Use of Dipeptidyl Peptidase-4 Inhibitors and the Reporting of Infections: A Disproportionality Analysis in the World Health Organization VigiBase
OBJECTIVE: Dipeptidyl peptidase-4 (DPP-4) inhibitors are a new class of antidiabetic drugs. They inactivate incretin hormones but also have many other effects throughout the body, among which are effects on the immune system. This might result in an increased infection risk. This study assessed the...
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| Veröffentlicht in: | Diabetes care 2011-02, Vol.34 (2), p.369-374 |
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| creator | Willemen, Marjolein J Mantel-Teeuwisse, Aukje K Straus, Sabine M Meyboom, Ron H Egberts, Toine C Leufkens, Hubert G |
| description | OBJECTIVE: Dipeptidyl peptidase-4 (DPP-4) inhibitors are a new class of antidiabetic drugs. They inactivate incretin hormones but also have many other effects throughout the body, among which are effects on the immune system. This might result in an increased infection risk. This study assessed the association between use of DPP-4 inhibitors and the reporting of infections. RESEARCH DESIGN AND METHODS: A nested case-control was conducted using VigiBase, the World Health Organization-Adverse Drug Reactions (WHO-ADR) database. The base cohort consisted of ADRs for antidiabetic drugs (Anatomical Therapeutic Chemical code A10). Cases were defined as ADRs of infection according to the Medical Dictionary for Regulatory Activities (MedDRA) classification system. All other ADRs were considered controls. Reporting odds ratios (RORs) were calculated to estimate the strength of the association between different classes of antidiabetic drugs and the reporting of infections. RESULTS: We identified 305,415 suspected ADRs involving antidiabetic drugs in 106,469 case reports, of which 8,083 involved DPP-4 inhibitors monotherapy. Overall, the reporting of infections was higher for patients using DPP-4 inhibitors compared with users of biguanides (ROR 2.3 [95% CI 1.9-2.7]). Reporting of upper respiratory tract infections (ROR 12.3 [95% CI 8.6-17.5]) was significantly associated with use of DPP-4 inhibitors. CONCLUSIONS: This study indicates an increased reporting of infections, in particular upper respiratory tract infections, for users of DPP-4 inhibitors compared with users of other antidiabetic drugs. However, the limitations of spontaneous reporting systems (e.g., underreporting, the Weber-effect, reporting bias) should be taken into account. Therefore, further research is needed to evaluate this suspicion and the underlying mechanism. |
| doi_str_mv | 10.2337/dc10-1771 |
| format | Article |
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They inactivate incretin hormones but also have many other effects throughout the body, among which are effects on the immune system. This might result in an increased infection risk. This study assessed the association between use of DPP-4 inhibitors and the reporting of infections. RESEARCH DESIGN AND METHODS: A nested case-control was conducted using VigiBase, the World Health Organization-Adverse Drug Reactions (WHO-ADR) database. The base cohort consisted of ADRs for antidiabetic drugs (Anatomical Therapeutic Chemical code A10). Cases were defined as ADRs of infection according to the Medical Dictionary for Regulatory Activities (MedDRA) classification system. All other ADRs were considered controls. Reporting odds ratios (RORs) were calculated to estimate the strength of the association between different classes of antidiabetic drugs and the reporting of infections. RESULTS: We identified 305,415 suspected ADRs involving antidiabetic drugs in 106,469 case reports, of which 8,083 involved DPP-4 inhibitors monotherapy. Overall, the reporting of infections was higher for patients using DPP-4 inhibitors compared with users of biguanides (ROR 2.3 [95% CI 1.9-2.7]). Reporting of upper respiratory tract infections (ROR 12.3 [95% CI 8.6-17.5]) was significantly associated with use of DPP-4 inhibitors. CONCLUSIONS: This study indicates an increased reporting of infections, in particular upper respiratory tract infections, for users of DPP-4 inhibitors compared with users of other antidiabetic drugs. However, the limitations of spontaneous reporting systems (e.g., underreporting, the Weber-effect, reporting bias) should be taken into account. Therefore, further research is needed to evaluate this suspicion and the underlying mechanism.