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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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 < 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. Prostate gland ; Urination Disorders - drug therapy ; Urination Disorders - etiology ; Urology</subject><ispartof>European urology, 2007-08, Vol.52 (2), p.503-509</ispartof><rights>European Association of Urology</rights><rights>2007 European Association of Urology</rights><rights>2007 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c445t-9f045d9f515064fdac0efefde266f6ec5ae338da9da8bcb782c8e9e0233673813</citedby><cites>FETCH-LOGICAL-c445t-9f045d9f515064fdac0efefde266f6ec5ae338da9da8bcb782c8e9e0233673813</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.eururo.2007.02.032$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=18902678$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/17343981$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Mills, Ian W</creatorcontrib><creatorcontrib>Crossland, Anna</creatorcontrib><creatorcontrib>Patel, Anup</creatorcontrib><creatorcontrib>Ramonas, Henrikas</creatorcontrib><title>Atorvastatin Treatment for Men with Lower Urinary Tract Symptoms and Benign Prostatic Enlargement</title><title>European urology</title><addtitle>Eur Urol</addtitle><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.</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 < 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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