Belatacept-Based Regimens Are Associated With Improved Cardiovascular and Metabolic Risk Factors Compared With Cyclosporine in Kidney Transplant Recipients (BENEFIT and BENEFIT-EXT Studies)
Cardiovascular disease, the most common cause of death with a functioning graft among kidney transplant recipients, can be exacerbated by immunosuppressive drugs, particularly the calcineurin inhibitors. Belatacept, a selective co-stimulation blocker, may provide a better cardiovascular/metabolic ri...
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| Veröffentlicht in: | Transplantation 2011-05, Vol.91 (9), p.976-983 |
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| creator | VANRENTERGHEM, Yves BRESNAHAN, Barbara BLOCK, Alan TAO DUAN GLICKLICH, Alan GUJRATHI, Sheila VINCENTI, Flavio CAMPISTOL, Josep DURRBACH, Antoine GRINYO, Josep NEUMAYER, Hans-Hellmut LANG, Philippe LARSEN, Christian P MANCILLA-URREA, Eduardo MEDINA PESTANA, José |
| description | Cardiovascular disease, the most common cause of death with a functioning graft among kidney transplant recipients, can be exacerbated by immunosuppressive drugs, particularly the calcineurin inhibitors. Belatacept, a selective co-stimulation blocker, may provide a better cardiovascular/metabolic risk profile than current immunosuppressants.
Cardiovascular and metabolic endpoints from two Phase III studies (BENEFIT and BENEFIT-EXT) of belatacept-based regimens in kidney transplant recipients were assessed at month 12. Each study assessed belatacept in more intensive (MI) and less intensive (LI) regimens versus cyclosporine A (CsA). These secondary endpoints included changes in blood pressure, changes in serum lipids, and the incidence of new-onset diabetes after transplant (NODAT).
A total of 1209 patients were randomized and transplanted across the two studies. Mean systolic blood pressure was 6 to 9 mm Hg lower and mean diastolic blood pressure was 3 to 4 mm Hg lower in the MI and LI groups versus CsA (P ≤ 0.002) across both studies at month 12. Non-HDL cholesterol was lower in the belatacept groups versus CsA (P |
| doi_str_mv | 10.1097/TP.0b013e31820c10eb |
| format | Article |
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Cardiovascular and metabolic endpoints from two Phase III studies (BENEFIT and BENEFIT-EXT) of belatacept-based regimens in kidney transplant recipients were assessed at month 12. Each study assessed belatacept in more intensive (MI) and less intensive (LI) regimens versus cyclosporine A (CsA). These secondary endpoints included changes in blood pressure, changes in serum lipids, and the incidence of new-onset diabetes after transplant (NODAT).
A total of 1209 patients were randomized and transplanted across the two studies. Mean systolic blood pressure was 6 to 9 mm Hg lower and mean diastolic blood pressure was 3 to 4 mm Hg lower in the MI and LI groups versus CsA (P ≤ 0.002) across both studies at month 12. Non-HDL cholesterol was lower in the belatacept groups versus CsA (P<0.01 MI or LI vs. CsA in each study). Serum triglycerides were lower in the belatacept groups versus CsA (P<0.02 MI or LI vs. CsA in each study). NODAT occurred less often in the belatacept groups versus CsA in a prespecified pooled analysis (P<0.05 MI or LI vs. CsA).
