Design of the omapatrilat in persons with enhanced risk of atherosclerotic events (OPERA) trial
Identifieur interne : 000131 ( Istex/Corpus ); précédent : 000130; suivant : 000132Design of the omapatrilat in persons with enhanced risk of atherosclerotic events (OPERA) trial
Auteurs : John B. Kostis ; Stuart Cobbe ; Colin Johnston ; Ian Ford ; Michael Murphy ; Michael A. Weber ; Henry R. Black ; Pierre Francois Plouin ; Daniel Levy ; Guiseppe Mancia ; Pierre Larochelle ; Rainer E. Kolloch ; Michael Alderman ; Luis Miguel Ruilope ; Björn Dahlöf ; John M. Flack ; Robert WolfSource :
- American Journal of Hypertension [ 0895-7061 ] ; 2002-02.
English descriptors
Abstract
The Omapatrilat in Persons with Enhanced Risk of Atherosclerotic events (OPERA) trial is a large clinical trial of omapatrilat, a vasopeptidase inhibitor, in patients with stage 1 isolated systolic hypertension (ISH). OPERA is the first study to examine whether effective antihypertensive treatment can provide survival and clinical end point benefits in older persons with this common condition. This 5-year multinational, randomized, double-blind, parallel-group, placebo-controlled, forced-titration study will be conducted in approximately 12,600 subjects randomized by approximately 1100 study centers worldwide over a recruitment period of approximately 2 years. The primary objective of OPERA is to determine whether treatment with once-daily omapatrilat (target dose 40 mg) will reduce cardiovascular (CV) morbidity and mortality in older (≥65 years) men and women with enhanced risk for atherosclerotic events due to stage 1 ISH plus other risk factors for which currently there is no evidence-based requirement for treatment. Blood pressure inclusion criteria are systolic blood pressure (SBP) 140 to 159 mm Hg (SBP 125 to 139 mm Hg in diabetic individuals) and diastolic blood pressure (DBP) <90 mm Hg. The primary end point is defined as the composite of fatal/nonfatal stroke, fatal/nonfatal myocardial infarction, fatal/nonfatal heart failure, and other CV mortality. Secondary end points include the individual components of the primary end point, CV mortality, and major cardiovascular end points, as well as effects on cognitive function and initiation of treatment for diabetes. Additional analyses will be conducted in men and women, in diabetic patients, in different risk classes and according to prior evidence of vascular disease.
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DOI: 10.1016/S0895-7061(01)02048-9
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Kolloch</name><affiliation><mods:affiliation></mods:affiliation></affiliation></author><author><name sortKey="Alderman, Michael" sort="Alderman, Michael" uniqKey="Alderman M" first="Michael" last="Alderman">Michael Alderman</name><affiliation><mods:affiliation></mods:affiliation></affiliation></author><author><name sortKey="Ruilope, Luis Miguel" sort="Ruilope, Luis Miguel" uniqKey="Ruilope L" first="Luis Miguel" last="Ruilope">Luis Miguel Ruilope</name><affiliation><mods:affiliation></mods:affiliation></affiliation></author><author><name sortKey="Dahlof, Bjorn" sort="Dahlof, Bjorn" uniqKey="Dahlof B" first="Björn" last="Dahlöf">Björn Dahlöf</name><affiliation><mods:affiliation></mods:affiliation></affiliation></author><author><name sortKey="Flack, John M" sort="Flack, John M" uniqKey="Flack J" first="John M" last="Flack">John M. Flack</name><affiliation><mods:affiliation></mods:affiliation></affiliation></author><author><name sortKey="Wolf, Robert" sort="Wolf, Robert" uniqKey="Wolf R" first="Robert" last="Wolf">Robert Wolf</name><affiliation><mods:affiliation></mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">American Journal of Hypertension</title><title level="j" type="abbrev">AJH</title><idno type="ISSN">0895-7061</idno><idno type="eISSN">1941-7225</idno><imprint><publisher>Oxford University Press</publisher><date type="published" when="2002-02">2002-02</date><biblScope unit="volume">15</biblScope><biblScope unit="issue">2</biblScope><biblScope unit="page" from="193">193</biblScope><biblScope unit="page" to="198">198</biblScope></imprint><idno type="ISSN">0895-7061</idno></series><idno type="istex">A2F856FBAFF2AD64FF686B2160E4FFD09A3070FE</idno><idno type="DOI">10.1016/S0895-7061(01)02048-9</idno><idno type="href">15_2_193.pdf</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0895-7061</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Isolated