Re‐adjudication of the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) with study‐level meta‐analysis of hospitalization for heart failure from cardiovascular outcomes trials with dipeptidyl peptidase‐4 (DPP‐4) inhibitors
Background Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) assessed the cardiovascular (CV) safety of sitagliptin versus placebo on CV outcomes in patients with type 2 diabetes and CV disease and found sitagliptin noninferior to placebo. Subsequently, based on feedback from FDA, th...
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| Veröffentlicht in: | Clinical cardiology (Mahwah, N.J.) N.J.), 2022-07, Vol.45 (7), p.794-801 |
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| creator | Scirica, Benjamin M. Im, KyungAh Murphy, Sabina A. Kuder, Julia F. Rodriguez, Dolly A. Lopes, Renato D. Green, Jennifer B. Ruff, Christian T. Sabatine, Marc S. |
| description | Background
Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) assessed the cardiovascular (CV) safety of sitagliptin versus placebo on CV outcomes in patients with type 2 diabetes and CV disease and found sitagliptin noninferior to placebo. Subsequently, based on feedback from FDA, the Sponsor of the trial, Merck & Co., Inc., engaged a separate academic research organization, the TIMI Study Group, to re‐adjudicate a prespecified set of originally adjudicated events.
Methods
TIMI adjudicated in a blinded fashion all potential hospitalization for heart failure (HHF) events, all potential MACE+ events previously adjudicated as not an endpoint event, and a random subset (~10%) of MACE+ events previously adjudicated as an endpoint event. An updated study‐level meta‐analysis of four randomized, placebo‐controlled, CV outcomes trials with dipeptidyl peptidase 4 (DPP‐4) inhibitors was then performed.
Results
After re‐adjudication of potential HHF events in the intent‐to‐treat population, there were 224 patients with a confirmed event in the sitagliptin arm (1.05/100 person‐years) and 239 patients in the placebo arm (1.13/100 person‐years), corresponding to a hazard ratio (HR) of 0.94 (95% confidence interval [95% CI]: 0.78–1.13, p = .49). Concordance between the outcome of the original adjudication and the re‐adjudication for HHF events was 82.7%. The meta‐analysis of CV outcomes trials with DPP‐4 inhibitors with placebo and involving 43 522 patients yielded an HR of 1.07 (95% CI: 0.83–1.39), with moderate heterogeneity (p = .45, I2 = 62.07%).
Conclusion
The results of this independent re‐adjudication process and analyses of CV outcomes from TECOS were consistent with the original adjudication results and overall study findings. An updated study‐level meta‐analysis showed no overall significant risk for HHF with DPP‐4 inhibitors, but with statistical heterogeneity. |
| doi_str_mv | 10.1002/clc.23844 |
| format | Article |
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Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) assessed the cardiovascular (CV) safety of sitagliptin versus placebo on CV outcomes in patients with type 2 diabetes and CV disease and found sitagliptin noninferior to placebo. Subsequently, based on feedback from FDA, the Sponsor of the trial, Merck & Co., Inc., engaged a separate academic research organization, the TIMI Study Group, to re‐adjudicate a prespecified set of originally adjudicated events.
Methods
TIMI adjudicated in a blinded fashion all potential hospitalization for heart failure (HHF) events, all potential MACE+ events previously adjudicated as not an endpoint event, and a random subset (~10%) of MACE+ events previously adjudicated as an endpoint event. An updated study‐level meta‐analysis of four randomized, placebo‐controlled, CV outcomes trials with dipeptidyl peptidase 4 (DPP‐4) inhibitors was then performed.
Results
After re‐adjudication of potential HHF events in the intent‐to‐treat population, there were 224 patients with a confirmed event in the sitagliptin arm (1.05/100 person‐years) and 239 patients in the placebo arm (1.13/100 person‐years), corresponding to a hazard ratio (HR) of 0.94 (95% confidence interval [95% CI]: 0.78–1.13, p = .49). Concordance between the outcome of the original adjudication and the re‐adjudication for HHF events was 82.7%. The meta‐analysis of CV outcomes trials with DPP‐4 inhibitors with placebo and involving 43 522 patients yielded an HR of 1.07 (95% CI: 0.83–1.39), with moderate heterogeneity (p = .45, I2 = 62.07%).
