Design of the Omapatrilat in Persons with Enhanced Risk of Atherosclerotic events (OPERA) trial.
Identifieur interne : 000623 ( PubMed/Corpus ); précédent : 000622; suivant : 000624Design 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.
English descriptors
- KwdEn :
- Arteriosclerosis (etiology), Arteriosclerosis (prevention & control), Double-Blind Method, Female, Humans, Hypertension (complications), Hypertension (drug therapy), Male, Middle Aged, Placebos, Protease Inhibitors (therapeutic use), Pyridines (therapeutic use), Research Design, Risk Factors, Thiazepines (therapeutic use).
- MESH :
- chemical , therapeutic use : Protease Inhibitors, Pyridines, Thiazepines.
- chemical : Placebos.
- complications : Hypertension.
- drug therapy : Hypertension.
- etiology : Arteriosclerosis.
- prevention & control : Arteriosclerosis.
- Double-Blind Method, Female, Humans, Male, Middle Aged, Research Design, Risk Factors.
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 (> or = 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.
PubMed: 11863257
Links to Exploration step
pubmed:11863257Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Design of the Omapatrilat in Persons with Enhanced Risk of Atherosclerotic events (OPERA) trial.</title><author><name sortKey="Kostis, John B" sort="Kostis, John B" uniqKey="Kostis J" first="John B" last="Kostis">John B. Kostis</name><affiliation><nlm:affiliation>University of Medicine and Dentistry of New Jersey--Robert Wood Johnson Medical School, New Brunswick 08903-0019, USA. kostis@umdnj.edu</nlm:affiliation></affiliation></author><author><name sortKey="Cobbe, Stuart" sort="Cobbe, Stuart" uniqKey="Cobbe S" first="Stuart" last="Cobbe">Stuart Cobbe</name></author><author><name sortKey="Johnston, Colin" sort="Johnston, Colin" uniqKey="Johnston C" first="Colin" last="Johnston">Colin Johnston</name></author><author><name sortKey="Ford, Ian" sort="Ford, Ian" uniqKey="Ford I" first="Ian" last="Ford">Ian Ford</name></author><author><name sortKey="Murphy, Michael" sort="Murphy, Michael" uniqKey="Murphy M" first="Michael" last="Murphy">Michael Murphy</name></author><author><name sortKey="Weber, Michael A" sort="Weber, Michael A" uniqKey="Weber M" first="Michael A" last="Weber">Michael A. Weber</name></author><author><name sortKey="Black, Henry R" sort="Black, Henry R" uniqKey="Black H" first="Henry R" last="Black">Henry R. Black</name></author><author><name sortKey="Plouin, Pierre Francois" sort="Plouin, Pierre Francois" uniqKey="Plouin P" first="Pierre Francois" last="Plouin">Pierre Francois Plouin</name></author><author><name sortKey="Levy, Daniel" sort="Levy, Daniel" uniqKey="Levy D" first="Daniel" last="Levy">Daniel Levy</name></author><author><name sortKey="Mancia, Guiseppe" sort="Mancia, Guiseppe" uniqKey="Mancia G" first="Guiseppe" last="Mancia">Guiseppe Mancia</name></author><author><name sortKey="Larochelle, Pierre" sort="Larochelle, Pierre" uniqKey="Larochelle P" first="Pierre" last="Larochelle">Pierre Larochelle</name></author><author><name sortKey="Kolloch, Rainer E" sort="Kolloch, Rainer E" uniqKey="Kolloch R" first="Rainer E" last="Kolloch">Rainer E. Kolloch</name></author><author><name sortKey="Alderman, Michael" sort="Alderman, Michael" uniqKey="Alderman M" first="Michael" last="Alderman">Michael Alderman</name></author><author><name sortKey="Ruilope, Luis Miguel" sort="Ruilope, Luis Miguel" uniqKey="Ruilope L" first="Luis Miguel" last="Ruilope">Luis Miguel Ruilope</name></author><author><name sortKey="Dahlof, Bjorn" sort="Dahlof, Bjorn" uniqKey="Dahlof B" first="Björn" last="Dahlöf">Björn Dahlöf</name></author><author><name sortKey="Flack, John M" sort="Flack, John M" uniqKey="Flack J" first="John M" last="Flack">John M. Flack</name></author><author><name sortKey="Wolf, Robert" sort="Wolf, Robert" uniqKey="Wolf R" first="Robert" last="Wolf">Robert Wolf</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2002">2002</date><idno type="RBID">pubmed:11863257</idno><idno type="pmid">11863257</idno><idno type="wicri:Area/PubMed/Corpus">000623</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Design of the Omapatrilat in Persons with Enhanced Risk of Atherosclerotic events (OPERA) trial.