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A prospective multicentre study to evaluate the efficacy and tolerability of osmotic release oral system (OROS®) hydromorphone in opioid-naive cancer patients: Results of the Korean South West Oncology Group study

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      Abstract

      Early and active management of cancer pain is important for improving patients’ satisfaction with treatment and quality of life. The efficacy and tolerability of osmotic release oral system (OROS®) hydromorphone was evaluated in opioid-naive cancer patients experiencing moderate to severe cancer pain. The authors believe the results of this study will provide meaningful information regarding the clinical benefit of OROS hydromorphone as front-line therapy in opioid-naive cancer patients.

      Abstract

      BACKGROUND:

      Osmotic release oral system (OROS ®) hydromorphone is a potent, long-acting opioid analgesic, effective and safe for controlling cancer pain in patients who have received other strong opioids. To date, few studies have examined the efficacy of hydromorphone for pain relief in opioid-naive cancer patients.

      OBJECTIVES:

      A prospective, open-label, multicentre trial was conducted to determine the efficacy and tolerability of OROS hydromorphone as a single and front-line opioid therapy for patients experiencing moderate to severe cancer pain.

      METHODS:

      OROS hydromorphone was administered to patients who had not previously received strong, long-acting opioids. The baseline evaluation (visit 1) was followed by two evaluations (visits 2 and 3) performed two and 14 weeks later, respectively. The starting dose of OROS hydromorphone was 4 mg/day and was increased every two days when pain control was insufficient. Immediate-release hydromorphone was the only accepted alternative strong opioid for relief of breakthrough pain. The efficacy, safety and tolerability of OROS hydromorphone, including the effects on quality of life, and patients’ and investigators’ global impressions on pain relief were evaluated. The primary end point was pain intensity difference (PID) at visit 2 relative to visit 1 (expressed as %PID).

      RESULTS:

      A total of 107 patients were enrolled in the present study. An improvement in pain intensity of >50% (≥50% PID) was observed in 51.0% of the full analysis set and 58.6% of the per-protocol set. The mean pain score, measured using a numerical rating scale, was significantly reduced after two weeks of treatment, and most adverse events were manageable. Quality of life also improved, and >70% of patients and investigators were satisfied with the treatment.

      CONCLUSIONS:

      OROS hydromorphone provided effective pain relief and improved quality of life in opioid-naive cancer patients. As a single and front-line treatment, OROS hydromorphone delivered rapid pain control.

      Translated abstract

      HISTORIQUE :

      L’hydromorphone par système oral à libération osmotique (SOLO ®) est un puissant analgésique opioïde à longue durée d’action efficace et sécuritaire pour contrôler la douleur causée par le cancer chez les patients qui ont reçu d’autres puissants opioïdes. Jusqu’à présent, peu d’études ont porté sur l’efficacité de l’hydromorphone pour soulager la douleur chez des patients atteints du cancer naïfs aux opioïdes.

      OBJECTIFS :

      Les chercheurs ont mené un essai multicentrique prospectif ouvert pour déterminer l’efficacité et la tolérabilité de l’hydromorphone par SOLO comme thérapie opioïde unique en première ligne chez les patients souffrant de douleur modérée à grave causée par le cancer.

      MÉTHODOLOGIE :

      L’hydromorphone par SOLO a été administrée à des patients qui n’avaient pas reçu de puissants opioïdes à longue durée d’action auparavant. L’évaluation initiale (visite 1) était suivie de deux évaluations (visites 2 et 3) effectuées deux et 14 semaines plus tard, respectivement. La dose d’hydromorphone par SOLO initiale était de 4 mg/jour et accrue tous les deux jours lorsque le contrôle de la douleur était insuffisant. L’hydromorphone à libération immédiate était le seul autre puissant opioïde accepté pour soulager les accès douloureux paroxystiques. Les chercheurs ont évalué l’efficacité, l’innocuité et la tolérabilité de l’hydromorphone par SOLO, y compris les effets sur la qualité de vie, de même que les impressions globales des patients et des investigateurs. Le paramètre primaire était la différence d’intensité de la douleur (DID) lors de la visite 2 par rapport à la visite 1 (exprimé en pourcentage de DID).

