View in EDS HTML Full Text PDF Full Text

Tolerability, Safety, and Quality of Life with Tapentadol Prolonged Release ( PR) Compared with Oxycodone/Naloxone PR in Patients with Severe Chronic Low Back Pain with a Neuropathic Component: A Randomized, Controlled, Open-label, Phase 3b/4 Trial.

Saved in:
Bibliographic Details
Title: Tolerability, Safety, and Quality of Life with Tapentadol Prolonged Release ( PR) Compared with Oxycodone/Naloxone PR in Patients with Severe Chronic Low Back Pain with a Neuropathic Component: A Randomized, Controlled, Open-label, Phase 3b/4 Trial.
Authors: Baron, Ralf, Jansen, Jan ‐ Peter, Binder, Andreas, Pombo ‐ Suarez, Manuel, Kennes, Lieven, Müller, Matthias, Falke, Dietmar, Steigerwald, Ilona
Source: Pain Practice. Jun2016, Vol. 16 Issue 5, p600-619. 20p. 1 Chart, 11 Graphs.
Subjects: Analgesics, Backache, Chronic pain, Comparative studies, Constipation, Drug tolerance, Narcotics, Neuralgia, Quality of life, Questionnaires, Safety, Vomiting, Pain measurement, Randomized controlled trials
Abstract: Objective To evaluate tolerability, safety, and quality-of-life outcomes in non-opioid-pretreated patients with severe chronic low back pain with a neuropathic component receiving tapentadol PR vs. oxycodone/naloxone PR. Methods Eligible patients (average pain intensity [numerical rating scale] ≥ 6; pain DETECT positive/unclear ratings) were randomized to twice-daily tapentadol PR 50 mg or oxycodone/naloxone PR 10 mg/5 mg. After a 21-day titration (maximum twice-daily doses: tapentadol PR 250 mg, or oxycodone/naloxone PR 40 mg/20 mg plus oxycodone PR 10 mg), target doses were continued for 9 weeks. Change in the Patient Assessment of Constipation Symptoms ( PAC- SYM) total score from baseline to final evaluation was a primary endpoint. Results For the primary tolerability-related endpoint, the 97.5% exact repeated confidence interval for tapentadol PR minus oxycodone/naloxone PR for the PAC- SYM total score was [−0.259, 0.121], showing noninferiority (upper limit < 0.7). Incidences of constipation and vomiting were significantly lower with tapentadol PR than oxycodone/naloxone PR ( P ≤ 0.045). Confirmatory superiority based on formal noninferiority was shown for the primary effectiveness endpoint (change from baseline to final evaluation in pain intensity) for tapentadol PR vs. oxycodone/naloxone PR (presented separately). Improvements in the Short Form-12 physical component summary and EuroQol-5 Dimension health status index and health state assessment were significantly greater with tapentadol PR vs. oxycodone/naloxone PR ( P ≤ 0.024). Conclusions Tapentadol PR had a minimal impact on bowel function (noninferior to oxycodone/naloxone PR) and, along with superior effectiveness (presented separately), was associated with significantly lower incidences of constipation and vomiting and significant improvements in quality-of-life measures vs. oxycodone/naloxone PR. [ABSTRACT FROM AUTHOR]
Copyright of Pain Practice is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Psychology and Behavioral Sciences Collection
Full text is not displayed to guests.
FullText Links:
  – Type: pdflink
Text:
  Availability: 1
Header DbId: pbh
DbLabel: Psychology and Behavioral Sciences Collection
An: 115897967
AccessLevel: 6
PubType: Academic Journal
PubTypeId: academicJournal
PreciseRelevancyScore: 0
IllustrationInfo
Items – Name: Title
  Label: Title
  Group: Ti
  Data: Tolerability, Safety, and Quality of Life with Tapentadol Prolonged Release ( PR) Compared with Oxycodone/Naloxone PR in Patients with Severe Chronic Low Back Pain with a Neuropathic Component: A Randomized, Controlled, Open-label, Phase 3b/4 Trial.
– Name: Author
  Label: Authors
  Group: Au
  Data: &lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Baron%2C+Ralf%22&quot;&gt;Baron, Ralf&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Jansen%2C+Jan+‐+Peter%22&quot;&gt;Jansen, Jan ‐ Peter&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Binder%2C+Andreas%22&quot;&gt;Binder, Andreas&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Pombo+‐+Suarez%2C+Manuel%22&quot;&gt;Pombo ‐ Suarez, Manuel&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Kennes%2C+Lieven%22&quot;&gt;Kennes, Lieven&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22M&#252;ller%2C+Matthias%22&quot;&gt;M&#252;ller, Matthias&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Falke%2C+Dietmar%22&quot;&gt;Falke, Dietmar&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Steigerwald%2C+Ilona%22&quot;&gt;Steigerwald, Ilona&lt;/searchLink&gt;
– Name: TitleSource
  Label: Source
  Group: Src
  Data: &lt;searchLink fieldCode=&quot;JN&quot; term=&quot;%22Pain+Practice%22&quot;&gt;Pain Practice&lt;/searchLink&gt;. Jun2016, Vol. 16 Issue 5, p600-619. 20p. 1 Chart, 11 Graphs.
