Reduced Incidence of Cytomegalovirus Infection in Kidney Transplant Recipients Receiving Everolimus and Reduced Tacrolimus Doses
This study compared the incidence of CMV infection/disease in de novo kidney transplant recipients receiving everolimus or mycophenolate and no CMV pharmacological prophylaxis. We randomized 288 patients to receive a single 3 mg/kg dose of antithymocyte globulin, tacrolimus, everolimus, and predniso...
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| creator | Tedesco‐ Silva, H. Felipe, C. Ferreira, A. Cristelli, M. Oliveira, N. Sandes‐Freitas, T. Aguiar, W. Campos, E. Gerbase‐DeLima, M. Franco, M. Medina‐Pestana, J. |
| description | This study compared the incidence of CMV infection/disease in de novo kidney transplant recipients receiving everolimus or mycophenolate and no CMV pharmacological prophylaxis. We randomized 288 patients to receive a single 3 mg/kg dose of antithymocyte globulin, tacrolimus, everolimus, and prednisone (r‐ATG/EVR, n = 85); basiliximab, tacrolimus, everolimus, and prednisone (BAS/EVR, n = 102); or basiliximab, tacrolimus, mycophenolate, and prednisone (BAS/MPS, n = 101). The primary end‐point was the incidence of first CMV infection/disease in the intention‐to‐treat population at 12 months. Patients treated with r‐ATG/EVR showed a 90% proportional reduction (4.7% vs. 37.6%, HR 0.10, 95% CI 0.037–0.29; p |
| doi_str_mv | 10.1111/ajt.13327 |
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This study shows that in de novo kidney transplant recipients receiving no CMV pharmacological prophylaxis, the use of everolimus and low‐dose tacrolimus is associated with lower incidence of CMV infection/disease compared to a standard tacrolimus and mycophenolate combination.</description><identifier>ISSN: 1600-6135</identifier><identifier>EISSN: 1600-6143</identifier><identifier>DOI: 10.1111/ajt.13327</identifier><identifier>PMID: 25988935</identifier><language>eng</language><publisher>United States: Elsevier Limited</publisher><subject><![CDATA[Adult ; Antibodies, Monoclonal - therapeutic use ; Antilymphocyte serum ; Antilymphocyte Serum - therapeutic use ; Basiliximab ; Cytomegalovirus ; Cytomegalovirus Infections - epidemiology ; Cytomegalovirus Infections - immunology ; Cytomegalovirus Infections - prevention & control ; Dose-Response Relationship, Drug ; Drug Therapy, Combination ; Everolimus - administration & dosage ; Everolimus - therapeutic use ; Female ; Globulins ; Glomerular filtration rate ; Graft rejection ; Graft Rejection - prevention & control ; Humans ; Immune modulation ; immunosuppression ; Immunosuppressive Agents - administration & dosage ; Immunosuppressive Agents - therapeutic use ; Incidence ; Infections ; Inhibitor drugs ; Kidney Transplantation ; Kidney transplants ; Male ; Middle Aged ; Monoclonal antibodies ; Motivation ; Mycophenolic acid ; Mycophenolic Acid - therapeutic use ; nephrology ; Postoperative Complications - epidemiology ; Postoperative Complications - immunology ; Postoperative Complications - prevention & control ; Prednisone ; Prednisone - therapeutic use ; Prophylaxis ; Prospective Studies ; Proteinuria ; Recombinant Fusion Proteins - therapeutic use ; Sirolimus - therapeutic use ; Tacrolimus ; Tacrolimus - administration & dosage ; Tacrolimus - therapeutic use ; Thymocytes ; Treatment Outcome ; Wound healing]]></subject><ispartof>American journal of transplantation, 2015-10, Vol.15 (10), p.2655-2664</ispartof><rights>Copyright 2015 The American Society of Transplantation and the American Society of Transplant Surgeons</rights><rights>Copyright 2015 The American Society of Transplantation and the American Society of Transplant Surgeons.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4867-f0354f4211a5ab8195b7f50ec7792254ef9533fe0c386930aa16b5a417c6b17f3</citedby><cites>FETCH-LOGICAL-c4867-f0354f4211a5ab8195b7f50ec7792254ef9533fe0c386930aa16b5a417c6b17f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fajt.13327$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fajt.13327$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27903,27904,45553,45554</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25988935$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Tedesco‐ Silva, H.</creatorcontrib><creatorcontrib>Felipe, C.</creatorcontrib><creatorcontrib>Ferreira, A.