systolic hypertension</term><term>cardiovascular morbidity and mortality</term><term>omapatrilat</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The Omapatrilat in Persons with Enhanced Risk of Atherosclerotic events (OPERA) trial is a large clinical trial of omapatrilat, a vasopeptidase inhibitor, in patients with stage 1 isolated systolic hypertension (ISH). OPERA is the first study to examine whether effective antihypertensive treatment can provide survival and clinical end point benefits in older persons with this common condition. This 5-year multinational, randomized, double-blind, parallel-group, placebo-controlled, forced-titration study will be conducted in approximately 12,600 subjects randomized by approximately 1100 study centers worldwide over a recruitment period of approximately 2 years. The primary objective of OPERA is to determine whether treatment with once-daily omapatrilat (target dose 40 mg) will reduce cardiovascular (CV) morbidity and mortality in older (≥65 years) men and women with enhanced risk for atherosclerotic events due to stage 1 ISH plus other risk factors for which currently there is no evidence-based requirement for treatment. Blood pressure inclusion criteria are systolic blood pressure (SBP) 140 to 159 mm Hg (SBP 125 to 139 mm Hg in diabetic individuals) and diastolic blood pressure (DBP) <90 mm Hg. The primary end point is defined as the composite of fatal/nonfatal stroke, fatal/nonfatal myocardial infarction, fatal/nonfatal heart failure, and other CV mortality. Secondary end points include the individual components of the primary end point, CV mortality, and major cardiovascular end points, as well as effects on cognitive function and initiation of treatment for diabetes. Additional analyses will be conducted in men and women, in diabetic patients, in different risk classes and according to prior evidence of vascular disease.</div></front></TEI><istex><corpusName>oup</corpusName><author><json:item><name>John B Kostis</name><affiliations><json:string>University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswick, New Jersey, USA</json:string><json:string>E-mail: kostis@umdnj.edu</json:string></affiliations></json:item><json:item><name>Stuart Cobbe</name><affiliations><json:string>University of Glasgow, Glasgow, Scotland UK</json:string></affiliations></json:item><json:item><name>Colin Johnston</name><affiliations><json:string>Baker Medical Research Institute, Melbourne, Australia</json:string></affiliations></json:item><json:item><name>Ian Ford</name><affiliations><json:string>University of Glasgow, Glasgow, Scotland UK</json:string></affiliations></json:item><json:item><name>Michael Murphy</name><affiliations><json:string>Cork University Hospital, Cork, Ireland</json:string></affiliations></json:item><json:item><name>Michael A Weber</name><affiliations><json:string>Bookdale Hospital Medical Center, Brooklyn, New York USA</json:string></affiliations></json:item><json:item><name>Henry R Black</name><affiliations><json:string>Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois USA</json:string></affiliations></json:item><json:item><name>Pierre Francois Plouin</name><affiliations><json:string>Hôpital European Georges Pompidou, Paris, France</json:string></affiliations></json:item><json:item><name>Daniel Levy</name><affiliations><json:string>Framingham Heart Study Institution, Framingham, Massachusetts USA</json:string></affiliations></json:item><json:item><name>Guiseppe Mancia</name><affiliations><json:string>Ospedale S. Gerardo dei Tintori, Monza, Italy</json:string></affiliations></json:item><json:item><name>Pierre Larochelle</name><affiliations><json:string>Institut de Recherces Cliniques de Montreal, Montreal, Canada</json:string></affiliations></json:item><json:item><name>Rainer E Kolloch</name><affiliations><json:string>Wilhelms-Universitat, Bleiefeld, Germany</json:string></affiliations></json:item><json:item><name>Michael Alderman</name><affiliations><json:string>Albert Einstein College of Medicine, Bronx, New York USA</json:string></affiliations></json:item><json:item><name>Luis Miguel Ruilope</name><affiliations><json:string>Hospital Doce De Octubre, Madrid, Spain</json:string></affiliations></json:item><json:item><name>Björn Dahlöf</name><affiliations><json:string>Ostra University Hospital, Goteborg, Sweden</json:string></affiliations></json:item><json:item><name>John