 0842 2126, GRID grid.413967.e, Department of Orthopedic Surgery, , Asan Medical Center, ; Seoul, South Korea
            [3 ]Pain Management Unit, Department of Anaesthesiology and Intensive Care, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, SAR China
            [4 ]Department of Neurosurgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea
            [5 ]ISNI 0000 0004 0470 5905, GRID grid.31501.36, Department of Brain and Cognitive Science, , Seoul National University College of Natural Science, ; Seoul, South Korea
            [6 ]ISNI 0000 0004 0470 4224, GRID grid.411947.e, Department of Orthopaedic Surgery, , Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, ; Seoul, South Korea
            [7 ]Department of Orthopedic Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea
            [8 ]ISNI 0000 0004 0571 4942, GRID grid.416846.9, Section of Rheumatology, Department of Medicine, , St. Luke’s Medical Center, ; Manila, Philippines
            [9 ]ISNI 0000 0004 1771 3971, GRID grid.417336.4, Department of Medicine, , Tuen Mun Hospital, ; Hong Kong, SAR China
            [10 ]Department of Orthopedic Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea
            [11 ]ISNI 0000 0004 1771 3971, GRID grid.417336.4, Pain Management Unit, Department of Anaesthesia and Intensive Care, , Tuen Mun Hospital, ; Hong Kong, SAR China
            [12 ]ISNI 0000 0000 9650 2179, GRID grid.11159.3d, Section of Rheumatology, Department of Medicine, , University of the Philippines College of Medicine-Philippine General Hospital, ; Manila, Philippines
            [13 ]Mundipharma Pte Ltd, Asia Square Tower 2, Singapore
            Contributors
            ydoheum@yuhs.ac , shindongah@me.com
            sibin@amc.seoul.kr
            simonkcchan@cuhk.edu.hk
            chungc@snu.ac.kr
            iy1000@catholic.ac.kr
            hmkim21@gmail.com
            jombilichauco@yahoo.com
            ccmok2005@yahoo.com
            ywmoon@skku.edu
            tonyktng@gmail.com
            egpenserga@post.upm.edu.ph
            shindongah@me.com
            Dora.You@mundipharma.com.sg
            hanlim.moon@curencareresearch.com
            Journal
            BMC Musculoskelet Disord
            BMC Musculoskelet Disord
            BMC Musculoskeletal Disorders
            BioMed Central (London )
            1471-2474
            4 August 2017
            4 August 2017
            2017
            : 18
            28778219 5545039 1664 10.1186/s12891-017-1664-4
            © The Author(s). 2017

            Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. 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.

            Funding
            Funded by: Mundipharma Pte Ltd, Singapore
            Categories
            Research Article
            Custom metadata
            © The Author(s) 2017

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