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 > or =50 yr, with International Prostate Symptom Score (IPSS) > or = 13, total prostate volume (TPV) > or = 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 (Q(max)), 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.
RCT Entities:
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 > or =50 yr, with International Prostate Symptom Score (IPSS) > or = 13, total prostate volume (TPV) > or = 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 (Q(max)), 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.
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