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Efficacy and tolerability of tolterodine extended‐release in continent patients with overactive bladder and nocturia
Author(s) -
NITTI VICTOR W.,
DMOCHOWSKI ROGER,
APPELL RODNEY A.,
WANG JOSEPH T.,
BAVENDAM TAMARA,
GUAN ZHONGHONG
Publication year - 2006
Publication title -
bju international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.773
H-Index - 148
eISSN - 1464-410X
pISSN - 1464-4096
DOI - 10.1111/j.1464-410x.2006.06146.x
Subject(s) - tolterodine , nocturia , overactive bladder , tolerability , medicine , placebo , urology , adverse effect , post hoc analysis , urinary system , alternative medicine , pathology
OBJECTIVE To evaluate the clinical efficacy and tolerability of tolterodine extended‐release (ER) in continent patients with overactive bladder (OAB) and nocturia. PATIENTS AND METHODS A post hoc analysis was conducted of data from a 12‐week, double‐blind study of 850 patients randomized to tolterodine ER (4 mg once daily) or placebo, taken within 4 h of going to bed. Patients with a mean of ≥ 8 voids/24 h were enrolled, including a mean of ≥ 2.5 voids/night. Patients completed 7‐day voiding diaries, and for each void an urgency rating was assessed using a 5‐point scale (1, none; 5, urgency incontinence); 24‐h voids were categorized by urgency rating: total (1–5), non‐OAB (1–2), OAB (3–4), and severe OAB (4–5) voids. All adverse events were recorded. RESULTS The post hoc analysis included 513 patients (243 placebo; 270 tolterodine ER; 58% men) who were continent at baseline; 47% of 24‐h voids were classed as non‐OAB, and 12% as severe OAB. After 12 weeks of treatment, tolterodine ER significantly reduced mean urgency rating and 24‐h OAB, severe OAB, and total voids vs placebo. Tolterodine ER did not affect normal, non‐OAB voids, and there were no significant adverse events related to voiding. Other than dry mouth (tolterodine ER, 9% vs placebo, 2%), all the adverse events were reported in <3% of patients; <2% of patients receiving tolterodine ER withdrew because of adverse events. CONCLUSIONS In continent patients with OAB, tolterodine ER significantly improved urgency rating and reduced 24‐h OAB, severe OAB, and total voids, suggesting that it is an effective and well‐tolerated treatment option for this subpopulation. More studies are needed to better understand the clinical efficacy of tolterodine ER in this under evaluated group of OAB patients without incontinence.