</description><identifier>ISSN: 0149-5992</identifier><identifier>EISSN: 1935-5548</identifier><identifier>DOI: 10.2337/dc10-1771</identifier><identifier>PMID: 21270195</identifier><identifier>CODEN: DICAD2</identifier><language>eng</language><publisher>Alexandria, VA: American Diabetes Association</publisher><subject>Adverse Drug Reaction Reporting Systems - statistics & numerical data ; Aged ; Apoptosis ; Biological and medical sciences ; Case-Control Studies ; Clinical trials ; Complications and side effects ; Databases, Factual ; Diabetes Mellitus, Type 2 - drug therapy ; Diabetes Mellitus, Type 2 - epidemiology ; Diabetes. Impaired glucose tolerance ; Dipeptidyl Peptidase 4 - metabolism ; Dipeptidyl-Peptidase IV Inhibitors - administration & dosage ; Dipeptidyl-Peptidase IV Inhibitors - adverse effects ; Drug Therapy, Combination ; Endocrine pancreas. Apud cells (diseases) ; Endocrinopathies ; Female ; Humans ; Hypoglycemic agents ; Hypoglycemic Agents - administration & dosage ; Hypoglycemic Agents - adverse effects ; Immune system ; Infection ; Infection - epidemiology ; Male ; Medical research ; Medical sciences ; Medicine, Experimental ; Metabolic diseases ; Middle Aged ; Miscellaneous ; Original Research ; Pharmaceutical industry ; Public health ; Public health. Hygiene ; Public health. Hygiene-occupational medicine ; Regression analysis ; Risk Factors ; Studies ; World Health Organization</subject><ispartof>Diabetes care, 2011-02, Vol.34 (2), p.369-374</ispartof><rights>2015 INIST-CNRS</rights><rights>COPYRIGHT 2011 American Diabetes Association</rights><rights>Copyright American Diabetes Association Feb 2011</rights><rights>2011 by the American Diabetes Association.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c626t-2a232ece78e0815041a18639de0df8b9ed5d6e26550483a441d2a4b477e88eac3</citedby><cites>FETCH-LOGICAL-c626t-2a232ece78e0815041a18639de0df8b9ed5d6e26550483a441d2a4b477e88eac3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,27923,27924</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=23842095$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21270195$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Willemen, Marjolein J</creatorcontrib><creatorcontrib>Mantel-Teeuwisse, Aukje K</creatorcontrib><creatorcontrib>Straus, Sabine M</creatorcontrib><creatorcontrib>Meyboom, Ron H</creatorcontrib><creatorcontrib>Egberts, Toine C</creatorcontrib><creatorcontrib>Leufkens, Hubert G</creatorcontrib><title>Use of Dipeptidyl Peptidase-4 Inhibitors and the Reporting of Infections: A Disproportionality Analysis in the World Health Organization VigiBase</title><title>Diabetes care</title><addtitle>Diabetes Care</addtitle><description>OBJECTIVE: Dipeptidyl peptidase-4 (DPP-4) inhibitors are a new class of antidiabetic drugs. They inactivate incretin hormones but also have many other effects throughout the body, among which are effects on the immune system. This might result in an increased infection risk. This study assessed the association between use of DPP-4 inhibitors and the reporting of infections. RESEARCH DESIGN AND METHODS: A nested case-control was conducted using VigiBase, the World Health Organization-Adverse Drug Reactions (WHO-ADR) database. The base cohort consisted of ADRs for antidiabetic drugs (Anatomical Therapeutic Chemical code A10). Cases were defined as ADRs of infection according to the Medical Dictionary for Regulatory Activities (MedDRA) classification system. All other ADRs were considered