THE IMPACT OF MEDICAL THERAPY ON BOTHER DUE TO SYMPTOMS, QUALITY-OF-LIFE AND GLOBAL OUTCOME, AND FACTORS PREDICTING RESPONSE

Purpose: We determine the effect of placebo, finasteride, terazosin an d a combination of drugs on bother due to symptoms, quality of life an d patient perception of improvement, and identify baseline clinical fa ctors that predict clinical response to medical therapy. Materials and Methods: A total of 1,229 subjects with clinical benign prostatic hyp erplasia (BPH) were randomized to 1 year of placebo, finasteride, tera zosin or drug combination. The primary outcome measures were American Urological Association (AUA) symptom score and peak flow rate. Relevan t secondary outcome measures were symptom problem score, BPH impact sc ore and global rating of improvement. Results: Group mean differences in symptom problem and BPH impact scores between the finasteride versu s placebo, and terazosin versus combination groups were not statistica lly or clinically significant. Group mean differences in all outcome m easures were highly statistically significant between the terazosin an d finasteride, and combination and finasteride groups. The percentage of subjects who rated improvement as marked or moderate with placebo, finasteride, terazosin and combination was 39, 44, 61 and 65%, respect ively. In the subsets of men in the placebo, finasteride, terazosin an d combination groups with prostates greater than 50 cm.(3) group mean decrease from baseline in AUA symptom score was -2.5, -3.6, -6 and -7, group mean increase in peak flow rate was 0.6, 2.7, 3.6 and 3.7 mi. p er second, group mean decrease in symptom problem score was -2.2, -1.9 , -3.1 and -4.5, and group mean decrease in BPH impact score was -0.6, -0.3, -1.1 and -1.5, respectively. A correlational analysis failed to show a significant relationship between baseline prostate volume and treatment response to finasteride. There was a significant but weak re lationship between change in AUA symptom score and peak flow rate in t he finasteride and combination groups. The symptom responses with tera zosin were independent of baseline peak flow rate. Conclusions: In men with clinical BPH finasteride and placebo are equally effective, whil e terazosin and combination are significantly more effective. In men w ith clinical BPH and large prostates the advantage of finasteride over placebo in terms of symptom reduction, impact on bother due to sympto ms and quality of life is small at best, while the advantage of terazo sin and combination over finasteride and placebo is highly significant . Baseline prostate volume was not a predictor of response to finaster ide in the overall study population. On the basis of our results oil b lockers, such as terazosin, should be first line medical treatment for BPH.