Onset of efficacy of tolterodine extended release in patients with overactive bladder.
OBJECTIVE
To assess the onset of efficacy of tolterodine extended release (ER) in patients with overactive bladder (OAB).


METHODS
A post hoc analysis was conducted using 3-day bladder diary data from a 12-week, multicenter, prospective, open-label study of tolterodine ER (4 mg qd) in patients (aged > or = 18 years) with urinary frequency (> or = 8 micturitions/24 h) and urgency (strong and sudden desire to urinate) with or without urgency urinary incontinence (UUI).


METHODS
Changes in micturition frequency, urgency, and UUI episodes/24 h were evaluated for treatment Days 5, 6, and 7. The percentages of patients who achieved normal micturition frequency (< 8/day) and 50%, 70%, 90%, and 100% reductions in urgency and UUI episodes (i.e., responders) were determined at Days 5, 6, and 7. Week 12 data are presented as a referent for the magnitude of treatment efficacy during Week 1.


RESULTS
This analysis included 698 patients. On Day 5, there were significant reductions in all three diary variables (all p < 0.0001), and improvements continued on Days 6 and 7. More than half of the patients reported > or = 50% reductions in urgency or UUI episodes on Day 5. Responder rates for all three symptoms increased through Week 12.


CONCLUSIONS
Patients with OAB experienced significant reductions in OAB symptoms as early as Day 5 of treatment with tolterodine ER. These data extend the findings of a previous analysis, in which all 3 days of the bladder diary were pooled, that demonstrated improvements in micturition frequency, urgency episodes, and UUI episodes in patients with OAB after 1 week of treatment with tolterodine ER. Limitations are that efficacy was not assessed before Day 5, this was a post hoc analysis, and the study was not placebo-controlled.
Sussman
David O
DO
University of Medicine and Dentistry of New Jersey, Stratford, NJ 08084, USA. dosuss@comcast.net <dosuss@comcast.net>
Kraus
Stephen R
SR
Carlsson
Martin
M
Guan
Zhonghong
Z
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001559:Benzhydryl Compounds / Q000008:administration & dosage / Q000627:therapeutic use*; D003408:Cresols / Q000008:administration & dosage / Q000627:therapeutic use*; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000008:administration & dosage; D010665:Phenylpropanolamine / Q000008:administration & dosage / Q000627:therapeutic use*; D013997:Time Factors; D000068737:Tolterodine Tartrate; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000188:drug therapy*
D001559:Benzhydryl Compounds; D003408:Cresols; D003692:Delayed-Action Preparations; D018727:Muscarinic Antagonists; D010665:Phenylpropanolamine; D000068737:Tolterodine Tartrate