Cardiovascular and non-cardiovascular safety of dipeptidyl peptidase-4 inhibition: a meta-analysis of randomized controlled cardiovascular outcome trials
The full licensing of dipeptidyl peptidase‐4 (DPP‐4) inhibitors in the USA and Europe requires demonstration of cardiovascular (CV) safety with an upper boundary of harm of 30%. Relative risks (RRs) were: 0.99 [confidence interval (CI) 0.93–1.06] for composite CV‐specific death, non‐fatal myocardial...
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| Veröffentlicht in: | Diabetes, obesity & metabolism obesity & metabolism, 2016-03, Vol.18 (3), p.295-299 |
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| creator | Abbas, A. S. Dehbi, H.-M. Ray, K. K. |
| description | The full licensing of dipeptidyl peptidase‐4 (DPP‐4) inhibitors in the USA and Europe requires demonstration of cardiovascular (CV) safety with an upper boundary of harm of 30%. Relative risks (RRs) were: 0.99 [confidence interval (CI) 0.93–1.06] for composite CV‐specific death, non‐fatal myocardial infarction (MI) and non‐fatal stroke; 1.01 (CI 0.91–1.12) for CV‐specific death; 0.98 (CI 0.89–1.09) for non‐fatal MI; and 1.00 (CI 0.86–1.16) for non‐fatal stroke. The risk of acute pancreatitis was increased (RR 1.79; CI 1.13–2.81), equating to 5.5 extra cases/10 000 patients/year (weighted mean) and a number needed to harm of 1940/year. These data provide reassurance about the safety of DPP‐4 inhibitors with regard to individual atherothrombotic events and a safety signal for pancreatitis. |
| doi_str_mv | 10.1111/dom.12595 |
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The risk of acute pancreatitis was increased (RR 1.79; CI 1.13–2.81), equating to 5.5 extra cases/10 000 patients/year (weighted mean) and a number needed to harm of 1940/year. 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S.</creatorcontrib><creatorcontrib>Dehbi, H.-M.</creatorcontrib><creatorcontrib>Ray, K. K.</creatorcontrib><title>Cardiovascular and non-cardiovascular safety of dipeptidyl peptidase-4 inhibition: a meta-analysis of randomized controlled cardiovascular outcome trials</title><title>Diabetes, obesity & metabolism</title><addtitle>Diabetes Obes Metab</addtitle><description>The full licensing of dipeptidyl peptidase‐4 (DPP‐4) inhibitors in the USA and Europe requires demonstration of cardiovascular (CV) safety with an upper boundary of harm of <30%. We report a total of 3334 CV events during 86 716 person‐years of follow‐up in 36 543 patients, when combining data from three trials with formal and prospectively assessed endpoints. Fixed‐effect meta‐analysis showed that, compared with placebo, DPP‐4 inhibition did not increase the upper boundary of risk for the composite endpoint, nor for any individual component by >30%. Relative risks (RRs) were: 0.99 [confidence interval (CI) 0.93–1.06] for composite CV‐specific death, non‐fatal myocardial infarction (MI) and non‐fatal stroke; 1.01 (CI 0.91–1.12) for CV‐specific death; 0.98 (CI 0.89–1.09) for non‐fatal MI; and 1.00 (CI 0.86–1.16) for non‐fatal stroke. The risk of acute pancreatitis was increased (RR 1.79; CI 1.13–2.81), equating to 5.5 extra cases/10 000 patients/year (weighted mean) and a number needed to harm of 1940/year. These data provide reassurance about the safety of DPP‐4 inhibitors with regard to individual atherothrombotic events and a safety signal for pancreatitis.</description><subject>Adult</subject><subject>Aged</subject><subject>antidiabetic drug</subject><subject>Antidiabetics</subject><subject>cardiovascular disease</subject><subject>Cardiovascular Diseases - chemically induced</subject><subject>Cerebral infarction</subject><subject>Clinical trials</subject><subject>Confidence intervals</subject><subject>Diabetes Mellitus, Type 2 - drug therapy</subject><subject>Dipeptidyl-Peptidase IV Inhibitors - adverse effects</subject><subject>DPP-IV inhibitor</subject><subject>Drug Evaluation</subject><subject>Europe</subject><subject>Female</subject><subject>Heart attacks</subject><subject>Humans</subject><subject>Hypoglycemic Agents - adverse effects</subject><subject>Male</subject><subject>Meta-analysis</subject><subject>Middle Aged</subject><subject>Myocardial infarction</subject><subject>Pancreatitis</subject><subject>Pancreatitis - chemically induced</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Risk assessment</subject><subject>Safety</subject><subject>Treatment Outcome</subject><subject>United States</subject><issn>1462-8902</issn><issn>1463-1326</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kc1u1DAUhS0Eou3AghdAltjQhVv_JHbMrpqWFmlKET-CneWJbeGSxIPtAOFNeNt6mrZSkcCbe2R99_geXwCeEXxAyjk0oT8gtJb1A7BLKs4QYZQ_vNYUNRLTHbCX0iXGuGKNeAx2KK8JlrLaBX-WOhoffujUjp2OUA8GDmFA7f3rpJ3NEwwOGr-xm-zN1MFZ6GRRBf3w1a999mF4BTXsbdZID7qbkk_brlh8Q-9_WwPbMOQYum4r7z8SxtyG3sIcve7SE_DIlWKf3tQF-PT65OPyDK0uTt8sj1ao5QzXaO0ka0krt9F0I7BmzpX0xmrCmMVOOlJXRRhtMF9zITl1FZFUyrpxDRZsAV7OvpsYvo82ZdX71Nqu04MNY1JE8IoxQTkt6Iu_0MswxhIzqTKKrLBoKP8fVbwYreq6jLYA-zPVxpBStE5tou91nBTBartVVT5MXW-1sM9vHMd1b80debvGAhzOwE_f2enfTur44vzWEs0dPmX7665Dx2-KCyZq9fntqfqy-nD-jov3CrMrkNi8oA</recordid><startdate>201603</startdate><enddate>201603</enddate><creator>Abbas, A. S.