OBJECTIVE: To evaluate the effect of a fixed-dose combination (FDC) of solifenacin and an oral controlled absorption system (OCAS™) formulation of tamsulosin (TOCAS) on health-related quality of life (HRQoL) in men with lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH).
PATIENTS AND METHODS: Men with moderate-to-severe storage symptoms and voiding symptoms were treated for 12 weeks with FDC of solifenacin 6 mg or 9 mg plus TOCAS (0.4 mg), TOCAS monotherapy (0.4 mg) or placebo in a randomised, double-blind study (NEPTUNE). The co-primary endpoints were Total Urgency Frequency Score (TUFS) and total International Prostate Symptom Score (IPSS). HRQoL was assessed by several secondary endpoints: IPSS QoL index, overactive bladder questionnaire (OAB-q), and Patient Global Impression (PGI) scale. The correlation between symptom improvement (TUFS) and HRQoL was assessed by Spearman rank correlation coefficients. Single and double responder analyses, using subjective and objective measures, were also performed.
RESULTS: In the responder analyses, men treated with FDC of solifenacin 6 mg plus TOCAS consistently demonstrated significantly improved outcomes compared with placebo (8/8 responder analyses performed) and TOCAS (6/8 responder analyses performed). There was a significant correlation (p< 0.001) between the reduction in TUFS and the improvement in HRQoL defined by IPSS QoL score, OAB-q symptom bother score, PGI overall bladder symptoms and PGI general health.
CONCLUSIONS: In men with LUTS/BPH who have moderate-to-severe storage symptoms and voiding symptoms, the reduction in symptoms with an once-daily FDC of solifenacin and TOCAS was associated with consistent patient-relevant improvements in HRQoL compared with placebo and TOCAS monotherapy.
Written by:
Drake MJ, Sokol R, Coyne K, Hakimi Z, Nazir J, Dorey J, Klaver M, Traudtner K, Odeyemi I, Oelke M, van Kerrebroeck P. Are you the author?
University of Bristol and Bristol Urological Institute, Bristol, UK.
Reference: BJU Int. 2015 Apr 24. Epub ahead of print.
doi: 10.1111/bju.13162
PubMed Abstract
PMID: 25907003