At month 12, belatacept regimens were associated with better cardiovascular and metabolic risk profiles, with lower blood pressure and serum lipids and less NODAT versus CsA. The overall profile of belatacept will continue to be assessed over the 3-year trials.</description><identifier>ISSN: 0041-1337</identifier><identifier>EISSN: 1534-6080</identifier><identifier>DOI: 10.1097/TP.0b013e31820c10eb</identifier><identifier>PMID: 21372756</identifier><identifier>CODEN: TRPLAU</identifier><language>eng</language><publisher>Hagerstown, MD: Lippincott Williams & Wilkins</publisher><subject>Abatacept ; Adult ; Aged ; Atherosclerosis (general aspects, experimental research) ; Biological and medical sciences ; Blood and lymphatic vessels ; Blood Glucose - metabolism ; Blood pressure ; Blood Pressure - drug effects ; calcineurin inhibitors ; Cardiology. Vascular system ; Cardiovascular diseases ; Cardiovascular Diseases - etiology ; Cardiovascular Diseases - physiopathology ; Cardiovascular Diseases - prevention & control ; Cholesterol ; Clinical trials ; Cyclosporine - adverse effects ; Cyclosporine - therapeutic use ; Cyclosporins ; Diabetes mellitus ; Diabetes Mellitus - blood ; Diabetes Mellitus - etiology ; Diabetes Mellitus - prevention & control ; Drugs ; Female ; Fundamental and applied biological sciences. Psychology ; Fundamental immunology ; Humans ; Immunoconjugates - adverse effects ; Immunoconjugates - therapeutic use ; Immunosuppressive agents ; Immunosuppressive Agents - adverse effects ; Immunosuppressive Agents - therapeutic use ; Kidney transplantation ; Kidney Transplantation - adverse effects ; Lipids ; Lipids - blood ; Male ; Medical sciences ; Middle Aged ; Mortality ; Risk Factors ; Serum lipids ; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases ; Tissue, organ and graft immunology ; Triglycerides</subject><ispartof>Transplantation, 2011-05, Vol.91 (9), p.976-983</ispartof><rights>2015 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c412t-95f5fb5f1f39463ce9a9b82fb79d3f9e13f86cdce738c8ab732e50a237f5d7f33</citedby><cites>FETCH-LOGICAL-c412t-95f5fb5f1f39463ce9a9b82fb79d3f9e13f86cdce738c8ab732e50a237f5d7f33</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=24158334$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21372756$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>VANRENTERGHEM, Yves</creatorcontrib><creatorcontrib>BRESNAHAN, Barbara</creatorcontrib><creatorcontrib>BLOCK, Alan</creatorcontrib><creatorcontrib>TAO DUAN</creatorcontrib><creatorcontrib>GLICKLICH, Alan</creatorcontrib><creatorcontrib>GUJRATHI, Sheila</creatorcontrib><creatorcontrib>VINCENTI, Flavio</creatorcontrib><creatorcontrib>CAMPISTOL, Josep</creatorcontrib><creatorcontrib>DURRBACH, Antoine</creatorcontrib><creatorcontrib>GRINYO, Josep</creatorcontrib><creatorcontrib>NEUMAYER, Hans-Hellmut</creatorcontrib><creatorcontrib>LANG, Philippe</creatorcontrib><creatorcontrib>LARSEN, Christian P</creatorcontrib><creatorcontrib>MANCILLA-URREA, Eduardo</creatorcontrib><creatorcontrib>MEDINA PESTANA, José</creatorcontrib><title>Belatacept-Based Regimens Are Associated With Improved Cardiovascular and Metabolic Risk Factors Compared With Cyclosporine in Kidney Transplant Recipients (BENEFIT and BENEFIT-EXT Studies)</title><title>Transplantation</title><addtitle>Transplantation</addtitle><description>Cardiovascular disease, the most common cause of death with a functioning graft among kidney transplant recipients, can be exacerbated by immunosuppressive drugs, particularly the calcineurin inhibitors. Belatacept, a selective co-stimulation blocker, may provide a better cardiovascular/metabolic risk profile than current immunosuppressants.
Cardiovascular and metabolic endpoints from two Phase III studies (BENEFIT and BENEFIT-EXT) of belatacept-based regimens in kidney transplant recipients were assessed at month 12. Each study assessed belatacept in more intensive (MI) and less intensive (LI) regimens versus cyclosporine A (CsA). These secondary endpoints included changes in blood pressure, changes in serum lipids, and the incidence of new-onset diabetes after transplant (NODAT).
A total of 1209 patients were randomized and transplanted across the two studies. Mean systolic blood pressure was 6 to 9 mm Hg lower and mean diastolic blood pressure was 3 to 4 mm Hg lower in the MI and LI groups versus CsA (P ≤ 0.002) across both studies at month 12. Non-HDL cholesterol was lower in the belatacept groups versus CsA (P<0.01 MI or LI vs. CsA in each study). Serum triglycerides were lower in the belatacept groups versus CsA (P<0.02 MI or LI vs. CsA in each study). NODAT occurred less often in the belatacept groups versus CsA in a prespecified pooled analysis (P<0.05 MI or LI vs. CsA).
