Severe Hypoglycemia and Risks of Vascular Events and Death
Identifieur interne : 007548 ( Main/Exploration ); précédent : 007547; suivant : 007549Severe Hypoglycemia and Risks of Vascular Events and Death
Auteurs : Sophia Zoungas [Australie] ; Anushka Patel [Australie] ; John Chalmers [Australie] ; Bastiaan E. De Galan [Australie, Pays-Bas] ; QIANG LI [Australie] ; M. Biostat [Australie] ; Laurent Billot [Australie] ; Mark Woodward [États-Unis] ; Toshiharu Ninomiya [Australie] ; Bruce Neal [Australie] ; Stephen Macmahon [Australie] ; Diederick E. Grobbee [Pays-Bas] ; Andre Pascal Kengne [Australie] ; Michel Marre [France] ; Simon Heller [Royaume-Uni]Source :
- The New England journal of medicine [ 0028-4793 ] ; 2010.
Descripteurs français
- Pascal (Inist)
- Wicri :
English descriptors
- KwdEn :
Abstract
BACKGROUND Severe hypoglycemia may increase the risk of a poor outcome in patients with type 2 diabetes assigned to an intensive glucose-lowering intervention. We analyzed data from a large study of intensive glucose lowering to explore the relationship between severe hypoglycemia and adverse clinical outcomes. METHODS We examined the associations between severe hypoglycemia and the risks of macrovascular or microvascular events and death among 11,140 patients with type 2 diabetes, using Cox proportional-hazards models with adjustment for covariates measured at baseline and after randomization. RESULTS During a median follow-up period of 5 years, 231 patients (2.1%) had at least one severe hypoglycemic episode; 150 had been assigned to intensive glucose control (2.7% of the 5571 patients in that group), and 81 had been assigned to standard glucose control (1.5% of the 5569 patients in that group). The median times from the onset of severe hypoglycemia to the first major macrovascular event, the first major microvascular event, and death were 1.56 years (interquartile range, 0.84 to 2.41), 0.99 years (interquartile range, 0.40 to 2.17), and 1.05 years (interquartile range, 0.34 to 2.41), respectively. During follow-up, severe hypoglycemia was associated with a significant increase in the adjusted risks of major macrovascular events (hazard ratio, 2.88; 95% confidence interval [CI], 2.01 to 4.12), major microvascular events (hazard ratio, 1.81; 95% CI, 1.19 to 2.74), death from a cardiovascular cause (hazard ratio, 2.68; 95% CI, 1.72 to 4.19), and death from any cause (hazard ratio, 2.69; 95% CI, 1.97 to 3.67) (P<0.001 for all comparisons). Similar associations were apparent for a range of nonvascular outcomes, including respiratory, digestive, and skin conditions (P<0.01 for all comparisons). No relationship was found between repeated episodes of severe hypoglycemia and vascular outcomes or death. CONCLUSIONS Severe hypoglycemia was strongly associated with increased risks of a range of adverse clinical outcomes. It is possible that severe hypoglycemia contributes to adverse outcomes, but these analyses indicate that hypoglycemia is just as likely to be a marker of vulnerability to such events. (Funded by Servier and the National Health and Medical Research Council of Australia; ClinicalTrials.gov number, NCT00145925.).
