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 Pr...

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Veröffentlicht in:European urology 2007-08, Vol.52 (2), p.503-509
Hauptverfasser: Mills, Ian W, Crossland, Anna, Patel, Anup, Ramonas, Henrikas
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Crossland, Anna
Patel, Anup
Ramonas, Henrikas
description 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.
doi_str_mv 10.1016/j.eururo.2007.02.032
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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 &lt; 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.</description><identifier>ISSN: 0302-2838</identifier><identifier>EISSN: 1873-7560</identifier><identifier>DOI: 10.1016/j.eururo.2007.02.032</identifier><identifier>PMID: 17343981</identifier><identifier>CODEN: EUURAV</identifier><language>eng</language><publisher>Oxford: Elsevier B.V</publisher><subject>Aged ; Analysis of Variance ; Atorvastatin ; Atorvastatin Calcium ; Benign prostatic enlargement ; Benign prostatic hyperplasia ; Biological and medical sciences ; Double-Blind Method ; Heptanoic Acids - therapeutic use ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use ; Lower urinary tract symptoms ; Male ; Medical sciences ; Middle Aged ; Nephrology. Urinary tract diseases ; Prostate ; Prostate-Specific Antigen - blood ; Prostate-Specific Antigen - drug effects ; Prostatic Hyperplasia - complications ; Prostatic Hyperplasia - drug therapy ; PSA ; Pyrroles - therapeutic use ; Quality of Life ; Treatment Outcome ; Tumors of the urinary system ; Urinary system involvement in other diseases. Miscellaneous ; Urinary tract. 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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 &lt; 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.</description><subject>Aged</subject><subject>Analysis of Variance</subject><subject>Atorvastatin</subject><subject>Atorvastatin Calcium</subject><subject>Benign prostatic enlargement</subject><subject>Benign prostatic hyperplasia</subject><subject>Biological and medical sciences</subject><subject>Double-Blind Method</subject><subject>Heptanoic Acids - therapeutic use</subject><subject>Humans</subject><subject>Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use</subject><subject>Lower urinary tract symptoms</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Nephrology. Urinary tract diseases</subject><subject>Prostate</subject><subject>Prostate-Specific Antigen - blood</subject><subject>Prostate-Specific Antigen - drug effects</subject><subject>Prostatic Hyperplasia - complications</subject><subject>Prostatic Hyperplasia - drug therapy</subject><subject>PSA</subject><subject>Pyrroles - therapeutic use</subject><subject>Quality of Life</subject><subject>Treatment Outcome</subject><subject>Tumors of the urinary system</subject><subject>Urinary system involvement in other diseases. Miscellaneous</subject><subject>Urinary tract. Prostate gland</subject><subject>Urination Disorders - drug therapy</subject><subject>Urination Disorders - etiology</subject><subject>Urology</subject><issn>0302-2838</issn><issn>1873-7560</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2007</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkk1vEzEQhi0EoqHwDxDyBW4bxvZ-eC9IpSofUhBIbc-W4x0Xh1072N5W-fd4SaRKXDj58rzvjB8NIa8ZrBmw9v1ujXOcY1hzgG4NfA2CPyErJjtRdU0LT8kKBPCKSyHPyIuUdgAgml48J2esE7XoJVsRfZFDvNcp6-w8vYmo84Q-Uxsi_YaePrj8k27CA0Z6G53X8VAgbTK9Pkz7HKZEtR_oR_TuztMfMfwtMvTKjzre4VL1kjyzekz46vSek9tPVzeXX6rN989fLy82lanrJle9hboZetuwBtraDtoAWrQD8ra1LZpGoxBy0P2g5dZsO8mNxB6BC9F2QjJxTt4de_cx_J4xZTW5ZHActccwJ9VB23SyrQtYH0FT1k0RrdpHN5WfKQZqUat26qhWLWoVcFXUltibU_-8nXB4DJ1cFuDtCdDJ6NFG7Y1Lj5zsgbedLNyHI4fFxr3DqJJx6A0OLqLJagjuf5v8W2BG512Z-QsPmHZhjr6YVkylElDXyxksVwAdLLqE-AO3e6_m</recordid><startdate>20070801</startdate><enddate>20070801</enddate><creator>Mills, Ian