      RÉSULTATS :

      Au total, 107 patients ont participé à la présente étude. Les chercheurs ont remarqué une diminution de l’intensité de la douleur de plus de 50 % (≥50 % DID) chez 51,0 % du groupe d’analyse totale et de 58,6 % du groupe respectant le protocole. L’indice de douleur moyen, mesuré d’après une échelle d’évaluation numérique, avait considérablement diminué au bout de deux semaines de traitement, et la plupart des événements les plus indésirables pouvaient être gérés. La qualité de vie s’était également améliorée, et plus de 70 % des patients et des investigateurs étaient satisfaits du traitement.

      CONCLUSIONS :

      L’hydromorphone par SOLO apportait un soulagement efficace de la douleur et améliorait la qualité de vie chez les patients atteints du cancer naïfs aux opioïdes. Sous forme de traitement unique de première ligne, l’hydromorphone par SOLO assurait un contrôle rapide de la douleur.

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      Most cited references 22

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      What decline in pain intensity is meaningful to patients with acute pain?

      Despite widespread use of the 0-10 numeric rating scale (NRS) of pain intensity, relatively little is known about the meaning of decreases in pain intensity assessed by means of this scale to patients. We aimed to establish the meaning to patients of declines in pain intensity and percent pain reduction. Upon arrival to the postanesthesia care unit, postsurgical patients rated their baseline pain intensity on both a 0-10 NRS and on a 4-point verbal scale. Patients whose NRS was higher than 4/10 received intravenous opioids until their pain intensity declined to 4/10 or lower. During opioid titration, patients were asked every 10 min to rate pain intensity on a NRS and to indicate the degree of pain improvement on a 5-point Likert scale from 'no improvement' to 'complete pain relief'. Seven hundred adult patients were enrolled. For patients with moderate pain, a decrease of 1.3 units (20% reduction) corresponded to 'minimal' improvement, a decrease of 2.4 (35% reduction) to 'much' improvement, a decrease of 3.5 units (45% reduction) corresponded to 'very much' improvement. For patients with severe pain, the decrease in NRS pain score and the percentage of pain relief had to be larger to obtain similar degrees of pain relief. The change in pain intensity that is meaningful to patients increases as the severity of their baseline pain increases. The present findings are applicable in the clinical setting and research arena to assess treatment efficacy.
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        Deriving dichotomous outcome measures from continuous data in randomised controlled trials of analgesics.

        Reports of RCTs of analgesics frequently describe results of studies in the form of mean derived indices, rather than using discontinuous events--such as number or proportion of patients with 50% pain relief. Because mean data inadequately describe information with a non-normal distribution, combining mean data in systematic reviews may compromise the results. Showing that dichotomous data can reliably be derived from mean data, at least in acute pain models, indicates that more meaningful overviews or meta-analysis may be possible. This study investigated the relationship between continuous and dichotomous analgesic measures in a set of individual patient data, and then used that relationship to derive dichotomous from continuous information in randomised controlled trials (RCTs) of analgesics. Individual patient information from 13 RCTs of parallel-group and crossover design in acute postoperative pain was used to calculate the percentage of the maximum possible pain relief score (%maxTOTPAR) and the proportion of patients with greater than 50% pain relief (> 50%maxTOTPAR) for the different treatments. The relationship between the measures was investigated in 45 actual treatments and 10,000 treatments simulated using the underlying actual distribution; 1283 patients had 45 separate treatments. Mean %maxTOTPAR correlated with the proportion of patients with > 50%maxTOTPAR (r2 = 0.90). The relationship calculated from all the 45 treatments predicted to within three patients the number of patients with more than 50% pain relief in 42 of 45 treatments, and 98.8% of 10,000 simulated treatments. For seven effective treatments, actual numbers-needed-to-treat (NNT) to achieve > 50%maxTOTPAR compared with placebo were very similar to those derived from calculated data.
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          Deriving dichotomous outcome measures from continuous data in randomised controlled trials of analgesics: use of pain intensity and visual analogue scales.

