View in EDS PDF Full Text

The Effect of Gabapentin Enacarbil on Pain Associated with Moderate-to-Severe Primary Restless Legs Syndrome in Adults: Pooled Analyses from Three Randomized Controlled Trials.

Saved in:
Bibliographic Details
Title: The Effect of Gabapentin Enacarbil on Pain Associated with Moderate-to-Severe Primary Restless Legs Syndrome in Adults: Pooled Analyses from Three Randomized Controlled Trials.
Authors: Hermanowicz, Neal, Ellenbogen, Aaron, Irving, Gordon, Buchfuhrer, Mark, Jaros, Mark, Shang, Gwendoline, Kim, Richard, Jaros, Mark J (AUTHOR)
Source: CNS Drugs. May2016, Vol. 30 Issue 5, p443-454. 12p. 5 Charts, 4 Graphs.
Subjects: Restless legs syndrome, Gabapentin, Diseases in adults, Randomized controlled trials, Quality of life, Dopamine agonists, Acyclic acids, Clinical trials, Comparative studies, Dose-effect relationship in pharmacology, GABA, Research methodology, Medical cooperation, Pain, Research, Evaluation research, Treatment effectiveness, Blind experiment, Disease complications, Therapeutics
Abstract: Background: Adults with moderate-to-severe primary restless legs syndrome (RLS) often experience painful dysesthesias, which may lead to impaired quality of life.Objectives: The aim of this study was to assess the effects of gabapentin enacarbil (GEn) on pain associated with moderate-to-severe primary RLS in adults.Methods: Data were pooled from three double-blind, randomized, placebo-controlled, 12-week trials (NCT00298623, NCT00365352, NCT01332305) for adults receiving GEn or placebo once daily. Change in average daily RLS pain score and a combined International Restless Legs Scale (IRLS)-pain response were examined.Results: The modified intention-to-treat population included 671 adults (placebo, n = 244; GEn 600 mg, n = 161; GEn 1200 mg, n = 266). Both GEn doses significantly improved average daily RLS pain score at week 12 (p < 0.001 for GEn 600 mg vs. placebo and GEn 1200 mg vs. placebo). The combined IRLS-pain response subanalysis included 366 patients with a baseline IRLS total score ≥15 and pain score ≥4 (placebo, n = 133; GEn 600 mg, n = 86; GEn 1200 mg, n = 147). Most patients were both IRLS and pain responders (placebo, 40 %; GEn 600 mg, 70 %; GEn 1200 mg, 67 %). Spearman rank correlations between IRLS total and pain score (change from baseline to week 12) were moderate or strong. The most frequent treatment-emergent adverse events were somnolence (placebo, 5 %; GEn 600 mg, 20 %; GEn 1200 mg, 23 %) and dizziness (placebo, 4 %; GEn 600 mg, 13 %; GEn 1200 mg, 22 %).Conclusions: This post hoc pooled analysis suggests that GEn (600 and 1200 mg) once daily significantly improved pain associated with moderate-to-severe primary RLS in adults; however, the analysis was not powered to detect statistical differences between the two GEn doses. Numerically, more GEn-treated patients had a combined IRLS-pain response than placebo-treated patients. [ABSTRACT FROM AUTHOR]
Copyright of CNS Drugs is the property of Springer Nature 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
FullText Links:
  – Type: pdflink
Text:
  Availability: 0
Header DbId: pbh
DbLabel: Psychology and Behavioral Sciences Collection
An: 117355077
AccessLevel: 6
PubType: Academic Journal
PubTypeId: academicJournal
PreciseRelevancyScore: 0
IllustrationInfo
Items – Name: Title
  Label: Title
  Group: Ti
  Data: The Effect of Gabapentin Enacarbil on Pain Associated with Moderate-to-Severe Primary Restless Legs Syndrome in Adults: Pooled Analyses from Three Randomized Controlled Trials.
