Effectiveness and tolerability of second‐line therapy with vildagliptin vs. other oral agents in type 2 diabetes: A real‐life worldwide observational study (EDGE)
Identifieur interne : 001260 ( Istex/Corpus ); précédent : 001259; suivant : 001261Effectiveness and tolerability of second‐line therapy with vildagliptin vs. other oral agents in type 2 diabetes: A real‐life worldwide observational study (EDGE)
Auteurs : C. Mathieu ; A. H. Barnett ; H. Brath ; I. Conget ; J. J. De Castro ; R. Göke ; E. Márquez Rodriguez ; P. M. Nilsson ; E. Pagkalos ; A. Penfornis ; N. C. Schaper ; S. K. Wangnoo ; W. Kothny ; G. BaderSource :
- International Journal of Clinical Practice [ 1368-5031 ] ; 2013-10.
Abstract
Real‐life studies are needed to confirm the clinical relevance of findings from randomised controlled trials (RCTs). This study aimed to assess the effectiveness and tolerability of vildagliptin add‐on vs. other oral antihyperglycaemic drugs (OADs) added to OAD monotherapy in a real‐life setting, and to explore the advantages and limitations of large‐scale ‘pragmatic’ trials.
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DOI: 10.1111/ijcp.12252
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<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title xml:lang="en">Effectiveness and tolerability of second‐line therapy with vildagliptin vs. other oral agents in type 2 diabetes: A real‐life worldwide observational study (EDGE)</title><author><name sortKey="Mathieu, C" sort="Mathieu, C" uniqKey="Mathieu C" first="C." last="Mathieu">C. Mathieu</name><affiliation><mods:affiliation>I.G. – Endocrinologie, Campus Gasthuisberg, Leuven, Belgium</mods:affiliation></affiliation><affiliation><mods:affiliation>Prof. Dr Chantal Mathieu,I.G. – Endocrinologie, Campus Gasthuisberg,Herestraat 49, Leuven 3000, BelgiumTel.: +32 1634 6994Fax: +32 1634 6989E‐mail:</mods:affiliation></affiliation><affiliation><mods:affiliation>E-mail: chantal.mathieu@uz.kuleuven.ac.be</mods:affiliation></affiliation></author><author><name sortKey="Barnett, A H" sort="Barnett, A H" uniqKey="Barnett A" first="A. H." last="Barnett">A. H. Barnett</name><affiliation><mods:affiliation>Department of Medicine, Diabetes Centre, Heart of England NHS Foundation Trust, University of Birmingham, Birmingham, UK</mods:affiliation></affiliation></author><author><name sortKey="Brath, H" sort="Brath, H" uniqKey="Brath H" first="H." last="Brath">H. Brath</name><affiliation><mods:affiliation>Health Center South, Vienna, Austria</mods:affiliation></affiliation></author><author><name sortKey="Conget, I" sort="Conget, I" uniqKey="Conget I" first="I." last="Conget">I. Conget</name><affiliation><mods:affiliation>Department of Endocrinology & Diabetes, Armed Forces University Hospital, Lisboa, Portugal</mods:affiliation></affiliation></author><author><name sortKey="De Castro, J J" sort="De Castro, J J" uniqKey="De Castro J" first="J. J." last="De Castro">J. J. De Castro</name><affiliation><mods:affiliation>Diabetes Unit, Endocrinology and Nutrition Department, Hospital Clinic i Universitari, Barcelona, Spain</mods:affiliation></affiliation></author><author><name sortKey="Goke, R" sort="Goke, R" uniqKey="Goke R" first="R." last="Göke">R. Göke</name><affiliation><mods:affiliation>Innere Medizin, Schwerpkt Diabetologie, Kirchhain, Germany</mods:affiliation></affiliation></author><author><name sortKey="Marquez Rodriguez, E" sort="Marquez Rodriguez, E" uniqKey="Marquez Rodriguez E" first="E." last="Márquez Rodriguez">E. Márquez Rodriguez</name><affiliation><mods:affiliation>Hospital Civil Viejo, Guadalajara, Mexico</mods:affiliation></affiliation></author><author><name sortKey="Nilsson, P M" sort="Nilsson, P M" uniqKey="Nilsson P" first="P. M." last="Nilsson">P. M. Nilsson</name><affiliation><mods:affiliation>Clinical research unit, Skåne University Hospital, Malmö, Sweden</mods:affiliation></affiliation></author><author><name sortKey="Pagkalos, E" sort="Pagkalos, E" uniqKey="Pagkalos E" first="E." last="Pagkalos">E. Pagkalos</name><affiliation><mods:affiliation>Private Hospital “Thermi”, Thessaloniki, Greece</mods:affiliation></affiliation></author><author><name sortKey="Penfornis, A" sort="Penfornis, A" uniqKey="Penfornis A" first="A." last="Penfornis">A. Penfornis</name><affiliation><mods:affiliation>Department of Endocrinology‐Metabolism and Diabetology‐Nutrition, Jean Minjoz Hospital, University of Franche‐Comté, Besançon Cedex, France</mods:affiliation></affiliation></author><author><name sortKey="Schaper, N C" sort="Schaper, N C" uniqKey="Schaper N" first="N. C." last="Schaper">N. C. Schaper</name><affiliation><mods:affiliation>Division of Endocrinology, Department of Internal Medicine, University Hospital Maastricht, Maastricht, The Netherlands</mods:affiliation></affiliation></author><author><name sortKey="Wangnoo, S K" sort="Wangnoo, S K" uniqKey="Wangnoo S" first="S. K." last="Wangnoo">S. K. Wangnoo</name><affiliation><mods:affiliation>Apollo Centre for Obesity, Diabetes & Endocrinology (ACODE), Indraprastha Apollo Hospital, New Delhi, India</mods:affiliation></affiliation></author><author><name sortKey="Kothny, W" sort="Kothny, W" uniqKey="Kothny W" first="W." last="Kothny">W. Kothny</name><affiliation><mods:affiliation>Novartis Pharmaceuticals Corporation, NJ, East Hanover, USA</mods:affiliation></affiliation></author><author><name sortKey="Bader, G" sort="Bader, G" uniqKey="Bader G" first="G." last="Bader">G. Bader</name><affiliation><mods:affiliation>Global Medical Affairs – Diabetes, Novartis Pharma AG, Basel, Switzerland</mods:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:B9764C37982951C07B33DEC4808354C963EDE84F</idno><date when="2013" year="2013">2013</date><idno type="doi">10.1111/ijcp.12252</idno><idno type="url">https://api.istex.fr/document/B9764C37982951C07B33DEC4808354C963EDE84F/fulltext/pdf</idno><idno type="wicri:Area/Istex/Corpus">001260</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main" xml:lang="en">Effectiveness and tolerability of