Abstract | OBJECTIVE: METHODS: This was a pooled analysis of 4 randomized, placebo-controlled 12-week, phase 3 studies. Patients received placebo or solifenacin 10 mg once daily (2 studies), or placebo or solifenacin 5 mg or 10 mg once daily (2 studies). A subgroup of patients without incontinence at baseline was identified from a 3-day diary. Mean changes from baseline to endpoint for urgency episodes, micturition, frequency and nocturia episodes per 24 hours, and volume voided/micturition were evaluated. The proportion of patients with normalization of micturition frequency (<8 micturitions), resolution of urgency, or resolution of nocturia at endpoint was also determined. RESULTS: Of 2848 evaluable patients treated with placebo or solifenacin, 975 (34%) were OAB dry at baseline. Solifenacin 5 mg and 10 mg were significantly (p < 0.001) more effective than placebo for improving urgency, micturition frequency, and volume voided. In addition, solifenacin 10mg was significantly (p < 0.01) more effective than placebo for improving nocturia. Resolution of urgency occurred significantly (p < 0.05) more often with solifenacin 5 mg (37%) and 10 mg (33%) than with placebo (25%). Significantly (p < 0.01) more OAB dry patients had normalization of micturition frequency with solifenacin 5 mg (29%) and 10 mg (35%) compared with placebo (19%). Resolution of nocturia occurred in 14%, 21%, and 13% of patients treated with solifenacin 5mg, solifenacin 10 mg, and placebo, respectively (p < 0.01 for solifenacin 10 mg versus placebo). CONCLUSION:
Solifenacin significantly improved urgency, frequency, and nocturia symptoms and increased volume voided in OAB dry patients.
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Authors | Paul Abrams, Steven Swift |
Journal | European urology
(Eur Urol)
Vol. 48
Issue 3
Pg. 483-7
(Sep 2005)
ISSN: 0302-2838 [Print] Switzerland |
PMID | 16005564
(Publication Type: Journal Article, Meta-Analysis, Research Support, Non-U.S. Gov't)
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Chemical References |
- Quinuclidines
- Tetrahydroisoquinolines
- Solifenacin Succinate
|
Topics |
- Adult
- Clinical Trials, Phase III as Topic
- Female
- Humans
- Male
- Middle Aged
- Quinuclidines
(administration & dosage, therapeutic use)
- Randomized Controlled Trials as Topic
- Solifenacin Succinate
- Tetrahydroisoquinolines
(administration & dosage, therapeutic use)
- Treatment Outcome
- Urinary Incontinence
(drug therapy)
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