</creatorcontrib><creatorcontrib>Cristelli, M.</creatorcontrib><creatorcontrib>Oliveira, N.</creatorcontrib><creatorcontrib>Sandes‐Freitas, T.</creatorcontrib><creatorcontrib>Aguiar, W.</creatorcontrib><creatorcontrib>Campos, E.</creatorcontrib><creatorcontrib>Gerbase‐DeLima, M.</creatorcontrib><creatorcontrib>Franco, M.</creatorcontrib><creatorcontrib>Medina‐Pestana, J.</creatorcontrib><title>Reduced Incidence of Cytomegalovirus Infection in Kidney Transplant Recipients Receiving Everolimus and Reduced Tacrolimus Doses</title><title>American journal of transplantation</title><addtitle>Am J Transplant</addtitle><description>This study compared the incidence of CMV infection/disease in de novo kidney transplant recipients receiving everolimus or mycophenolate and no CMV pharmacological prophylaxis. We randomized 288 patients to receive a single 3 mg/kg dose of antithymocyte globulin, tacrolimus, everolimus, and prednisone (r‐ATG/EVR, n = 85); basiliximab, tacrolimus, everolimus, and prednisone (BAS/EVR, n = 102); or basiliximab, tacrolimus, mycophenolate, and prednisone (BAS/MPS, n = 101). The primary end‐point was the incidence of first CMV infection/disease in the intention‐to‐treat population at 12 months. Patients treated with r‐ATG/EVR showed a 90% proportional reduction (4.7% vs. 37.6%, HR 0.10, 95% CI 0.037–0.29; p < 0.001), while those treated with BAS/EVR showed a 75% proportional reduction (10.8% vs. 37.6%, HR 0.25, 95% CI 0.13–0.48; p < 0.001) in the incidence of CMV infection/disease compared to BAS/MPS. There were no differences in the incidence of acute rejection (9.4 vs. 18.6 vs. 15.8%, p = 0.403), wound‐healing complications, delayed graft function, and proteinuria. Mean estimated glomerular filtration rate was lower in BAS/EVR (65.7 ± 21.8 vs. 60.6 ± 20.9 vs. 69.5 ± 21.5 ml/min, p = 0.021). In de novo kidney transplant recipients receiving no pharmacological CMV prophylaxis, reduced‐dose tacrolimus and everolimus was associated with a significant reduction in the incidence of CMV infection/disease compared to standard tacrolimus dose and mycophenolate (ClinicalTrials.gov NCT01354301).
This study shows that in de novo kidney transplant recipients receiving no CMV pharmacological prophylaxis, the use of everolimus and low‐dose tacrolimus is associated with lower incidence of CMV infection/disease compared to a standard tacrolimus and mycophenolate combination.</description><subject>Adult</subject><subject>Antibodies, Monoclonal - therapeutic use</subject><subject>Antilymphocyte serum</subject><subject>Antilymphocyte Serum - therapeutic use</subject><subject>Basiliximab</subject><subject>Cytomegalovirus</subject><subject>Cytomegalovirus Infections - epidemiology</subject><subject>Cytomegalovirus Infections - immunology</subject><subject>Cytomegalovirus Infections - prevention & control</subject><subject>Dose-Response Relationship, Drug</subject><subject>Drug Therapy, Combination</subject><subject>Everolimus - administration & dosage</subject><subject>Everolimus - therapeutic use</subject><subject>Female</subject><subject>Globulins</subject><subject>Glomerular filtration rate</subject><subject>Graft rejection</subject><subject>Graft Rejection - prevention & control</subject><subject>Humans</subject><subject>Immune modulation</subject><subject>immunosuppression</subject><subject>Immunosuppressive Agents - administration & dosage</subject><subject>Immunosuppressive Agents - therapeutic use</subject><subject>Incidence</subject><subject>Infections</subject><subject>Inhibitor drugs</subject><subject>Kidney Transplantation</subject><subject>Kidney transplants</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Monoclonal antibodies</subject><subject>Motivation</subject><subject>Mycophenolic acid</subject><subject>Mycophenolic Acid - therapeutic use</subject><subject>nephrology</subject><subject>Postoperative Complications - epidemiology</subject><subject>Postoperative Complications - immunology</subject><subject>Postoperative Complications - prevention & control</subject><subject>Prednisone</subject><subject>Prednisone - therapeutic use</subject><subject>Prophylaxis</subject><subject>Prospective Studies</subject><subject>Proteinuria</subject><subject>Recombinant Fusion Proteins - therapeutic use</subject><subject>Sirolimus - therapeutic