second‐line therapy with vildagliptin vs. other oral agents in type 2 diabetes: A real‐life worldwide observational study (EDGE)</title><author><name sortKey="Mathieu, C" sort="Mathieu, C" uniqKey="Mathieu C" first="C." last="Mathieu">C. Mathieu</name><affiliation><mods:affiliation>I.G. – Endocrinologie, Campus Gasthuisberg, Leuven, Belgium</mods:affiliation></affiliation><affiliation><mods:affiliation>Prof. Dr Chantal Mathieu,I.G. – Endocrinologie, Campus Gasthuisberg,Herestraat 49, Leuven 3000, BelgiumTel.: +32 1634 6994Fax: +32 1634 6989E‐mail:</mods:affiliation></affiliation><affiliation><mods:affiliation>E-mail: chantal.mathieu@uz.kuleuven.ac.be</mods:affiliation></affiliation></author><author><name sortKey="Barnett, A H" sort="Barnett, A H" uniqKey="Barnett A" first="A. H." last="Barnett">A. H. Barnett</name><affiliation><mods:affiliation>Department of Medicine, Diabetes Centre, Heart of England NHS Foundation Trust, University of Birmingham, Birmingham, UK</mods:affiliation></affiliation></author><author><name sortKey="Brath, H" sort="Brath, H" uniqKey="Brath H" first="H." last="Brath">H. Brath</name><affiliation><mods:affiliation>Health Center South, Vienna, Austria</mods:affiliation></affiliation></author><author><name sortKey="Conget, I" sort="Conget, I" uniqKey="Conget I" first="I." last="Conget">I. Conget</name><affiliation><mods:affiliation>Department of Endocrinology & Diabetes, Armed Forces University Hospital, Lisboa, Portugal</mods:affiliation></affiliation></author><author><name sortKey="De Castro, J J" sort="De Castro, J J" uniqKey="De Castro J" first="J. J." last="De Castro">J. J. De Castro</name><affiliation><mods:affiliation>Diabetes Unit, Endocrinology and Nutrition Department, Hospital Clinic i Universitari, Barcelona, Spain</mods:affiliation></affiliation></author><author><name sortKey="Goke, R" sort="Goke, R" uniqKey="Goke R" first="R." last="Göke">R. Göke</name><affiliation><mods:affiliation>Innere Medizin, Schwerpkt Diabetologie, Kirchhain, Germany</mods:affiliation></affiliation></author><author><name sortKey="Marquez Rodriguez, E" sort="Marquez Rodriguez, E" uniqKey="Marquez Rodriguez E" first="E." last="Márquez Rodriguez">E. Márquez Rodriguez</name><affiliation><mods:affiliation>Hospital Civil Viejo, Guadalajara, Mexico</mods:affiliation></affiliation></author><author><name sortKey="Nilsson, P M" sort="Nilsson, P M" uniqKey="Nilsson P" first="P. M." last="Nilsson">P. M. Nilsson</name><affiliation><mods:affiliation>Clinical research unit, Skåne University Hospital, Malmö, Sweden</mods:affiliation></affiliation></author><author><name sortKey="Pagkalos, E" sort="Pagkalos, E" uniqKey="Pagkalos E" first="E." last="Pagkalos">E. Pagkalos</name><affiliation><mods:affiliation>Private Hospital “Thermi”, Thessaloniki, Greece</mods:affiliation></affiliation></author><author><name sortKey="Penfornis, A" sort="Penfornis, A" uniqKey="Penfornis A" first="A." last="Penfornis">A. Penfornis</name><affiliation><mods:affiliation>Department of Endocrinology‐Metabolism and Diabetology‐Nutrition, Jean Minjoz Hospital, University of Franche‐Comté, Besançon Cedex, France</mods:affiliation></affiliation></author><author><name sortKey="Schaper, N C" sort="Schaper, N C" uniqKey="Schaper N" first="N. C." last="Schaper">N. C. Schaper</name><affiliation><mods:affiliation>Division of Endocrinology, Department of Internal Medicine, University Hospital Maastricht, Maastricht, The Netherlands</mods:affiliation></affiliation></author><author><name sortKey="Wangnoo, S K" sort="Wangnoo, S K" uniqKey="Wangnoo S" first="S. K." last="Wangnoo">S. K. Wangnoo</name><affiliation><mods:affiliation>Apollo Centre for Obesity, Diabetes & Endocrinology (ACODE), Indraprastha Apollo Hospital, New Delhi, India</mods:affiliation></affiliation></author><author><name sortKey="Kothny, W" sort="Kothny, W" uniqKey="Kothny W" first="W." last="Kothny">W. Kothny</name><affiliation><mods:affiliation>Novartis Pharmaceuticals Corporation, NJ, East Hanover, USA</mods:affiliation></affiliation></author><author><name sortKey="Bader, G" sort="Bader, G" uniqKey="Bader G" first="G." last="Bader">G. Bader</name><affiliation><mods:affiliation>Global Medical Affairs – Diabetes, Novartis Pharma AG, Basel, Switzerland</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">International Journal of Clinical Practice</title><title level="j" type="abbrev">Int J Clin Pract</title><idno type="ISSN">1368-5031</idno><idno type="eISSN">1742-1241</idno><imprint><publisher>Blackwell Publishing Ltd</publisher><date type="published" when="2013-10">2013-10</date><biblScope unit="volume">67</biblScope><biblScope unit="issue">10</biblScope><biblScope unit="page" from="947">947</biblScope><biblScope unit="page" to="956">956</biblScope></imprint><idno type="ISSN">1368-5031</idno></series><idno type="istex">B9764C37982951C07B33DEC4808354C963EDE84F</idno><idno type="DOI">10.1111/ijcp.12252</idno><idno type="ArticleID">IJCP12252</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">1368-5031</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract">Real‐life studies are needed to confirm the clinical relevance of findings from randomised controlled trials (RCTs). This study aimed to assess the effectiveness and tolerability of vildagliptin add‐on vs. other oral antihyperglycaemic drugs (OADs) added to OAD monotherapy in a real‐life setting, and to explore the advantages and limitations of large‐scale ‘pragmatic’ trials.