M Flack</name><affiliations><json:string>Harper Hospital, Detroit, Michigan USA</json:string></affiliations></json:item><json:item><name>Robert Wolf</name><affiliations><json:string>Bristol-Myers Squibb, Princeton, New Jersey USA</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>Original Contributions</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>Isolated systolic hypertension</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>omapatrilat</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>cardiovascular morbidity and mortality</value></json:item></subject><language><json:string>eng</json:string></language><abstract>The Omapatrilat in Persons with Enhanced Risk of Atherosclerotic events (OPERA) trial is a large clinical trial of omapatrilat, a vasopeptidase inhibitor, in patients with stage 1 isolated systolic hypertension (ISH). OPERA is the first study to examine whether effective antihypertensive treatment can provide survival and clinical end point benefits in older persons with this common condition. This 5-year multinational, randomized, double-blind, parallel-group, placebo-controlled, forced-titration study will be conducted in approximately 12,600 subjects randomized by approximately 1100 study centers worldwide over a recruitment period of approximately 2 years. The primary objective of OPERA is to determine whether treatment with once-daily omapatrilat (target dose 40 mg) will reduce cardiovascular (CV) morbidity and mortality in older (≥65 years) men and women with enhanced risk for atherosclerotic events due to stage 1 ISH plus other risk factors for which currently there is no evidence-based requirement for treatment. Blood pressure inclusion criteria are systolic blood pressure (SBP) 140 to 159 mm Hg (SBP 125 to 139 mm Hg in diabetic individuals) and diastolic blood pressure (DBP) >90 mm Hg. The primary end point is defined as the composite of fatal/nonfatal stroke, fatal/nonfatal myocardial infarction, fatal/nonfatal heart failure, and other CV mortality. Secondary end points include the individual components of the primary end point, CV mortality, and major cardiovascular end points, as well as effects on cognitive function and initiation of treatment for diabetes. Additional analyses will be conducted in men and women, in diabetic patients, in different risk classes and according to prior evidence of vascular disease.</abstract><qualityIndicators><score>6.676</score><pdfVersion>1.2</pdfVersion><pdfPageSize>587 x 786 pts</pdfPageSize><refBibsNative>true</refBibsNative><keywordCount>4</keywordCount><abstractCharCount>1753</abstractCharCount><pdfWordCount>3676</pdfWordCount><pdfCharCount>23035</pdfCharCount><pdfPageCount>6</pdfPageCount><abstractWordCount>253</abstractWordCount></qualityIndicators><title>Design of the omapatrilat in persons with enhanced risk of atherosclerotic events (OPERA) trial</title><genre><json:string>brief communication</json:string></genre><host><volume>15</volume><pages><last>198</last><first>193</first></pages><issn><json:string>0895-7061</json:string></issn><issue>2</issue><genre></genre><language><json:string>unknown</json:string></language><eissn><json:string>1941-7225</json:string></eissn><title>American Journal of Hypertension</title></host><categories><wos><json:string>PERIPHERAL VASCULAR DISEASE</json:string></wos></categories><publicationDate>2002</publicationDate><copyrightDate>2002</copyrightDate><doi><json:string>10.1016/S0895-7061(01)02048-9</json:string></doi><id>A2F856FBAFF2AD64FF686B2160E4FFD09A3070FE</id><fulltext><json:item><original>true</original><mimetype>application/pdf</mimetype><extension>pdf</extension><uri>https://api.istex.fr/document/A2F856FBAFF2AD64FF686B2160E4FFD09A3070FE/fulltext/pdf</uri></json:item><json:item><original>false</original><mimetype>application/zip</mimetype><extension>zip</extension><uri>https://api.istex.fr/document/A2F856FBAFF2AD64FF686B2160E4FFD09A3070FE/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/A2F856FBAFF2AD64FF686B2160E4FFD09A3070FE/fulltext/tei"><teiHeader><fileDesc><titleStmt><title level="a">Design of the omapatrilat in persons with enhanced risk of atherosclerotic events (OPERA) trial</title></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>Oxford University Press</publisher><availability><p>OUP</p></availability><date>2002</date></publicationStmt><notesStmt><note>This study is supported by a grant from Bristol-Myers Squibb, Princeton, NJ.