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Simvastatin for the Prevention of Exacerbations in Moderate-to-Severe COPD

Identifieur interne : 004F35 ( Main/Exploration ); précédent : 004F34; suivant : 004F36

Simvastatin for the Prevention of Exacerbations in Moderate-to-Severe COPD

Auteurs : G. J. Criner [États-Unis] ; J. E. Connett [États-Unis] ; S. D. Aaron [Canada] ; R. K. Albert [États-Unis] ; W. C. Bailey [États-Unis] ; R. Casaburi [États-Unis] ; J. A. D. Jr Cooper [États-Unis] ; J. L. Curtis [États-Unis] ; M. T. Dransfield [États-Unis] ; M. K. Han [États-Unis] ; B. Make [États-Unis] ; N. Marchetti [États-Unis] ; F. J. Martinez [États-Unis] ; D. E. Niewoehner [États-Unis] ; P. D. Scanlon [États-Unis] ; F. C. Sciurba [États-Unis] ; S. M. Scharf [États-Unis] ; D. D. Sin [Canada] ; H. Voelker [États-Unis] ; G. R. Washko [États-Unis] ; P. G. Woodruff [États-Unis] ; S. C. Lazarus [États-Unis]

Source :

RBID : Pascal:14-0181020

Descripteurs français

English descriptors

Abstract

BACKGROUND Retrospective studies have shown that statins decrease the rate and severity of exacerbations, the rate of hospitalization, and mortality in chronic obstructive pulmonary disease (COPD). We prospectively studied the efficacy of simvastatin in preventing exacerbations in a large, multicenter, randomized trial. METHODS We designed the Prospective Randomized Placebo-Controlled Trial of Simvastatin in the Prevention of COPD Exacerbations (STATCOPE) as a randomized, controlled trial of simvastatin (at a daily dose of 40 mg) versus placebo, with annual exacerbation rates as the primary outcome. Patients were eligible if they were 40 to 80 years of age, had COPD (defined by a forced expiratory volume in 1 second [FEV1] of less than 80% and a ratio of FEV1 to forced vital capacity of less than 70%), and had a smoking history of 10 or more pack-years, were receiving supplemental oxygen or treatment with glucocorticoids or antibiotic agents, or had had an emergency department visit or hospitalization for COPD within the past year. Patients with diabetes or cardiovascular disease and those who were taking statins or who required statins on the basis of Adult Treatment Panel III criteria were excluded. Participants were treated from 12 to 36 months at 45 centers. RESULTS A total of 885 participants with COPD were enrolled for approximately 641 days; 44% of the patients were women. The patients had a mean (±SD) age of 62.2±8.4 years, an FEV1 that was 41.6±17.7% of the predicted value, and a smoking history of 50.6±27.4 pack-years. At the time of study closeout, the low-density lipoprotein cholesterol levels were lower in the simvastatin-treated patients than in those who received placebo.