</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>C. Mathieu</name><affiliations><json:string>I.G. – Endocrinologie, Campus Gasthuisberg, Leuven, Belgium</json:string><json:string>Prof. Dr Chantal Mathieu,I.G. – Endocrinologie, Campus Gasthuisberg,Herestraat 49, Leuven 3000, BelgiumTel.: +32 1634 6994Fax: +32 1634 6989E‐mail:</json:string><json:string>E-mail: chantal.mathieu@uz.kuleuven.ac.be</json:string></affiliations></json:item><json:item><name>A. H. Barnett</name><affiliations><json:string>Department of Medicine, Diabetes Centre, Heart of England NHS Foundation Trust, University of Birmingham, Birmingham, UK</json:string></affiliations></json:item><json:item><name>H. Brath</name><affiliations><json:string>Health Center South, Vienna, Austria</json:string></affiliations></json:item><json:item><name>I. Conget</name><affiliations><json:string>Department of Endocrinology & Diabetes, Armed Forces University Hospital, Lisboa, Portugal</json:string></affiliations></json:item><json:item><name>J. J. de Castro</name><affiliations><json:string>Diabetes Unit, Endocrinology and Nutrition Department, Hospital Clinic i Universitari, Barcelona, Spain</json:string></affiliations></json:item><json:item><name>R. Göke</name><affiliations><json:string>Innere Medizin, Schwerpkt Diabetologie, Kirchhain, Germany</json:string></affiliations></json:item><json:item><name>E. Márquez Rodriguez</name><affiliations><json:string>Hospital Civil Viejo, Guadalajara, Mexico</json:string></affiliations></json:item><json:item><name>P. M. Nilsson</name><affiliations><json:string>Clinical research unit, Skåne University Hospital, Malmö, Sweden</json:string></affiliations></json:item><json:item><name>E. Pagkalos</name><affiliations><json:string>Private Hospital “Thermi”, Thessaloniki, Greece</json:string></affiliations></json:item><json:item><name>A. Penfornis</name><affiliations><json:string>Department of Endocrinology‐Metabolism and Diabetology‐Nutrition, Jean Minjoz Hospital, University of Franche‐Comté, Besançon Cedex, France</json:string></affiliations></json:item><json:item><name>N.C. Schaper</name><affiliations><json:string>Division of Endocrinology, Department of Internal Medicine, University Hospital Maastricht, Maastricht, The Netherlands</json:string></affiliations></json:item><json:item><name>S. K. Wangnoo</name><affiliations><json:string>Apollo Centre for Obesity, Diabetes & Endocrinology (ACODE), Indraprastha Apollo Hospital, New Delhi, India</json:string></affiliations></json:item><json:item><name>W. Kothny</name><affiliations><json:string>Novartis Pharmaceuticals Corporation, NJ, East Hanover, USA</json:string></affiliations></json:item><json:item><name>G. Bader</name><affiliations><json:string>Global Medical Affairs – Diabetes, Novartis Pharma AG, Basel, Switzerland</json:string></affiliations></json:item></author><articleId><json:string>IJCP12252</json:string></articleId><language><json:string>eng</json:string></language><originalGenre><json:string>article</json:string></originalGenre><qualityIndicators><score>7.636</score><pdfVersion>1.7</pdfVersion><pdfPageSize>595.276 x 782.362 pts</pdfPageSize><refBibsNative>true</refBibsNative><keywordCount>0</keywordCount><abstractCharCount>378</abstractCharCount><pdfWordCount>6285</pdfWordCount><pdfCharCount>42070</pdfCharCount><pdfPageCount>10</pdfPageCount><abstractWordCount>53</abstractWordCount></qualityIndicators><title>Effectiveness and tolerability of second‐line therapy with vildagliptin vs. other oral agents in type 2 diabetes: A real‐life worldwide observational study (EDGE)</title><genre><json:string>article</json:string></genre><host><volume>67</volume><publisherId><json:string>IJCP</json:string></publisherId><pages><total>10</total><last>956</last><first>947</first></pages><issn><json:string>1368-5031</json:string></issn><issue>10</issue><subject><json:item><value>Original Paper</value></json:item></subject><genre><json:string>journal</json:string></genre><language><json:string>unknown</json:string></language><eissn><json:string>1742-1241</json:string></eissn><title>International Journal of Clinical Practice</title><doi><json:string>10.1111/(ISSN)1742-1241</json:string></doi></host><publicationDate>2013</publicationDate><copyrightDate>2013</copyrightDate><doi><json:string>10.1111/ijcp.12252</json:string></doi><id>B9764C37982951C07B33DEC4808354C963EDE84F</id><score>0.23367424</score><fulltext><json:item><original>true</original><mimetype>application/pdf</mimetype><extension>pdf</extension><uri>https://api.istex.fr/document/B9764C37982951C07B33DEC4808354C963EDE84F/fulltext/pdf</uri></json:item><json:item><original>false</original><mimetype>application/zip</mimetype><extension>zip</extension><uri>https://api.istex.fr/document/B9764C37982951C07B33DEC4808354C963EDE84F/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/B9764C37982951C07B33DEC4808354C963EDE84F/fulltext/tei"><teiHeader><fileDesc><titleStmt><title level="a" type="main" xml:lang="en">Effectiveness and tolerability of second‐line therapy with vildagliptin vs. other oral agents in type 2 diabetes: A real‐life worldwide observational study (EDGE)</title></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>Blackwell Publishing Ltd</publisher><availability status="free"><p>Open Access</p></availability><date>2013-07-22</date></publicationStmt><notesStmt><note>Table S1. Regions, countries, number of centres and patients participating in EDGE. Table S2A. Number and reasons for discontinuations by cohort (ITT population). Table S2B. Deviations from protocol requiring exclusion from the PP population by cohort. Table S3. Index medication (ITT population). Table S4. Adverse events by primary System Organ Class (SOC) and cohort (ITT population). Table S5. Serious adverse events by SOC and cohort (ITT population).</note><note>Novartis</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">Effectiveness and tolerability of second‐line therapy with vildagliptin vs. other oral agents in type 2 diabetes: A real‐life worldwide observational study (EDGE)</title><author xml:id="author-1"><persName><forename type="first">C.</forename><surname>Mathieu</surname></persName><email>chantal.mathieu@uz.kuleuven.ac.be</email><affiliation>I.G. – Endocrinologie, Campus Gasthuisberg, Leuven, Belgium</affiliation><affiliation>Prof. Dr Chantal Mathieu,I.G. – Endocrinologie, Campus Gasthuisberg,Herestraat 49, Leuven 3000, BelgiumTel.: +32 1634 6994Fax: +32 1634 6989E‐mail:</affiliation></author><author xml:id="author-2"><persName><forename type="first">A. H.