</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a">Design of the omapatrilat in persons with enhanced risk of atherosclerotic events (OPERA) trial</title><author corresp="yes"><persName><forename type="first">John B</forename><surname>Kostis</surname></persName><email>kostis@umdnj.edu</email><affiliation></affiliation></author><author><persName><forename type="first">Stuart</forename><surname>Cobbe</surname></persName><affiliation></affiliation></author><author><persName><forename type="first">Colin</forename><surname>Johnston</surname></persName><affiliation></affiliation></author><author><persName><forename type="first">Ian</forename><surname>Ford</surname></persName><affiliation></affiliation></author><author><persName><forename type="first">Michael</forename><surname>Murphy</surname></persName><affiliation></affiliation></author><author><persName><forename type="first">Michael A</forename><surname>Weber</surname></persName><affiliation></affiliation></author><author><persName><forename type="first">Henry R</forename><surname>Black</surname></persName><affiliation></affiliation></author><author><persName><forename type="first">Pierre Francois</forename><surname>Plouin</surname></persName><affiliation></affiliation></author><author><persName><forename type="first">Daniel</forename><surname>Levy</surname></persName><affiliation></affiliation></author><author><persName><forename type="first">Guiseppe</forename><surname>Mancia</surname></persName><affiliation></affiliation></author><author><persName><forename type="first">Pierre</forename><surname>Larochelle</surname></persName><affiliation></affiliation></author><author><persName><forename type="first">Rainer E</forename><surname>Kolloch</surname></persName><affiliation></affiliation></author><author><persName><forename type="first">Michael</forename><surname>Alderman</surname></persName><affiliation></affiliation></author><author><persName><forename type="first">Luis Miguel</forename><surname>Ruilope</surname></persName><affiliation></affiliation></author><author><persName><forename type="first">Björn</forename><surname>Dahlöf</surname></persName><affiliation></affiliation></author><author><persName><forename type="first">John M</forename><surname>Flack</surname></persName><affiliation></affiliation></author><author><persName><forename type="first">Robert</forename><surname>Wolf</surname></persName><affiliation></affiliation></author></analytic><monogr><title level="j">American Journal of Hypertension</title><title level="j" type="abbrev">AJH</title><idno type="pISSN">0895-7061</idno><idno type="eISSN">1941-7225</idno><imprint><publisher>Oxford University Press</publisher><date type="published" when="2002-02"></date><biblScope unit="volume">15</biblScope><biblScope unit="issue">2</biblScope><biblScope unit="page" from="193">193</biblScope><biblScope unit="page" to="198">198</biblScope></imprint></monogr><idno type="istex">A2F856FBAFF2AD64FF686B2160E4FFD09A3070FE</idno><idno type="DOI">10.1016/S0895-7061(01)02048-9</idno><idno type="href">15_2_193.pdf</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2002</date></creation><langUsage><language ident="en">en</language></langUsage><abstract xml:lang="en"><p>The Omapatrilat in Persons with Enhanced Risk of Atherosclerotic events (OPERA) trial is a large clinical trial of omapatrilat, a vasopeptidase inhibitor, in patients with stage 1 isolated systolic hypertension (ISH). OPERA is the first study to examine whether effective antihypertensive treatment can provide survival and clinical end point benefits in older persons with this common condition. This 5-year multinational, randomized, double-blind, parallel-group, placebo-controlled, forced-titration study will be conducted in approximately 12,600 subjects randomized by approximately 1100 study centers worldwide over a recruitment period of approximately 2 years. The primary objective of OPERA is to determine whether treatment with once-daily omapatrilat (target dose 40 mg) will reduce cardiovascular (CV) morbidity and mortality in older (≥65 years) men and women with enhanced risk for atherosclerotic events due to stage 1 ISH plus other risk factors for which currently there is no evidence-based requirement for treatment. Blood pressure inclusion criteria are systolic blood pressure (SBP) 140 to 159 mm Hg (SBP 125 to 139 mm Hg in diabetic individuals) and diastolic blood pressure (DBP) <90 mm Hg. The primary end point is defined as the composite of fatal/nonfatal stroke, fatal/nonfatal myocardial infarction, fatal/nonfatal heart failure, and other CV mortality. Secondary end points include the individual components of the primary end point, CV mortality, and major cardiovascular end points, as well as effects on cognitive function and initiation of treatment for diabetes. Additional analyses will be conducted in men and women, in diabetic patients, in different risk classes and according to prior evidence of vascular disease.