use</subject><subject>Tacrolimus</subject><subject>Tacrolimus - administration & dosage</subject><subject>Tacrolimus - therapeutic use</subject><subject>Thymocytes</subject><subject>Treatment Outcome</subject><subject>Wound healing</subject><issn>1600-6135</issn><issn>1600-6143</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kUtLAzEUhYMoWh8L_4AEXLmo5jFJJstS6xsEqeshk7mRlGmmTmYq3fnTTa11p9nkcPPlHC4HoVNKLmk6V2bWXVLOmdpBAyoJGUqa8d1fzcUBOoxxRghVLGf76IAJneeaiwH6fIGqt1Dh-2B9BcECbhwer7pmDm-mbpa-7WN6dGA73wTsA370VYAVnrYmxEVtQodfwPqFh9DFtQS_9OENT5bQNrWfp-8mVHibMzV2O75uIsRjtOdMHeHk5z5CrzeT6fhu-PR8ez8ePQ1tlks1dISLzGWMUiNMmVMtSuUEAauUZkxk4LTg3AGxPJeaE2OoLIXJqLKypMrxI3S-8V20zXsPsStmTd-GFFkwInXGMq3z_yiqKJdKprBEXWyotEqMLbhi0fq5aVcFJcW6kSI1Unw3ktizH8e-nEP1S24rSMDVBvjwNaz-dipGD9ON5RekN5VE</recordid><startdate>201510</startdate><enddate>201510</enddate><creator>Tedesco‐ Silva, H.</creator><creator>Felipe, C.</creator><creator>Ferreira, A.</creator><creator>Cristelli, M.</creator><creator>Oliveira, N.</creator><creator>Sandes‐Freitas, T.</creator><creator>Aguiar, W.</creator><creator>Campos, E.</creator><creator>Gerbase‐DeLima, M.</creator><creator>Franco, M.</creator><creator>Medina‐Pestana, J.</creator><general>Elsevier Limited</general><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>7QP</scope><scope>7T5</scope><scope>7U9</scope><scope>H94</scope><scope>K9.</scope></search><sort><creationdate>201510</creationdate><title>Reduced Incidence of Cytomegalovirus Infection in Kidney Transplant Recipients Receiving Everolimus and Reduced Tacrolimus Doses</title><author>Tedesco‐ Silva, H. ; Felipe, C. ; Ferreira, A. ; Cristelli, M. ; Oliveira, N. ; Sandes‐Freitas, T. ; Aguiar, W. ; Campos, E. ; Gerbase‐DeLima, M. ; Franco, M. ; Medina‐Pestana, J.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4867-f0354f4211a5ab8195b7f50ec7792254ef9533fe0c386930aa16b5a417c6b17f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Adult</topic><topic>Antibodies, Monoclonal - therapeutic use</topic><topic>Antilymphocyte serum</topic><topic>Antilymphocyte Serum - therapeutic use</topic><topic>Basiliximab</topic><topic>Cytomegalovirus</topic><topic>Cytomegalovirus Infections - epidemiology</topic><topic>Cytomegalovirus Infections - immunology</topic><topic>Cytomegalovirus Infections - prevention & control</topic><topic>Dose-Response Relationship, Drug</topic><topic>Drug Therapy, Combination</topic><topic>Everolimus - administration & dosage</topic><topic>Everolimus - therapeutic use</topic><topic>Female</topic><topic>Globulins</topic><topic>Glomerular filtration rate</topic><topic>Graft rejection</topic><topic>Graft Rejection - prevention & control</topic><topic>Humans</topic><topic>Immune modulation</topic><topic>immunosuppression</topic><topic>Immunosuppressive Agents - administration & dosage</topic><topic>Immunosuppressive Agents - therapeutic use</topic><topic>Incidence</topic><topic>Infections</topic><topic>Inhibitor drugs</topic><topic>Kidney Transplantation</topic><topic>Kidney transplants</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Monoclonal antibodies</topic><topic>Motivation</topic><topic>Mycophenolic acid</topic><topic>Mycophenolic Acid - therapeutic use</topic><topic>nephrology</topic><topic>Postoperative Complications - epidemiology</topic><topic>Postoperative Complications - immunology</topic><topic>Postoperative Complications - prevention & control</topic><topic>Prednisone</topic><topic>Prednisone - therapeutic use</topic><topic>Prophylaxis</topic><topic>Prospective Studies</topic><topic>Proteinuria</topic><topic>Recombinant Fusion Proteins - therapeutic use</topic><topic>Sirolimus - therapeutic use</topic><topic>Tacrolimus</topic><topic>Tacrolimus - administration & dosage</topic><topic>Tacrolimus - therapeutic use</topic><topic>Thymocytes</topic><topic>Treatment Outcome</topic><topic>Wound healing</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Tedesco‐ Silva, H.</creatorcontrib><creatorcontrib>Felipe, C.</creatorcontrib><creatorcontrib>Ferreira, A.</creatorcontrib><creatorcontrib>Cristelli, M.</creatorcontrib><creatorcontrib>Oliveira, N.</creatorcontrib><creatorcontrib>Sandes‐Freitas, T.</creatorcontrib><creatorcontrib>Aguiar, W.</creatorcontrib><creatorcontrib>Campos, E.</creatorcontrib><creatorcontrib>Gerbase‐DeLima, M.</creatorcontrib><creatorcontrib>Franco, M.