</forename><surname>Barnett</surname></persName><affiliation>Department of Medicine, Diabetes Centre, Heart of England NHS Foundation Trust, University of Birmingham, Birmingham, UK</affiliation></author><author xml:id="author-3"><persName><forename type="first">H.</forename><surname>Brath</surname></persName><affiliation>Health Center South, Vienna, Austria</affiliation></author><author xml:id="author-4"><persName><forename type="first">I.</forename><surname>Conget</surname></persName><affiliation>Department of Endocrinology & Diabetes, Armed Forces University Hospital, Lisboa, Portugal</affiliation></author><author xml:id="author-5"><persName><forename type="first">J. J.</forename><surname>de Castro</surname></persName><affiliation>Diabetes Unit, Endocrinology and Nutrition Department, Hospital Clinic i Universitari, Barcelona, Spain</affiliation></author><author xml:id="author-6"><persName><forename type="first">R.</forename><surname>Göke</surname></persName><affiliation>Innere Medizin, Schwerpkt Diabetologie, Kirchhain, Germany</affiliation></author><author xml:id="author-7"><persName><forename type="first">E.</forename><surname>Márquez Rodriguez</surname></persName><affiliation>Hospital Civil Viejo, Guadalajara, Mexico</affiliation></author><author xml:id="author-8"><persName><forename type="first">P. M.</forename><surname>Nilsson</surname></persName><affiliation>Clinical research unit, Skåne University Hospital, Malmö, Sweden</affiliation></author><author xml:id="author-9"><persName><forename type="first">E.</forename><surname>Pagkalos</surname></persName><affiliation>Private Hospital “Thermi”, Thessaloniki, Greece</affiliation></author><author xml:id="author-10"><persName><forename type="first">A.</forename><surname>Penfornis</surname></persName><affiliation>Department of Endocrinology‐Metabolism and Diabetology‐Nutrition, Jean Minjoz Hospital, University of Franche‐Comté, Besançon Cedex, France</affiliation></author><author xml:id="author-11"><persName><forename type="first">N.C.</forename><surname>Schaper</surname></persName><affiliation>Division of Endocrinology, Department of Internal Medicine, University Hospital Maastricht, Maastricht, The Netherlands</affiliation></author><author xml:id="author-12"><persName><forename type="first">S. K.</forename><surname>Wangnoo</surname></persName><affiliation>Apollo Centre for Obesity, Diabetes & Endocrinology (ACODE), Indraprastha Apollo Hospital, New Delhi, India</affiliation></author><author xml:id="author-13"><persName><forename type="first">W.</forename><surname>Kothny</surname></persName><affiliation>Novartis Pharmaceuticals Corporation, NJ, East Hanover, USA</affiliation></author><author xml:id="author-14"><persName><forename type="first">G.</forename><surname>Bader</surname></persName><affiliation>Global Medical Affairs – Diabetes, Novartis Pharma AG, Basel, Switzerland</affiliation></author></analytic><monogr><title level="j">International Journal of Clinical Practice</title><title level="j" type="abbrev">Int J Clin Pract</title><idno type="pISSN">1368-5031</idno><idno type="eISSN">1742-1241</idno><idno type="DOI">10.1111/(ISSN)1742-1241</idno><imprint><publisher>Blackwell Publishing Ltd</publisher><date type="published" when="2013-10"></date><biblScope unit="volume">67</biblScope><biblScope unit="issue">10</biblScope><biblScope unit="page" from="947">947</biblScope><biblScope unit="page" to="956">956</biblScope></imprint></monogr><idno type="istex">B9764C37982951C07B33DEC4808354C963EDE84F</idno><idno type="DOI">10.1111/ijcp.12252</idno><idno type="ArticleID">IJCP12252</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2013-07-22</date></creation><langUsage><language ident="en">en</language></langUsage><abstract><p>Real‐life studies are needed to confirm the clinical relevance of findings from randomised controlled trials (RCTs). This study aimed to assess the effectiveness and tolerability of vildagliptin add‐on vs. other oral antihyperglycaemic drugs (OADs) added to OAD monotherapy in a real‐life setting, and to explore the advantages and limitations of large‐scale ‘pragmatic’ trials.</p></abstract><abstract><p>EDGE was a prospective, 1‐year, worldwide, real‐life observational study in which 2957 physicians reported on the effects of second‐line OADs in 45,868 patients with T2DM not reaching glycaemic targets with monotherapy. Physicians could add any OAD, and patients entered either vildagliptin or (pooled) comparator cohort. The primary effectiveness and tolerability end‐point (PEP) evaluated proportions of patients decreasing HbA1c > 0.3%, without hypoglycaemia, weight gain, peripheral oedema or gastrointestinal side effects. The most clinically relevant secondary end‐point (SEP 3) was attainment of end‐point HbA1c < 7% without hypoglycaemia or ≥ 3% increase in body weight.</p></abstract><abstract><p>In this large group of T2DM patients, a second OAD was added at mean HbA1c of 8.2 ± 1.3%, with no baseline HbA1c difference between cohorts. Second‐line OAD therapy attained the PEP in the majority of patients, with higher attainment in those prescribed a vildagliptin‐based regimen. The adjusted odds ratio was 1.49 (95% CI: 1.42, 1.55; p < 0.001). In patients with baseline HbA1c ≥ 7%, SEP 3 was achieved by 35% of patients on a vildagliptin‐based combination and by 23% of those receiving comparator combinations. The adjusted odds ratio was 1.96 (95% CI: 1.85, 2.07; p < 0.001). Safety events were reported infrequently and safety profiles of vildagliptin and other OADs were consistent with previous data.</p></abstract><abstract><p>EDGE demonstrates that in a ‘real‐life’ setting, vildagliptin as second OAD can lower HbA1c to target without well‐recognised OAD side effects, more frequently than comparator OADs. In addition, EDGE illustrates that conducting large‐scale, prospective, real‐life studies poses challenges but yields valuable clinical information complementary to RCTs.