          The aim of this study was to examine whether mean data from categorical pain intensity and visual analogue scales for both pain intensity and relief could be used reliably to derive dichotomous outcome measures for meta-analysis. Individual patient data from randomised controlled trials of single-dose analgesics in acute postoperative pain were used. The methods used were as follows: data from 132 treatments with over 4700 patients were used to calculate mean %maxSPID (categorical pain intensity), %maxVAS-SPID (visual analogue pain intensity) and %maxVAS-TOTPAR (visual analogue pain relief); these were used to derive relationships with the number of patients who achieved at least 50% pain relief (%maxTOTPAR). Good agreement was obtained between the actual number of patients with > 50%maxTOTPAR and the number calculated for all three measures. For SPID, verification included independent data sets. For calculations involving each measure, summing the positive and negative differences between actual and calculated numbers of patients with > 50%maxTOTPAR gave an average difference of less than 0.25 patients per treatment arm. Reports of randomised trials of analgesics frequently describe results of studies in the form of mean derived indices, rather than using discontinuous events, such as number of proportion of patients obtaining at least 50% pain relief. Because mean data inadequately describe information with a non-normal distribution, combining such mean data in systematic reviews may compromise the results. Showing that dichotomous data can reliably be derived from mean SPID, VAS-SPID and VAS-TOTPAR as well as TOTPAR data in previously published acute pain studies makes much more information accessible for meta-analysis.
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            Author and article information

            Affiliations
            [1 ]Department of Internal Medicine, Chonbuk National University Medical School and Research Institute of Clinical Medicine of Chonbuk National University – Biomedical Research Institute of Chonbuk National University Hospital, Jeonju;
            [2 ]Department of Internal Medicine, Chonnam National University Hwasun Hospital, Gwangju;
            [3 ]Department of Internal Medicine, College of Medicine, Chungbuk National University, Cheongju;
            [4 ]Department of Internal Medicine, St. Mary’s Hospital, Cheongju;
            [5 ]Department of Internal Medicine, Dankook University Hospital, Choenan;
            [6 ]Department of Internal Medicine, Gyeongsang National University Hospital, Jinju;
            [7 ]Department of Internal Medicine, Soon Chun Hyang University Cheonan Hospital, Cheonan;
            [8 ]Department of Internal Medicine, Konyang University Hospital, Nonsan;
            [9 ]Department of Internal Medicine, Eulji University Hospital, Republic of Korea
            [10 ]Department of Internal Medicine, The Catholic University Korea Daejeon St Mary’s Hospital, Republic of Korea
            [11 ]Department of Internal Medicine, Chungnam National University Hospital, Deajeon, Republic of Korea
            Author notes
            Correspondence: Dr Chang-Yeol Yim, Department of Internal Medicine, Chonbuk National University Medical School, 20, Geonjiro, Deokjin-gu, Jeonju-si, 561-180, Republic of Korea. Telephone 82-63-250-1682, fax 82-63-254-1609, e-mail cyyim@ 123456chonbuk.ac.kr
            Journal
            Pain Res Manag
            Pain Res Manag
            PGI
            Pain Research & Management : The Journal of the Canadian Pain Society
            Pulsus Group Inc
            1203-6765
            1918-1523
            Nov-Dec 2015
            : 20
            : 6
            : 293-299
            26474382
            4676498
            prm-20-293
            © 2015, Pulsus Group Inc. All rights reserved

            This open-access article is distributed under the terms of the Creative Commons Attribution Non-Commercial License (CC BY-NC) ( http://creativecommons.org/licenses/by-nc/4.0/), which permits reuse, distribution and reproduction of the article, provided that the original work is properly cited and the reuse is restricted to noncommercial purposes. For commercial reuse, contact support@ 123456pulsus.com

            Categories
            Original Article

            pain, cancer, hydromorphone, opioid

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