– Name: Author
  Label: Authors
  Group: Au
  Data: &lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Hermanowicz%2C+Neal%22&quot;&gt;Hermanowicz, Neal&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Ellenbogen%2C+Aaron%22&quot;&gt;Ellenbogen, Aaron&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Irving%2C+Gordon%22&quot;&gt;Irving, Gordon&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Buchfuhrer%2C+Mark%22&quot;&gt;Buchfuhrer, Mark&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Jaros%2C+Mark%22&quot;&gt;Jaros, Mark&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Shang%2C+Gwendoline%22&quot;&gt;Shang, Gwendoline&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Kim%2C+Richard%22&quot;&gt;Kim, Richard&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Jaros%2C+Mark+J%22&quot;&gt;Jaros, Mark J&lt;/searchLink&gt; (AUTHOR)
– Name: TitleSource
  Label: Source
  Group: Src
  Data: &lt;searchLink fieldCode=&quot;JN&quot; term=&quot;%22CNS+Drugs%22&quot;&gt;CNS Drugs&lt;/searchLink&gt;. May2016, Vol. 30 Issue 5, p443-454. 12p. 5 Charts, 4 Graphs.
– Name: Subject
  Label: Subjects
  Group: Su
  Data: &lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Restless+legs+syndrome%22&quot;&gt;Restless legs syndrome&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Gabapentin%22&quot;&gt;Gabapentin&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Diseases+in+adults%22&quot;&gt;Diseases in adults&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;&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;%22Dopamine+agonists%22&quot;&gt;Dopamine agonists&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Acyclic+acids%22&quot;&gt;Acyclic acids&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Clinical+trials%22&quot;&gt;Clinical trials&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;%22Dose-effect+relationship+in+pharmacology%22&quot;&gt;Dose-effect relationship in pharmacology&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22GABA%22&quot;&gt;GABA&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Research+methodology%22&quot;&gt;Research methodology&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Medical+cooperation%22&quot;&gt;Medical cooperation&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Pain%22&quot;&gt;Pain&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Research%22&quot;&gt;Research&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Evaluation+research%22&quot;&gt;Evaluation research&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Treatment+effectiveness%22&quot;&gt;Treatment effectiveness&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Blind+experiment%22&quot;&gt;Blind experiment&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Disease+complications%22&quot;&gt;Disease complications&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Therapeutics%22&quot;&gt;Therapeutics&lt;/searchLink&gt;
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: &lt;bold&gt;Background: &lt;/bold&gt;Adults with moderate-to-severe primary restless legs syndrome (RLS) often experience painful dysesthesias, which may lead to impaired quality of life.&lt;bold&gt;Objectives: &lt;/bold&gt;The aim of this study was to assess the effects of gabapentin enacarbil (GEn) on pain associated with moderate-to-severe primary RLS in adults.&lt;bold&gt;Methods: &lt;/bold&gt;Data were pooled from three double-blind, randomized, placebo-controlled, 12-week trials (NCT00298623, NCT00365352, NCT01332305) for adults receiving GEn or placebo once daily. Change in average daily RLS pain score and a combined International Restless Legs Scale (IRLS)-pain response were examined.