</title><author><name sortKey="Kostis, John B" sort="Kostis, John B" uniqKey="Kostis J" first="John B" last="Kostis">John B. Kostis</name><affiliation><nlm:affiliation>University of Medicine and Dentistry of New Jersey--Robert Wood Johnson Medical School, New Brunswick 08903-0019, USA. kostis@umdnj.edu</nlm:affiliation></affiliation></author><author><name sortKey="Cobbe, Stuart" sort="Cobbe, Stuart" uniqKey="Cobbe S" first="Stuart" last="Cobbe">Stuart Cobbe</name></author><author><name sortKey="Johnston, Colin" sort="Johnston, Colin" uniqKey="Johnston C" first="Colin" last="Johnston">Colin Johnston</name></author><author><name sortKey="Ford, Ian" sort="Ford, Ian" uniqKey="Ford I" first="Ian" last="Ford">Ian Ford</name></author><author><name sortKey="Murphy, Michael" sort="Murphy, Michael" uniqKey="Murphy M" first="Michael" last="Murphy">Michael Murphy</name></author><author><name sortKey="Weber, Michael A" sort="Weber, Michael A" uniqKey="Weber M" first="Michael A" last="Weber">Michael A. Weber</name></author><author><name sortKey="Black, Henry R" sort="Black, Henry R" uniqKey="Black H" first="Henry R" last="Black">Henry R. Black</name></author><author><name sortKey="Plouin, Pierre Francois" sort="Plouin, Pierre Francois" uniqKey="Plouin P" first="Pierre Francois" last="Plouin">Pierre Francois Plouin</name></author><author><name sortKey="Levy, Daniel" sort="Levy, Daniel" uniqKey="Levy D" first="Daniel" last="Levy">Daniel Levy</name></author><author><name sortKey="Mancia, Guiseppe" sort="Mancia, Guiseppe" uniqKey="Mancia G" first="Guiseppe" last="Mancia">Guiseppe Mancia</name></author><author><name sortKey="Larochelle, Pierre" sort="Larochelle, Pierre" uniqKey="Larochelle P" first="Pierre" last="Larochelle">Pierre Larochelle</name></author><author><name sortKey="Kolloch, Rainer E" sort="Kolloch, Rainer E" uniqKey="Kolloch R" first="Rainer E" last="Kolloch">Rainer E. Kolloch</name></author><author><name sortKey="Alderman, Michael" sort="Alderman, Michael" uniqKey="Alderman M" first="Michael" last="Alderman">Michael Alderman</name></author><author><name sortKey="Ruilope, Luis Miguel" sort="Ruilope, Luis Miguel" uniqKey="Ruilope L" first="Luis Miguel" last="Ruilope">Luis Miguel Ruilope</name></author><author><name sortKey="Dahlof, Bjorn" sort="Dahlof, Bjorn" uniqKey="Dahlof B" first="Björn" last="Dahlöf">Björn Dahlöf</name></author><author><name sortKey="Flack, John M" sort="Flack, John M" uniqKey="Flack J" first="John M" last="Flack">John M. Flack</name></author><author><name sortKey="Wolf, Robert" sort="Wolf, Robert" uniqKey="Wolf R" first="Robert" last="Wolf">Robert Wolf</name></author></analytic><series><title level="j">American journal of hypertension</title><idno type="ISSN">0895-7061</idno><imprint><date when="2002" type="published">2002</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Arteriosclerosis (etiology)</term><term>Arteriosclerosis (prevention & control)</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Hypertension (complications)</term><term>Hypertension (drug therapy)</term><term>Male</term><term>Middle Aged</term><term>Placebos</term><term>Protease Inhibitors (therapeutic use)</term><term>Pyridines (therapeutic use)</term><term>Research Design</term><term>Risk Factors</term><term>Thiazepines (therapeutic use)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Protease Inhibitors</term><term>Pyridines</term><term>Thiazepines</term></keywords><keywords scheme="MESH" type="chemical" xml:lang="en"><term>Placebos</term></keywords><keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>Hypertension</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Hypertension</term></keywords><keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Arteriosclerosis</term></keywords><keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Arteriosclerosis</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Research Design</term><term>Risk Factors</term></keywords></textClass></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 (> or = 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><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">11863257</PMID><DateCreated><Year>2002</Year><Month>02</Month><Day>26</Day></DateCreated><DateCompleted><Year>2002</Year><Month>08</Month><Day>14</Day></DateCompleted><DateRevised><Year>2014</Year><Month>01</Month><Day>09</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Print">0895-7061</ISSN><JournalIssue CitedMedium="Print"><Volume>15</Volume><Issue>2 Pt 1</Issue><PubDate><Year>2002</Year><Month>Feb</Month></PubDate></JournalIssue><Title>American journal of hypertension</Title><ISOAbbreviation>Am. J. Hypertens.</ISOAbbreviation></Journal><ArticleTitle>Design of the Omapatrilat in Persons with Enhanced Risk of Atherosclerotic events (OPERA) trial.</ArticleTitle><Pagination><MedlinePgn>193-8</MedlinePgn></Pagination><Abstract><AbstractText>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 (> or = 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.