Tamsulosin is an alpha1 adrenoceptor antagonist that reduces smooth muscle tone in the prostate and bladder neck to increase urine flow. Solifenacin is a competitive and selective muscarinic receptor antagonist that reduces urinary urgency and frequency.1
The safety and efficacy of tamsulosin/solifenacin was established in the double-blind phase III NEPTUNE trial. The trial included 1,334 men who had storage and voiding lower urinary tract symptoms (LUTS) associated with BPH, defined as ≥2 urgency episodes per 24 hours, ≥8 micturitions in the 24 hours preceding randomisation, an International Prostate Symptom Score (IPSS) ≥13, a maximum urinary flow rate 4.0−12.0ml/s and a voided volume of ≥120ml during free flow.
Patients were randomised to receive placebo, a fixed-dose combination of tamsulosin and solifenacin, or tamsulosin alone for 12 weeks.2
Non-inferior to tamsulosin monotherapy
Combination therapy with 400 microgram tamsulosin plus solifenacin 6mg produced a significantly greater reduction from baseline than placebo in the primary endpoint, total IPSS [-7.0 vs -5.4 (p<0.001)], and was non-inferior to tamsulosin monotherapy for this endpoint (p=0.001; change from baseline -7.0 vs -6.2).2
The combination showed superiority to placebo and tamsulosin monotherapy in terms of the other primary endpoint, total urgency and frequency score (changes from baseline -8.1 vs -4.4 [p<0.001] and -6.7 [p<0.05], respectively).2
Improved quality of life
Patients receiving the combination tablet also reported significant improvements in IPSS and Overactive Bladder Questionnaire (OAB-q) quality of life scores (p<0.001 vs placebo; p<0.01 vs tamsulosin alone) and OAB-q sleep subscore (p<0.01 and p<0.05 vs placebo and tamsulosin, respectively).2
Tamsulosin/solifenacin was generally well tolerated. The most common adverse effects, including dry mouth, constipation and dyspepsia, reflect those typically associated with anticholinergics. Acute urinary retention was the most serious adverse effect but occurred in less than 1% of patients.1,2
NICE recommends considering an anticholinergic in combination with an alpha-blocker for men who still have storage symptoms after treatment with an alpha-blocker alone.3
- Vesomni Summary of Product Characteristics, October 2013.
- van Kerrebroeck P et al. Eur Urol 2013; 64: 1003–12.
- NICE Clinical Guideline 97 (May 2010). The management of lower urinary tract symptoms in men.
Further information: Astellas