Article date: May 2012
By: Martin C. Michel, Piotr Radziszewski, Christian Falconer, Daniela Marschall‐Kehrel, Koenraad Blot, in Volume 73, Issue 5, pages 821-825
WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT
AIMS
To determine efficacy of the analgesic flupirtine in the treatment of overactive bladder syndrome in a proof‐of‐concept study.
METHODS
Double‐blind, double‐dummy, three‐armed comparison of flupirtine extended release (400 mg/day, titrated to 600 mg/day), tolterodine extended release (4 mg/day) and placebo for 12 weeks.
RESULTS
When major elevations of liver enzymes (more than three times the upper normal limit) were detected in several flupirtine‐exposed patients, the study was prematurely discontinued. Based on study‐end data, hepatotoxicity was detected in 31% of patients receiving flupirtine for ≥6 weeks.
CONCLUSIONS
Unexpected frequent and relevant toxicity can occur when testing an established drug for a new indication.
DOI: 10.1111/j.1365-2125.2011.04138.x
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