A Randomized, Double-Blind, Placebo-Controlled Trial of Duloxetine for the Treatment of Pain in Patients with Multiple Sclerosis.
Background Patients with multiple sclerosis ( MS) often report neuropathic pain ( NP- MS). The purpose of this study was to assess the efficacy and tolerability of duloxetine as treatment for NP- MS. Methods In this study, 239 adults with NP- MS (duloxetine = 118, placebo = 121) were randomized to d...
| Published in: | Pain Practice Vol. 14; no. 8; pp. 732 - 745 |
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| Main Authors: | , , , |
| Format: | research tables/charts randomized controlled trial Journal Article |
| Published: |
Wiley-Blackwell
Nov2014
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| Online Access: | View this record in EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=103913471&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 103913471 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 15307085 HYN jtl: Pain Practice issn: 15307085 maglogo: Y pubinfo: dt: Nov2014 vid: 14 iid: 8 pid: 480 pub: Wiley-Blackwell place: Malden, Massachusetts artinfo: ui: 103913471 99218518 10.1111/papr.12127 NLM24152240 103913471 ppf: 732 ppct: 13 formats: fmt: @attributes: type: P tig: atl: A Randomized, Double-Blind, Placebo-Controlled Trial of Duloxetine for the Treatment of Pain in Patients with Multiple Sclerosis. aug: au: Vollmer, Timothy L. Robinson, Michael J. Risser, Richard C. Malcolm, Sandra K. affil: Department of Neurology, University of Colorado Health Sciences Center sug: subj: Duloxetine Hydrochloride Administration and Dosage Multiple Sclerosis Complications Pain Etiology Pain Drug Therapy Human Randomized Controlled Trials Double-Blind Studies Placebos Administration and Dosage Descriptive Statistics Scales Fisher's Exact Test Repeated Measures Diaries Multicenter Studies Europe North America T-Tests Analysis of Covariance Data Analysis Software Analysis of Variance Male Female Wilcoxon Signed Rank Test Adult Middle Age Aged Funding Source Brief Pain Inventory Adult: 19-44 years Middle Aged: 45-64 years Aged: 65+ years Male Female ab: Background Patients with multiple sclerosis ( MS) often report neuropathic pain ( NP- MS). The purpose of this study was to assess the efficacy and tolerability of duloxetine as treatment for NP- MS. Methods In this study, 239 adults with NP- MS (duloxetine = 118, placebo = 121) were randomized to duloxetine 60 mg (30 mg for 1 week, then 60 mg for 5 weeks) or placebo once daily for a 6-week acute therapy phase, followed by a 12-week open-label extension phase (duloxetine 30 to 120 mg/day). Eligible patients had MS for ≥ 1 year and a score ≥ 4 on daily average pain intensity ( API) ratings for ≥ 4 of 7 days immediately before randomization. Patients rated API daily on an 11-point numeric scale (0 [no pain] to 10 [worst possible pain]) in an electronic diary. The primary efficacy measure, change in weekly API ratings, was analyzed longitudinally with a mixed-model repeated-measures analysis. Completion, reasons for discontinuation, and treatment-emergent adverse event incidence were compared by Fisher's exact test. Results Duloxetine-treated patients had statistically greater mean improvement in API vs. placebo at Week 6 (−1.83 vs. −1.07, P = 0.001). Treatment completion did not significantly differ between groups. Discontinuation due to adverse events was statistically greater for duloxetine vs. placebo (13.6% vs. 4.1%, P = 0.012). Decreased appetite was reported significantly more often by duloxetine-treated patients (5.9% vs. 0%, P = 0.007). Conclusions This study found analgesic efficacy of duloxetine for NP- MS. Duloxetine is not approved for treatment of this condition. The duloxetine safety profile of this study was consistent with the known profile in other patient populations. pubtype: Academic Journal doctype: research tables/charts randomized controlled trial Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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