At month 12, belatacept regimens were associated with better cardiovascular and metabolic risk profiles, with lower blood pressure and serum lipids and less NODAT versus CsA. The overall profile of belatacept will continue to be assessed over the 3-year trials.</description><subject>Abatacept</subject><subject>Adult</subject><subject>Aged</subject><subject>Atherosclerosis (general aspects, experimental research)</subject><subject>Biological and medical sciences</subject><subject>Blood and lymphatic vessels</subject><subject>Blood Glucose - metabolism</subject><subject>Blood pressure</subject><subject>Blood Pressure - drug effects</subject><subject>calcineurin inhibitors</subject><subject>Cardiology. Vascular system</subject><subject>Cardiovascular diseases</subject><subject>Cardiovascular Diseases - etiology</subject><subject>Cardiovascular Diseases - physiopathology</subject><subject>Cardiovascular Diseases - prevention & control</subject><subject>Cholesterol</subject><subject>Clinical trials</subject><subject>Cyclosporine - adverse effects</subject><subject>Cyclosporine - therapeutic use</subject><subject>Cyclosporins</subject><subject>Diabetes mellitus</subject><subject>Diabetes Mellitus - blood</subject><subject>Diabetes Mellitus - etiology</subject><subject>Diabetes Mellitus - prevention & control</subject><subject>Drugs</subject><subject>Female</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>Fundamental immunology</subject><subject>Humans</subject><subject>Immunoconjugates - adverse effects</subject><subject>Immunoconjugates - therapeutic use</subject><subject>Immunosuppressive agents</subject><subject>Immunosuppressive Agents - adverse effects</subject><subject>Immunosuppressive Agents - therapeutic use</subject><subject>Kidney transplantation</subject><subject>Kidney Transplantation - adverse effects</subject><subject>Lipids</subject><subject>Lipids - blood</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Mortality</subject><subject>Risk Factors</subject><subject>Serum lipids</subject><subject>Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases</subject><subject>Tissue, organ and graft immunology</subject><subject>Triglycerides</subject><issn>0041-1337</issn><issn>1534-6080</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kc9u1DAQxi0EokvhCZCQL4hySLEz8do57ka7sKJAVYLgFjnOGAz5h-2ttA_Hu2HoFiQOnDy2fvN94_kIeczZOWelfFFfnrOWcUDgKmeGM2zvkAUXUGRLpthdsmCs4BkHkCfkQQhfGWMCpLxPTnIOMpdiuSA_1tjrqA3OMVvrgB29ws9uwDHQlUe6CmEyTsf0_tHFL3Q3zH66TrdK-85N1zqYfa891WNH32DU7dQ7Q69c-Ea32sTJB1pNw6z9rUB1MP0U5sm7Eakb6WvXjXigtddjmHs9xuRv3OxwjIGerTdvN9td_Vv-WGebTzV9H_edw_D8IblndR_w0fE8JR-2m7p6lV28e7mrVheZKXges1JYYVthuYWyWILBUpetym0ryw5siRysWprOoARllG4l5CiYzkFa0UkLcEqe3eim33_fY4jN4ILBPg2M0z40SnLGcsl5Is_-SyZOqUKCYAmFG9T4KQSPtpm9G7Q_JKj5lXBTXzb_Jpy6nhwN9u2A3Z-e20gT8PQIpHB0b9NmjQt_uYILBVDAT6a0sTE</recordid><startdate>20110515</startdate><enddate>20110515</enddate><creator>VANRENTERGHEM, Yves</creator><creator>BRESNAHAN, Barbara</creator><creator>BLOCK, Alan</creator><creator>TAO DUAN</creator><creator>GLICKLICH, Alan</creator><creator>GUJRATHI, Sheila</creator><creator>VINCENTI, Flavio</creator><creator>CAMPISTOL, Josep</creator><creator>DURRBACH, Antoine</creator><creator>GRINYO, Josep</creator><creator>NEUMAYER, Hans-Hellmut</creator><creator>LANG, Philippe</creator><creator>LARSEN, Christian P</creator><creator>MANCILLA-URREA, Eduardo</creator><creator>MEDINA PESTANA, José</creator><general>Lippincott Williams & Wilkins</general><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>7T5</scope><scope>7U1</scope><scope>7U2</scope><scope>C1K</scope><scope>H94</scope><scope>7X8</scope></search><sort><creationdate>20110515</creationdate><title>Belatacept-Based Regimens Are Associated With Improved Cardiovascular and Metabolic Risk Factors Compared With Cyclosporine in Kidney Transplant Recipients (BENEFIT and BENEFIT-EXT Studies)</title><author>VANRENTERGHEM, Yves ; BRESNAHAN, Barbara ; BLOCK, Alan ; TAO DUAN ; GLICKLICH, Alan ; GUJRATHI, Sheila ; VINCENTI, Flavio ; CAMPISTOL, Josep ; DURRBACH, Antoine ; GRINYO, Josep ; NEUMAYER, Hans-Hellmut ; LANG, Philippe ; LARSEN, Christian P ; MANCILLA-URREA, Eduardo ; MEDINA