Atorvastatin Treatment for Men with Lower Urinary Tract Symptoms and Benign Prostatic Enlargement

Abstract 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 (Qmax ), 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), Qmax (+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.