controls. Reporting odds ratios (RORs) were calculated to estimate the strength of the association between different classes of antidiabetic drugs and the reporting of infections. RESULTS: We identified 305,415 suspected ADRs involving antidiabetic drugs in 106,469 case reports, of which 8,083 involved DPP-4 inhibitors monotherapy. Overall, the reporting of infections was higher for patients using DPP-4 inhibitors compared with users of biguanides (ROR 2.3 [95% CI 1.9-2.7]). Reporting of upper respiratory tract infections (ROR 12.3 [95% CI 8.6-17.5]) was significantly associated with use of DPP-4 inhibitors. CONCLUSIONS: This study indicates an increased reporting of infections, in particular upper respiratory tract infections, for users of DPP-4 inhibitors compared with users of other antidiabetic drugs. However, the limitations of spontaneous reporting systems (e.g., underreporting, the Weber-effect, reporting bias) should be taken into account. Therefore, further research is needed to evaluate this suspicion and the underlying mechanism.</description><subject>Adverse Drug Reaction Reporting Systems - statistics & numerical data</subject><subject>Aged</subject><subject>Apoptosis</subject><subject>Biological and medical sciences</subject><subject>Case-Control Studies</subject><subject>Clinical trials</subject><subject>Complications and side effects</subject><subject>Databases, Factual</subject><subject>Diabetes Mellitus, Type 2 - drug therapy</subject><subject>Diabetes Mellitus, Type 2 - epidemiology</subject><subject>Diabetes. Impaired glucose tolerance</subject><subject>Dipeptidyl Peptidase 4 - metabolism</subject><subject>Dipeptidyl-Peptidase IV Inhibitors - administration & dosage</subject><subject>Dipeptidyl-Peptidase IV Inhibitors - adverse effects</subject><subject>Drug Therapy, Combination</subject><subject>Endocrine pancreas. Apud cells (diseases)</subject><subject>Endocrinopathies</subject><subject>Female</subject><subject>Humans</subject><subject>Hypoglycemic agents</subject><subject>Hypoglycemic Agents - administration & dosage</subject><subject>Hypoglycemic Agents - adverse effects</subject><subject>Immune system</subject><subject>Infection</subject><subject>Infection - epidemiology</subject><subject>Male</subject><subject>Medical research</subject><subject>Medical sciences</subject><subject>Medicine, Experimental</subject><subject>Metabolic diseases</subject><subject>Middle Aged</subject><subject>Miscellaneous</subject><subject>Original Research</subject><subject>Pharmaceutical industry</subject><subject>Public health</subject><subject>Public health. Hygiene</subject><subject>Public health. Hygiene-occupational medicine</subject><subject>Regression analysis</subject><subject>Risk Factors</subject><subject>Studies</subject><subject>World Health Organization</subject><issn>0149-5992</issn><issn>1935-5548</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNptks1uEzEUhUcIRENhwQuABWLBYop_Mx4WSKH8NFKlIiCwtBz7zsTVxB7sCVJ4C94YTxIKlSIvruX7nXN1rVMUjwk-o4xVr6whuCRVRe4UE1IzUQrB5d1iggmvS1HX9KR4kNI1xphzKe8XJ5TQCpNaTIrfiwQoNOid66EfnN126NPuohOUHM39yi3dEGJC2ls0rAB9hj7Ewfl2lM19A2ZwwafXaJZNUh_Drh287tywRbNct8kl5PxO_T3EzqIL0N2wQlex1d790iOOvrnWvc1THxb3Gt0leHSop8Xiw_uv5xfl5dXH-fnssjRTOh1KqimjYKCSgCURmBNN5JTVFrBt5LIGK-wU6FTklmSac2Kp5kteVSAlaMNOizd7336zXIM14IeoO9VHt9Zxq4J26nbHu5Vqw0_FMOVMkGzw7GAQw48NpEFdh03M-yYlBRUVz5-coed7qNUdKOebkL3M2iWjZpTXTJKqZpkqj1AteMiDg4fG5edb_NkRPh8La2eOCl7uBSaGlCI0N3sSrMYMqTFDasxQZp_8_zE35N_QZODFAdDJ6K6J2huX_nFMcop33NM91-igdBszs_hCMWF4DOlUEvYHFazYBw</recordid><startdate>20110201</startdate><enddate>20110201</enddate><creator>Willemen, Marjolein J</creator><creator>Mantel-Teeuwisse, Aukje K</creator><creator>Straus, Sabine M</creator><creator>Meyboom, Ron H</creator><creator>Egberts, Toine C</creator><creator>Leufkens, Hubert G</creator><general>American Diabetes