</p></abstract><textClass><keywords scheme="Journal Subject"><list><head>article-category</head><item><term>Original Paper</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2013-05-22">Received</change><change when="2013-07-14">Registration</change><change when="2013-07-22">Created</change><change when="2013-10">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><original>false</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/B9764C37982951C07B33DEC4808354C963EDE84F/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="Wiley, elements deleted: body"><istex:xmlDeclaration>version="1.0" encoding="UTF-8" standalone="yes"</istex:xmlDeclaration><istex:document><component type="serialArticle" version="2.0" xml:id="ijcp12252" xml:lang="en"><header><publicationMeta level="product"><doi origin="wiley" registered="yes">10.1111/(ISSN)1742-1241</doi><issn type="print">1368-5031</issn><issn type="electronic">1742-1241</issn><idGroup><id type="product" value="IJCP"></id></idGroup><titleGroup><title sort="INTERNATIONAL JOURNAL OF CLINICAL PRACTICE" type="main">International Journal of Clinical Practice</title><title type="short">Int J Clin Pract</title></titleGroup></publicationMeta><publicationMeta level="part" position="10110"><doi origin="wiley">10.1111/ijcp.2013.67.issue-10</doi><copyright ownership="publisher">Copyright © 2013 John Wiley & Sons Ltd</copyright><numberingGroup><numbering type="journalVolume" number="67">67</numbering><numbering type="journalIssue">10</numbering></numberingGroup><coverDate startDate="2013-10">October 2013</coverDate></publicationMeta><publicationMeta level="unit" position="80" status="forIssue" type="article" accessType="open"><doi>10.1111/ijcp.12252</doi><idGroup><id type="unit" value="IJCP12252"></id></idGroup><countGroup><count number="10" type="pageTotal"></count></countGroup><titleGroup><title type="articleCategory">Original Paper</title><title type="tocHeading1">Endocrinology</title></titleGroup><copyright ownership="publisher">© 2013 The Authors. International Journal of Clinical Practice published by John Wiley & Sons Ltd.</copyright><legalStatement type="creativeCommonsBy-nc-nd"><p>This is an open access article under the terms of the <url href="http://creativecommons.org/licenses/by-nc-nd/3.0/">Creative Commons Attribution‐NonCommercial‐NoDerivs</url> License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.</p></legalStatement><eventGroup><event date="2013-05-22" type="manuscriptReceived"></event><event date="2013-07-14" type="manuscriptAccepted"></event><event agent="SPS" date="2013-07-22" type="xmlCreated"></event><event type="publishedOnlineEarlyUnpaginated" date="2013-08-21"></event><event type="firstOnline" date="2013-08-21"></event><event type="publishedOnlineFinalForm" date="2013-09-20"></event><event type="xmlConverted" agent="Converter:WILEY_ML3G_TO_WILEY_ML3GV2 version:4.0.1" date="2014-03-13"></event><event type="xmlConverted" agent="Converter:WML3G_To_WML3G version:4.6.4 mode:FullText" date="2015-10-02"></event></eventGroup><numberingGroup><numbering type="pageFirst">947</numbering><numbering type="pageLast">956</numbering></numberingGroup><correspondenceTo><lineatedText><line><b>Correspondence to:</b></line><line>Prof. Dr Chantal Mathieu,</line><line>I.G. – Endocrinologie, Campus Gasthuisberg,</line><line>Herestraat 49, Leuven 3000, Belgium</line><line>Tel.: +32 1634 6994</line><line>Fax: +32 1634 6989</line><line>E‐mail: <email>chantal.mathieu@uz.kuleuven.ac.be</email></line></lineatedText></correspondenceTo><linkGroup><link type="toTypesetVersion" href="file:IJCP.IJCP12252.pdf"></link></linkGroup></publicationMeta><contentMeta><titleGroup><title type="main">Effectiveness and tolerability of second‐line therapy with vildagliptin vs. other oral agents in type 2 diabetes: A real‐life worldwide observational study (<fc>EDGE</fc>)</title><title type="shortAuthors">Effectiveness and tolerability of second‐line therapy</title></titleGroup><creators><creator affiliationRef="#ijcp12252-aff-0001" corresponding="yes" creatorRole="author" xml:id="ijcp12252-cr-0001"><personName><givenNames>C.</givenNames> <familyName>Mathieu</familyName></personName></creator><creator affiliationRef="#ijcp12252-aff-0002" creatorRole="author" xml:id="ijcp12252-cr-0002"><personName><givenNames>A. H.</givenNames> <familyName>Barnett</familyName></personName></creator><creator affiliationRef="#ijcp12252-aff-0003" creatorRole="author" xml:id="ijcp12252-cr-0003"><personName><givenNames>H.</givenNames> <familyName>Brath</familyName></personName></creator><creator affiliationRef="#ijcp12252-aff-0004" creatorRole="author" xml:id="ijcp12252-cr-0004"><personName><givenNames>I.</givenNames> <familyName>Conget</familyName></personName></creator><creator affiliationRef="#ijcp12252-aff-0005" creatorRole="author" xml:id="ijcp12252-cr-0005"><personName><givenNames>J. J.</givenNames> <familyNamePrefix>de</familyNamePrefix> <familyName>Castro</familyName></personName></creator><creator affiliationRef="#ijcp12252-aff-0006" creatorRole="author" xml:id="ijcp12252-cr-0006"><personName><givenNames>R.</givenNames> <familyName>Göke</familyName></personName></creator><creator affiliationRef="#ijcp12252-aff-0007" creatorRole="author" xml:id="ijcp12252-cr-0007"><personName><givenNames>E.</givenNames> <familyName>Márquez Rodriguez</familyName></personName></creator><creator affiliationRef="#ijcp12252-aff-0008" creatorRole="author" xml:id="ijcp12252-cr-0008"><personName><givenNames>P. M.</givenNames> <familyName>Nilsson</familyName></personName></creator><creator affiliationRef="#ijcp12252-aff-0009" creatorRole="author" xml:id="ijcp12252-cr-0009"><personName><givenNames>E.</givenNames> <familyName>Pagkalos</familyName></personName></creator><creator affiliationRef="#ijcp12252-aff-0010" creatorRole="author" xml:id="ijcp12252-cr-0010"><personName><givenNames>A.</givenNames> <familyName>Penfornis</familyName></personName></creator><creator affiliationRef="#ijcp12252-aff-0011" creatorRole="author" xml:id="ijcp12252-cr-0011"><personName><givenNames>N.C.