Conclusion
The results of this independent re‐adjudication process and analyses of CV outcomes from TECOS were consistent with the original adjudication results and overall study findings. An updated study‐level meta‐analysis showed no overall significant risk for HHF with DPP‐4 inhibitors, but with statistical heterogeneity.</description><identifier>ISSN: 0160-9289</identifier><identifier>EISSN: 1932-8737</identifier><identifier>DOI: 10.1002/clc.23844</identifier><identifier>PMID: 35715946</identifier><language>eng</language><publisher>Hoboken: John Wiley & Sons, Inc</publisher><subject>Angina pectoris ; Clinical Investigations ; diabetes ; dipeptidyl peptidase‐4 (DPP‐4) inhibitor ; FDA approval ; Heart attacks ; Heart failure ; Hospitalization ; Meta-analysis ; Patients ; Population ; Stroke</subject><ispartof>Clinical cardiology (Mahwah, N.J.), 2022-07, Vol.45 (7), p.794-801</ispartof><rights>2022 The Authors. published by Wiley Periodicals, LLC.</rights><rights>2022. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4204-7ef0752d74244867c0ec235655c1b5a4ea327e80b6a4771b1e31c96ee1f277583</citedby><cites>FETCH-LOGICAL-c4204-7ef0752d74244867c0ec235655c1b5a4ea327e80b6a4771b1e31c96ee1f277583</cites><orcidid>0000-0002-7093-7048</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC9286326/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC9286326/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,1417,11562,27924,27925,45574,45575,46052,46476,53791,53793</link.rule.ids></links><search><creatorcontrib>Scirica, Benjamin M.</creatorcontrib><creatorcontrib>Im, KyungAh</creatorcontrib><creatorcontrib>Murphy, Sabina A.</creatorcontrib><creatorcontrib>Kuder, Julia F.</creatorcontrib><creatorcontrib>Rodriguez, Dolly A.</creatorcontrib><creatorcontrib>Lopes, Renato D.</creatorcontrib><creatorcontrib>Green, Jennifer B.</creatorcontrib><creatorcontrib>Ruff, Christian T.</creatorcontrib><creatorcontrib>Sabatine, Marc S.</creatorcontrib><title>Re‐adjudication of the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) with study‐level meta‐analysis of hospitalization for heart failure from cardiovascular outcomes trials with dipeptidyl peptidase‐4 (DPP‐4) inhibitors</title><title>Clinical cardiology (Mahwah, N.J.)</title><description>Background
Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) assessed the cardiovascular (CV) safety of sitagliptin versus placebo on CV outcomes in patients with type 2 diabetes and CV disease and found sitagliptin noninferior to placebo. Subsequently, based on feedback from FDA, the Sponsor of the trial, Merck & Co., Inc., engaged a separate academic research organization, the TIMI Study Group, to re‐adjudicate a prespecified set of originally adjudicated events.
Methods
TIMI adjudicated in a blinded fashion all potential hospitalization for heart failure (HHF) events, all potential MACE+ events previously adjudicated as not an endpoint event, and a random subset (~10%) of MACE+ events previously adjudicated as an endpoint event. An updated study‐level meta‐analysis of four randomized, placebo‐controlled, CV outcomes trials with dipeptidyl peptidase 4 (DPP‐4) inhibitors was then performed.
Results
After re‐adjudication of potential HHF events in the intent‐to‐treat population, there were 224 patients with a confirmed event in the sitagliptin arm (1.05/100 person‐years) and 239 patients in the placebo arm (1.13/100 person‐years), corresponding to a hazard ratio (HR) of 0.94 (95% confidence interval [95% CI]: 0.78–1.13, p = .49). Concordance between the outcome of the original adjudication and the re‐adjudication for HHF events was 82.7%. The meta‐analysis of CV outcomes trials with DPP‐4 inhibitors with placebo and involving 43 522 patients yielded an HR of 1.07 (95% CI: 0.83–1.39), with moderate heterogeneity (p = .45, I2 = 62.07%).