Association</general><scope>FBQ</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X2</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88I</scope><scope>8AF</scope><scope>8AO</scope><scope>8C1</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AN0</scope><scope>ATCPS</scope><scope>AZQEC</scope><scope>BEC</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>HCIFZ</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>M0K</scope><scope>M0R</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2O</scope><scope>M2P</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>S0X</scope><scope>5PM</scope></search><sort><creationdate>20110201</creationdate><title>Use of Dipeptidyl Peptidase-4 Inhibitors and the Reporting of Infections: A Disproportionality Analysis in the World Health Organization VigiBase</title><author>Willemen, Marjolein J ; Mantel-Teeuwisse, Aukje K ; Straus, Sabine M ; Meyboom, Ron H ; Egberts, Toine C ; Leufkens, Hubert G</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c626t-2a232ece78e0815041a18639de0df8b9ed5d6e26550483a441d2a4b477e88eac3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Adverse Drug Reaction Reporting Systems - statistics & numerical data</topic><topic>Aged</topic><topic>Apoptosis</topic><topic>Biological and medical sciences</topic><topic>Case-Control Studies</topic><topic>Clinical trials</topic><topic>Complications and side effects</topic><topic>Databases, Factual</topic><topic>Diabetes Mellitus, Type 2 - drug therapy</topic><topic>Diabetes Mellitus, Type 2 - epidemiology</topic><topic>Diabetes. Impaired glucose tolerance</topic><topic>Dipeptidyl Peptidase 4 - metabolism</topic><topic>Dipeptidyl-Peptidase IV Inhibitors - administration & dosage</topic><topic>Dipeptidyl-Peptidase IV Inhibitors - adverse effects</topic><topic>Drug Therapy, Combination</topic><topic>Endocrine pancreas. Apud cells (diseases)</topic><topic>Endocrinopathies</topic><topic>Female</topic><topic>Humans</topic><topic>Hypoglycemic agents</topic><topic>Hypoglycemic Agents - administration & dosage</topic><topic>Hypoglycemic Agents - adverse effects</topic><topic>Immune system</topic><topic>Infection</topic><topic>Infection - epidemiology</topic><topic>Male</topic><topic>Medical research</topic><topic>Medical sciences</topic><topic>Medicine, Experimental</topic><topic>Metabolic diseases</topic><topic>Middle Aged</topic><topic>Miscellaneous</topic><topic>Original Research</topic><topic>Pharmaceutical industry</topic><topic>Public health</topic><topic>Public health. Hygiene</topic><topic>Public health. Hygiene-occupational medicine</topic><topic>Regression analysis</topic><topic>Risk Factors</topic><topic>Studies</topic><topic>World Health Organization</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Willemen, Marjolein J</creatorcontrib><creatorcontrib>Mantel-Teeuwisse, Aukje K</creatorcontrib><creatorcontrib>Straus, Sabine M</creatorcontrib><creatorcontrib>Meyboom, Ron H</creatorcontrib><creatorcontrib>Egberts, Toine C</creatorcontrib><creatorcontrib>Leufkens, Hubert G</creatorcontrib><collection>AGRIS</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Agricultural Science Collection</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Science Database (Alumni Edition)</collection><collection>STEM Database</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>British Nursing Database</collection><collection>Agricultural & Environmental Science Collection</collection><collection>ProQuest Central Essentials</collection><collection>eLibrary</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>SciTech Premium Collection</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Agricultural Science Database</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Science Database</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><collection>SIRS Editorial</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Diabetes care</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Willemen, Marjolein J</au><au>Mantel-Teeuwisse, Aukje K</au><au>Straus, Sabine M</au><au>Meyboom, Ron H</au><au>Egberts, Toine C</au><au>Leufkens, Hubert