title: Efficacy and tolerability of solifenacin in patients aged ≥ 65 years with overactive bladder: post-hoc analysis of 2 open-label studies.
abstract: BACKGROUND
  Antimuscarinics have proven efficacy as first-line therapy in overactive bladder (OAB); however, data on their use in older adults are needed.
  
  
  OBJECTIVE
  To assess the efficacy and tolerability of solifenacin in patients aged ≥ 65 years, we conducted post-hoc analyses of data from VESIcare® Open-Label Trial (VOLT) and VESIcare® Efficacy and Research Study US (VERSUS).
  
  
  METHODS
  In both of these 12-week, open-label, flexible-dosing studies involving 2645 patients with OAB for ≥ 3 months, patients received 5 mg solifenacin daily for 4 weeks, with an option to increase to 10 mg at week 4 (both studies) and week 8 (VOLT). VERSUS patients had received tolterodine extended release 4 mg for ≥ 4 weeks without sufficient subjective improvement in urgency (mean ≥ 3 urgency episodes/24 h). Baseline values 14 days after tolterodine washout were used for comparison with VOLT. Common study endpoints were the Patient Perception of Bladder Condition (PPBC) scale and the Overactive Bladder Questionnaire (OAB-q). VOLT used a horizontal visual analog scale (VAS), and diary-recorded symptom data were captured in VERSUS.
  
  
  RESULTS
  In the full analysis sets (FAS), 40% of VOLT and 44% of VERSUS patients were aged ≥ 65 years. After 12 weeks of solifenacin, older patients experienced decreases in OAB symptoms, and improvements from baseline on the PPBC, OAB-q, and VAS. In total, 59% of older VOLT and 62% of older VERSUS patients reported ≥ 1 treatment-emergent adverse event (AE); the AEs were mostly anticholinergic and of mild-to-moderate severity. Results were consistent with younger patients and the FAS.
  
  
  CONCLUSIONS
  In this large group of older patients, flexibly dosed solifenacin was associated with reductions in diary-documented OAB symptoms (VERSUS). In both studies, solifenacin was associated with improvements in measures assessing patients' perception of their bladder problems, symptom bother, and aspects of health-related quality of life. Adverse event rates in older patients were comparable to those in younger patients and the FAS.
authors.affiliation: Internal Medicine Associates of Atlanta, Executive Health and Research, Atlanta, GA 30342, USA. jcapo@imaamd.org
authors.forename: James P
authors.initials: JP
authors.lastname: Capo'
authors.forename: Vincent
authors.initials: V
authors.lastname: Lucente
authors.forename: Sergio
authors.initials: S
authors.lastname: Forero-Schwanhaeuser
authors.forename: Weizhong
authors.initials: W
authors.lastname: He
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001559:Benzhydryl Compounds / Q000627:therapeutic use; D002986:Clinical Trials as Topic; D003408:Cresols / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D010665:Phenylpropanolamine / Q000627:therapeutic use; D011812:Quinuclidines / Q000009:adverse effects / Q000627:therapeutic use*; D000069464:Solifenacin Succinate; D044005:Tetrahydroisoquinolines / Q000009:adverse effects / Q000627:therapeutic use*; D000068737:Tolterodine Tartrate; D053201:Urinary Bladder, Overactive / Q000188:drug therapy*
chemical_list: D001559:Benzhydryl Compounds; D003408:Cresols; D018727:Muscarinic Antagonists; D011812:Quinuclidines; D044005:Tetrahydroisoquinolines; D010665:Phenylpropanolamine; D000068737:Tolterodine Tartrate; D000069464:Solifenacin Succinate