– Name: Subject
  Label: Subjects
  Group: Su
  Data: &lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Analgesics%22&quot;&gt;Analgesics&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Backache%22&quot;&gt;Backache&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Chronic+pain%22&quot;&gt;Chronic pain&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Comparative+studies%22&quot;&gt;Comparative studies&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Constipation%22&quot;&gt;Constipation&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Drug+tolerance%22&quot;&gt;Drug tolerance&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Narcotics%22&quot;&gt;Narcotics&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Neuralgia%22&quot;&gt;Neuralgia&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Quality+of+life%22&quot;&gt;Quality of life&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Questionnaires%22&quot;&gt;Questionnaires&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Safety%22&quot;&gt;Safety&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Vomiting%22&quot;&gt;Vomiting&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Pain+measurement%22&quot;&gt;Pain measurement&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Randomized+controlled+trials%22&quot;&gt;Randomized controlled trials&lt;/searchLink&gt;
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: Objective To evaluate tolerability, safety, and quality-of-life outcomes in non-opioid-pretreated patients with severe chronic low back pain with a neuropathic component receiving tapentadol PR vs. oxycodone/naloxone PR. Methods Eligible patients (average pain intensity [numerical rating scale] ≥ 6; pain DETECT positive/unclear ratings) were randomized to twice-daily tapentadol PR 50 mg or oxycodone/naloxone PR 10 mg/5 mg. After a 21-day titration (maximum twice-daily doses: tapentadol PR 250 mg, or oxycodone/naloxone PR 40 mg/20 mg plus oxycodone PR 10 mg), target doses were continued for 9 weeks. Change in the Patient Assessment of Constipation Symptoms ( PAC- SYM) total score from baseline to final evaluation was a primary endpoint. Results For the primary tolerability-related endpoint, the 97.5% exact repeated confidence interval for tapentadol PR minus oxycodone/naloxone PR for the PAC- SYM total score was [−0.259, 0.121], showing noninferiority (upper limit &lt; 0.7). Incidences of constipation and vomiting were significantly lower with tapentadol PR than oxycodone/naloxone PR ( P ≤ 0.045). Confirmatory superiority based on formal noninferiority was shown for the primary effectiveness endpoint (change from baseline to final evaluation in pain intensity) for tapentadol PR vs. oxycodone/naloxone PR (presented separately). Improvements in the Short Form-12 physical component summary and EuroQol-5 Dimension health status index and health state assessment were significantly greater with tapentadol PR vs. oxycodone/naloxone PR ( P ≤ 0.024). Conclusions Tapentadol PR had a minimal impact on bowel function (noninferior to oxycodone/naloxone PR) and, along with superior effectiveness (presented separately), was associated with significantly lower incidences of constipation and vomiting and significant improvements in quality-of-life measures vs. oxycodone/naloxone PR. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
  Label:
  Group: Ab
  Data: &lt;i&gt;Copyright of Pain Practice is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder&#39;s express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.&lt;/i&gt; (Copyright applies to all Abstracts.)
PLink https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=pbh&AN=115897967
RecordInfo BibRecord:
  BibEntity:
    Identifiers:
      – Type: doi
        Value: 10.1111/papr.12361
    Languages:
      – Code: eng
        Text: English
    PhysicalDescription:
      Pagination:
        PageCount: 20
        StartPage: 600
    Subjects:
      – SubjectFull: Analgesics
        Type: general
      – SubjectFull: Backache
        Type: general
      – SubjectFull: Chronic pain
        Type: general
      – SubjectFull: Comparative studies
        Type: general
      – SubjectFull: Constipation
        Type: general
      – SubjectFull: Drug tolerance
        Type: general
      – SubjectFull: Narcotics
        Type: general
      – SubjectFull: Neuralgia
        Type: general
      – SubjectFull: Quality of life
        Type: general
      – SubjectFull: Questionnaires
        Type: general
      – SubjectFull: Safety
        Type: general
      – SubjectFull: Vomiting
        Type: general
      – SubjectFull: Pain measurement
        Type: general
      – SubjectFull: Randomized controlled trials
        Type: general
    Titles:
      – TitleFull: Tolerability, Safety, and Quality of Life with Tapentadol Prolonged Release ( PR) Compared with Oxycodone/Naloxone PR in Patients with Severe Chronic Low Back Pain with a Neuropathic Component: A Randomized, Controlled, Open-label, Phase 3b/4 Trial.
        Type: main
  BibRelationships:
    HasContributorRelationships:
      – PersonEntity:
          Name:
            NameFull: Baron, Ralf
      – PersonEntity:
          Name:
            NameFull: Jansen, Jan ‐ Peter
      – PersonEntity:
          Name:
            NameFull: Binder, Andreas
      – PersonEntity:
          Name:
            NameFull: Pombo ‐ Suarez, Manuel
      – PersonEntity:
          Name:
            NameFull: Kennes, Lieven
      – PersonEntity:
          Name:
            NameFull: Müller, Matthias
      – PersonEntity:
          Name:
            NameFull: Falke, Dietmar
      – PersonEntity:
          Name:
            NameFull: Steigerwald, Ilona
    IsPartOfRelationships:
      – BibEntity:
          Dates:
            – D: 01
              M: 06
              Text: Jun2016
              Type: published
              Y: 2016
          Identifiers:
            – Type: issn-print
              Value: 15307085
          Numbering:
            – Type: volume
              Value: 16
            – Type: issue
              Value: 5
          Titles:
            – TitleFull: Pain Practice
              Type: main
ResultId 1