International journal of clinical pharmacology and therapeutics · 2002
Trospium chloride in patients with detrusor overactivity: meta-analysis of placebo-controlled, randomized, double-blind, multi-center clinical trials on the efficacy and safety of 20 mg trospium chloride twice daily.
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Fröhlich G, Bulitta M, Strösser W
Аннотация
OBJECTIVES: Primary objective of this meta-analysis was to produce a systematic and quantitative review of two independent clinical trials of 20 mg trospium chloride (TCI) twice daily (b.i.d.) in patients with detrusor overactivity [Alloussi et al. 1998, Cardozo et al. 2000].
PATIENTS AND METHODS: In two placebo-controlled, double-blind, multi-center studies, the effect of TCl on detrusor function was evaluated using urodynamic measurements. All 517 patients were randomized to receive TCl or placebo for 3 weeks. Urodynamic variables were measured at the beginning and at the end of the treatment. Safety was evaluated on the basis of adverse events (AEs), vital signs and laboratory tests.
RESULTS: TCl produced significant improvements in 'maximum cystometric bladder capacity' (median treatment effect = 52 ml, 95% confidence interval 32-71 ml, p<0.0001) and 'urinary volume at first unstable contraction' (median treatment effect = 48 ml, 95% confidence interval 28 to 68 ml, p = 0.0001). The patients' assessment of efficacy also showed significantly greater clinical improvement in the TCl group than in the placebo group (p < 0.0001). The patients recorded a 'cure' or a 'marked improvement' more often in the TCl group than in the placebo group (47.9% and 19.7%, respectively). TCl was well tolerated, with similar frequencies of AEs reported in both groups (TCl: 35.7%, placebo group: 38.9%).
CONCLUSIONS: Trospium chloride (20 mg twice daily) is an effective and safe medication for the treatment of detrusor overactivity.
PATIENTS AND METHODS: In two placebo-controlled, double-blind, multi-center studies, the effect of TCl on detrusor function was evaluated using urodynamic measurements. All 517 patients were randomized to receive TCl or placebo for 3 weeks. Urodynamic variables were measured at the beginning and at the end of the treatment. Safety was evaluated on the basis of adverse events (AEs), vital signs and laboratory tests.
RESULTS: TCl produced significant improvements in 'maximum cystometric bladder capacity' (median treatment effect = 52 ml, 95% confidence interval 32-71 ml, p<0.0001) and 'urinary volume at first unstable contraction' (median treatment effect = 48 ml, 95% confidence interval 28 to 68 ml, p = 0.0001). The patients' assessment of efficacy also showed significantly greater clinical improvement in the TCl group than in the placebo group (p < 0.0001). The patients recorded a 'cure' or a 'marked improvement' more often in the TCl group than in the placebo group (47.9% and 19.7%, respectively). TCl was well tolerated, with similar frequencies of AEs reported in both groups (TCl: 35.7%, placebo group: 38.9%).
CONCLUSIONS: Trospium chloride (20 mg twice daily) is an effective and safe medication for the treatment of detrusor overactivity.