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A Randomized, Double Blind, Placebo-Controlled Trial of Pioglitazone in Combination with Riluzole in Amyotrophic Lateral Sclerosis

Please always quote using this URN: urn:nbn:de:bvb:20-opus-130255
  • 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 andBackground: 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.show moreshow less

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Metadaten
Author: Luc Dupuis, Reinhard Dengler, Michael T. Heneka, Thomas Meyer, Stephan Zierz, Jan Kassubek, Wilhelm Fischer, Franziska Steiner, Eva Lindauer, Markus Otto, Jens Dreyhaupt, Torsten Grehl, Andreas Hermann, Andrea S. Winkler, Ulrich Bogdahn, Reiner Benecke, Bertold Schrank, Carsten Wessig, Julian Grosskreutz, Albert C. Ludolph
URN:urn:nbn:de:bvb:20-opus-130255
Document Type:Journal article
Faculties:Medizinische Fakultät / Neurologische Klinik und Poliklinik
Language:English
Parent Title (English):PLoS One
Year of Completion:2012
Volume:7
Issue:6
Pagenumber:e37885
Source:PLoS ONE 7(6): e37885. doi:10.1371/journal.pone.0037885
DOI:https://doi.org/10.1371/journal.pone.0037885
Dewey Decimal Classification:6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit
Tag:ALS; PPAR-gamme; SOD1 mutations; central nervous system; delays progression; disease progression; hexanucleotide repeat; monocycline; nonalcoholic steatohepatitis; transgenic mouse model
Release Date:2016/11/28
Licence (German):License LogoCC BY: Creative-Commons-Lizenz: Namensnennung