Evidence map›Paper›PMID 27448285›Full record

ArticleClinical drug investigation2016

Pregabalin for Neuropathic Pain: Why Benefits Could Be Expected for Multiple Pain Conditions.

Setsuro Ogawa, Akio Arakawa, Kazuhiro Hayakawa, Tamotsu Yoshiyama

7 registry-linked trialsAbstract read
PubMed Publisher
In one paragraph

Article in Clinical drug investigation, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 7 registered trials, which are not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00394901 phase3completednot on this map

A 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin In The Treatment Of Postherpetic Neuralgia

TypeinterventionalSponsorPfizer's Upjohn has merged with Mylan to form Viatris Inc.Ran2006 to 2007Enrolled372ConditionsNeuralgia, PostherpeticArmsPlacebo, Pregabalin
NCT00407745 phase3completednot on this map

A 17-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial Of Pregabalin For The Treatment Of Chronic Central Neuropathic Pain After Spinal Cord Injury

TypeinterventionalSponsorPfizer's Upjohn has merged with Mylan to form Viatris Inc.Ran2007 to 2011Enrolled220ConditionsNeuralgia, Spinal Cord InjuriesArmsplacebo, pregabalin
NCT00424372 phase3completednot on this map

A long-term study to evaluate safety and efficacy study of pregabalin in the treatment of postherpetic neuralgia.

TypeinterventionalSponsorPfizer's Upjohn has merged with Mylan to form Viatris Inc.Ran2007 to 2008Enrolled126ConditionsNeuralgia, PostherpeticArmspregabalin
NCT00553280 phase3completednot on this map

An Open-Label Extension Safety And Efficacy Study Of Pregabalin (CI-1008) For Pain Associated With Diabetic Peripheral Neuropathy

TypeinterventionalSponsorPfizer's Upjohn has merged with Mylan to form Viatris Inc.Ran2008 to 2010Enrolled123ConditionsDiabetic Neuropathy, PainfulArmspregabalin
NCT00553475 phase3completednot on this map

Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin (CI-1008) In The Treatment For Pain Associated With Diabetic Peripheral Neuropathy

TypeinterventionalSponsorPfizer's Upjohn has merged with Mylan to form Viatris Inc.Ran2007 to 2009Enrolled314ConditionsDiabetic Neuropathy, PainfulArmsplacebo, pregabalin
NCT01202227 phase3completednot on this map

An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain (Post Spinal Cord Injury Pain, Post Stroke Pain, And Multiple Sclerosis Pain)

TypeinterventionalSponsorPfizer's Upjohn has merged with Mylan to form Viatris Inc.Ran2010 to 2012Enrolled104ConditionsSpinal Cord Diseases, Spinal Cord Injuries, Neuralgia, PainArmspregabalin
NCT03714867 phase4withdrawnnot on this mapstarted 2019, after this paper: background citation

Use of Single Dose Pre-Operative Pregabalin for Post-Operative Analgesia in Bilateral Head and Neck Cancer Surgery: A Randomized, Double-Blinded, Placebo-Controlled Trial

TypeinterventionalSponsorAugusta UniversityRan2019 to 2020Enrolled0ConditionsHead and Neck Cancer, Pain, PostoperativeArmsPregabalin 150mg, Placebo
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Trial
  2. Review
  3. Review
  4. Pregabalin in the Management of Painful Diabetic Neuropathy: A Narrative Review.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2019
    Review
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Setsuro OgawaDepartment of Anesthesiology, Nihon University School of Medicine/Surugadai Nihon University Hospital, Tokyo, Japan.
Akio ArakawaPortfolio and Project Management, Pfizer Japan Inc., Tokyo, Japan.
Kazuhiro HayakawaMedical Affairs, Pfizer Japan Inc., Tokyo, Japan.
Tamotsu YoshiyamaClinical Statistics, Pfizer Japan Inc., 3-22-7 Yoyogi, Shibuya-ku, Tokyo, 151-8589, Japan. tamotsu.yoshiyama@pfizer.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveLimited research exists to support the extrapolation of the analgesic efficacy of pregabalin from one neuropathic pain condition to another. This retrospective analysis evaluated similarities in the efficacy of pregabalin for treating neuropathic pain associated with post-herpetic neuralgia (PHN), diabetic peripheral neuropathy (DPN), and spinal cord injury (SCI) in a Japanese population, as a basis for considering the extrapolation of these data to other neuropathic pain conditions.

methodsData were analysed across pregabalin doses within each pain condition, from three comparable 13- to 16-week, randomized, double-blind, placebo-controlled trials (RCTs) and the corresponding 52-week, open-label extension trials of pregabalin in Japanese patients with PHN, DPN or SCI. Efficacy outcomes in the RCTs included endpoint and weekly mean pain and sleep interference scores; endpoint proportions of responders in pain; Patient Global Impression of Change scores; and 36-Item Short Form Health Survey (SF-36) scores or Hospital Anxiety and Depression Scale (HADS) assessments. Study discontinuation rates were compared between treatment groups. The extension trials assessed pain intensity, using the Short-Form McGill Pain Questionnaire.

resultsIn the RCTs for all pain conditions, significant improvements in comparison with placebo in mean pain and sleep interference scores were evident after 1 week with pregabalin and were sustained throughout the treatment periods (p < 0.05). At the study endpoint, in comparison with placebo, a significantly greater percentage of pregabalin-treated patients experienced a ≥30 % reduction in pain across the RCTs (p < 0.05), and pregabalin significantly improved six of 16 SF-36 subscale scores in the PHN and DPN trials (p < 0.05). In the SCI trial, pregabalin-treated patients had numerically better outcomes of HADS scores. In the extension trials, improvements in pain intensity were maintained over a 52-week period.

conclusionSimilarities in the pregabalin efficacy profiles, including time to onset and magnitude of response, were confirmed regardless of the neuropathic pain condition. These data support the potential for extrapolating analgesic efficacy to other neuropathic pain conditions. CLINICALTRIALS. GOV IDENTIFIERS: NCT00394901, NCT00553475, NCT00407745, NCT00424372, NCT00553280, NCT01202227.

Indexed as

AdultAgedAged, 80 and overAnalgesicsDiabetic NeuropathiesDouble-Blind MethodFemaleHumansMaleMiddle AgedNeuralgiaNeuralgia, PostherpeticPain MeasurementPregabalinRandomized Controlled Trials as TopicRetrospective StudiesAnalgesicsPregabalin

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

and 1 more above

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.