Tolterodine: A safe and effective treatment for older patients with overactive bladder

OBJECTIVE: To investigate the clinical safety and efficacy of two dosages o f tolterodine in older patients with symptoms attributable to overactive bl adder. DESIGN: Randomized, double-blind, placebo-controlled, parallel-group, multi national, 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 65 years) w ith symptoms of urinary urgency, increased frequency of micturition (greate r than or equal to8 micturitions/24 hours), and/or urge incontinence (great er than or equal to1 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/2 4 hours. RESULTS: The mean age of the patient population was 75 years. Overall, grea ter than or equal to 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 a nd tolterodine treatment groups. Three percent of patients in the tolterodi ne 2 mg bid group discontinued treatment because of dry mouth, compared wit h 2% of placebo-treated patients. Compared with placebo, statistically sign ificant decreases in micturition frequency were apparent in both tolterodin e treatment groups. Furthermore, patients treated with tolterodine 2 mg bid had statistically significant decreases in urge incontinence episodes/24 h ours and increases in volume voided per micturition compared with placebo. CONCLUSION: Tolterodine (taken for 4 weeks) is safe and shows efficacy, par ticularly at a dosage of 2 mg bid, in the treatment of older patients with urinary symptoms attributable to overactive bladder.