</p></abstract><textClass><keywords scheme="keyword"><list><item><term>Original Contributions</term></item></list></keywords></textClass><textClass xml:lang="en"><keywords scheme="keyword"><list><head>Keywords</head><item><term>Isolated systolic hypertension</term></item><item><term>omapatrilat</term></item><item><term>cardiovascular morbidity and mortality</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2002-02">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><original>false</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/A2F856FBAFF2AD64FF686B2160E4FFD09A3070FE/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="corpus oup" wicri:toSee="no header"><istex:xmlDeclaration>version="1.0" encoding="utf-8"</istex:xmlDeclaration><istex:docType PUBLIC="-//NLM//DTD Journal Publishing DTD v2.3 20070202//EN" URI="http://dtd.nlm.nih.gov/publishing/2.3/journalpublishing.dtd" name="istex:docType"></istex:docType><istex:document><article article-type="brief-report" dtd-version="2.3"><front><journal-meta><journal-id journal-id-type="hwp">ajh</journal-id><journal-id journal-id-type="nlm-ta">AJH</journal-id><journal-id journal-id-type="publisher-id">ajh</journal-id><journal-title>American Journal of Hypertension</journal-title><issn pub-type="ppub">0895-7061</issn><issn pub-type="epub">1941-7225</issn><publisher><publisher-name>Oxford University Press</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.1016/S0895-7061(01)02048-9</article-id><article-categories><subj-group><subject>Original Contributions</subject></subj-group></article-categories><title-group><article-title>Design of the omapatrilat in persons with enhanced risk of atherosclerotic events (OPERA) trial<xref ref-type="fn" rid="fn1"><sup>*</sup></xref></article-title></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name><surname>Kostis</surname><given-names>John B</given-names></name><xref ref-type="aff" rid="AF0001"><sup>1</sup></xref><xref ref-type="corresp" rid="cor1"></xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Cobbe</surname><given-names>Stuart</given-names></name><xref ref-type="aff" rid="AF0002"><sup>2</sup></xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Johnston</surname><given-names>Colin</given-names></name><xref ref-type="aff" rid="AF0003"><sup>3</sup></xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Ford</surname><given-names>Ian</given-names></name><xref ref-type="aff" rid="AF0002"><sup>2</sup></xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Murphy</surname><given-names>Michael</given-names></name><xref ref-type="aff" rid="AF0004"><sup>4</sup></xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Weber</surname><given-names>Michael A</given-names></name><xref ref-type="aff" rid="AF0005"><sup>5</sup></xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Black</surname><given-names>Henry R</given-names></name><xref ref-type="aff" rid="AF0006"><sup>6</sup></xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Plouin</surname><given-names>Pierre Francois</given-names></name><xref ref-type="aff" rid="AF0007"><sup>7</sup></xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Levy</surname><given-names>Daniel</given-names></name><xref ref-type="aff" rid="AF0008"><sup>8</sup></xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Mancia</surname><given-names>Guiseppe</given-names></name><xref ref-type="aff" rid="AF0009"><sup>9</sup></xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Larochelle</surname><given-names>Pierre</given-names></name><xref ref-type="aff" rid="AF0010"><sup>10</sup></xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Kolloch</surname><given-names>Rainer E</given-names></name><xref ref-type="aff" rid="AF0011"><sup>11</sup></xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Alderman</surname><given-names>Michael</given-names></name><xref