Conclusion
The results of this independent re‐adjudication process and analyses of CV outcomes from TECOS were consistent with the original adjudication results and overall study findings. An updated study‐level meta‐analysis showed no overall significant risk for HHF with DPP‐4 inhibitors, but with statistical heterogeneity.</description><subject>Angina pectoris</subject><subject>Clinical Investigations</subject><subject>diabetes</subject><subject>dipeptidyl peptidase‐4 (DPP‐4) inhibitor</subject><subject>FDA approval</subject><subject>Heart attacks</subject><subject>Heart failure</subject><subject>Hospitalization</subject><subject>Meta-analysis</subject><subject>Patients</subject><subject>Population</subject><subject>Stroke</subject><issn>0160-9289</issn><issn>1932-8737</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>WIN</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><recordid>eNp1ks-O0zAQxiMEYsvCgTewxKU9dNd2nDi5IKFQ_kiVumLLOXKdSePKiYvtdBVOPAKPwLPwKDwGJxxSkBaJiz3y_Ga-z_ZE0XOCrwjG9FpqeUXjjLEH0YzkMV1mPOYPoxkmKV7mNMsvoifOHQKKMxo_ji7ihJMkZ-ks-vkBfnz5KqpDXykpvDIdMjXyDaCtVUKj1UnoPpx3e1QIWylzEk72Wli06b00LTh0p3yDbpUXe62OgUTz7arY3C6mhPN9NQQJDSfQqAUvRr1O6MEpN2o1xh1DsVafJ_naWNSAsB7VQuneAqqtaZG8r27-qPvR5tlEpY4QHFSDRlMg3Hg7huavb27GYPH9m-oatVPeWPc0elSHUnh23i-jj29W2-Ldcr15-754tV5KRjFbcqgxT2jFGWUsS7nEIGmcpEkiyS4RDERMOWR4lwrGOdkRiInMUwBSU86TLL6MXk59j_2uhUpC563Q5dGqVtihNEKV9zOdasq9OZXh59KYpqHB_NzAmk89OF-2yknQWnRgelfSlGeM0kAG9MU_6MH0Nrz2SGV5moeFB2oxUdIa5yzUf80QXI4TVYaJKn9PVGCvJ_ZOaRj-D5bFupgqfgE2o9e1</recordid><startdate>202207</startdate><enddate>202207</enddate><creator>Scirica, Benjamin M.</creator><creator>Im, KyungAh</creator><creator>Murphy, Sabina A.</creator><creator>Kuder, Julia F.</creator><creator>Rodriguez, Dolly A.</creator><creator>Lopes, Renato D.</creator><creator>Green, Jennifer B.</creator><creator>Ruff, Christian T.</creator><creator>Sabatine, Marc S.</creator><general>John Wiley & Sons, Inc</general><general>John Wiley and Sons Inc</general><scope>24P</scope><scope>WIN</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-7093-7048</orcidid></search><sort><creationdate>202207</creationdate><title>Re‐adjudication of the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) with study‐level meta‐analysis of hospitalization for heart failure from cardiovascular outcomes trials with dipeptidyl peptidase‐4 (DPP‐4) inhibitors</title><author>Scirica, Benjamin M. ; Im, KyungAh ; Murphy, Sabina A. ; Kuder, Julia F. ; Rodriguez, Dolly A. ; Lopes, Renato D. ; Green, Jennifer B. ; Ruff, Christian T. ; Sabatine, Marc S.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4204-7ef0752d74244867c0ec235655c1b5a4ea327e80b6a4771b1e31c96ee1f277583</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Angina pectoris</topic><topic>Clinical Investigations</topic><topic>diabetes</topic><topic>dipeptidyl peptidase‐4 (DPP‐4) inhibitor</topic><topic>FDA approval</topic><topic>Heart attacks</topic><topic>Heart failure</topic><topic>Hospitalization</topic><topic>Meta-analysis</topic><topic>Patients</topic><topic>Population</topic><topic>Stroke</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Scirica, Benjamin M.</creatorcontrib><creatorcontrib>Im, KyungAh</creatorcontrib><creatorcontrib>Murphy, Sabina A.</creatorcontrib><creatorcontrib>Kuder, Julia F.</creatorcontrib><creatorcontrib>Rodriguez, Dolly A.</creatorcontrib><creatorcontrib>Lopes, Renato D.</creatorcontrib><creatorcontrib>Green, Jennifer B.</creatorcontrib><creatorcontrib>Ruff, Christian T.</creatorcontrib><creatorcontrib>Sabatine, Marc S.</creatorcontrib><collection>Wiley Online Library Open Access</collection><collection>Wiley Online Library (Open Access Collection)</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</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 Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Access via ProQuest (Open Access)</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>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Clinical cardiology (Mahwah, N.J.