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<name sortKey="Dransfield, M T" sort="Dransfield, M T" uniqKey="Dransfield M" first="M. T." last="Dransfield">M. T. Dransfield</name>
<affiliation wicri:level="3">
<inist:fA14 i1="10">
<s1>Department of Pulmonary Allergy and Critical Care Medicine, University of Alabama at Birmingham and Birmingham Veterans Affairs Medical Center</s1>
<s2>Birmingham</s2>
<s3>USA</s3>
<sZ>5 aut.</sZ>
<sZ>9 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName>
<settlement type="city">Birmingham</settlement>
<region type="country">Angleterre</region>
<region type="région" nuts="1">Midlands de l'Ouest</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Han, M K" sort="Han, M K" uniqKey="Han M" first="M. K." last="Han">M. K. Han</name>
<affiliation wicri:level="1">
<inist:fA14 i1="14">
<s1>Department of Pulmonary and Critical Care Medicine, University of Michigan Health System</s1>
<s2>Ann Arbor</s2>
<s3>USA</s3>
<sZ>10 aut.</sZ>
<sZ>13 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Ann Arbor</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Make, B" sort="Make, B" uniqKey="Make B" first="B." last="Make">B. Make</name>
<affiliation wicri:level="1">
<inist:fA14 i1="09">
<s1>Division of Pulmonary Critical Care and Sleep Medicine, National Jewish Health</s1>
<s2>Denver</s2>
<s3>USA</s3>
<sZ>11 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Denver</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Marchetti, N" sort="Marchetti, N" uniqKey="Marchetti N" first="N." last="Marchetti">N. Marchetti</name>
<affiliation wicri:level="3">
<inist:fA14 i1="01">
<s1>Department of Pulmonary and Critical Care Medicine, Temple University School of Medicine</s1>
<s2>Philadelphia</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName>
<settlement type="city">Philadelphie</settlement>
<region type="state">Pennsylvanie</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Martinez, F J" sort="Martinez, F J" uniqKey="Martinez F" first="F. J." last="Martinez">F. J. Martinez</name>
<affiliation wicri:level="1">
<inist:fA14 i1="14">
<s1>Department of Pulmonary and Critical Care Medicine, University of Michigan Health System</s1>
<s2>Ann Arbor</s2>
<s3>USA</s3>
<sZ>10 aut.</sZ>
<sZ>13 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Ann Arbor</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Niewoehner, D E" sort="Niewoehner, D E" uniqKey="Niewoehner D" first="D. E." last="Niewoehner">D. E. Niewoehner</name>
<affiliation wicri:level="2">
<inist:fA14 i1="04">
<s1>Department of Pulmonary, Allergy, Critical Care, and Sleep Medicine, University of Minnesota</s1>
<s2>Minneapolis, Minnesota</s2>
<s3>USA</s3>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName>
<region type="state">Minnesota</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Scanlon, P D" sort="Scanlon, P D" uniqKey="Scanlon P" first="P. D." last="Scanlon">P. D. Scanlon</name>
<affiliation wicri:level="2">
<inist:fA14 i1="05">
<s1>Department of Pulmonary and Critical Care Medicine, Mayo Clinic</s1>
<s2>Rochester, Minnesota</s2>
<s3>USA</s3>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName>
<region type="state">Minnesota</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Sciurba, F C" sort="Sciurba, F C" uniqKey="Sciurba F" first="F. C." last="Sciurba">F. C. Sciurba</name>
<affiliation wicri:level="3">
<inist:fA14 i1="15">
<s1>Department of Pulmonary, Allergy, and Critical Care Medicine, University of Pittsburgh Medical Center</s1>
<s2>Pittsburgh</s2>
<s3>USA</s3>
<sZ>16 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName>
<settlement type="city">Pittsburgh</settlement>
<region type="state">Pennsylvanie</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Scharf, S M" sort="Scharf, S M" uniqKey="Scharf S" first="S. M." last="Scharf">S. M. Scharf</name>
<affiliation wicri:level="4">
<inist:fA14 i1="16">
<s1>Department of Pulmonary and Critical Care Medicine, University of Maryland</s1>
<s2>Baltimore</s2>
<s3>USA</s3>
<sZ>17 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName>
<settlement type="city">Baltimore</settlement>
<region type="state">Maryland</region>
<settlement type="city">College Park (Maryland)</settlement>
</placeName>
<orgName type="university">Université du Maryland</orgName>
</affiliation>
</author>
<author>
