A large, prospective, randomized, open-label, multicentre study of corticosteroid withdrawal in SPK transplantation: a 3-year report

Background. Simultaneous pancreas–kidney (SPK) transplantation is the treatment of choice for selected diabetic patients. Corticosteroids are an important element of immunosuppressive protocols, but their long-term use has detrimental effects on patients' health, necessitating eventual disconti...

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Veröffentlicht in:Nephrology, dialysis, transplantation dialysis, transplantation, 2005-05, Vol.20 (suppl-2), p.ii40-ii47
Hauptverfasser: Nakache, Richard, Malaise, Jacques, Van Ophem, Dominique
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container_title Nephrology, dialysis, transplantation
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creator Nakache, Richard
Malaise, Jacques
Van Ophem, Dominique
description Background. Simultaneous pancreas–kidney (SPK) transplantation is the treatment of choice for selected diabetic patients. Corticosteroids are an important element of immunosuppressive protocols, but their long-term use has detrimental effects on patients' health, necessitating eventual discontinuation. Methods. This prospective study evaluated the safety and feasibility of corticosteroid withdrawal in 205 SPK transplant recipients randomized to immunosuppressive treatment with either tacrolimus and mycophenolate mofetil (MMF) (n = 103) or cyclosporin microemulsion (ME) and MMF (n = 102). Results. Corticosteroid withdrawal was successful in the majority of in-study patients (66% tacrolimus, 73% cyclosporin-ME). Compared with out-of-study patients or those continuing corticosteroid therapy, in-study patients withdrawn from corticosteroids experienced fewer pancreas or kidney graft losses, fewer episodes of acute rejection and were less likely to be withdrawn from the study. Acute rejection occurred after corticosteroid withdrawal in two patients who had a previous rejection and in five patients who were rejection-free before corticosteroid withdrawal. No rejection episodes were associated with graft loss or immediate serious consequences. Overall, corticosteroid withdrawal was achieved with an increase in the dose of both MMF and tacrolimus. Conclusions. A long-term survey of corticosteroid withdrawal in SPK transplantation with multifactorial analyses is necessary to confirm these early results and to evaluate the positive effects on glucose metabolism and hypertension.
doi_str_mv 10.1093/ndt/gfh1081
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Simultaneous pancreas–kidney (SPK) transplantation is the treatment of choice for selected diabetic patients. Corticosteroids are an important element of immunosuppressive protocols, but their long-term use has detrimental effects on patients' health, necessitating eventual discontinuation. Methods. This prospective study evaluated the safety and feasibility of corticosteroid withdrawal in 205 SPK transplant recipients randomized to immunosuppressive treatment with either tacrolimus and mycophenolate mofetil (MMF) (n = 103) or cyclosporin microemulsion (ME) and MMF (n = 102). Results. Corticosteroid withdrawal was successful in the majority of in-study patients (66% tacrolimus, 73% cyclosporin-ME). Compared with out-of-study patients or those continuing corticosteroid therapy, in-study patients withdrawn from corticosteroids experienced fewer pancreas or kidney graft losses, fewer episodes of acute rejection and were less likely to be withdrawn from the study. Acute rejection occurred after corticosteroid withdrawal in two patients who had a previous rejection and in five patients who were rejection-free before corticosteroid withdrawal. No rejection episodes were associated with graft loss or immediate serious consequences. Overall, corticosteroid withdrawal was achieved with an increase in the dose of both MMF and tacrolimus. Conclusions. A long-term survey of corticosteroid withdrawal in SPK transplantation with multifactorial analyses is necessary to confirm these early results and to evaluate the positive effects on glucose metabolism and hypertension.