Clinical efficacy and safety of tolterodine in the treatment of overactive bladder: a pooled analysis.
OBJECTIVE
To examine the safety, efficacy, and tolerability of tolterodine in four randomized, double-blind, parallel, multicenter, 12-week studies of patients with overactive bladder.


METHODS
Two of the four studies compared tolterodine (2 mg twice daily) to oxybutynin (5 mg three times daily) and placebo, one study compared tolterodine (2 mg twice daily) to oxybutynin (5 mg three times daily), and one study compared two dosages of tolterodine (1 and 2 mg twice daily) to placebo. Efficacy was determined from micturition diaries and patient perception of their bladder condition. Safety and tolerability were assessed from adverse events and laboratory measures.


RESULTS
A total of 1,120 patients were randomized and treated at 134 centers. For the primary efficacy variable, the number of micturitions/24 hours, pooled results showed a significant decrease from baseline for the 1 mg tolterodine (P < 0.001), 2 mg tolterodine (P < 0.001), and 5 mg oxybutynin (P < 0.01) groups, compared to placebo. Both tolterodine doses and oxybutynin significantly decreased incontinence episodes/24 hours and significantly increased volume voided/micturition, compared to placebo. Tolterodine at a dose of 2 mg twice daily and 5 mg oxybutynin twice daily were significantly more effective in improving patient perception of bladder condition than placebo. Tolterodine at a dose of 2 mg and 5 mg oxybutynin were equivalent in their effectiveness. Tolterodine at doses of 1 mg and 2 mg were tolerated significantly better than oxybutynin when adverse events, dry mouth (both frequency and intensity), dose reductions, and patient withdrawals were considered.


CONCLUSIONS
Although oxybutynin is highly effective, its clinical utility is limited by systemic side effects that lead to frequent discontinuation of treatment or dose reductions. Patients receiving tolterodine should not experience these limitations and instead will get safe and long-term effective treatment for their condition.
Appell
R A
RA
Section of Voiding Dysfunction and Female Urology, Cleveland Clinic Foundation, OH 44195, USA.
D000328:Adult; D000704:Analysis of Variance; D001559:Benzhydryl Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D018680:Cholinergic Antagonists / Q000009:adverse effects / Q000627:therapeutic use; D016001:Confidence Intervals; D003408:Cresols / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008333:Mandelic Acids / Q000009:adverse effects / Q000627:therapeutic use; D018727:Muscarinic Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D010665:Phenylpropanolamine; D018709:Statistics, Nonparametric; D013997:Time Factors; D000068737:Tolterodine Tartrate; D001750:Urinary Bladder, Neurogenic / Q000188:drug therapy* / Q000503:physiopathology; D014549:Urinary Incontinence / Q000188:drug therapy / Q000503:physiopathology; D014554:Urination / Q000187:drug effects
D001559:Benzhydryl Compounds; D018680:Cholinergic Antagonists; D003408:Cresols; D008333:Mandelic Acids; D018727:Muscarinic Antagonists; D010665:Phenylpropanolamine; D000068737:Tolterodine Tartrate; C005419:oxybutynin