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Improved quality of life in patients with overactive bladder symptoms treated with solifenacin.

BJU International 2005 January
OBJECTIVE: To assess the effect of solifenacin succinate treatment on quality of life (QoL) measured in clinical trials in patients with overactive bladder (OAB).

PATIENTS AND METHODS: QoL data using the King's Health Questionnaire (KHQ) were analysed from two phase-3, 12-week studies (1984 patients) and a long-term extension of these studies (1637 patients) where patients received solifenacin for up to an additional 40 weeks (i.e. a 52-week exposure to solifenacin). The 12-week studies were multinational, multicentre, randomized, double-blind, and placebo-controlled. The 10 domains from the KHQ evaluated were general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy, severity measures, and symptom severity. Changes from baseline to endpoint in QoL variables were assessed by analysis of variance, and from pooled outcomes of the 12-week studies by analysis of covariance. Descriptive statistics were used to evaluate data in the extension study.

RESULTS: In the two 12-week studies (1033 and 857 patients), those receiving once-daily solifenacin had statistically significantly better QoL than those on placebo. Changes in the KHQ were statistically significantly (P < 0.05) different from placebo for both solifenacin 5 and 10 mg once daily on five of the 10 KHQ domains in each of the studies. Pooled data from the two 12-week studies showed statistically significant (P < 0.05) differences from placebo for both solifenacin doses in nine of the 10 domains. Improvements in QoL scores for solifenacin were 35-48% in nine of the 10 domains for the 1347 patients providing QoL data in the extension study. About two-thirds of this overall improvement occurred during the original 12-week study, with an additional third reported during the extension, with an improvement in QoL over time in patients treated with solifenacin.

CONCLUSIONS: Results from the KHQ in study participants in the two double-blind studies showed that solifenacin significantly improved the QoL in patients with OAB symptoms after 12 weeks of treatment, with further improvements during long-term administration up to 1 year. Clinical trial outcomes show a favourable balance of efficacy and tolerability with solifenacin; the present report further supports this efficacy and tolerability by providing evidence for both short- and long-term improvements in QoL.

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