title: Treatment outcomes in the STAR study: a subanalysis of solifenacin 5 mg and tolterodine ER 4 mg.
abstract: OBJECTIVE
  To compare OAB symptom outcomes following initial randomised treatment with solifenacin 5 mg or tolterodine ER 4 mg at the 4-week clinic-visit and again at 12 weeks for patients choosing to remain on this treatment dose from 4 weeks.
  
  
  METHODS
  A prospective, double blind, double-dummy, two-arm, parallel-group, 12-week study (The STAR study) was conducted to compare the efficacy and safety of solifenacin 5/10 mg and tolterodine extended release (ER) 4 mg in OAB patients.
  
  
  RESULTS
  At 4 weeks mean improvements in OAB symptoms, including urgency, frequency (primary variable), incontinence and nocturia, were larger in patients randomised to solifenacin 5 mg; with the difference for incontinence being statistically significant (mean reduction in incontinence episodes/24 hrs in the solifenacin group of -1.30 vs. -0.90 (p=0.0181); the mean result for solifenacin 5 mg amounted to a 44% additional improvement.) There was an associated significant reduction in pad use (reduced by -1.21 vs. -0.80; p=0.0089); the mean result for solifenacin 5 mg amounted to a 51% additional improvement over that of tolterodine ER 4 mg. For patients choosing to remain on these treatments improvements in favour of solifenacin were maintained at study end (12-weeks). Treatments were well tolerated.
  
  
  CONCLUSIONS
  Within 4 weeks solifenacin 5mg was statistically significantly better than tolterodine ER 4 mg in improving incontinence and reducing incontinence pad use. Differences in efficacy in favour of solifenacin 5 mg were maintained from 4 weeks for the duration of the study for patients choosing to remain on their starting dose.
authors.affiliation: Urology Research Office, Royal Hallamshire Hospital, Sheffield, UK. c.r.chapple@sheffield.ac.uk
authors.forename: Christopher R
authors.initials: CR
authors.lastname: Chapple
authors.forename: Aino
authors.initials: A
authors.lastname: Fianu-Jonsson
authors.forename: Mark
authors.initials: M
authors.lastname: Indig
authors.forename: Vik
authors.initials: V
authors.lastname: Khullar
authors.forename: José
authors.initials: J
authors.lastname: Rosa
authors.forename: Roberto M
authors.initials: RM
authors.lastname: Scarpa
authors.forename: Arun
authors.initials: A
authors.lastname: Mistry
authors.forename: D Mark
authors.initials: DM
authors.lastname: Wright
authors.forename: John
authors.initials: J
authors.lastname: Bolodeoku
mesh_terms: D000368:Aged; D001559:Benzhydryl Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D003408:Cresols / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D010665:Phenylpropanolamine / Q000009:adverse effects / Q000627:therapeutic use*; D011812:Quinuclidines / Q000009:adverse effects / Q000627:therapeutic use*; D012449:Safety; D000069464:Solifenacin Succinate; D044005:Tetrahydroisoquinolines / Q000009:adverse effects / Q000627:therapeutic use*; D000068737:Tolterodine Tartrate; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000188:drug therapy*; D014550:Urinary Incontinence, Stress / Q000188:drug therapy; D014554:Urination / Q000187:drug effects / Q000502:physiology
chemical_list: D001559:Benzhydryl Compounds; D003408:Cresols; D018727:Muscarinic Antagonists; D011812:Quinuclidines; D044005:Tetrahydroisoquinolines; D010665:Phenylpropanolamine; D000068737:Tolterodine Tartrate; D000069464:Solifenacin Succinate