</description><identifier>ISSN: 0931-0509</identifier><identifier>EISSN: 1460-2385</identifier><identifier>DOI: 10.1093/ndt/gfh1081</identifier><identifier>PMID: 15814549</identifier><language>eng</language><publisher>England: Oxford University Press</publisher><subject>Biopsy ; corticosteroid withdrawal ; cyclosporin microemulsion ; Cyclosporine - therapeutic use ; Diabetes Mellitus, Type 1 - complications ; Diabetes Mellitus, Type 1 - surgery ; Diabetic Nephropathies - complications ; Diabetic Nephropathies - surgery ; Drug Therapy, Combination ; Europe ; Feasibility Studies ; Follow-Up Studies ; Glucocorticoids - adverse effects ; Glucocorticoids - therapeutic use ; Graft Rejection - pathology ; Graft Rejection - prevention &amp; control ; Humans ; Immunosuppressive Agents - therapeutic use ; Israel ; Kidney Failure, Chronic - etiology ; Kidney Failure, Chronic - surgery ; Kidney Transplantation ; Mycophenolic Acid - analogs &amp; derivatives ; Mycophenolic Acid - therapeutic use ; Pancreas Transplantation ; Prospective Studies ; rejection ; Safety ; simultaneous pancreas–kidney transplantation ; tacrolimus ; Tacrolimus - therapeutic use ; Time Factors ; Treatment Outcome ; Withholding Treatment</subject><ispartof>Nephrology, dialysis, transplantation, 2005-05, Vol.20 (suppl-2), p.ii40-ii47</ispartof><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c393t-82b6c1955a3788ae49c1a0e23b61213801a55ad0df8f338f59f85e8e314e4acd3</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,778,782,27911,27912</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/15814549$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Nakache, Richard</creatorcontrib><creatorcontrib>Malaise, Jacques</creatorcontrib><creatorcontrib>Van Ophem, Dominique</creatorcontrib><creatorcontrib>Euro-SPK Study Group</creatorcontrib><title>A large, prospective, randomized, open-label, multicentre study of corticosteroid withdrawal in SPK transplantation: a 3-year report</title><title>Nephrology, dialysis, transplantation</title><addtitle>Nephrol. Dial. Transplant</addtitle><description>Background. Simultaneous pancreas–kidney (SPK) transplantation is the treatment of choice for selected diabetic patients. Corticosteroids are an important element of immunosuppressive protocols, but their long-term use has detrimental effects on patients' health, necessitating eventual discontinuation. Methods. This prospective study evaluated the safety and feasibility of corticosteroid withdrawal in 205 SPK transplant recipients randomized to immunosuppressive treatment with either tacrolimus and mycophenolate mofetil (MMF) (n = 103) or cyclosporin microemulsion (ME) and MMF (n = 102). Results. Corticosteroid withdrawal was successful in the majority of in-study patients (66% tacrolimus, 73% cyclosporin-ME). Compared with out-of-study patients or those continuing corticosteroid therapy, in-study patients withdrawn from corticosteroids experienced fewer pancreas or kidney graft losses, fewer episodes of acute rejection and were less likely to be withdrawn from the study. Acute rejection occurred after corticosteroid withdrawal in two patients who had a previous rejection and in five patients who were rejection-free before corticosteroid withdrawal. No rejection episodes were associated with graft loss or immediate serious consequences. Overall, corticosteroid withdrawal was achieved with an increase in the dose of both MMF and tacrolimus. Conclusions. A long-term survey of corticosteroid withdrawal in SPK transplantation with multifactorial analyses is necessary to confirm these early results and to evaluate the positive effects on glucose metabolism and hypertension.</description><subject>Biopsy</subject><subject>corticosteroid withdrawal</subject><subject>cyclosporin microemulsion</subject><subject>Cyclosporine - therapeutic use</subject><subject>Diabetes Mellitus, Type 1 - complications</subject><subject>Diabetes Mellitus, Type 1 - surgery</subject><subject>Diabetic Nephropathies - complications</subject><subject>Diabetic Nephropathies - surgery</subject><subject>Drug Therapy, Combination</subject><subject>Europe</subject><subject>Feasibility Studies</subject><subject>Follow-Up Studies</subject><subject>Glucocorticoids - adverse effects</subject><subject>Glucocorticoids - therapeutic use</subject><subject>Graft Rejection - pathology</subject><subject>Graft Rejection - prevention &amp; control</subject><subject>Humans</subject><subject>Immunosuppressive Agents - therapeutic use</subject><subject>Israel</subject><subject>Kidney Failure, Chronic - etiology</subject><subject>Kidney Failure, Chronic - surgery</subject><subject>Kidney Transplantation</subject><subject>Mycophenolic Acid - analogs &amp; derivatives</subject><subject>Mycophenolic Acid - therapeutic use</subject><subject>Pancreas Transplantation</subject><subject>Prospective Studies</subject><subject>rejection</subject><subject>Safety</subject><subject>simultaneous pancreas–kidney transplantation</subject><subject>tacrolimus</subject><subject>Tacrolimus - therapeutic use</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><subject>Withholding Treatment</subject><issn>0931-0509</issn><issn>1460-2385</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2005</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkUFv1DAQhS0EotvCiTvyiQub1hPbicOtaku3ohJUBVFxsbzxpDUkcbCdluXMD8doV3DkZI3fN08z8wh5AewQWMOPRpuObrs7YAoekQWIihUlV_IxWWQVCiZZs0f2Y_zKGGvKun5K9kAqEFI0C_LrmPYm3OKSTsHHCdvk7nMRzGj94H6iXVI_4Vj0Zo39kg5zn1yLYwpIY5rthvqOtj7kTx8TBu8sfXDpzgbzYHrqRnr94R1N2S5OvRmTSc6Pb6ihvNigCTTglJufkSed6SM-370H5NPbs48nq-Ly_fnFyfFl0fKGp0KV66qFRkrDa6UMiqYFw7Dk6wpK4IqByZpltlMd56qTTackKuQgUJjW8gPyauubd_0-Y0x6cLHFPk-Gfo66qmuouID_glBzXpeiyuDrLdjm68WAnZ6CG0zYaGD6Tzo6p6N36WT65c52Xg9o_7G7ODJQbAGXj_njr27Ctzwbr6Ve3XzRV1fnn0_F9Urf8N_oHpzG</recordid><startdate>200505</startdate><enddate>200505</enddate><creator>Nakache, Richard</creator><creator>Malaise, Jacques</creator><creator>Van