G</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Use of Dipeptidyl Peptidase-4 Inhibitors and the Reporting of Infections: A Disproportionality Analysis in the World Health Organization VigiBase</atitle><jtitle>Diabetes care</jtitle><addtitle>Diabetes Care</addtitle><date>2011-02-01</date><risdate>2011</risdate><volume>34</volume><issue>2</issue><spage>369</spage><epage>374</epage><pages>369-374</pages><issn>0149-5992</issn><eissn>1935-5548</eissn><coden>DICAD2</coden><abstract>OBJECTIVE: Dipeptidyl peptidase-4 (DPP-4) inhibitors are a new class of antidiabetic drugs. They inactivate incretin hormones but also have many other effects throughout the body, among which are effects on the immune system. This might result in an increased infection risk. This study assessed the association between use of DPP-4 inhibitors and the reporting of infections. RESEARCH DESIGN AND METHODS: A nested case-control was conducted using VigiBase, the World Health Organization-Adverse Drug Reactions (WHO-ADR) database. The base cohort consisted of ADRs for antidiabetic drugs (Anatomical Therapeutic Chemical code A10). Cases were defined as ADRs of infection according to the Medical Dictionary for Regulatory Activities (MedDRA) classification system. All other ADRs were considered controls. Reporting odds ratios (RORs) were calculated to estimate the strength of the association between different classes of antidiabetic drugs and the reporting of infections. RESULTS: We identified 305,415 suspected ADRs involving antidiabetic drugs in 106,469 case reports, of which 8,083 involved DPP-4 inhibitors monotherapy. Overall, the reporting of infections was higher for patients using DPP-4 inhibitors compared with users of biguanides (ROR 2.3 [95% CI 1.9-2.7]). Reporting of upper respiratory tract infections (ROR 12.3 [95% CI 8.6-17.5]) was significantly associated with use of DPP-4 inhibitors. CONCLUSIONS: This study indicates an increased reporting of infections, in particular upper respiratory tract infections, for users of DPP-4 inhibitors compared with users of other antidiabetic drugs. However, the limitations of spontaneous reporting systems (e.g., underreporting, the Weber-effect, reporting bias) should be taken into account. Therefore, further research is needed to evaluate this suspicion and the underlying mechanism.</abstract><cop>Alexandria, VA</cop><pub>American Diabetes Association</pub><pmid>21270195</pmid><doi>10.2337/dc10-1771</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Diabetes care, 2011-02, Vol.34 (2), p.369-374 |
| issn | 0149-5992 1935-5548 |
| language | eng |
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| source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Journals@Ovid Complete |
| subjects | Adverse Drug Reaction Reporting Systems - statistics & numerical data Aged Apoptosis Biological and medical sciences Case-Control Studies Clinical trials Complications and side effects Databases, Factual Diabetes Mellitus, Type 2 - drug therapy Diabetes Mellitus, Type 2 - epidemiology Diabetes. Impaired glucose tolerance Dipeptidyl Peptidase 4 - metabolism Dipeptidyl-Peptidase IV Inhibitors - administration & dosage Dipeptidyl-Peptidase IV Inhibitors - adverse effects Drug Therapy, Combination Endocrine pancreas. Apud cells (diseases) Endocrinopathies Female Humans Hypoglycemic agents Hypoglycemic Agents - administration & dosage Hypoglycemic Agents - adverse effects Immune system Infection Infection - epidemiology Male Medical research Medical sciences Medicine, Experimental Metabolic diseases Middle Aged Miscellaneous Original Research Pharmaceutical industry Public health Public health. Hygiene Public health. Hygiene-occupational medicine Regression analysis Risk Factors Studies World Health Organization |
| title | Use of Dipeptidyl Peptidase-4 Inhibitors and the Reporting of Infections: A Disproportionality Analysis in the World Health Organization VigiBase |
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