Monograph Solifenacin

REGIONAL DRUG AND THERAPEUTICS CENTRE

NEW DRUG EVALUATION

No.   68 January 2005
SOLIFENACIN
Solifenacin is a urinary antispasmodic agent licensed for the treatment of incontinence and increased urinary frequency and   urgency.   In clinical   trials solifenacin produced a modest improvement in the   symptoms of overactive bladder.   The most common reported adverse reaction was   dry mouth.   There are no published clinical   trials comparing it to oxybutynin, which has   a greater evidence base and   remains the   treatment of   choice for patients with an unstable bladder.

What is it?

Solifenacin (Vesicare┬«,   Yamanouchi Pharma) is a urinary   antispasmodic agent licensed   for   the treatment of   urge   incontinence and/or increased urinary   frequency and   urgency, as   may   occur   in patients with   overactive bladder   syndrome.1     The recommended dose   is 5 mg once   daily, which   may be increased to 10 mg once   daily if needed.1

How effective is it?

Four   12   week   randomised,   multi-centre, double- blind,   placebo controlled studies have been completed and two have been published in full.2,3 In the   first   study   1081   patients were   randomised to receive either solifenacin 5 mg or 10 mg once   daily, tolterodine 2   mg   twice   daily   or   placebo for   12 weeks.2 The mean number of urgency episodes/24h at   baseline   was   5.30     for   placebo,   5.77     for solifenacin 5mg, 5.82   for   solifenacin 10   mg   and
5.45   for tolterodine.   Compared with   placebo the change from   baseline (-1.41,   -33%)   in   the   mean number of urgency episodes per 24 hour   was lower with   solifenacin 5 mg   (-2.85,   -52%)   and   10   mg   (-
3.07, -55% both p<0.001), but not with tolterodine (-2.05,   -38%;   p=0.0511). This study did   not   demonstrate   that   solifenacin is   clinically superior to tolterodine.

In the   second study   857 patients were   randomised to receive placebo, solifenacin 5 mg or 10 mg once daily.3   The primary   objective was the   mean...