</givenNames> <familyName>Schaper</familyName></personName></creator><creator affiliationRef="#ijcp12252-aff-0012" creatorRole="author" xml:id="ijcp12252-cr-0012"><personName><givenNames>S. K.</givenNames> <familyName>Wangnoo</familyName></personName></creator><creator affiliationRef="#ijcp12252-aff-0013" creatorRole="author" xml:id="ijcp12252-cr-0013"><personName><givenNames>W.</givenNames> <familyName>Kothny</familyName></personName></creator><creator affiliationRef="#ijcp12252-aff-0014" creatorRole="author" xml:id="ijcp12252-cr-0014"><personName><givenNames>G.</givenNames> <familyName>Bader</familyName></personName></creator></creators><affiliationGroup><affiliation countryCode="BE" type="organization" xml:id="ijcp12252-aff-0001"><orgDiv>I.G. – Endocrinologie</orgDiv> <orgName>Campus Gasthuisberg</orgName> <address><city>Leuven</city> <country>Belgium</country></address></affiliation><affiliation countryCode="GB" type="organization" xml:id="ijcp12252-aff-0002"><orgDiv>Department of Medicine</orgDiv> <orgDiv>Diabetes Centre</orgDiv> <orgName>Heart of England NHS Foundation Trust</orgName> <orgName>University of Birmingham</orgName> <address><city>Birmingham</city> <country>UK</country></address></affiliation><affiliation countryCode="AT" type="organization" xml:id="ijcp12252-aff-0003"><orgName>Health Center South</orgName> <address><city>Vienna</city> <country>Austria</country></address></affiliation><affiliation countryCode="PT" type="organization" xml:id="ijcp12252-aff-0004"><orgDiv>Department of Endocrinology & Diabetes</orgDiv> <orgName>Armed Forces University Hospital</orgName> <address><city>Lisboa</city> <country>Portugal</country></address></affiliation><affiliation countryCode="ES" type="organization" xml:id="ijcp12252-aff-0005"><orgDiv>Diabetes Unit</orgDiv> <orgDiv>Endocrinology and Nutrition Department</orgDiv> <orgName>Hospital Clinic i Universitari</orgName> <address><city>Barcelona</city> <country>Spain</country></address></affiliation><affiliation countryCode="DE" type="organization" xml:id="ijcp12252-aff-0006"><orgDiv>Innere Medizin</orgDiv> <orgName>Schwerpkt Diabetologie</orgName> <address><city>Kirchhain</city> <country>Germany</country></address></affiliation><affiliation countryCode="MX" type="organization" xml:id="ijcp12252-aff-0007"><orgName>Hospital Civil Viejo</orgName> <address><city>Guadalajara</city><country>Mexico</country></address></affiliation><affiliation countryCode="SE" type="organization" xml:id="ijcp12252-aff-0008"><orgDiv>Clinical research unit</orgDiv> <orgName>Skåne University Hospital</orgName> <address><city>Malmö</city> <country>Sweden</country></address></affiliation><affiliation countryCode="GR" type="organization" xml:id="ijcp12252-aff-0009"><orgDiv>Private Hospital “Thermi”</orgDiv> <address><city>Thessaloniki</city> <country>Greece</country></address></affiliation><affiliation countryCode="FR" type="organization" xml:id="ijcp12252-aff-0010"><orgDiv>Department of Endocrinology‐Metabolism and Diabetology‐Nutrition</orgDiv> <orgName>Jean Minjoz Hospital</orgName> <orgName>University of Franche‐Comté</orgName> <address><city>Besançon Cedex</city> <country>France</country></address></affiliation><affiliation countryCode="NL" type="organization" xml:id="ijcp12252-aff-0011"><orgDiv>Division of Endocrinology</orgDiv> <orgDiv>Department of Internal Medicine</orgDiv> <orgName>University Hospital Maastricht</orgName> <address><city>Maastricht</city> <country>The Netherlands</country></address></affiliation><affiliation countryCode="IN" type="organization" xml:id="ijcp12252-aff-0012"><orgName>Apollo Centre for Obesity, Diabetes & Endocrinology (ACODE)</orgName> <orgName>Indraprastha Apollo Hospital</orgName> <address><city>New Delhi</city> <country>India</country></address></affiliation><affiliation countryCode="US" type="organization" xml:id="ijcp12252-aff-0013"><orgName>Novartis Pharmaceuticals Corporation</orgName> <address><city>East Hanover</city> <countryPart>NJ</countryPart> <country>USA</country></address></affiliation><affiliation countryCode="CH" type="organization" xml:id="ijcp12252-aff-0014"><orgDiv>Global Medical Affairs – Diabetes</orgDiv> <orgName>Novartis Pharma AG</orgName> <address><city>Basel</city> <country>Switzerland</country></address></affiliation></affiliationGroup><fundingInfo><fundingAgency>Novartis</fundingAgency></fundingInfo><supportingInformation><supportingInfoItem><mediaResource alt="supporting" mimeType="application/msword" href="urn-x:wiley:13685031:media:ijcp12252:ijcp12252-sup-0001-Appendix"></mediaResource><caption><p><b>Table S1.</b> Regions, countries, number of centres and patients participating in EDGE.</p><p><b>Table S2A.</b> Number and reasons for discontinuations by cohort (ITT population).</p><p><b>Table S2B.</b> Deviations from protocol requiring exclusion from the PP population by cohort.</p><p><b>Table S3.</b> Index medication (ITT population).</p><p><b>Table S4.</b> Adverse events by primary System Organ Class (SOC) and cohort (ITT population).</p><p><b>Table S5.</b> Serious adverse events by SOC and cohort (ITT population).</p></caption></supportingInfoItem></supportingInformation><abstractGroup><abstract type="main" xml:id="ijcp12252-abs-0001"><title type="main">Summary</title><section xml:id="ijcp12252-sec-0001"><title type="main">Aim</title><p>Real‐life studies are needed to confirm the clinical relevance of findings from randomised controlled trials (<fc>RCT</fc>s). This study aimed to assess the effectiveness and tolerability of vildagliptin add‐on vs. other oral antihyperglycaemic drugs (<fc>OAD</fc>s) added to <fc>OAD</fc> monotherapy in a real‐life setting, and to explore the advantages and limitations of large‐scale ‘pragmatic’ trials.