Tolterodine: A Safe and Effective Treatment for Older Patients with Overactive Bladder

• Published in: Journal of the American Geriatrics Society (JAGS) 2001-06, Vol.49 (6), p.700-705
• Main Authors: Malone-Lee, James G., Walsh, J. Bernard, Maugourd, Marie-France, The Tolterodine in the Elderly Study Group
• Format: Article
• Language: English
• Subjects: Age Factors; Aged; Aged, 80 and over; Benzhydryl Compounds - pharmacology; Benzhydryl Compounds - therapeutic use; Biological and medical sciences; Bladder disorders; Clinical trials; Cresols - pharmacology; Cresols - therapeutic use; Double-Blind Method; Drug Monitoring; Drug therapy; Drugs; Elderly people; Female; Humans; Male; Medical sciences; Middle Aged; Muscarinic Antagonists - pharmacology; Muscarinic Antagonists - therapeutic use; Nephrology. Urinary tract diseases; older; Older people; overactive bladder; Pharmacology. Drug treatments; Phenylpropanolamine; Placebos; Safety; tolterodine; Tolterodine Tartrate; Treatment; Treatment Outcome; Urinary incontinence; Urinary Incontinence - diagnosis; Urinary Incontinence - drug therapy; Urinary Incontinence - etiology; Urinary Incontinence - physiopathology; Urinary system; Urinary system involvement in other diseases. Miscellaneous; Urinary tract. Prostate gland; Urination Disorders - diagnosis; Urination Disorders - drug therapy; Urination Disorders - etiology; Urination Disorders - physiopathology; Xerostomia - chemically induced
• ISSN: 0002-8614; 1532-5415
• DOI: 10.1046/j.1532-5415.2001.49144.x

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 ≥65 years) with symptoms of urinary urgency, increased frequency of micturition (≥8 micturitions/24 hours), and/or urge incontinence (≥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, ≥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. J Am Geriatr Soc 49:700–705, 2001.