An international, randomized, double-blind, placebo-controlled, phase III trial of pregabalin monotherapy in treatment of patients with fibromyalgia.
Details
Serval ID
serval:BIB_319D658B5A73
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
An international, randomized, double-blind, placebo-controlled, phase III trial of pregabalin monotherapy in treatment of patients with fibromyalgia.
Journal
Journal of Rheumatology
Working group(s)
A0081100 Investigators
Contributor(s)
Littlejohn G., Bashford G., Clemens L., Cook M., Nash P., Brown J., Cloutier C., D'Ignazio G., Latimer P., Moldofsky H., Wade A., Giguere N., Young M., Fitzcharles M., Baron M., Sutton I., Danneskiold-Samsoe B., Bjerregaard K., Perrot S., Blotman F., Hatron P., Laurent B., Riaux F., Buttgereit F., Burmester GR., Krause A., Pongratz D., Weiss T., Misra R., Singh Y., Mehta P., Bhandari G., Mehta P., Puri S., Bombardieri S., Giamberardino M., De Tommaso M., Malavolta N., Gerli R., Bae SC., Lee SH., Suh CH., Hernandez-Paz R., Abud-Mendoza C., Garza-Elizondo M., Martinez-Lavin M., André R., Branco J., Faustino A., Leitão R., Vidal Fuentes J., Alegre De Miguel C., Collantes E., Carbonell J., Zachrisson O., Sörensen J., Hallstrom Y., Mansson B., Dudler J., Theiler R., Uebelhart D., Griep EN., Van Den Brink HR. , Griep-Wentink JR., Barendregt PJ., Zijlstra TR., Richards S., Marshall D., Walker D., Johnson T., Duncan B., Bencosme G., Liendo V., Villegas de Morales S.
ISSN
0315-162X (Print)
ISSN-L
0315-162X
Publication state
Published
Issued date
2011
Volume
38
Number
12
Pages
2643-2652
Language
english
Notes
Publication types: Clinical Trial, Phase III ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Publication Status: ppublish
Abstract
OBJECTIVE: To evaluate the efficacy and safety of pregabalin monotherapy versus placebo for symptomatic pain relief and improvement of patient global assessment in patients with fibromyalgia (FM) enrolled from countries outside the United States.
METHODS: This international, multicenter, double-blind, placebo-controlled trial randomly assigned 747 patients with FM to placebo or 300, 450, or 600 mg/day pregabalin twice daily for 14 weeks. Primary efficacy measures were endpoint mean pain scores and Patient Global Impression of Change (PGIC). Secondary outcomes included assessments of sleep and function.
RESULTS: Patients in the 450 mg/day pregabalin group showed significant improvements versus placebo in endpoint mean pain score (-0.56; p = 0.0132), PGIC (73% improved vs 56% placebo; p = 0.0017), and function [Fibromyalgia Impact Questionnaire (FIQ) total score -5.85; p = 0.0012]. PGIC was also significant for 600 mg/day pregabalin (69% improved; p = 0.0227). Results for these endpoints were nonsignificant for pregabalin at 300 mg/day and for pain and FIQ score at 600 mg/day. Early onset of pain relief was seen, with separation from placebo detected by Week 1 in all pregabalin groups. All pregabalin doses demonstrated superiority to placebo on the Medical Outcomes Study-Sleep Scale Sleep Disturbance subscale and the Sleep Quality diary. Dizziness and somnolence were the most frequently reported adverse events.
CONCLUSION: Pregabalin demonstrated modest efficacy in pain, global assessment, and function in FM at 450 mg/day, and improved sleep across all dose levels, but it did not provide consistent evidence of benefit at 300 and 600 mg/day in this study. Pregabalin was generally well tolerated for the treatment of FM. (Clinical trial registry NCT00333866).
METHODS: This international, multicenter, double-blind, placebo-controlled trial randomly assigned 747 patients with FM to placebo or 300, 450, or 600 mg/day pregabalin twice daily for 14 weeks. Primary efficacy measures were endpoint mean pain scores and Patient Global Impression of Change (PGIC). Secondary outcomes included assessments of sleep and function.
RESULTS: Patients in the 450 mg/day pregabalin group showed significant improvements versus placebo in endpoint mean pain score (-0.56; p = 0.0132), PGIC (73% improved vs 56% placebo; p = 0.0017), and function [Fibromyalgia Impact Questionnaire (FIQ) total score -5.85; p = 0.0012]. PGIC was also significant for 600 mg/day pregabalin (69% improved; p = 0.0227). Results for these endpoints were nonsignificant for pregabalin at 300 mg/day and for pain and FIQ score at 600 mg/day. Early onset of pain relief was seen, with separation from placebo detected by Week 1 in all pregabalin groups. All pregabalin doses demonstrated superiority to placebo on the Medical Outcomes Study-Sleep Scale Sleep Disturbance subscale and the Sleep Quality diary. Dizziness and somnolence were the most frequently reported adverse events.
CONCLUSION: Pregabalin demonstrated modest efficacy in pain, global assessment, and function in FM at 450 mg/day, and improved sleep across all dose levels, but it did not provide consistent evidence of benefit at 300 and 600 mg/day in this study. Pregabalin was generally well tolerated for the treatment of FM. (Clinical trial registry NCT00333866).
Keywords
Adult, Aged, Aged, 80 and over, Analgesics/pharmacology, Analgesics/therapeutic use, Double-Blind Method, Female, Fibromyalgia/complications, Fibromyalgia/drug therapy, Humans, Male, Middle Aged, Placebos/therapeutic use, Questionnaires, Sleep/drug effects, Sleep Disorders/drug therapy, Sleep Disorders/etiology, Treatment Outcome, Young Adult, gamma-Aminobutyric Acid/analogs & derivatives, gamma-Aminobutyric Acid/pharmacology
Pubmed
Web of science
Create date
26/04/2013 10:32
Last modification date
20/08/2019 14:16
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