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.
RCT Entities:
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.
Authors: M Otto; L Cepek; P Ratzka; S Doehlinger; I Boekhoff; J Wiltfang; E Irle; G Pergande; B Ellers-Lenz; O Windl; H A Kretzschmar; S Poser; H Prange Journal: Neurology Date: 2004-03-09 Impact factor: 9.910
Authors: Lionel D Lewis; Andrew Somogyi; Yoon K Loke; Albert Ferro; Adam F Cohen; James M Ritter Journal: Br J Clin Pharmacol Date: 2013-01 Impact factor: 4.335