ref-type="aff" rid="AF0012"><sup>12</sup></xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Ruilope</surname><given-names>Luis Miguel</given-names></name><xref ref-type="aff" rid="AF0013"><sup>13</sup></xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Dahlöf</surname><given-names>Björn</given-names></name><xref ref-type="aff" rid="AF0014"><sup>14</sup></xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Flack</surname><given-names>John M</given-names></name><xref ref-type="aff" rid="AF0015"><sup>15</sup></xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Wolf</surname><given-names>Robert</given-names></name><xref ref-type="aff" rid="AF0016"><sup>16</sup></xref></contrib><on-behalf-of>for the OPERA Study Group</on-behalf-of><aff id="AF0001"><label>1</label><institution>University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School</institution>, <addr-line>New Brunswick, New Jersey</addr-line>, <country>USA</country></aff><aff id="AF0002"><label>2</label><institution>University of Glasgow</institution>, <addr-line>Glasgow, Scotland</addr-line> <country>UK</country></aff><aff id="AF0003"><label>3</label><institution>Baker Medical Research Institute</institution>, <addr-line>Melbourne</addr-line>, <country>Australia</country></aff><aff id="AF0004"><label>4</label><institution>Cork University Hospital</institution>, <addr-line>Cork</addr-line>, <country>Ireland</country></aff><aff id="AF0005"><label>5</label><institution>Bookdale Hospital Medical Center</institution>, <addr-line>Brooklyn, New York</addr-line> <country>USA</country></aff><aff id="AF0006"><label>6</label><institution>Rush-Presbyterian-St. Luke's Medical Center</institution>, <addr-line>Chicago, Illinois</addr-line> <country>USA</country></aff><aff id="AF0007"><label>7</label><institution>Hôpital European Georges Pompidou</institution>, <addr-line>Paris</addr-line>, <country>France</country></aff><aff id="AF0008"><label>8</label><institution>Framingham Heart Study Institution</institution>, <addr-line>Framingham, Massachusetts</addr-line> <country>USA</country></aff><aff id="AF0009"><label>9</label><institution>Ospedale S. Gerardo dei Tintori</institution>, <addr-line>Monza</addr-line>, <country>Italy</country></aff><aff id="AF0010"><label>10</label><institution>Institut de Recherces Cliniques de Montreal</institution>, <addr-line>Montreal</addr-line>, <country>Canada</country></aff><aff id="AF0011"><label>11</label><institution>Wilhelms-Universitat</institution>, <addr-line>Bleiefeld</addr-line>, <country>Germany</country></aff><aff id="AF0012"><label>12</label><institution>Albert Einstein College of Medicine</institution>, <addr-line>Bronx, New York</addr-line> <country>USA</country></aff><aff id="AF0013"><label>13</label><institution>Hospital Doce De Octubre</institution>, <addr-line>Madrid</addr-line>, <country>Spain</country></aff><aff id="AF0014"><label>14</label><institution>Ostra University Hospital</institution>, <addr-line>Goteborg</addr-line>, <country>Sweden</country></aff><aff id="AF0015"><label>15</label><institution>Harper Hospital, Detroit</institution>, <addr-line>Michigan</addr-line> <country>USA</country></aff><aff id="AF0016"><label>16</label><institution>Bristol-Myers Squibb</institution>, <addr-line>Princeton, New Jersey</addr-line> <country>USA</country></aff></contrib-group><author-notes><corresp id="cor1">Address correspondence and reprint requests to Dr. John B. Kostis <institution>University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, One Robert Wood Johnson PI.</institution>, P.O. Box 19, <addr-line>New Brunswick, NJ 08903-0019</addr-line> <country>USA</country> E-mail: <email>kostis@umdnj.edu</email></corresp><fn id="fn1"><label>*</label><p>This study is supported by a grant from Bristol-Myers Squibb, Princeton, NJ.</p></fn></author-notes><pub-date pub-type="ppub"><month>2</month><year>2002</year></pub-date><volume>15</volume><issue>2</issue><fpage>193</fpage><lpage>198</lpage><history><date date-type="received"><day>14</day><month>12</month><year>2000</year></date><date date-type="accepted"><day>1</day><month>11</month><year>2001</year></date></history><permissions><copyright-statement>© 2002 by the American Journal of Hypertension, Ltd.</copyright-statement><copyright-year>2002</copyright-year><copyright-holder>American Journal of Hypertension, Ltd.