Monograph Solifenacin
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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...
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...