</p></section><section xml:id="ijcp12252-sec-0002"><title type="main">Methods</title><p><fc>EDGE</fc> was a prospective, 1‐year, worldwide, real‐life observational study in which 2957 physicians reported on the effects of second‐line <fc>OAD</fc>s in 45,868 patients with T2<fc>DM</fc> not reaching glycaemic targets with monotherapy. Physicians could add any <fc>OAD</fc>, and patients entered either vildagliptin or (pooled) comparator cohort. The primary effectiveness and tolerability end‐point (<fc>PEP</fc>) evaluated proportions of patients decreasing HbA<sub>1c</sub> > 0.3%, without hypoglycaemia, weight gain, peripheral oedema or gastrointestinal side effects. The most clinically relevant secondary end‐point (<fc>SEP</fc> 3) was attainment of end‐point HbA<sub>1c</sub> < 7% without hypoglycaemia or ≥ 3% increase in body weight.</p></section><section xml:id="ijcp12252-sec-0003"><title type="main">Results</title><p>In this large group of T2<fc>DM</fc> patients, a second <fc>OAD</fc> was added at mean HbA<sub>1c</sub> of 8.2 ± 1.3%, with no baseline HbA<sub>1c</sub> difference between cohorts. Second‐line <fc>OAD</fc> therapy attained the <fc>PEP</fc> in the majority of patients, with higher attainment in those prescribed a vildagliptin‐based regimen. The adjusted odds ratio was 1.49 (95% <fc>CI</fc>: 1.42, 1.55; p < 0.001). In patients with baseline HbA<sub>1c</sub> ≥ 7%, <fc>SEP</fc> 3 was achieved by 35% of patients on a vildagliptin‐based combination and by 23% of those receiving comparator combinations. The adjusted odds ratio was 1.96 (95% <fc>CI</fc>: 1.85, 2.07; p < 0.001). Safety events were reported infrequently and safety profiles of vildagliptin and other <fc>OAD</fc>s were consistent with previous data.</p></section><section xml:id="ijcp12252-sec-0004"><title type="main">Conclusion</title><p><fc>EDGE</fc> demonstrates that in a ‘real‐life’ setting, vildagliptin as second <fc>OAD</fc> can lower HbA<sub>1c</sub> to target without well‐recognised <fc>OAD</fc> side effects, more frequently than comparator <fc>OAD</fc>s. In addition, <fc>EDGE</fc> illustrates that conducting large‐scale, prospective, real‐life studies poses challenges but yields valuable clinical information complementary to <fc>RCT</fc>s.</p></section></abstract></abstractGroup></contentMeta><noteGroup xml:id="ijcp12252-ntgp-0001"><note numbered="no" xml:id="ijcp12252-note-0001"><p><b>Disclosure</b></p><p>CM has received honoraria for lectures and/or advisory work from Novo Nordisk, sanofi‐aventis, MSD, Eli Lilly, Novartis, BMS, AstraZeneca, Pfizer, J&J, and Mankind; her institution has received research support from Novo Nordisk, sanofi‐avenis, MSD, Eli Lilly and Novartis. AHB has received honoraria for lectures and advisory work from Novartis, MSD, Boehinger‐Ingleheim, Janssen Cilag, BMS/Astra‐Zeneca, Novo Nordisk, Eli Lilly, Roche and sanofi‐aventis. HB has received honoraria for lectures and advisory boards from all major diabetes companies, including Novartis, but has no specific conflict of interest relevant to the study. JJdC has received honoraria for advisory boards, consultancies and speakers bureaus from Bial, Bayer, BMS‐Astra Zeneca, Boehringer‐Ingelheim, Eli Lilly, Merck‐Serono, Novartis, Novo Nordisk, and Recordati. IC has received honoraria and consulting fees as a member of scientific advisory board from Medtronic, Bayer, GSK, Eli Lilly, Novo Nordisk, sanofi‐aventis, MSD and Novartis. RG has received honoraria for lectures. PMN has received honoraria for advisory boards and lectures from Novartis. AP has been on advisory boards for Novartis, Novo Nordisk, and sanofi‐aventis has received compensation for development of educational materials from Abbott, Astra‐Zeneca, BMS, J&J, MSD, Novartis, sanofi‐aventis, Lilly and Boehringer‐Ingelheim. He has travelled for and received expense reimbursement by MSD and sanofi‐aventis. NCS and SKW declare no conflicts of interest. WK is an employee and shareholder of Novartis. GB is an employee of Novartis.</p></note></noteGroup></header></component></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Effectiveness and tolerability of second‐line therapy with vildagliptin vs. other oral agents in type 2 diabetes: A real‐life worldwide observational study (EDGE)</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Effectiveness and tolerability of second‐line therapy with vildagliptin vs. other oral agents in type 2 diabetes: A real‐life worldwide observational study (EDGE)</title></titleInfo><name type="personal"><namePart type="given">C.</namePart><namePart type="family">Mathieu</namePart><affiliation>I.G. – Endocrinologie, Campus Gasthuisberg, Leuven, Belgium</affiliation><affiliation>Prof. Dr Chantal Mathieu,I.G. – Endocrinologie, Campus Gasthuisberg,Herestraat 49, Leuven 3000, BelgiumTel.: +32 1634 6994Fax: +32 1634 6989E‐mail:</affiliation><affiliation>E-mail: chantal.mathieu@uz.kuleuven.ac.be</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">A. H.</namePart><namePart type="family">Barnett</namePart><affiliation>Department of Medicine, Diabetes Centre, Heart of England NHS Foundation Trust, University of Birmingham, Birmingham, UK</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">H.</namePart><namePart type="family">Brath</namePart><affiliation>Health Center South, Vienna, Austria</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">I.</namePart><namePart type="family">Conget</namePart><affiliation>Department of Endocrinology & Diabetes, Armed Forces University Hospital, Lisboa, Portugal</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J. J.</namePart><namePart type="family">de Castro</namePart><affiliation>Diabetes Unit, Endocrinology and Nutrition Department, Hospital Clinic i Universitari, Barcelona, Spain</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">R.</namePart><namePart type="family">Göke</namePart><affiliation>Innere Medizin, Schwerpkt Diabetologie, Kirchhain, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">E.</namePart><namePart type="family">Márquez Rodriguez</namePart><affiliation>Hospital Civil Viejo, Guadalajara, Mexico</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">P. M.</namePart><namePart type="family">Nilsson</namePart><affiliation>Clinical research unit, Skåne University Hospital, Malmö, Sweden</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">E.