A randomized, double blind, placebo-controlled trial of pioglitazone in combination with riluzole in amyotrophic lateral sclerosis.

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State: Public
Version: author
Serval ID
serval:BIB_923C9FD96A89
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
A randomized, double blind, placebo-controlled trial of pioglitazone in combination with riluzole in amyotrophic lateral sclerosis.
Journal
Plos One
Author(s)
Dupuis L., Dengler R., Heneka M.T., Meyer T., Zierz S., Kassubek J., Fischer W., Steiner F., Lindauer E., Otto M., Dreyhaupt J., Grehl T., Hermann A., Winkler A.S., Bogdahn U., Benecke R., Schrank B., Wessig C., Grosskreutz J., Ludolph A.C.
Working group(s)
GERP ALS Study Group
Contributor(s)
Borisow N., Holm T., Maier A., Meyer T., Budde P., Grehl T., Guettsches AK., Bewersdorff M., Heneka M., Hermann A., Storch A., Frank T., Göricke B., Weishaupt J., Eger K., Hanisch F., Zierz S., Cordes AL., Dengler R., Koerner S., Kollewe K., Petri S., Grosskreutz J., Kunze A., Prell T., Ringer T., Zinke J., Anneser J., Borasio GD., Chahli C., Winkler AS., Boentert M., Stubbe-Draeger B., Young P., Bogdahn U., Franz S., Haringer V., Weidner N., Benecke R., Meister S., Prudlo J., Wittstock M., Dorst J., Hendrich C., Ludolph AC., Sperfeld AD., Weiland U., Neidhardt S., Schrank B., Beck M., Kraft P., Toyka K., Ulzheimer J., Wessig C.
ISSN
1932-6203 (Electronic)
ISSN-L
1932-6203
Publication state
Published
Issued date
2012
Volume
7
Number
6
Pages
e37885
Language
english
Notes
Publication types: Journal Article ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Abstract
BACKGROUND: Pioglitazone, an oral anti-diabetic that stimulates the PPAR-gamma transcription factor, increased survival of mice with amyotrophic lateral sclerosis (ALS).
METHODS/PRINCIPAL FINDINGS: We performed a phase II, double blind, multicentre, placebo controlled trial of pioglitazone in ALS patients under riluzole. 219 patients were randomly assigned to receive 45 mg/day of pioglitazone or placebo (one: one allocation ratio). The primary endpoint was survival. Secondary endpoints included incidence of non-invasive ventilation and tracheotomy, and slopes of ALS-FRS, slow vital capacity, and quality of life as assessed using EUROQoL EQ-5D. The study was conducted under a two-stage group sequential test, allowing to stop for futility or superiority after interim analysis. Shortly after interim analysis, 30 patients under pioglitazone and 24 patients under placebo had died. The trial was stopped for futility; the hazard ratio for primary endpoint was 1.21 (95% CI: 0.71-2.07, p = 0.48). Secondary endpoints were not modified by pioglitazone treatment. Pioglitazone was well tolerated.
CONCLUSION/SIGNIFICANCE: Pioglitazone has no beneficial effects on the survival of ALS patients as add-on therapy to riluzole.
TRIAL REGISTRATION: Clinicaltrials.gov NCT00690118.
Pubmed
Web of science
Open Access
Yes
Create date
05/02/2013 15:33
Last modification date
20/08/2019 14:55
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