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Efficacy of solifenacin in patients with severe symptoms of overactive bladder: a pooled analysis.
Curr Med Res Opin. 2006 Jan; 22(1):41-8.CM

Abstract

BACKGROUND

The efficacy of antimuscarinic drug therapy in patients who have more severe symptoms of overactive bladder (OAB) at baseline has not been evaluated thoroughly.

OBJECTIVE

This analysis determined the effects of solifenacin in patients with severe OAB symptoms at baseline.

METHODS

All randomized, placebo-controlled phase III studies of solifenacin were pooled to determine the effects in patients with severe OAB symptoms at baseline. In these studies, patients were randomized to treatment with placebo or solifenacin 5 or 10 mg once daily. Baseline severity was defined according to the number of incontinence episodes/24 h, number of urgency episodes/24 h, and micturition frequency/24 h. The proportion of patients with restoration of continence, resolution of urgency, and normalization of micturition frequency at endpoint was determined. Mean change from baseline to endpoint in the number of episodes/24 h for incontinence, urgency, and micturition, and in the volume voided/micturition were assessed. Comparisons of change from baseline to endpoint were done with analysis of covariance (ANCOVA), and comparisons of percentage change from baseline to endpoint were based on van Elteren's test.

RESULTS

Results from four multinational phase III studies of solifenacin with 2848 patients were pooled. The proportion of patients with restoration of continence, resolution of urgency, and normalization of micturition frequency at endpoint was significantly greater with solifenacin than with placebo among patients with severe OAB at baseline. Solifenacin 5 and 10 mg were significantly (p < 0.05) more effective than placebo for reductions in the number of episodes of incontinence, urgency, and micturition, and for the increase in volume voided/micturition among most subgroups of patients who were highly symptomatic at baseline (incontinence, urgency, or micturitions).

CONCLUSION

Solifenacin was significantly more effective than placebo for patients with severe symptoms of OAB. The significant and consistent response was observed for all endpoints with solifenacin 10 mg and for most endpoints with solifenacin 5 mg using different definitions of baseline disease severity, and supports the overall effectiveness of solifenacin in highly symptomatic patients.

Authors+Show Affiliations

Department of Surgery, Prince of Wales Hospital, New South Wales, Australia. millardr@sesahs.nsw.gov.auNo affiliation info available

Pub Type(s)

Journal Article
Meta-Analysis
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16393429

Citation

Millard, R J., and M Halaska. "Efficacy of Solifenacin in Patients With Severe Symptoms of Overactive Bladder: a Pooled Analysis." Current Medical Research and Opinion, vol. 22, no. 1, 2006, pp. 41-8.
Millard RJ, Halaska M. Efficacy of solifenacin in patients with severe symptoms of overactive bladder: a pooled analysis. Curr Med Res Opin. 2006;22(1):41-8.
Millard, R. J., & Halaska, M. (2006). Efficacy of solifenacin in patients with severe symptoms of overactive bladder: a pooled analysis. Current Medical Research and Opinion, 22(1), 41-8.
Millard RJ, Halaska M. Efficacy of Solifenacin in Patients With Severe Symptoms of Overactive Bladder: a Pooled Analysis. Curr Med Res Opin. 2006;22(1):41-8. PubMed PMID: 16393429.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of solifenacin in patients with severe symptoms of overactive bladder: a pooled analysis. AU - Millard,R J, AU - Halaska,M, PY - 2006/1/6/pubmed PY - 2006/4/21/medline PY - 2006/1/6/entrez SP - 41 EP - 8 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 22 IS - 1 N2 - BACKGROUND: The efficacy of antimuscarinic drug therapy in patients who have more severe symptoms of overactive bladder (OAB) at baseline has not been evaluated thoroughly. OBJECTIVE: This analysis determined the effects of solifenacin in patients with severe OAB symptoms at baseline. METHODS: All randomized, placebo-controlled phase III studies of solifenacin were pooled to determine the effects in patients with severe OAB symptoms at baseline. In these studies, patients were randomized to treatment with placebo or solifenacin 5 or 10 mg once daily. Baseline severity was defined according to the number of incontinence episodes/24 h, number of urgency episodes/24 h, and micturition frequency/24 h. The proportion of patients with restoration of continence, resolution of urgency, and normalization of micturition frequency at endpoint was determined. Mean change from baseline to endpoint in the number of episodes/24 h for incontinence, urgency, and micturition, and in the volume voided/micturition were assessed. Comparisons of change from baseline to endpoint were done with analysis of covariance (ANCOVA), and comparisons of percentage change from baseline to endpoint were based on van Elteren's test. RESULTS: Results from four multinational phase III studies of solifenacin with 2848 patients were pooled. The proportion of patients with restoration of continence, resolution of urgency, and normalization of micturition frequency at endpoint was significantly greater with solifenacin than with placebo among patients with severe OAB at baseline. Solifenacin 5 and 10 mg were significantly (p < 0.05) more effective than placebo for reductions in the number of episodes of incontinence, urgency, and micturition, and for the increase in volume voided/micturition among most subgroups of patients who were highly symptomatic at baseline (incontinence, urgency, or micturitions). CONCLUSION: Solifenacin was significantly more effective than placebo for patients with severe symptoms of OAB. The significant and consistent response was observed for all endpoints with solifenacin 10 mg and for most endpoints with solifenacin 5 mg using different definitions of baseline disease severity, and supports the overall effectiveness of solifenacin in highly symptomatic patients. SN - 0300-7995 UR - https://www.unboundmedicine.com/medline/citation/16393429/Efficacy_of_solifenacin_in_patients_with_severe_symptoms_of_overactive_bladder:_a_pooled_analysis_ L2 - https://www.tandfonline.com/doi/full/10.1185/030079905X74907 DB - PRIME DP - Unbound Medicine ER -