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Kostis</LastName><ForeName>John B</ForeName><Initials>JB</Initials><AffiliationInfo><Affiliation>University of Medicine and Dentistry of New Jersey--Robert Wood Johnson Medical School, New Brunswick 08903-0019, USA. kostis@umdnj.edu</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Cobbe</LastName><ForeName>Stuart</ForeName><Initials>S</Initials></Author><Author ValidYN="Y"><LastName>Johnston</LastName><ForeName>Colin</ForeName><Initials>C</Initials></Author><Author ValidYN="Y"><LastName>Ford</LastName><ForeName>Ian</ForeName><Initials>I</Initials></Author><Author ValidYN="Y"><LastName>Murphy</LastName><ForeName>Michael</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><LastName>Weber</LastName><ForeName>Michael A</ForeName><Initials>MA</Initials></Author><Author ValidYN="Y"><LastName>Black</LastName><ForeName>Henry R</ForeName><Initials>HR</Initials></Author><Author ValidYN="Y"><LastName>Plouin</LastName><ForeName>Pierre Francois</ForeName><Initials>PF</Initials></Author><Author ValidYN="Y"><LastName>Levy</LastName><ForeName>Daniel</ForeName><Initials>D</Initials></Author><Author ValidYN="Y"><LastName>Mancia</LastName><ForeName>Guiseppe</ForeName><Initials>G</Initials></Author><Author ValidYN="Y"><LastName>Larochelle</LastName><ForeName>Pierre</ForeName><Initials>P</Initials></Author><Author ValidYN="Y"><LastName>Kolloch</LastName><ForeName>Rainer E</ForeName><Initials>RE</Initials></Author><Author ValidYN="Y"><LastName>Alderman</LastName><ForeName>Michael</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><LastName>Ruilope</LastName><ForeName>Luis Miguel</ForeName><Initials>LM</Initials></Author><Author ValidYN="Y"><LastName>Dahlöf</LastName><ForeName>Björn</ForeName><Initials>B</Initials></Author><Author ValidYN="Y"><LastName>Flack</LastName><ForeName>John M</ForeName><Initials>JM</Initials></Author><Author ValidYN="Y"><LastName>Wolf</LastName><ForeName>Robert</ForeName><Initials>R</Initials></Author><Author ValidYN="Y"><CollectiveName>OPERA Study Group. Omapatrilat in Persons with Enhanced Risk of Atherosclerotic events</CollectiveName></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016430">Clinical Trial</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Am J Hypertens</MedlineTA><NlmUniqueID>8803676</NlmUniqueID><ISSNLinking>0895-7061</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D010919">Placebos</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D011480">Protease Inhibitors</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D011725">Pyridines</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D013841">Thiazepines</NameOfSubstance></Chemical><Chemical><RegistryNumber>36NLI90E7T</RegistryNumber><NameOfSubstance UI="C106266">omapatrilat</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName MajorTopicYN="N" UI="D001161">Arteriosclerosis</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000209">etiology</QualifierName><QualifierName MajorTopicYN="Y" UI="Q000517">prevention & control</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004311">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D005260">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D006801">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D006973">Hypertension</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000150">complications</QualifierName><QualifierName MajorTopicYN="Y" UI="Q000188">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008297">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008875">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D010919">Placebos</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D011480">Protease Inhibitors</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D011725">Pyridines</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D012107">Research Design</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D012307">Risk Factors</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D013841">Thiazepines</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000627">therapeutic use</QualifierName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="pubmed"><Year>2002</Year><Month>2</Month><Day>28</Day><Hour>10</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2002</Year><Month>8</Month><Day>15</Day><Hour>10</Hour><Minute>1</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2002</Year><Month>2</Month><Day>28</Day><Hour>10</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">11863257</ArticleId><ArticleId IdType="pii">S0895706101020489</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Musique/explor/OperaV1/Data/PubMed/Corpus
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 000623 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/PubMed/Corpus/biblio.hfd -nk 000623 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Wicri/Musique
|area= OperaV1
|flux= PubMed
|étape= Corpus
|type= RBID
|clé= pubmed:11863257
|texte= Design of the Omapatrilat in Persons with Enhanced Risk of Atherosclerotic events (OPERA) trial.
}}
Pour générer des pages wiki
HfdIndexSelect -h $EXPLOR_AREA/Data/PubMed/Corpus/RBID.i -Sk "pubmed:11863257" \
| HfdSelect -Kh $EXPLOR_AREA/Data/PubMed/Corpus/biblio.hfd \
| NlmPubMed2Wicri -a OperaV1
| This area was generated with Dilib version V0.6.21. |  |