title: Responder and health-related quality of life analyses in men with lower urinary tract symptoms treated with a fixed-dose combination of solifenacin and tamsulosin oral-controlled absorption system: results from the NEPTUNE study.
abstract: 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).
  
  
  METHODS
  Men with moderate-to-severe storage symptoms and voiding symptoms were treated for 12 weeks with a FDC of solifenacin 6 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 a FDC of solifenacin 6 mg plus TOCAS consistently had 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 a once-daily FDC of solifenacin and TOCAS was associated with consistent patient-relevant improvements in HRQoL compared with placebo and TOCAS monotherapy.
authors.affiliation: University of Bristol and Bristol Urological Institute, Bristol, UK.
authors.forename: Marcus J
authors.initials: MJ
authors.lastname: Drake
authors.affiliation: Private Urological Care Centre, Piaristicka, Trencin, Slovakia.
authors.forename: Roman
authors.initials: R
authors.lastname: Sokol
authors.affiliation: Evidera, Bethesda, MD, USA.
authors.forename: Karin
authors.initials: K
authors.lastname: Coyne
authors.affiliation: Astellas Pharma B.V., Leiden, The Netherlands.
authors.forename: Zalmai
authors.initials: Z
authors.lastname: Hakimi
authors.affiliation: Astellas Pharma Europe Ltd., Chertsey, UK.
authors.forename: Jameel
authors.initials: J
authors.lastname: Nazir
authors.affiliation: Creativ-Ceutical, Chicago, IL, USA.
authors.forename: Julie
authors.initials: J
authors.lastname: Dorey
authors.affiliation: Astellas Pharma B.V., Leiden, The Netherlands.
authors.forename: Monique
authors.initials: M
authors.lastname: Klaver
authors.affiliation: Astellas Pharma B.V., Leiden, The Netherlands.
authors.forename: Klaudia
authors.initials: K
authors.lastname: Traudtner
authors.affiliation: Astellas Pharma Europe Ltd., Chertsey, UK.
authors.forename: Isaac A
authors.initials: IA
authors.lastname: Odeyemi
authors.affiliation: Hannover Medical School, Hannover, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Oelke
authors.affiliation: Maastricht University Medical Center, Maastricht, The Netherlands.
authors.forename: Philip
authors.initials: P
authors.lastname: van Kerrebroeck
mesh_terms: D004311:Double-Blind Method; D006801:Humans; D059411:Lower Urinary Tract Symptoms / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D011470:Prostatic Hyperplasia / Q000150:complications; D011788:Quality of Life; D000069464:Solifenacin Succinate / Q000627:therapeutic use*; D013449:Sulfonamides / Q000627:therapeutic use*; D000077409:Tamsulosin; D064804:Urological Agents / Q000627:therapeutic use*
chemical_list: D013449:Sulfonamides; D064804:Urological Agents; D000077409:Tamsulosin; D000069464:Solifenacin Succinate
keywords: benign prostatic hyperplasia; health-related quality of life; lower urinary tract symptoms; solifenacin; tamsulosin