Atorvastatin treatment for men with lower urinary tract symptoms and benign prostatic enlargement

Objective: To evaluate the effects of atorvastatin in men with lower urinary tract symptoms (LUTS) and prostatic enlargement due to presumed BPH. Methods: This was a phase 2, double-blind, randomised, placebo-controlled clinical study. Eligible patients were aged >= 50 yr, with international Prostate Symptom Score (IPSS) >= 13, total prostate volume (TPV) >= 30 ml, and maximum urinary flow rate 5-15 ml/s. All patients had serum low-density lipoprotein (LDL) 100-190 mg/dl at baseline. Patients received either atorvastatin 80 mg daily (n = 176) or placebo (n = 174) for 26 wk. End points included IPSS, TPV, transition zone volume (TZV), maximum urinary flow rate (Qa,), serum PSA, and lipids. Results: There was no difference between the effects of atorvastatin and placebo on the primary end point of mean change from baseline in IPSS after 26 wk of double-blind treatment (-4.5 vs. -4.3; p = 0.263). Similarly, no effect was seen on the lower urinary tract secondary end points including TPV (-1.6 vs. -1.9 ml; p = 0.654), TZV (-0.0 vs. -0.8 ml; p = 0.421), Q(max) (+1.1 vs. +0.7 ml/s; p = 0.612), and PSA (-0.24 vs. -0.14 ng/ml; p = 0.235). Atorvastatin had a significant effect on serum lipid levels compared with placebo (eg, LDL: -75.6 vs. -6.1 mg/dl; p < 0.001). Conclusions: Atorvastatin is not effective over 6 mo in the treatment of men with LUTS and prostatic enlargement due to presumed BPH who have serum LDL in the range 100-190 mg/dl. (C) 2007 European Association of Urology. Published by Elsevier B.V. All rights reserved.