PESTANA, José</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c412t-95f5fb5f1f39463ce9a9b82fb79d3f9e13f86cdce738c8ab732e50a237f5d7f33</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Abatacept</topic><topic>Adult</topic><topic>Aged</topic><topic>Atherosclerosis (general aspects, experimental research)</topic><topic>Biological and medical sciences</topic><topic>Blood and lymphatic vessels</topic><topic>Blood Glucose - metabolism</topic><topic>Blood pressure</topic><topic>Blood Pressure - drug effects</topic><topic>calcineurin inhibitors</topic><topic>Cardiology. Vascular system</topic><topic>Cardiovascular diseases</topic><topic>Cardiovascular Diseases - etiology</topic><topic>Cardiovascular Diseases - physiopathology</topic><topic>Cardiovascular Diseases - prevention & control</topic><topic>Cholesterol</topic><topic>Clinical trials</topic><topic>Cyclosporine - adverse effects</topic><topic>Cyclosporine - therapeutic use</topic><topic>Cyclosporins</topic><topic>Diabetes mellitus</topic><topic>Diabetes Mellitus - blood</topic><topic>Diabetes Mellitus - etiology</topic><topic>Diabetes Mellitus - prevention & control</topic><topic>Drugs</topic><topic>Female</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>Fundamental immunology</topic><topic>Humans</topic><topic>Immunoconjugates - adverse effects</topic><topic>Immunoconjugates - therapeutic use</topic><topic>Immunosuppressive agents</topic><topic>Immunosuppressive Agents - adverse effects</topic><topic>Immunosuppressive Agents - therapeutic use</topic><topic>Kidney transplantation</topic><topic>Kidney Transplantation - adverse effects</topic><topic>Lipids</topic><topic>Lipids - blood</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Mortality</topic><topic>Risk Factors</topic><topic>Serum lipids</topic><topic>Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases</topic><topic>Tissue, organ and graft immunology</topic><topic>Triglycerides</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>VANRENTERGHEM, Yves</creatorcontrib><creatorcontrib>BRESNAHAN, Barbara</creatorcontrib><creatorcontrib>BLOCK, Alan</creatorcontrib><creatorcontrib>TAO DUAN</creatorcontrib><creatorcontrib>GLICKLICH, Alan</creatorcontrib><creatorcontrib>GUJRATHI, Sheila</creatorcontrib><creatorcontrib>VINCENTI, Flavio</creatorcontrib><creatorcontrib>CAMPISTOL, Josep</creatorcontrib><creatorcontrib>DURRBACH, Antoine</creatorcontrib><creatorcontrib>GRINYO, Josep</creatorcontrib><creatorcontrib>NEUMAYER, Hans-Hellmut</creatorcontrib><creatorcontrib>LANG, Philippe</creatorcontrib><creatorcontrib>LARSEN, Christian P</creatorcontrib><creatorcontrib>MANCILLA-URREA, Eduardo</creatorcontrib><creatorcontrib>MEDINA PESTANA, José</creatorcontrib><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>Immunology Abstracts</collection><collection>Risk Abstracts</collection><collection>Safety Science and Risk</collection><collection>Environmental Sciences and Pollution Management</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Transplantation</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>VANRENTERGHEM, Yves</au><au>BRESNAHAN, Barbara</au><au>BLOCK, Alan</au><au>TAO DUAN</au><au>GLICKLICH, Alan</au><au>GUJRATHI, Sheila</au><au>VINCENTI, Flavio</au><au>CAMPISTOL, Josep</au><au>DURRBACH, Antoine</au><au>GRINYO, Josep</au><au>NEUMAYER, Hans-Hellmut</au><au>LANG, Philippe</au><au>LARSEN, Christian P</au><au>MANCILLA-URREA, Eduardo</au><au>MEDINA PESTANA, José</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Belatacept-Based Regimens Are Associated With Improved Cardiovascular and Metabolic Risk Factors Compared With Cyclosporine in Kidney Transplant Recipients (BENEFIT and BENEFIT-EXT Studies)</atitle><jtitle>Transplantation</jtitle><addtitle>Transplantation</addtitle><date>2011-05-15</date><risdate>2011</risdate><volume>91</volume><issue>9</issue><spage>976</spage><epage>983</epage><pages>976-983</pages><issn>0041-1337</issn><eissn>1534-6080</eissn><coden>TRPLAU</coden><abstract>Cardiovascular disease, the most common cause of death with a functioning graft among kidney transplant recipients, can be exacerbated by immunosuppressive drugs, particularly the calcineurin inhibitors. Belatacept, a selective co-stimulation blocker, may provide a better cardiovascular/metabolic risk profile than current immunosuppressants.
