title: Comparison of tamsulosin and naftopidil for efficacy and safety in the treatment of benign prostatic hyperplasia: a randomized controlled trial.
abstract: OBJECTIVE
  To compare the efficacy and safety of two alpha1a/alpha1d adrenoceptor (AR) antagonists with different affinity for the alpha1AR subtypes, tamsulosin and naftopidil, in the treatment of benign prostatic hyperplasia (BPH).
  
  
  METHODS
  Patients with BPH were randomized to receive either tamsulosin or naftopidil. The primary efficacy variables were the changes in the total International Prostate Symptom Score (IPSS), maximum flow rate on free uroflowmetry, and residual urine volume. The secondary efficacy variables were average flow rate, changes in the IPSS storage score, IPSS voiding score, and quality-of-life (QoL) Index score, from baseline to endpoint (12 weeks). Data on all randomized patients were included in the safety analyses for adverse effects and changes in blood pressure.
  
  
  RESULTS
  Of the 185 patients enrolled data for 144 who were eligible for inclusion in the efficacy analysis were analysed (75 from the tamsulosin and 69 from the naftopidil group). There was no significant difference in any variable at baseline between the groups. There were statistically significant improvements for all primary and secondary variables in both groups, except for residual urine in the tamsulosin group. However, there was no significant intergroup difference in the improvement of any efficacy variable between the groups. The adverse effects were comparable, with no significant differences in systolic and diastolic blood pressure after treatment in both groups.
  
  
  CONCLUSIONS
  This study suggests that naftopidil is as effective and safe as tamsulosin. Both drugs were effective in improving storage and voiding symptoms. However, there was no difference in clinical efficacy or adverse effects between the alpha1 AR antagonists with different affinity to alpha1 subtypes, alpha1a and alpha1d.
authors.affiliation: Department of Urology, Nagoya University Graduate School of Medicine, Nagoya, Japan. gotoh@med.nagoya-u.ac.jp
authors.forename: Momokazu
authors.initials: M
authors.lastname: Gotoh
authors.forename: Osamu
authors.initials: O
authors.lastname: Kamihira
authors.forename: Tsuneo
authors.initials: T
authors.lastname: Kinukawa
authors.forename: Yoshinari
authors.initials: Y
authors.lastname: Ono
authors.forename: Shinichi
authors.initials: S
authors.lastname: Ohshima
authors.forename: Hideki
authors.initials: H
authors.lastname: Origasa
mesh_terms: D000317:Adrenergic alpha-Antagonists / Q000627:therapeutic use*; D000368:Aged; D001794:Blood Pressure / Q000187:drug effects; D006801:Humans; D008297:Male; D009281:Naphthalenes / Q000627:therapeutic use*; D010879:Piperazines / Q000627:therapeutic use*; D011446:Prospective Studies; D011470:Prostatic Hyperplasia / Q000188:drug therapy* / Q000503:physiopathology; D018340:Receptors, Adrenergic, alpha-1 / Q000187:drug effects; D018709:Statistics, Nonparametric; D013449:Sulfonamides / Q000627:therapeutic use*; D000077409:Tamsulosin; D014563:Urodynamics / Q000187:drug effects
chemical_list: D000317:Adrenergic alpha-Antagonists; D009281:Naphthalenes; D010879:Piperazines; D018340:Receptors, Adrenergic, alpha-1; D013449:Sulfonamides; D000077409:Tamsulosin; C064357:naftopidil