gms | German Medical Science

78. Jahresversammlung der Deutschen Gesellschaft für Hals-Nasen-Ohren-Heilkunde, Kopf- und Hals-Chirurgie e. V.

Deutsche Gesellschaft für Hals-Nasen-Ohren-Heilkunde, Kopf- und Hals-Chirurgie e. V.

16.05. - 20.05.2007, München

Randomized, double blind, placebo controlled trial on the safety and efficacy of continuous intratympanic dexamethasone delivered via catheter for severe to profound sudden idiopathic sensorineural hearing loss after failure of systemic therapy

Meeting Abstract

  • corresponding author Stefan K. Plontke - Dept. of Otolaryngology, University of Tuebingen, Tuebingen, Germany
  • author Hubert Loewenheim - Dept. of Otolaryngology, University of Tuebingen, Tuebingen, Germany
  • Juergen Mertens - St. Vinzentius-Hospital, Karlsruhe, Germany
  • Andreas Weidner - St. Vinzentius-Hospital, Karlsruhe, Germany
  • author Christoph Meisner - Institute for Medical Information Technology, Tuebingen, Germany
  • author Rainer Zimmermann - Dept. of Otolaryngology, University of Tuebingen, Tuebingen, Germany
  • author Serena Preyer - Dept. of Otolaryngology, University of Tuebingen, Tuebingen, Germany
  • author Assen Koitschev - Dept. of Otolaryngology, University of Tuebingen, Tuebingen, Germany
  • author Hans-Peter Zenner - Dept. of Otolaryngology, University of Tuebingen, Tuebingen, Germany

German Society of Oto-Rhino-Laryngology, Head and Neck Surgery. 78th Annual Meeting of the German Society of Oto-Rhino-Laryngology, Head and Neck Surgery. Munich, 16.-20.05.2007. Düsseldorf, Köln: German Medical Science; 2007. Doc07hno009

Die elektronische Version dieses Artikels ist vollständig und ist verfügbar unter: http://www.egms.de/de/meetings/hno2007/07hno009.shtml

Veröffentlicht: 8. August 2007

© 2007 Plontke et al.
Dieser Artikel ist ein Open Access-Artikel und steht unter den Creative Commons Lizenzbedingungen (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.de). Er darf vervielf&aauml;ltigt, verbreitet und &oauml;ffentlich zug&aauml;nglich gemacht werden, vorausgesetzt dass Autor und Quelle genannt werden.


Gliederung

Text

Background: The prognosis for complete recovery of hearing in patients with severe to profound idiopathic sudden sensorineural hearing loss (ISSHL) -especially after failure of systemic therapy - is poor. With local drug delivery higher inner ear drug levels can be reached while systemic side effects are minimized.

Methods: The study was performed as a GCP-conform, randomized, double-blind, placebo controlled multicenter trial. Twelve to twenty-one days after severe to profound ISSHL or sudden idiopathic anacusis and insufficient recovery after systemic high dose glucocorticoid therapy patients received either dexamethasone-21-dihydrogenphosphate (4mg/ml) or placebo (NaCl 0,9%) continuously applied for 14 days into the round window niche via a temporarily implanted catheter. In all cases of incomplete hearing recovery during the study period, treatment was continued for another 14 days with verum medication. As requested by the regulatory body (BfArM) an interim analysis was performed after inclusion of 23 patients.

Results: Intention-to-treat interim analysis for the primary outcome criterion during the placebo controlled study period (14 days) showed an average hearing improvement in the treatment group of 13.9 dB (95% CI: -0.4; 28.2) for the pure tone average (4-PTA: 0.5 to 3kHz) and in the placebo group of 5.4 dB (95% CI: -2.0; 12.9). The difference in hearing improvement was statistically not significant (0.26). No serious adverse events were observed.

Discussion: With respect to the conservative inclusion criteria, the limited placebo-controlled observation period and the absence of serious adverse events, the results support to further investigate this treatment option with an earlier start of this second line or "rescue therapy" after ISSHL or even as an primary therapeutic option.

This study was supported by University of Tuebingen fortüne grant 66-0-0 (to SKP).