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Scirica, Benjamin M.</au><au>Im, KyungAh</au><au>Murphy, Sabina A.</au><au>Kuder, Julia F.</au><au>Rodriguez, Dolly A.</au><au>Lopes, Renato D.</au><au>Green, Jennifer B.</au><au>Ruff, Christian T.</au><au>Sabatine, Marc S.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Re‐adjudication of the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) with study‐level meta‐analysis of hospitalization for heart failure from cardiovascular outcomes trials with dipeptidyl peptidase‐4 (DPP‐4) inhibitors</atitle><jtitle>Clinical cardiology (Mahwah, N.J.)</jtitle><date>2022-07</date><risdate>2022</risdate><volume>45</volume><issue>7</issue><spage>794</spage><epage>801</epage><pages>794-801</pages><issn>0160-9289</issn><eissn>1932-8737</eissn><abstract>Background
Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) assessed the cardiovascular (CV) safety of sitagliptin versus placebo on CV outcomes in patients with type 2 diabetes and CV disease and found sitagliptin noninferior to placebo. Subsequently, based on feedback from FDA, the Sponsor of the trial, Merck & Co., Inc., engaged a separate academic research organization, the TIMI Study Group, to re‐adjudicate a prespecified set of originally adjudicated events.
Methods
TIMI adjudicated in a blinded fashion all potential hospitalization for heart failure (HHF) events, all potential MACE+ events previously adjudicated as not an endpoint event, and a random subset (~10%) of MACE+ events previously adjudicated as an endpoint event. An updated study‐level meta‐analysis of four randomized, placebo‐controlled, CV outcomes trials with dipeptidyl peptidase 4 (DPP‐4) inhibitors was then performed.
Results
After re‐adjudication of potential HHF events in the intent‐to‐treat population, there were 224 patients with a confirmed event in the sitagliptin arm (1.05/100 person‐years) and 239 patients in the placebo arm (1.13/100 person‐years), corresponding to a hazard ratio (HR) of 0.94 (95% confidence interval [95% CI]: 0.78–1.13, p = .49). Concordance between the outcome of the original adjudication and the re‐adjudication for HHF events was 82.7%. The meta‐analysis of CV outcomes trials with DPP‐4 inhibitors with placebo and involving 43 522 patients yielded an HR of 1.07 (95% CI: 0.83–1.39), with moderate heterogeneity (p = .45, I2 = 62.07%).
Conclusion
The results of this independent re‐adjudication process and analyses of CV outcomes from TECOS were consistent with the original adjudication results and overall study findings. An updated study‐level meta‐analysis showed no overall significant risk for HHF with DPP‐4 inhibitors, but with statistical heterogeneity.</abstract><cop>Hoboken</cop><pub>John Wiley & Sons, Inc</pub><pmid>35715946</pmid><doi>10.1002/clc.23844</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0002-7093-7048</orcidid><oa>free_for_read</oa></addata></record> |
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| source | DOAJ Directory of Open Access Journals; Access via Wiley Online Library; Wiley Online Library Open Access; EZB-FREE-00999 freely available EZB journals; PubMed Central |
| subjects | Angina pectoris Clinical Investigations diabetes dipeptidyl peptidase‐4 (DPP‐4) inhibitor FDA approval Heart attacks Heart failure Hospitalization Meta-analysis Patients Population Stroke |
| title | Re‐adjudication of the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) with study‐level meta‐analysis of hospitalization for heart failure from cardiovascular outcomes trials with dipeptidyl peptidase‐4 (DPP‐4) inhibitors |
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