Affiliations:
- Australie, France, Pays-Bas, Royaume-Uni, États-Unis
- Gueldre, Nouvelle-Galles du Sud, Utrecht (province), Victoria (État), État de New York, Île-de-France
- Melbourne, Nimègue, Paris, Sydney, Utrecht
- Université de Sydney
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Le document en format XML
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<author><name sortKey="Biostat, M" sort="Biostat, M" uniqKey="Biostat M" first="M." last="Biostat">M. Biostat</name>
<affiliation wicri:level="4"><inist:fA14 i1="01"><s1>George Institute for International Health, University of Sydney</s1>
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<country>Australie</country>
<placeName><settlement type="city">Sydney</settlement>
<region type="état">Nouvelle-Galles du Sud</region>
</placeName>
<orgName type="university">Université de Sydney</orgName>
</affiliation>
</author>
<author><name sortKey="Billot, Laurent" sort="Billot, Laurent" uniqKey="Billot L" first="Laurent" last="Billot">Laurent Billot</name>
<affiliation wicri:level="4"><inist:fA14 i1="01"><s1>George Institute for International Health, University of Sydney</s1>
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<country>Australie</country>
<placeName><settlement type="city">Sydney</settlement>
<region type="état">Nouvelle-Galles du Sud</region>
</placeName>
<orgName type="university">Université de Sydney</orgName>
</affiliation>
</author>
<author><name sortKey="Woodward, Mark" sort="Woodward, Mark" uniqKey="Woodward M" first="Mark" last="Woodward">Mark Woodward</name>
<affiliation wicri:level="2"><inist:fA14 i1="05"><s1>Mount Sinai School of Medicine</s1>
<s2>New York</s2>
<s3>USA</s3>
<sZ>8 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">État de New York</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Ninomiya, Toshiharu" sort="Ninomiya, Toshiharu" uniqKey="Ninomiya T" first="Toshiharu" last="Ninomiya">Toshiharu Ninomiya</name>
<affiliation wicri:level="4"><inist:fA14 i1="01"><s1>George Institute for International Health, University of Sydney</s1>
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<country>Australie</country>
<placeName><settlement type="city">Sydney</settlement>
<region type="état">Nouvelle-Galles du Sud</region>
</placeName>
<orgName type="university">Université de Sydney</orgName>
</affiliation>
</author>
<author><name sortKey="Neal, Bruce" sort="Neal, Bruce" uniqKey="Neal B" first="Bruce" last="Neal">Bruce Neal</name>
<affiliation wicri:level="4"><inist:fA14 i1="01"><s1>George Institute for International Health, University of Sydney</s1>
<s3>AUS</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
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<sZ>10 aut.</sZ>
<sZ>11 aut.</sZ>
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</inist:fA14>
<country>Australie</country>
<placeName><settlement type="city">Sydney</settlement>
<region type="état">Nouvelle-Galles du Sud</region>
</placeName>
<orgName type="university">Université de Sydney</orgName>
</affiliation>
</author>
<author><name sortKey="Macmahon, Stephen" sort="Macmahon, Stephen" uniqKey="Macmahon S" first="Stephen" last="Macmahon">Stephen Macmahon</name>
<affiliation wicri:level="4"><inist:fA14 i1="01"><s1>George Institute for International Health, University of Sydney</s1>
<s3>AUS</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>3 aut.</sZ>
<sZ>4 aut.</sZ>
<sZ>5 aut.</sZ>
<sZ>6 aut.</sZ>
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<sZ>9 aut.</sZ>
<sZ>10 aut.</sZ>
<sZ>11 aut.</sZ>
<sZ>13 aut.</sZ>
</inist:fA14>
<country>Australie</country>
<placeName><settlement type="city">Sydney</settlement>
<region type="état">Nouvelle-Galles du Sud</region>
</placeName>
<orgName type="university">Université de Sydney</orgName>
</affiliation>
</author>
<author><name sortKey="Grobbee, Diederick E" sort="Grobbee, Diederick E" uniqKey="Grobbee D" first="Diederick E." last="Grobbee">Diederick E. Grobbee</name>
<affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht</s1>
<s2>Utrecht</s2>
<s3>NLD</s3>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>Pays-Bas</country>
<placeName><settlement type="city">Utrecht</settlement>
<region nuts="2" type="province">Utrecht (province)</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Pascal Kengne, Andre" sort="Pascal Kengne, Andre" uniqKey="Pascal Kengne A" first="Andre" last="Pascal Kengne">Andre Pascal Kengne</name>
<affiliation wicri:level="4"><inist:fA14 i1="01"><s1>George Institute for International Health, University of Sydney</s1>
<s3>AUS</s3>
<sZ>1 aut.</sZ>
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<sZ>9 aut.</sZ>
<sZ>10 aut.</sZ>
<sZ>11 aut.</sZ>
<sZ>13 aut.</sZ>
</inist:fA14>
<country>Australie</country>
<placeName><settlement type="city">Sydney</settlement>
<region type="état">Nouvelle-Galles du Sud</region>
</placeName>
<orgName type="university">Université de Sydney</orgName>
</affiliation>
</author>
<author><name sortKey="Marre, Michel" sort="Marre, Michel" uniqKey="Marre M" first="Michel" last="Marre">Michel Marre</name>
<affiliation wicri:level="3"><inist:fA14 i1="06"><s1>Hôpital Bichat-Claude Bernard and Université Paris</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Heller, Simon" sort="Heller, Simon" uniqKey="Heller S" first="Simon" last="Heller">Simon Heller</name>
<affiliation wicri:level="1"><inist:fA14 i1="07"><s1>University of Sheffield and Sheffield Teaching Hospitals National Health Service Foundation Trust</s1>
<s2>Sheffield</s2>
<s3>GBR</s3>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
<wicri:noRegion>University of Sheffield and Sheffield Teaching Hospitals National Health Service Foundation Trust</wicri:noRegion>
</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="2010">2010</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>Blood vessel</term>
<term>Death</term>
<term>Hypoglycemia</term>
<term>Medicine</term>
<term>Mortality</term>
<term>Risk</term>
<term>Risk factor</term>
<term>Severe</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Grave</term>
<term>Hypoglycémie</term>
<term>Facteur risque</term>
<term>Risque</term>
<term>Vaisseau sanguin</term>
<term>Mort</term>
<term>Mortalité</term>
<term>Médecine</term>
<term>Forme grave</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Mort</term>
<term>Mortalité</term>
<term>Médecine</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">BACKGROUND Severe hypoglycemia may increase the risk of a poor outcome in patients with type 2 diabetes assigned to an intensive glucose-lowering intervention. We analyzed data from a large study of intensive glucose lowering to explore the relationship between severe hypoglycemia and adverse clinical outcomes. METHODS We examined the associations between severe hypoglycemia and the risks of macrovascular or microvascular events and death among 11,140 patients with type 2 diabetes, using Cox proportional-hazards models with adjustment for covariates measured at baseline and after randomization. RESULTS During a median follow-up period of 5 years, 231 patients (2.1%) had at least one severe hypoglycemic episode; 150 had been assigned to intensive glucose control (2.7% of the 5571 patients in that group), and 81 had been assigned to standard glucose control (1.5% of the 5569 patients in that group). The median times from the onset of severe hypoglycemia to the first major macrovascular event, the first major microvascular event, and death were 1.56 years (interquartile range, 0.84 to 2.41), 0.99 years (interquartile range, 0.40 to 2.17), and 1.05 years (interquartile range, 0.34 to 2.41), respectively. During follow-up, severe hypoglycemia was associated with a significant increase in the adjusted risks of major macrovascular events (hazard ratio, 2.88; 95% confidence interval [CI], 2.01 to 4.12), major microvascular events (hazard ratio, 1.81; 95% CI, 1.19 to 2.74), death from a cardiovascular cause (hazard ratio, 2.68; 95% CI, 1.72 to 4.19), and death from any cause (hazard ratio, 2.69; 95% CI, 1.97 to 3.67) (P<0.001 for all comparisons). Similar associations were apparent for a range of nonvascular outcomes, including respiratory, digestive, and skin conditions (P<0.01 for all comparisons). No relationship was found between repeated episodes of severe hypoglycemia and vascular outcomes or death. CONCLUSIONS Severe hypoglycemia was strongly associated with increased risks of a range of adverse clinical outcomes. It is possible that severe hypoglycemia contributes to adverse outcomes, but these analyses indicate that hypoglycemia is just as likely to be a marker of vulnerability to such events. (Funded by Servier and the National Health and Medical Research Council of Australia; ClinicalTrials.gov number, NCT00145925.).</div>
</front>
</TEI>
<affiliations><list><country><li>Australie</li>
<li>France</li>
<li>Pays-Bas</li>
<li>Royaume-Uni</li>
<li>États-Unis</li>
</country>
<region><li>Gueldre</li>
<li>Nouvelle-Galles du Sud</li>
<li>Utrecht (province)</li>
<li>Victoria (État)</li>
<li>État de New York</li>
<li>Île-de-France</li>
</region>
<settlement><li>Melbourne</li>
<li>Nimègue</li>
<li>Paris</li>
<li>Sydney</li>
<li>Utrecht</li>
</settlement>
<orgName><li>Université de Sydney</li>
</orgName>
</list>
<tree><country name="Australie"><region name="Nouvelle-Galles du Sud"><name sortKey="Zoungas, Sophia" sort="Zoungas, Sophia" uniqKey="Zoungas S" first="Sophia" last="Zoungas">Sophia Zoungas</name>
</region>
<name sortKey="Billot, Laurent" sort="Billot, Laurent" uniqKey="Billot L" first="Laurent" last="Billot">Laurent Billot</name>
<name sortKey="Biostat, M" sort="Biostat, M" uniqKey="Biostat M" first="M." last="Biostat">M. Biostat</name>
<name sortKey="Chalmers, John" sort="Chalmers, John" uniqKey="Chalmers J" first="John" last="Chalmers">John Chalmers</name>
<name sortKey="De Galan, Bastiaan E" sort="De Galan, Bastiaan E" uniqKey="De Galan B" first="Bastiaan E." last="De Galan">Bastiaan E. De Galan</name>
<name sortKey="Macmahon, Stephen" sort="Macmahon, Stephen" uniqKey="Macmahon S" first="Stephen" last="Macmahon">Stephen Macmahon</name>
<name sortKey="Neal, Bruce" sort="Neal, Bruce" uniqKey="Neal B" first="Bruce" last="Neal">Bruce Neal</name>
<name sortKey="Ninomiya, Toshiharu" sort="Ninomiya, Toshiharu" uniqKey="Ninomiya T" first="Toshiharu" last="Ninomiya">Toshiharu Ninomiya</name>
<name sortKey="Pascal Kengne, Andre" sort="Pascal Kengne, Andre" uniqKey="Pascal Kengne A" first="Andre" last="Pascal Kengne">Andre Pascal Kengne</name>
<name sortKey="Patel, Anushka" sort="Patel, Anushka" uniqKey="Patel A" first="Anushka" last="Patel">Anushka Patel</name>
<name sortKey="Qiang Li" sort="Qiang Li" uniqKey="Qiang Li" last="Qiang Li">QIANG LI</name>
<name sortKey="Zoungas, Sophia" sort="Zoungas, Sophia" uniqKey="Zoungas S" first="Sophia" last="Zoungas">Sophia Zoungas</name>
</country>
<country name="Pays-Bas"><region name="Gueldre"><name sortKey="De Galan, Bastiaan E" sort="De Galan, Bastiaan E" uniqKey="De Galan B" first="Bastiaan E." last="De Galan">Bastiaan E. De Galan</name>
</region>
<name sortKey="Grobbee, Diederick E" sort="Grobbee, Diederick E" uniqKey="Grobbee D" first="Diederick E." last="Grobbee">Diederick E. Grobbee</name>
</country>
<country name="États-Unis"><region name="État de New York"><name sortKey="Woodward, Mark" sort="Woodward, Mark" uniqKey="Woodward M" first="Mark" last="Woodward">Mark Woodward</name>
</region>
</country>
<country name="France"><region name="Île-de-France"><name sortKey="Marre, Michel" sort="Marre, Michel" uniqKey="Marre M" first="Michel" last="Marre">Michel Marre</name>
</region>
</country>
<country name="Royaume-Uni"><noRegion><name sortKey="Heller, Simon" sort="Heller, Simon" uniqKey="Heller S" first="Simon" last="Heller">Simon Heller</name>
</noRegion>
</country>
</tree>
</affiliations>
</record>
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