title: Combination therapy with rofecoxib and finasteride in the treatment of men with lower urinary tract symptoms (LUTS) and benign prostatic hyperplasia (BPH).
abstract: OBJECTIVE
  Cyclooxygenase-2 (COX-2) is expressed in human BPH tissue and displays either a pro-inflammatory effect or a proliferative effect on prostate cells. The aim of this study is to analyze whether combination therapy with rofecoxib, a COX-2 inhibitor, and finasteride offers an advantage compared to finasteride monotherapy in patients with BPH.
  
  
  METHODS
  This is a single centre unblinded trial. Forty-six consecutive men with LUTS and BPH were entered into the study and were randomized to receive rofecoxib 25mg/day plus finasteride 5mg/day (group B) versus finasteride 5mg/day alone (group A) for 24 weeks. Inclusion criteria included also a prostate size greater than 40 cc. The efficacy and safety of treatments were assessed at baseline and at week 4, 12 and 24.
  
  
  RESULTS
  In our population, both treatments (groups A and B) produced statistically significant improvements in total IPSS and Q(max) from baseline during follow-up, although they were very low in particular for the finasteride alone group at 4 weeks. We found that finasteride monotherapy produces very little improvement at the 1 month interval. In comparing group A with group B, a significantly higher improvement in IPSS (p=0.0001) and Q(max) (p=0.03) was obtained in group B at 4 weeks interval (% cases with IPSS reduction >4 points: group B=34.7, group A=0; % cases with Q(max) improvement >3 ml/s: group B=8.7, group A=0), whereas at week 24, the differences between the two treatments were not significant (p>0.05).
  
  
  CONCLUSIONS
  In our population, the advantage of the combination therapy compared to finasteride alone is significant in a short-term interval (4 weeks). It can be hypothesized that the association of rofecoxib with finasteride induces a more rapid improvement in clinical results until the effect of finasteride becomes predominant.
authors.affiliation: Department Urology, University La Sapienza, Urology U Bracci, V. Policlinico, 00161 Rome, Italy.
authors.forename: Franco
authors.initials: F
authors.lastname: Di Silverio
authors.forename: Cesare
authors.initials: C
authors.lastname: Bosman
authors.forename: Monti
authors.initials: M
authors.lastname: Salvatori
authors.forename: Luca
authors.initials: L
authors.lastname: Albanesi
authors.forename: Laura
authors.initials: L
authors.lastname: Proietti Pannunzi
authors.forename: Mauro
authors.initials: M
authors.lastname: Ciccariello
authors.forename: Antonio
authors.initials: A
authors.lastname: Cardi
authors.forename: Gianfilippo
authors.initials: G
authors.lastname: Salvatori
authors.forename: Alessandro
authors.initials: A
authors.lastname: Sciarra
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D016861:Cyclooxygenase Inhibitors / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D004791:Enzyme Inhibitors / Q000008:administration & dosage*; D018120:Finasteride / Q000008:administration & dosage*; D006801:Humans; D007783:Lactones / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011470:Prostatic Hyperplasia / Q000150:complications / Q000188:drug therapy*; D013450:Sulfones / Q000008:administration & dosage*; D014570:Urologic Diseases / Q000188:drug therapy* / Q000209:etiology
chemical_list: D016861:Cyclooxygenase Inhibitors; D004791:Enzyme Inhibitors; D007783:Lactones; D013450:Sulfones; C116926:rofecoxib; D018120:Finasteride