</creatorcontrib><creatorcontrib>Medina‐Pestana, J.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Immunology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><jtitle>American journal of transplantation</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Tedesco‐ Silva, H.</au><au>Felipe, C.</au><au>Ferreira, A.</au><au>Cristelli, M.</au><au>Oliveira, N.</au><au>Sandes‐Freitas, T.</au><au>Aguiar, W.</au><au>Campos, E.</au><au>Gerbase‐DeLima, M.</au><au>Franco, M.</au><au>Medina‐Pestana, J.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Reduced Incidence of Cytomegalovirus Infection in Kidney Transplant Recipients Receiving Everolimus and Reduced Tacrolimus Doses</atitle><jtitle>American journal of transplantation</jtitle><addtitle>Am J Transplant</addtitle><date>2015-10</date><risdate>2015</risdate><volume>15</volume><issue>10</issue><spage>2655</spage><epage>2664</epage><pages>2655-2664</pages><issn>1600-6135</issn><eissn>1600-6143</eissn><abstract>This study compared the incidence of CMV infection/disease in de novo kidney transplant recipients receiving everolimus or mycophenolate and no CMV pharmacological prophylaxis. We randomized 288 patients to receive a single 3 mg/kg dose of antithymocyte globulin, tacrolimus, everolimus, and prednisone (r‐ATG/EVR, n = 85); basiliximab, tacrolimus, everolimus, and prednisone (BAS/EVR, n = 102); or basiliximab, tacrolimus, mycophenolate, and prednisone (BAS/MPS, n = 101). The primary end‐point was the incidence of first CMV infection/disease in the intention‐to‐treat population at 12 months. Patients treated with r‐ATG/EVR showed a 90% proportional reduction (4.7% vs. 37.6%, HR 0.10, 95% CI 0.037–0.29; p < 0.001), while those treated with BAS/EVR showed a 75% proportional reduction (10.8% vs. 37.6%, HR 0.25, 95% CI 0.13–0.48; p < 0.001) in the incidence of CMV infection/disease compared to BAS/MPS. There were no differences in the incidence of acute rejection (9.4 vs. 18.6 vs. 15.8%, p = 0.403), wound‐healing complications, delayed graft function, and proteinuria. Mean estimated glomerular filtration rate was lower in BAS/EVR (65.7 ± 21.8 vs. 60.6 ± 20.9 vs. 69.5 ± 21.5 ml/min, p = 0.021). In de novo kidney transplant recipients receiving no pharmacological CMV prophylaxis, reduced‐dose tacrolimus and everolimus was associated with a significant reduction in the incidence of CMV infection/disease compared to standard tacrolimus dose and mycophenolate (ClinicalTrials.gov NCT01354301).
This study shows that in de novo kidney transplant recipients receiving no CMV pharmacological prophylaxis, the use of everolimus and low‐dose tacrolimus is associated with lower incidence of CMV infection/disease compared to a standard tacrolimus and mycophenolate combination.</abstract><cop>United States</cop><pub>Elsevier Limited</pub><pmid>25988935</pmid><doi>10.1111/ajt.13327</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adult Antibodies, Monoclonal - therapeutic use Antilymphocyte serum Antilymphocyte Serum - therapeutic use Basiliximab Cytomegalovirus Cytomegalovirus Infections - epidemiology Cytomegalovirus Infections - immunology Cytomegalovirus Infections - prevention & control Dose-Response Relationship, Drug Drug Therapy, Combination Everolimus - administration & dosage Everolimus - therapeutic use Female Globulins Glomerular filtration rate Graft rejection Graft Rejection - prevention & control Humans Immune modulation immunosuppression Immunosuppressive Agents - administration & dosage Immunosuppressive Agents - therapeutic use Incidence Infections Inhibitor drugs Kidney Transplantation Kidney transplants Male Middle Aged Monoclonal antibodies Motivation Mycophenolic acid Mycophenolic Acid - therapeutic use nephrology Postoperative Complications - epidemiology Postoperative Complications - immunology Postoperative Complications - prevention & control Prednisone Prednisone - therapeutic use Prophylaxis Prospective Studies Proteinuria Recombinant Fusion Proteins - therapeutic use Sirolimus - therapeutic use Tacrolimus Tacrolimus - administration & dosage Tacrolimus - therapeutic use Thymocytes Treatment Outcome Wound healing |
| title | Reduced Incidence of Cytomegalovirus Infection in Kidney Transplant Recipients Receiving Everolimus and Reduced Tacrolimus Doses |
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