Purpose: 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. Materials and 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 25 mg/day plus finasteride 5 mg/day (group B) versus finasteride 5 mg/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 I 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. 2004 Elsevier B.V. All rights reserved.
Combination therapy with rofecoxib and finasteride in the treatment of men with lower urinary tract symptoms (LUTS) and benign prostatic hyperplasia (BPH) / DI SILVERIO, Franco; C., Bosman; M., Salvatori; L., Albanesi; L., Proietti; L. P., Pannunzi; Ciccariello, Mauro; A., Cardi; G., Salvatori; Sciarra, Alessandro. - In: EUROPEAN UROLOGY. - ISSN 0302-2838. - 47:1(2005), pp. 72-79. [10.1016/j.eururo.2004.08.024]
Combination therapy with rofecoxib and finasteride in the treatment of men with lower urinary tract symptoms (LUTS) and benign prostatic hyperplasia (BPH)
DI SILVERIO, Franco;CICCARIELLO, Mauro;SCIARRA, Alessandro
2005
Abstract
Purpose: 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. Materials and 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 25 mg/day plus finasteride 5 mg/day (group B) versus finasteride 5 mg/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 I 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. 2004 Elsevier B.V. All rights reserved.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