W</creator><creator>Crossland, Anna</creator><creator>Patel, Anup</creator><creator>Ramonas, Henrikas</creator><general>Elsevier B.V</general><general>Elsevier</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20070801</creationdate><title>Atorvastatin Treatment for Men with Lower Urinary Tract Symptoms and Benign Prostatic Enlargement</title><author>Mills, Ian W ; Crossland, Anna ; Patel, Anup ; Ramonas, Henrikas</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c445t-9f045d9f515064fdac0efefde266f6ec5ae338da9da8bcb782c8e9e0233673813</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2007</creationdate><topic>Aged</topic><topic>Analysis of Variance</topic><topic>Atorvastatin</topic><topic>Atorvastatin Calcium</topic><topic>Benign prostatic enlargement</topic><topic>Benign prostatic hyperplasia</topic><topic>Biological and medical sciences</topic><topic>Double-Blind Method</topic><topic>Heptanoic Acids - therapeutic use</topic><topic>Humans</topic><topic>Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use</topic><topic>Lower urinary tract symptoms</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Nephrology. Urinary tract diseases</topic><topic>Prostate</topic><topic>Prostate-Specific Antigen - blood</topic><topic>Prostate-Specific Antigen - drug effects</topic><topic>Prostatic Hyperplasia - complications</topic><topic>Prostatic Hyperplasia - drug therapy</topic><topic>PSA</topic><topic>Pyrroles - therapeutic use</topic><topic>Quality of Life</topic><topic>Treatment Outcome</topic><topic>Tumors of the urinary system</topic><topic>Urinary system involvement in other diseases. Miscellaneous</topic><topic>Urinary tract. Prostate gland</topic><topic>Urination Disorders - drug therapy</topic><topic>Urination Disorders - etiology</topic><topic>Urology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Mills, Ian W</creatorcontrib><creatorcontrib>Crossland, Anna</creatorcontrib><creatorcontrib>Patel, Anup</creatorcontrib><creatorcontrib>Ramonas, Henrikas</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>European urology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Mills, Ian W</au><au>Crossland, Anna</au><au>Patel, Anup</au><au>Ramonas, Henrikas</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Atorvastatin Treatment for Men with Lower Urinary Tract Symptoms and Benign Prostatic Enlargement</atitle><jtitle>European urology</jtitle><addtitle>Eur Urol</addtitle><date>2007-08-01</date><risdate>2007</risdate><volume>52</volume><issue>2</issue><spage>503</spage><epage>509</epage><pages>503-509</pages><issn>0302-2838</issn><eissn>1873-7560</eissn><coden>EUURAV</coden><abstract>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 &lt; 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.</abstract><cop>Oxford</cop><pub>Elsevier B.V</pub><pmid>17343981</pmid><doi>10.1016/j.eururo.2007.02.032</doi><tpages>7</tpages></addata></record>
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subjects Aged
Analysis of Variance
Atorvastatin
Atorvastatin Calcium
Benign prostatic enlargement
Benign prostatic hyperplasia
Biological and medical sciences
Double-Blind Method
Heptanoic Acids - therapeutic use
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use
Lower urinary tract symptoms
Male
Medical sciences
Middle Aged
Nephrology. Urinary tract diseases
Prostate
Prostate-Specific Antigen - blood
Prostate-Specific Antigen - drug effects
Prostatic Hyperplasia - complications
Prostatic Hyperplasia - drug therapy
PSA
Pyrroles - therapeutic use
Quality of Life
Treatment Outcome
Tumors of the urinary system
Urinary system involvement in other diseases. Miscellaneous
Urinary tract. Prostate gland
Urination Disorders - drug therapy
Urination Disorders - etiology
Urology
title Atorvastatin Treatment for Men with Lower Urinary Tract Symptoms and Benign Prostatic Enlargement
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