</namePart><namePart type="family">Pagkalos</namePart><affiliation>Private Hospital “Thermi”, Thessaloniki, Greece</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">A.</namePart><namePart type="family">Penfornis</namePart><affiliation>Department of Endocrinology‐Metabolism and Diabetology‐Nutrition, Jean Minjoz Hospital, University of Franche‐Comté, Besançon Cedex, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">N.C.</namePart><namePart type="family">Schaper</namePart><affiliation>Division of Endocrinology, Department of Internal Medicine, University Hospital Maastricht, Maastricht, The Netherlands</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">S. K.</namePart><namePart type="family">Wangnoo</namePart><affiliation>Apollo Centre for Obesity, Diabetes & Endocrinology (ACODE), Indraprastha Apollo Hospital, New Delhi, India</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">W.</namePart><namePart type="family">Kothny</namePart><affiliation>Novartis Pharmaceuticals Corporation, NJ, East Hanover, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">G.</namePart><namePart type="family">Bader</namePart><affiliation>Global Medical Affairs – Diabetes, Novartis Pharma AG, Basel, Switzerland</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="article" displayLabel="article"></genre><originInfo><publisher>Blackwell Publishing Ltd</publisher><dateIssued encoding="w3cdtf">2013-10</dateIssued><dateCreated encoding="w3cdtf">2013-07-22</dateCreated><dateCaptured encoding="w3cdtf">2013-05-22</dateCaptured><dateValid encoding="w3cdtf">2013-07-14</dateValid><copyrightDate encoding="w3cdtf">2013</copyrightDate></originInfo><language><languageTerm type="code" authority="rfc3066">en</languageTerm><languageTerm type="code" authority="iso639-2b">eng</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType></physicalDescription><abstract>Real‐life studies are needed to confirm the clinical relevance of findings from randomised controlled trials (RCTs). This study aimed to assess the effectiveness and tolerability of vildagliptin add‐on vs. other oral antihyperglycaemic drugs (OADs) added to OAD monotherapy in a real‐life setting, and to explore the advantages and limitations of large‐scale ‘pragmatic’ trials.</abstract><abstract>EDGE was a prospective, 1‐year, worldwide, real‐life observational study in which 2957 physicians reported on the effects of second‐line OADs in 45,868 patients with T2DM not reaching glycaemic targets with monotherapy. Physicians could add any OAD, and patients entered either vildagliptin or (pooled) comparator cohort. The primary effectiveness and tolerability end‐point (PEP) evaluated proportions of patients decreasing HbA1c > 0.3%, without hypoglycaemia, weight gain, peripheral oedema or gastrointestinal side effects. The most clinically relevant secondary end‐point (SEP 3) was attainment of end‐point HbA1c < 7% without hypoglycaemia or ≥ 3% increase in body weight.</abstract><abstract>In this large group of T2DM patients, a second OAD was added at mean HbA1c of 8.2 ± 1.3%, with no baseline HbA1c difference between cohorts. Second‐line OAD therapy attained the PEP in the majority of patients, with higher attainment in those prescribed a vildagliptin‐based regimen. The adjusted odds ratio was 1.49 (95% CI: 1.42, 1.55; p < 0.001). In patients with baseline HbA1c ≥ 7%, SEP 3 was achieved by 35% of patients on a vildagliptin‐based combination and by 23% of those receiving comparator combinations. The adjusted odds ratio was 1.96 (95% CI: 1.85, 2.07; p < 0.001). Safety events were reported infrequently and safety profiles of vildagliptin and other OADs were consistent with previous data.</abstract><abstract>EDGE demonstrates that in a ‘real‐life’ setting, vildagliptin as second OAD can lower HbA1c to target without well‐recognised OAD side effects, more frequently than comparator OADs. In addition, EDGE illustrates that conducting large‐scale, prospective, real‐life studies poses challenges but yields valuable clinical information complementary to RCTs.</abstract><note type="additional physical form">Table S1. Regions, countries, number of centres and patients participating in EDGE. Table S2A. Number and reasons for discontinuations by cohort (ITT population). Table S2B. Deviations from protocol requiring exclusion from the PP population by cohort. Table S3. Index medication (ITT population). Table S4. Adverse events by primary System Organ Class (SOC) and cohort (ITT population). Table S5. Serious adverse events by SOC and cohort (ITT population).</note><note type="funding">Novartis</note><relatedItem type="host"><titleInfo><title>International Journal of Clinical Practice</title></titleInfo><titleInfo type="abbreviated"><title>Int J Clin Pract</title></titleInfo><genre type="journal">journal</genre><subject><genre>article-category</genre><topic>Original Paper</topic></subject><identifier type="ISSN">1368-5031</identifier><identifier type="eISSN">1742-1241</identifier><identifier type="DOI">10.1111/(ISSN)1742-1241</identifier><identifier type="PublisherID">IJCP</identifier><part><date>2013</date><detail type="volume"><caption>vol.</caption><number>67</number></detail><detail type="issue"><caption>no.</caption><number>10</number></detail><extent unit="pages"><start>947</start><end>956</end><total>10</total></extent></part></relatedItem><identifier type="istex">B9764C37982951C07B33DEC4808354C963EDE84F</identifier><identifier type="DOI">10.1111/ijcp.12252</identifier><identifier type="ArticleID">IJCP12252</identifier><accessCondition type="use and reproduction" contentType="creativeCommonsBy-nc-nd">This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.</accessCondition><recordInfo><recordContentSource>WILEY</recordContentSource></recordInfo></mods></metadata><enrichments><json:item><type>multicat</type><uri>https://api.istex.fr/document/B9764C37982951C07B33DEC4808354C963EDE84F/enrichments/multicat</uri></json:item></enrichments><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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