RESUMO
OBJECTIVE: To investigate the clinical safety and efficacy of two dosages of tolterodine in older patients with symptoms attributable to overactive bladder. DESIGN: Randomized, double-blind, placebo-controlled, parallel-group, multinational, phase III study. SETTING: Incontinence, older care, urological, and urogynecological clinics in the United Kingdom, France, and the Republic of Ireland. PARTICIPANTS: One hundred and seventy-seven older patients (age > or =65 years) with symptoms of urinary urgency, increased frequency of micturition (> or =8 micturitions/24 hours), and/or urge incontinence (> or =1 episode/24 hours). INTERVENTION: Tolterodine 1 mg or 2 mg twice daily (bid), or placebo, for 4 weeks. MEASUREMENTS: Safety and tolerability were evaluated through spontaneously reported adverse events, electrocardiogram, and blood pressure measurements. Efficacy was assessed using micturition diary variables: mean change from baseline in frequency of micturition and number of incontinence episodes/24 hours. RESULTS: The mean age of the patient population was 75 years. Overall, > or =87% of patients completed the study. Neither dosage of tolterodine was associated with serious drug-related adverse events during the study. No cardiac arrythmogenic events were noted. Dry mouth (mild to moderate intensity) was the most common adverse event in both the placebo and tolterodine treatment groups. Three percent of patients in the tolterodine 2 mg bid group discontinued treatment because of dry mouth, compared with 2% of placebo-treated patients. Compared with placebo, statistically significant decreases in micturition frequency were apparent in both tolterodine treatment groups. Furthermore, patients treated with tolterodine 2 mg bid had statistically significant decreases in urge incontinence episodes/24 hours and increases in volume voided per micturition compared with placebo. CONCLUSION: Tolterodine (taken for 4 weeks) is safe and shows efficacy, particularly at a dosage of 2 mg bid, in the treatment of older patients with urinary symptoms attributable to overactive bladder.
Assuntos
Compostos Benzidrílicos/uso terapêutico , Cresóis/uso terapêutico , Antagonistas Muscarínicos/uso terapêutico , Fenilpropanolamina , Incontinência Urinária/tratamento farmacológico , Transtornos Urinários/tratamento farmacológico , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Compostos Benzidrílicos/farmacologia , Cresóis/farmacologia , Método Duplo-Cego , Monitoramento de Medicamentos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Antagonistas Muscarínicos/farmacologia , Placebos , Segurança , Tartarato de Tolterodina , Resultado do Tratamento , Incontinência Urinária/diagnóstico , Incontinência Urinária/etiologia , Incontinência Urinária/fisiopatologia , Transtornos Urinários/diagnóstico , Transtornos Urinários/etiologia , Transtornos Urinários/fisiopatologia , Xerostomia/induzido quimicamenteRESUMO
THERAPEUTIC OPTIONS: Appropriate management of urinary incontinence in the elderly basically depends on the patient's medical status and degree of dependence and the type of incontinence. For outpatients, secondary effects of drugs limit their use, in favor of behavioral intervention and pelvic floor training, with good success. Recently proposed surgical approaches offer a promising alternative for the aged population. TEAM MANAGEMENT: Assessment and management of institutional urinary incontinence should be systematically elaborated by the medical care team. Potentially reversible conditions and precipitating factors may be causing or contributing to the incontinence. Their correction and bladder training are the principal items of the management scheme.