Solifenacin significantly improves all symptoms of overactive bladder syndrome

Abstract

Overactive bladder syndrome (OAB) is a chronic condition characterised by urgency, with or without associated urge incontinence. Solifenacin succinate is a once daily, bladder selective antimuscarinic available in two doses (5 and 10 mg). The recommended dose is 5 mg once daily and can be increased to 10 mg once daily if 5 mg is well tolerated. This article presents pooled efficacy and safety data from four large, placebo-controlled, multinational phase III trials of solifenacin succinate with a total enrolment of over 2800 patients. Data from these trials show that solifenacin 5 and 10 mg once daily is significantly more effective than placebo at reducing urgency, incontinence, micturition frequency and nocturia and at increasing volume voided per micturition. Adverse events were mainly mild-to-moderate in all treatment groups. The results of these phase III trials support the use of solifenacin in the treatment of OAB.

Figure 1

The role of urgency in initiating overactive bladder syndrome symptoms (reproduced from Chapple et al. 2005– permission requested (2))

Figure 2

Study design. n = number of patients evaluated for efficacy; od = once daily. The tolterodine treatment arm was included in only one of the four phase III studies

Figure 3

Median per cent changes in overactive bladder syndrome symptoms from baseline to endpoint. *p < 0.05 vs. placebo; †p < 0.001 vs. placebo. p-values for the per cent change from baseline are based on the Van Elteren's test. od = once daily

Figure 4

Percentage of subjects achieving a clinically meaningful minimally important difference (MID) (≥5 points)‡ in King's Health Questionnaire individual domain scores (mean change from baseline to end of study). *p < 0.05; †p ≤ 0.001 vs. placebo using a logistic regression model. od = once daily; ‡ MIDs based on Reese et al. (25)