Cardiovascular and metabolic endpoints from two Phase III studies (BENEFIT and BENEFIT-EXT) of belatacept-based regimens in kidney transplant recipients were assessed at month 12. Each study assessed belatacept in more intensive (MI) and less intensive (LI) regimens versus cyclosporine A (CsA). These secondary endpoints included changes in blood pressure, changes in serum lipids, and the incidence of new-onset diabetes after transplant (NODAT).
A total of 1209 patients were randomized and transplanted across the two studies. Mean systolic blood pressure was 6 to 9 mm Hg lower and mean diastolic blood pressure was 3 to 4 mm Hg lower in the MI and LI groups versus CsA (P ≤ 0.002) across both studies at month 12. Non-HDL cholesterol was lower in the belatacept groups versus CsA (P<0.01 MI or LI vs. CsA in each study). Serum triglycerides were lower in the belatacept groups versus CsA (P<0.02 MI or LI vs. CsA in each study). NODAT occurred less often in the belatacept groups versus CsA in a prespecified pooled analysis (P<0.05 MI or LI vs. CsA).
At month 12, belatacept regimens were associated with better cardiovascular and metabolic risk profiles, with lower blood pressure and serum lipids and less NODAT versus CsA. The overall profile of belatacept will continue to be assessed over the 3-year trials.</abstract><cop>Hagerstown, MD</cop><pub>Lippincott Williams & Wilkins</pub><pmid>21372756</pmid><doi>10.1097/TP.0b013e31820c10eb</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Transplantation, 2011-05, Vol.91 (9), p.976-983 |
| issn | 0041-1337 1534-6080 |
| language | eng |
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| source | MEDLINE; Journals@Ovid Complete |
| subjects | Abatacept Adult Aged Atherosclerosis (general aspects, experimental research) Biological and medical sciences Blood and lymphatic vessels Blood Glucose - metabolism Blood pressure Blood Pressure - drug effects calcineurin inhibitors Cardiology. Vascular system Cardiovascular diseases Cardiovascular Diseases - etiology Cardiovascular Diseases - physiopathology Cardiovascular Diseases - prevention & control Cholesterol Clinical trials Cyclosporine - adverse effects Cyclosporine - therapeutic use Cyclosporins Diabetes mellitus Diabetes Mellitus - blood Diabetes Mellitus - etiology Diabetes Mellitus - prevention & control Drugs Female Fundamental and applied biological sciences. Psychology Fundamental immunology Humans Immunoconjugates - adverse effects Immunoconjugates - therapeutic use Immunosuppressive agents Immunosuppressive Agents - adverse effects Immunosuppressive Agents - therapeutic use Kidney transplantation Kidney Transplantation - adverse effects Lipids Lipids - blood Male Medical sciences Middle Aged Mortality Risk Factors Serum lipids Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases Tissue, organ and graft immunology Triglycerides |
| title | Belatacept-Based Regimens Are Associated With Improved Cardiovascular and Metabolic Risk Factors Compared With Cyclosporine in Kidney Transplant Recipients (BENEFIT and BENEFIT-EXT Studies) |
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