title: Open-label, 9-month extension study investigating the uro-selective alpha-blocker silodosin in men with LUTS associated with BPH.
abstract: OBJECTIVE
  To evaluate the long-term safety (primary objective) and efficacy/impact on quality of life (QoL, secondary objectives) of silodosin 8 mg once daily in men with LUTS/BPH.
  
  
  METHODS
  Men who completed the 12-week double-blind study with silodosin 8 mg, tamsulosin 0.4 mg, or placebo were offered to continue with the 9-month open-label study during which all patients received silodosin 8 mg once daily. Safety was assessed by analysing vital signs, electrocardiograms, laboratory tests, and adverse events. Efficacy was evaluated with the International Prostate Symptom Score (IPSS), IPSS voiding and storage sub-scores, IPSS-QoL, and maximum urinary flow rate (Q max).
  
  
  RESULTS
  A total of 500 patients (mean age 66 years) entered the 9-month open-label study. Treatment-emergent adverse events (TEAE) were experienced by 33.4% patients. Ejaculation dysfunction was the most common TEAE (9.0%) but led to study discontinuations in only 1.6% of patients. Dizziness without orthostatic hypotension occurred in 0.8%. A marked reduction in total IPSS (-2.7 ± 3.8) was documented at the first visit of this extension phase in patients having de novo silodosin compared with lesser improvement in patients previously treated with silodosin (-0.82 ± 4.2) or tamsulosin (-0.83 ± 3.8). Improvements were maintained throughout the open-label phase. QoL also improved, with the greatest improvement in de novo silodosin patients. No relevant changes in Q max occurred.
  
  
  CONCLUSIONS
  Long-term treatment with silodosin was safe and efficacious. Abnormal ejaculation was the most common TEAE, but led to treatment discontinuation in only 1.6% of patients. Orthostatic hypotension was not seen, and only a few patients experienced dizziness.
authors.affiliation: Department of Urology, The Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Foundation Trust, Glossop Road, Sheffield, S10 2JF, UK.
authors.forename: Nadir I
authors.initials: NI
authors.lastname: Osman
authors.forename: Christopher R
authors.initials: CR
authors.lastname: Chapple
authors.forename: Teuvo L
authors.initials: TL
authors.lastname: Tammela
authors.forename: Andreas
authors.initials: A
authors.lastname: Eisenhardt
authors.forename: Matthias
authors.initials: M
authors.lastname: Oelke
mesh_terms: D058668:Adrenergic alpha-1 Receptor Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D000368:Aged; D004244:Dizziness / Q000453:epidemiology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D006801:Humans; D015994:Incidence; D007211:Indoles / Q000009:adverse effects / Q000627:therapeutic use*; D059411:Lower Urinary Tract Symptoms / Q000188:drug therapy* / Q000209:etiology*; D008297:Male; D008875:Middle Aged; D061686:Premature Ejaculation / Q000453:epidemiology; D011446:Prospective Studies; D011470:Prostatic Hyperplasia / Q000150:complications*; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D058668:Adrenergic alpha-1 Receptor Antagonists; D007211:Indoles; C095285:silodosin