Efficacy and cardiac safety of propiverine in elderly patients - a double-blind, placebo-controlled clinical study.
Eur Urol
; 37(6): 702-8, 2000 Jun.
Article
en En
| MEDLINE
| ID: mdl-10828671
ABSTRACT
The study investigated the efficacy and cardiac safety of propiverine in the elderly, because the induction of life-threatening ventricular arrhythmia has been reported for some drugs prescribed in the therapy of urinary incontinence. Ninety-eight patients (21 male, 77 female; 67.7+/-6.3 years of age) suffering from urgency, urge incontinence or mixed urge-stress incontinence were included in the double-blind, multicentre, placebo-controlled, randomized study. After a 2-week placebo run-in period, the patients received propiverine (15 mg t.i.d.) or placebo (t.i.d.) for 4 weeks. Before (V1, V2) and during the treatment period (V3, V4), standard ECGs and 24-hour long-term ECGs were recorded. Propiverine caused a significant reduction of the micturition frequency (V2 8.7+/-4.2, V4 6.5+/-3.2 ml; p< or =0.01), reflected in a significant increase in the average micturition volume (V2 163.5+/-65.9, V4 216.3+/-101.5 ml; p< or =0.01) and a significant decrease in episodes of incontinence (-54%; p = 0.048). These findings were confirmed by the overall assessment at V4, in which approximately 90% of patients under propiverine either had no urge incontinence or urge symptoms, or showed improvement. Resting and ambulatory electrocardiograms indicated no significant changes. Neither the frequency-corrected Q-T interval nor other cardiac parameters were relevantly altered. The frequency of cardiac events (Lown classes IVa/b) was random, revealing no difference between placebo and propiverine. The incidence of adverse events was very low (2% dryness of the mouth under propiverine) and confirmed by the findings from the quality of life questionnaires. A favourable benefit-risk ratio without the induction of any cardiac arrhythmia in the treatment of elderly patients suffering from urgency, urge incontinence or combined urge-stress incontinence is therefore proven for propiverine.
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Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Trastornos Urinarios
/
Bencilatos
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Bloqueadores de los Canales de Calcio
/
Cardiopatías
Tipo de estudio:
Clinical_trials
/
Diagnostic_studies
/
Observational_studies
/
Risk_factors_studies
Aspecto:
Patient_preference
Límite:
Female
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Humans
/
Male
Idioma:
En
Revista:
Eur Urol
Año:
2000
Tipo del documento:
Article
País de afiliación:
Alemania