</creator><creator>Dehbi, H.-M.</creator><creator>Ray, K. K.</creator><general>Blackwell Publishing Ltd</general><general>Wiley Subscription Services, Inc</general><scope>BSCLL</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>7T5</scope><scope>7TK</scope><scope>H94</scope><scope>K9.</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0001-9150-2142</orcidid></search><sort><creationdate>201603</creationdate><title>Cardiovascular and non-cardiovascular safety of dipeptidyl peptidase-4 inhibition: a meta-analysis of randomized controlled cardiovascular outcome trials</title><author>Abbas, A. S. ; Dehbi, H.-M. ; Ray, K. K.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c6305-bf93c1c90438a870a3ff326dea133e0f9f1543e0dad06b67962f41929958f8073</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Adult</topic><topic>Aged</topic><topic>antidiabetic drug</topic><topic>Antidiabetics</topic><topic>cardiovascular disease</topic><topic>Cardiovascular Diseases - chemically induced</topic><topic>Cerebral infarction</topic><topic>Clinical trials</topic><topic>Confidence intervals</topic><topic>Diabetes Mellitus, Type 2 - drug therapy</topic><topic>Dipeptidyl-Peptidase IV Inhibitors - adverse effects</topic><topic>DPP-IV inhibitor</topic><topic>Drug Evaluation</topic><topic>Europe</topic><topic>Female</topic><topic>Heart attacks</topic><topic>Humans</topic><topic>Hypoglycemic Agents - adverse effects</topic><topic>Male</topic><topic>Meta-analysis</topic><topic>Middle Aged</topic><topic>Myocardial infarction</topic><topic>Pancreatitis</topic><topic>Pancreatitis - chemically induced</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Risk assessment</topic><topic>Safety</topic><topic>Treatment Outcome</topic><topic>United States</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Abbas, A. S.</creatorcontrib><creatorcontrib>Dehbi, H.-M.</creatorcontrib><creatorcontrib>Ray, K. K.</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>Diabetes, obesity & metabolism</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Abbas, A. S.</au><au>Dehbi, H.-M.</au><au>Ray, K. K.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Cardiovascular and non-cardiovascular safety of dipeptidyl peptidase-4 inhibition: a meta-analysis of randomized controlled cardiovascular outcome trials</atitle><jtitle>Diabetes, obesity & metabolism</jtitle><addtitle>Diabetes Obes Metab</addtitle><date>2016-03</date><risdate>2016</risdate><volume>18</volume><issue>3</issue><spage>295</spage><epage>299</epage><pages>295-299</pages><issn>1462-8902</issn><eissn>1463-1326</eissn><coden>DOMEF6</coden><abstract>The full licensing of dipeptidyl peptidase‐4 (DPP‐4) inhibitors in the USA and Europe requires demonstration of cardiovascular (CV) safety with an upper boundary of harm of <30%. We report a total of 3334 CV events during 86 716 person‐years of follow‐up in 36 543 patients, when combining data from three trials with formal and prospectively assessed endpoints. Fixed‐effect meta‐analysis showed that, compared with placebo, DPP‐4 inhibition did not increase the upper boundary of risk for the composite endpoint, nor for any individual component by >30%. Relative risks (RRs) were: 0.99 [confidence interval (CI) 0.93–1.06] for composite CV‐specific death, non‐fatal myocardial infarction (MI) and non‐fatal stroke; 1.01 (CI 0.91–1.12) for CV‐specific death; 0.98 (CI 0.89–1.09) for non‐fatal MI; and 1.00 (CI 0.86–1.16) for non‐fatal stroke. The risk of acute pancreatitis was increased (RR 1.79; CI 1.13–2.81), equating to 5.5 extra cases/10 000 patients/year (weighted mean) and a number needed to harm of 1940/year. These data provide reassurance about the safety of DPP‐4 inhibitors with regard to individual atherothrombotic events and a safety signal for pancreatitis.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>26510994</pmid><doi>10.1111/dom.12595</doi><tpages>5</tpages><orcidid>https://orcid.org/0000-0001-9150-2142</orcidid><oa>free_for_read</oa></addata></record> |
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| subjects | Adult Aged antidiabetic drug Antidiabetics cardiovascular disease Cardiovascular Diseases - chemically induced Cerebral infarction Clinical trials Confidence intervals Diabetes Mellitus, Type 2 - drug therapy Dipeptidyl-Peptidase IV Inhibitors - adverse effects DPP-IV inhibitor Drug Evaluation Europe Female Heart attacks Humans Hypoglycemic Agents - adverse effects Male Meta-analysis Middle Aged Myocardial infarction Pancreatitis Pancreatitis - chemically induced Randomized Controlled Trials as Topic Risk assessment Safety Treatment Outcome United States |
| title | Cardiovascular and non-cardiovascular safety of dipeptidyl peptidase-4 inhibition: a meta-analysis of randomized controlled cardiovascular outcome trials |
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