Combination Therapy with Rofecoxib and Finasteride in the Treatment of Men with Lower Urinary Tract Symptoms (LUTS) and Benign Prostatic Hyperplasia (BPH)

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. 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. 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). 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.