Atorvastatin treatment for men with lower urinary tract symptoms and benign prostatic enlargement
Atorvastatin treatment for men with lower urinary tract symptoms and benign prostatic enlargement
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DOI：
10.1016/j.eururo.2007.02.032
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发表时间：
2007-08-01
期刊：
影响因子：
23.4
通讯作者：
Ramonas, Henrikas
中科院分区：
文献类型：
--
作者：
Mills, Ian W.;Crossland, Anna;Ramonas, Henrikas
目的：评价阿托伐他汀对男性下尿路症状（LUTS）和前列腺增生的影响。方法：这是一项2期、双盲、随机、安慰剂对照的临床研究。入选患者年龄>= 50岁，国际前列腺症状评分(IPSS) >= 13，前列腺总容积(TPV) >= 30 ml，最大尿流率5 ~ 15 ml/s。所有患者基线时血清低密度脂蛋白（LDL）为100-190 mg/dl。患者接受每日80毫克的阿托伐他汀（n = 176）或安慰剂（n = 174），持续26周。终点包括IPSS、TPV、过渡区容积（TZV）、最大尿流率（Qa,）、血清PSA和血脂。结果：双盲治疗26周后，阿托伐他汀和安慰剂对IPSS基线平均变化的主要终点的影响没有差异（-4.5 vs -4.3; p = 0.263）。同样，对下尿路次要终点没有影响，包括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）和PSA （-0.24 vs -0.14 ng/ml, p = 0.235）。与安慰剂相比，阿托伐他汀对血脂水平有显著影响（例如，LDL: -75.6 vs -6.1 mg/dl; p < 0.001）。结论：阿托伐他汀对血清LDL在100-190 mg/dl范围内的LUTS和前列腺增生（假定为BPH）患者治疗6个月以上无效。(C) 2007年欧洲泌尿外科协会。Elsevier B.V.版权所有。
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.