<name sortKey="Sin, D D" sort="Sin, D D" uniqKey="Sin D" first="D. D." last="Sin">D. D. Sin</name>
<affiliation wicri:level="1">
<inist:fA14 i1="07">
<s1>Department of Medicine and University of British Columbia James Hogg Research Centre, Institute for Heart and Lung Health, University of British Columbia</s1>
<s2>Vancouver</s2>
<s3>CAN</s3>
<sZ>18 aut.</sZ>
</inist:fA14>
<country>Canada</country>
<wicri:noRegion>Vancouver</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Voelker, H" sort="Voelker, H" uniqKey="Voelker H" first="H." last="Voelker">H. Voelker</name>
<affiliation wicri:level="2">
<inist:fA14 i1="03">
<s1>Data Coordinating Center, University of Minnesota</s1>
<s2>Minneapolis, Minnesota</s2>
<s3>USA</s3>
<sZ>2 aut.</sZ>
<sZ>19 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName>
<region type="state">Minnesota</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Washko, G R" sort="Washko, G R" uniqKey="Washko G" first="G. R." last="Washko">G. R. Washko</name>
<affiliation wicri:level="3">
<inist:fA14 i1="17">
<s1>Department of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital</s1>
<s2>Boston</s2>
<s3>USA</s3>
<sZ>20 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName>
<settlement type="city">Boston</settlement>
<region type="state">Massachusetts</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Woodruff, P G" sort="Woodruff, P G" uniqKey="Woodruff P" first="P. G." last="Woodruff">P. G. Woodruff</name>
<affiliation wicri:level="3">
<inist:fA14 i1="18">
<s1>Department of Pulmonary and Critical Care Medicine, University of California</s1>
<s2>San Francisco, San Francisco</s2>
<s3>USA</s3>
<sZ>21 aut.</sZ>
<sZ>22 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName>
<settlement type="city">San Francisco</settlement>
<region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Lazarus, S C" sort="Lazarus, S C" uniqKey="Lazarus S" first="S. C." last="Lazarus">S. C. Lazarus</name>
<affiliation wicri:level="3">
<inist:fA14 i1="18">
<s1>Department of Pulmonary and Critical Care Medicine, University of California</s1>
<s2>San Francisco, San Francisco</s2>
<s3>USA</s3>
<sZ>21 aut.</sZ>
<sZ>22 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName>
<settlement type="city">San Francisco</settlement>
<region type="state">Californie</region>
</placeName>
</affiliation>
</author>
</analytic>
<series>
<title level="j" type="main">The New England journal of medicine</title>
<title level="j" type="abbreviated">N. Engl. j. med.</title>
<idno type="ISSN">0028-4793</idno>
<imprint>
<date when="2014">2014</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt>
<title level="j" type="main">The New England journal of medicine</title>
<title level="j" type="abbreviated">N. Engl. j. med.</title>
<idno type="ISSN">0028-4793</idno>
</seriesStmt>
</fileDesc>
<profileDesc>
<textClass>
<keywords scheme="KwdEn" xml:lang="en">
<term>Antilipemic agent</term>
<term>Chronic obstructive pulmonary disease</term>
<term>Hypocholesterolemic agent</term>
<term>Medicine</term>
<term>Prevention</term>
<term>Simvastatin</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr">
<term>Bronchopneumopathie chronique obstructive</term>
<term>Simvastatine</term>
<term>Prévention</term>
<term>Médecine</term>
<term>Hypolipémiant</term>
<term>Hypocholestérolémiant</term>
<term>Forme grave</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr">
<term>Médecine</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front>
<div type="abstract" xml:lang="en">BACKGROUND Retrospective studies have shown that statins decrease the rate and severity of exacerbations, the rate of hospitalization, and mortality in chronic obstructive pulmonary disease (COPD). We prospectively studied the efficacy of simvastatin in preventing exacerbations in a large, multicenter, randomized trial. METHODS We designed the Prospective Randomized Placebo-Controlled Trial of Simvastatin in the Prevention of COPD Exacerbations (STATCOPE) as a randomized, controlled trial of simvastatin (at a daily dose of 40 mg) versus placebo, with annual exacerbation rates as the primary outcome. Patients were eligible if they were 40 to 80 years of age, had COPD (defined by a forced expiratory volume in 1 second [FEV
<sub>1</sub>
] of less than 80% and a ratio of FEV
<sub>1</sub>