&lt;bold&gt;Results: &lt;/bold&gt;The modified intention-to-treat population included 671 adults (placebo, n&#160;=&#160;244; GEn 600&#160;mg, n&#160;=&#160;161; GEn 1200&#160;mg, n&#160;=&#160;266). Both GEn doses significantly improved average daily RLS pain score at week 12 (p&#160;&lt;&#160;0.001 for GEn 600&#160;mg vs. placebo and GEn 1200&#160;mg vs. placebo). The combined IRLS-pain response subanalysis included 366 patients with a baseline IRLS total score ≥15 and pain score ≥4 (placebo, n = 133; GEn 600&#160;mg, n = 86; GEn 1200&#160;mg, n&#160;=&#160;147). Most patients were both IRLS and pain responders (placebo, 40&#160;%; GEn 600&#160;mg, 70&#160;%; GEn 1200&#160;mg, 67&#160;%). Spearman rank correlations between IRLS total and pain score (change from baseline to week 12) were moderate or strong. The most frequent treatment-emergent adverse events were somnolence (placebo, 5&#160;%; GEn 600&#160;mg, 20&#160;%; GEn 1200&#160;mg, 23&#160;%) and dizziness (placebo, 4&#160;%; GEn 600&#160;mg, 13&#160;%; GEn 1200&#160;mg, 22&#160;%).&lt;bold&gt;Conclusions: &lt;/bold&gt;This post hoc pooled analysis suggests that GEn (600 and 1200&#160;mg) once daily significantly improved pain associated with moderate-to-severe primary RLS in adults; however, the analysis was not powered to detect statistical differences between the two GEn doses. Numerically, more GEn-treated patients had a combined IRLS-pain response than placebo-treated patients. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
  Label:
  Group: Ab
  Data: &lt;i&gt;Copyright of CNS Drugs is the property of Springer Nature 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=117355077
RecordInfo BibRecord:
  BibEntity:
    Identifiers:
      – Type: doi
        Value: 10.1007/s40263-016-0333-8
    Languages:
      – Code: eng
        Text: English
    PhysicalDescription:
      Pagination:
        PageCount: 12
        StartPage: 443
    Subjects:
      – SubjectFull: Restless legs syndrome
        Type: general
      – SubjectFull: Gabapentin
        Type: general
      – SubjectFull: Diseases in adults
        Type: general
      – SubjectFull: Randomized controlled trials
        Type: general
      – SubjectFull: Quality of life
        Type: general
      – SubjectFull: Dopamine agonists
        Type: general
      – SubjectFull: Acyclic acids
        Type: general
      – SubjectFull: Clinical trials
        Type: general
      – SubjectFull: Comparative studies
        Type: general
      – SubjectFull: Dose-effect relationship in pharmacology
        Type: general
      – SubjectFull: GABA
        Type: general
      – SubjectFull: Research methodology
        Type: general
      – SubjectFull: Medical cooperation
        Type: general
      – SubjectFull: Pain
        Type: general
      – SubjectFull: Research
        Type: general
      – SubjectFull: Evaluation research
        Type: general
      – SubjectFull: Treatment effectiveness
        Type: general
      – SubjectFull: Blind experiment
        Type: general
      – SubjectFull: Disease complications
        Type: general
      – SubjectFull: Therapeutics
        Type: general
    Titles:
      – TitleFull: The Effect of Gabapentin Enacarbil on Pain Associated with Moderate-to-Severe Primary Restless Legs Syndrome in Adults: Pooled Analyses from Three Randomized Controlled Trials.
        Type: main
  BibRelationships:
    HasContributorRelationships:
      – PersonEntity:
          Name:
            NameFull: Hermanowicz, Neal
      – PersonEntity:
          Name:
            NameFull: Ellenbogen, Aaron
      – PersonEntity:
          Name:
            NameFull: Irving, Gordon
      – PersonEntity:
          Name:
            NameFull: Buchfuhrer, Mark
      – PersonEntity:
          Name:
            NameFull: Jaros, Mark
      – PersonEntity:
          Name:
            NameFull: Shang, Gwendoline
      – PersonEntity:
          Name:
            NameFull: Kim, Richard
      – PersonEntity:
          Name:
            NameFull: Jaros, Mark J
    IsPartOfRelationships:
      – BibEntity:
          Dates:
            – D: 01
              M: 05
              Text: May2016
              Type: published
              Y: 2016
          Identifiers:
            – Type: issn-print
              Value: 11727047
          Numbering:
            – Type: volume
              Value: 30
            – Type: issue
              Value: 5
          Titles:
            – TitleFull: CNS Drugs
              Type: main
ResultId 1