Vesomni: combination tablet for urinary storage symptoms associated with BPH

Vesomni is a fixed-dose, modified-release combination tablet containing tamsulosin and solifenacin that is indicated for the treatment of moderate to severe storage symptoms and voiding symptoms associated with BPH, when the response to treatment with monotherapy is inadequate.

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.
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.

PHARMACOLOGY

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

CLINICAL STUDIES

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

Tolerability

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  recommendation

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

References:

  1. Vesomni Summary of Product Characteristics, October 2013.
  2. van Kerrebroeck P et al. Eur Urol 2013; 64: 1003–12.
  3. NICE Clinical Guideline 97 (May 2010). The management of lower urinary tract symptoms in men.

View Vesomni drug record

Further information: Astellas

Follow MIMS on Twitter


MIMS Clinics

Prescribing news and resources for key therapeutic areas, collated by the MIMS editors.

Register or Subscribe to MIMS

GPs can get MIMS print & online and GPonline for free when they register online – take 2 minutes, and make sure you get your free MIMS access! If you're not a GP, you can subscribe to MIMS for full access.

Register or subscribe

MIMS bulletins

News and updates straight to your inbox.

Prescribing Update: Fortnightly news bulletin
Alert:
Urgent prescribing updates
Spotlight: Disease-themed monthly round-up

Sign me up

MIMS Dermatology

Read the latest issue online exclusively on MIMS Learning.

Read MIMS Dermatology

Mobile apps

MIMS: access the full drug database and quick-reference tables on the go

MIMS Diagnosis and Management: concise information on signs and symptoms, investigations and diseases

Promo Image

Clinical calculators

Handy calculators and conversions for primary care.