to forced vital capacity of less than 70%), and had a smoking history of 10 or more pack-years, were receiving supplemental oxygen or treatment with glucocorticoids or antibiotic agents, or had had an emergency department visit or hospitalization for COPD within the past year. Patients with diabetes or cardiovascular disease and those who were taking statins or who required statins on the basis of Adult Treatment Panel III criteria were excluded. Participants were treated from 12 to 36 months at 45 centers. RESULTS A total of 885 participants with COPD were enrolled for approximately 641 days; 44% of the patients were women. The patients had a mean (±SD) age of 62.2±8.4 years, an FEV
<sub>1</sub>
that was 41.6±17.7% of the predicted value, and a smoking history of 50.6±27.4 pack-years. At the time of study closeout, the low-density lipoprotein cholesterol levels were lower in the simvastatin-treated patients than in those who received placebo.</div>
</front>
</TEI>
<affiliations>
<list>
<country>
<li>Canada</li>
<li>États-Unis</li>
</country>
<region>
<li>Angleterre</li>
<li>Californie</li>
<li>Maryland</li>
<li>Massachusetts</li>
<li>Midlands de l'Ouest</li>
<li>Minnesota</li>
<li>Pennsylvanie</li>
</region>
<settlement>
<li>Baltimore</li>
<li>Birmingham</li>
<li>Boston</li>
<li>College Park (Maryland)</li>
<li>Los Angeles</li>
<li>Philadelphie</li>
<li>Pittsburgh</li>
<li>San Francisco</li>
</settlement>
<orgName>
<li>Université du Maryland</li>
</orgName>
</list>
<tree>
<country name="États-Unis">
<region name="Pennsylvanie">
<name sortKey="Criner, G J" sort="Criner, G J" uniqKey="Criner G" first="G. J." last="Criner">G. J. Criner</name>
</region>
<name sortKey="Albert, R K" sort="Albert, R K" uniqKey="Albert R" first="R. K." last="Albert">R. K. Albert</name>
<name sortKey="Bailey, W C" sort="Bailey, W C" uniqKey="Bailey W" first="W. C." last="Bailey">W. C. Bailey</name>
<name sortKey="Casaburi, R" sort="Casaburi, R" uniqKey="Casaburi R" first="R." last="Casaburi">R. Casaburi</name>
<name sortKey="Connett, J E" sort="Connett, J E" uniqKey="Connett J" first="J. E." last="Connett">J. E. Connett</name>
<name sortKey="Connett, J E" sort="Connett, J E" uniqKey="Connett J" first="J. E." last="Connett">J. E. Connett</name>
<name sortKey="Cooper, J A D Jr" sort="Cooper, J A D Jr" uniqKey="Cooper J" first="J. A. D. Jr" last="Cooper">J. A. D. Jr Cooper</name>
<name sortKey="Curtis, J L" sort="Curtis, J L" uniqKey="Curtis J" first="J. L." last="Curtis">J. L. Curtis</name>
<name sortKey="Dransfield, M T" sort="Dransfield, M T" uniqKey="Dransfield M" first="M. T." last="Dransfield">M. T. Dransfield</name>
<name sortKey="Han, M K" sort="Han, M K" uniqKey="Han M" first="M. K." last="Han">M. K. Han</name>
<name sortKey="Lazarus, S C" sort="Lazarus, S C" uniqKey="Lazarus S" first="S. C." last="Lazarus">S. C. Lazarus</name>
<name sortKey="Make, B" sort="Make, B" uniqKey="Make B" first="B." last="Make">B. Make</name>
<name sortKey="Marchetti, N" sort="Marchetti, N" uniqKey="Marchetti N" first="N." last="Marchetti">N. Marchetti</name>
<name sortKey="Martinez, F J" sort="Martinez, F J" uniqKey="Martinez F" first="F. J." last="Martinez">F. J. Martinez</name>
<name sortKey="Niewoehner, D E" sort="Niewoehner, D E" uniqKey="Niewoehner D" first="D. E." last="Niewoehner">D. E. Niewoehner</name>
<name sortKey="Scanlon, P D" sort="Scanlon, P D" uniqKey="Scanlon P" first="P. D." last="Scanlon">P. D. Scanlon</name>
<name sortKey="Scharf, S M" sort="Scharf, S M" uniqKey="Scharf S" first="S. M." last="Scharf">S. M. Scharf</name>
<name sortKey="Sciurba, F C" sort="Sciurba, F C" uniqKey="Sciurba F" first="F. C." last="Sciurba">F. C. Sciurba</name>
<name sortKey="Voelker, H" sort="Voelker, H" uniqKey="Voelker H" first="H." last="Voelker">H. Voelker</name>
<name sortKey="Washko, G R" sort="Washko, G R" uniqKey="Washko G" first="G. R." last="Washko">G. R. Washko</name>
<name sortKey="Woodruff, P G" sort="Woodruff, P G" uniqKey="Woodruff P" first="P. G." last="Woodruff">P. G. Woodruff</name>
</country>
<country name="Canada">
<noRegion>
<name sortKey="Aaron, S D" sort="Aaron, S D" uniqKey="Aaron S" first="S. D." last="Aaron">S. D. Aaron</name>
</noRegion>
<name sortKey="Sin, D D" sort="Sin, D D" uniqKey="Sin D" first="D. D." last="Sin">D. D. Sin</name>
</country>
</tree>
</affiliations>
</record>

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