</copyright-holder></permissions><self-uri content-type="pdf" xlink:href="15_2_193.pdf"></self-uri><abstract xml:lang="en"><p>The <italic>O</italic>mapatrilat in <italic>P</italic>ersons with <italic>E</italic>nhanced <italic>R</italic>isk of <italic>A</italic>therosclerotic events (OPERA) trial is a large clinical trial of omapatrilat, a vasopeptidase inhibitor, in patients with stage 1 isolated systolic hypertension (ISH). OPERA is the first study to examine whether effective antihypertensive treatment can provide survival and clinical end point benefits in older persons with this common condition. This 5-year multinational, randomized, double-blind, parallel-group, placebo-controlled, forced-titration study will be conducted in approximately 12,600 subjects randomized by approximately 1100 study centers worldwide over a recruitment period of approximately 2 years. The primary objective of OPERA is to determine whether treatment with once-daily omapatrilat (target dose 40 mg) will reduce cardiovascular (CV) morbidity and mortality in older (≥65 years) men and women with enhanced risk for atherosclerotic events due to stage 1 ISH plus other risk factors for which currently there is no evidence-based requirement for treatment. Blood pressure inclusion criteria are systolic blood pressure (SBP) 140 to 159 mm Hg (SBP 125 to 139 mm Hg in diabetic individuals) and diastolic blood pressure (DBP) <90 mm Hg.</p><p>The primary end point is defined as the composite of fatal/nonfatal stroke, fatal/nonfatal myocardial infarction, fatal/nonfatal heart failure, and other CV mortality. Secondary end points include the individual components of the primary end point, CV mortality, and major cardiovascular end points, as well as effects on cognitive function and initiation of treatment for diabetes. Additional analyses will be conducted in men and women, in diabetic patients, in different risk classes and according to prior evidence of vascular disease.</p></abstract><kwd-group xml:lang="en"><kwd>Isolated systolic hypertension</kwd><kwd>omapatrilat</kwd><kwd>cardiovascular morbidity and mortality</kwd></kwd-group></article-meta></front></article></istex:document></istex:metadataXml><mods version="3.6"><titleInfo><title>Design of the omapatrilat in persons with enhanced risk of atherosclerotic events (OPERA) trial</title></titleInfo><titleInfo type="alternative" contentType="CDATA"><title>Design of the omapatrilat in persons with enhanced risk of atherosclerotic events (OPERA) trial*</title></titleInfo><name type="personal" displayLabel="corresp"><namePart type="given">John B</namePart><namePart type="family">Kostis</namePart><affiliation></affiliation><affiliation>E-mail: kostis@umdnj.edu</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Stuart</namePart><namePart type="family">Cobbe</namePart><affiliation></affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Colin</namePart><namePart type="family">Johnston</namePart><affiliation></affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Ian</namePart><namePart type="family">Ford</namePart><affiliation></affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Michael</namePart><namePart type="family">Murphy</namePart><affiliation></affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Michael A</namePart><namePart type="family">Weber</namePart><affiliation></affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Henry R</namePart><namePart type="family">Black</namePart><affiliation></affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Pierre Francois</namePart><namePart type="family">Plouin</namePart><affiliation></affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Daniel</namePart><namePart type="family">Levy</namePart><affiliation></affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Guiseppe</namePart><namePart type="family">Mancia</namePart><affiliation></affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Pierre</namePart><namePart type="family">Larochelle</namePart><affiliation></affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Rainer E</namePart><namePart type="family">Kolloch</namePart><affiliation></affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Michael</namePart><namePart type="family">Alderman</namePart><affiliation></affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Luis Miguel</namePart><namePart type="family">Ruilope</namePart><affiliation></affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Björn</namePart><namePart type="family">Dahlöf</namePart><affiliation></affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">John M</namePart><namePart type="family">Flack</namePart><affiliation></affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Robert</namePart><namePart type="family">Wolf</namePart><affiliation></affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="brief communication" displayLabel="brief-report"></genre><subject><topic>Original Contributions</topic></subject><originInfo><publisher>Oxford University Press</publisher><dateIssued encoding="w3cdtf">2002-02</dateIssued><copyrightDate encoding="w3cdtf">2002</copyrightDate></originInfo><language><languageTerm type="code" authority="iso639-2b">eng</languageTerm><languageTerm type="code" authority="rfc3066">en</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType></physicalDescription><abstract lang="en">The Omapatrilat in Persons with Enhanced Risk of Atherosclerotic events (OPERA) trial is a large clinical trial of omapatrilat, a vasopeptidase inhibitor, in patients with stage 1 isolated systolic hypertension (ISH). OPERA is the first study to examine whether effective antihypertensive treatment can provide survival and clinical end point benefits in older persons with this common condition. This 5-year multinational, randomized, double-blind, parallel-group, placebo-controlled, forced-titration study will be conducted in approximately 12,600 subjects randomized by approximately 1100 study centers worldwide over a recruitment period of approximately 2 years. The primary objective of OPERA is to determine whether treatment with once-daily omapatrilat (target dose 40 mg) will reduce cardiovascular (CV) morbidity and mortality in older (≥65 years) men and women with enhanced risk for atherosclerotic events due to stage 1 ISH plus other risk factors for which currently there is no evidence-based requirement for treatment. Blood pressure inclusion criteria are systolic blood pressure (SBP) 140 to 159 mm Hg (SBP 125 to 139 mm Hg in diabetic individuals) and diastolic blood pressure (DBP) <90 mm Hg. The primary end point is defined as the composite of fatal/nonfatal stroke, fatal/nonfatal myocardial infarction, fatal/nonfatal heart failure, and other CV mortality. Secondary end points include the individual components of the primary end point, CV mortality, and major cardiovascular end points, as well as effects on cognitive function and initiation of treatment for diabetes. Additional analyses will be conducted in men and women, in diabetic patients, in different risk classes and according to prior evidence of vascular disease.</abstract><note type="footnotes">This study is supported by a grant from Bristol-Myers Squibb, Princeton, NJ.</note><subject lang="en"><genre>Keywords</genre><topic>Isolated systolic hypertension</topic><topic>omapatrilat</topic><topic>cardiovascular morbidity and mortality</topic></subject><relatedItem type="host"><titleInfo><title>American Journal of Hypertension</title></titleInfo><titleInfo type="abbreviated"><title>AJH</title></titleInfo><genre type="Journal">journal</genre><identifier type="ISSN">0895-7061</identifier><identifier type="eISSN">1941-7225</identifier><identifier type="PublisherID">ajh</identifier><identifier type="PublisherID-hwp">ajh</identifier><identifier type="PublisherID-nlm-ta">AJH</identifier><part><date>2002</date><detail type="volume"><caption>vol.</caption><number>15</number></detail><detail type="issue"><caption>no.</caption><number>2</number></detail><extent unit="pages"><start>193</start><end>198</end></extent></part></relatedItem><identifier type="istex">A2F856FBAFF2AD64FF686B2160E4FFD09A3070FE</identifier><identifier type="DOI">10.1016/S0895-7061(01)02048-9</identifier><identifier type="href">15_2_193.pdf</identifier><accessCondition type="use and reproduction" contentType="copyright">© 2002 by the American Journal of Hypertension, Ltd.</accessCondition><recordInfo><recordContentSource>OUP</recordContentSource><recordOrigin>American Journal of Hypertension, Ltd.</recordOrigin></recordInfo></mods></metadata><enrichments><istex:catWosTEI uri="https://api.istex.fr/document/A2F856FBAFF2AD64FF686B2160E4FFD09A3070FE/enrichments/catWos"><teiHeader><profileDesc><textClass><classCode scheme="WOS">PERIPHERAL VASCULAR DISEASE</classCode></textClass></profileDesc></teiHeader></istex:catWosTEI></enrichments><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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