Ophem, Dominique</creator><general>Oxford University Press</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>H94</scope><scope>7X8</scope></search><sort><creationdate>200505</creationdate><title>A large, prospective, randomized, open-label, multicentre study of corticosteroid withdrawal in SPK transplantation: a 3-year report</title><author>Nakache, Richard ; Malaise, Jacques ; Van Ophem, Dominique</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c393t-82b6c1955a3788ae49c1a0e23b61213801a55ad0df8f338f59f85e8e314e4acd3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2005</creationdate><topic>Biopsy</topic><topic>corticosteroid withdrawal</topic><topic>cyclosporin microemulsion</topic><topic>Cyclosporine - therapeutic use</topic><topic>Diabetes Mellitus, Type 1 - complications</topic><topic>Diabetes Mellitus, Type 1 - surgery</topic><topic>Diabetic Nephropathies - complications</topic><topic>Diabetic Nephropathies - surgery</topic><topic>Drug Therapy, Combination</topic><topic>Europe</topic><topic>Feasibility Studies</topic><topic>Follow-Up Studies</topic><topic>Glucocorticoids - adverse effects</topic><topic>Glucocorticoids - therapeutic use</topic><topic>Graft Rejection - pathology</topic><topic>Graft Rejection - prevention &amp; control</topic><topic>Humans</topic><topic>Immunosuppressive Agents - therapeutic use</topic><topic>Israel</topic><topic>Kidney Failure, Chronic - etiology</topic><topic>Kidney Failure, Chronic - surgery</topic><topic>Kidney Transplantation</topic><topic>Mycophenolic Acid - analogs &amp; derivatives</topic><topic>Mycophenolic Acid - therapeutic use</topic><topic>Pancreas Transplantation</topic><topic>Prospective Studies</topic><topic>rejection</topic><topic>Safety</topic><topic>simultaneous pancreas–kidney transplantation</topic><topic>tacrolimus</topic><topic>Tacrolimus - therapeutic use</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><topic>Withholding Treatment</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Nakache, Richard</creatorcontrib><creatorcontrib>Malaise, Jacques</creatorcontrib><creatorcontrib>Van Ophem, Dominique</creatorcontrib><creatorcontrib>Euro-SPK Study Group</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>AIDS and Cancer Research Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Nephrology, dialysis, transplantation</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Nakache, Richard</au><au>Malaise, Jacques</au><au>Van Ophem, Dominique</au><aucorp>Euro-SPK Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A large, prospective, randomized, open-label, multicentre study of corticosteroid withdrawal in SPK transplantation: a 3-year report</atitle><jtitle>Nephrology, dialysis, transplantation</jtitle><addtitle>Nephrol. Dial. Transplant</addtitle><date>2005-05</date><risdate>2005</risdate><volume>20</volume><issue>suppl-2</issue><spage>ii40</spage><epage>ii47</epage><pages>ii40-ii47</pages><issn>0931-0509</issn><eissn>1460-2385</eissn><abstract>Background. Simultaneous pancreas–kidney (SPK) transplantation is the treatment of choice for selected diabetic patients. Corticosteroids are an important element of immunosuppressive protocols, but their long-term use has detrimental effects on patients' health, necessitating eventual discontinuation. Methods. This prospective study evaluated the safety and feasibility of corticosteroid withdrawal in 205 SPK transplant recipients randomized to immunosuppressive treatment with either tacrolimus and mycophenolate mofetil (MMF) (n = 103) or cyclosporin microemulsion (ME) and MMF (n = 102). Results. Corticosteroid withdrawal was successful in the majority of in-study patients (66% tacrolimus, 73% cyclosporin-ME). Compared with out-of-study patients or those continuing corticosteroid therapy, in-study patients withdrawn from corticosteroids experienced fewer pancreas or kidney graft losses, fewer episodes of acute rejection and were less likely to be withdrawn from the study. Acute rejection occurred after corticosteroid withdrawal in two patients who had a previous rejection and in five patients who were rejection-free before corticosteroid withdrawal. No rejection episodes were associated with graft loss or immediate serious consequences. Overall, corticosteroid withdrawal was achieved with an increase in the dose of both MMF and tacrolimus. Conclusions. A long-term survey of corticosteroid withdrawal in SPK transplantation with multifactorial analyses is necessary to confirm these early results and to evaluate the positive effects on glucose metabolism and hypertension.</abstract><cop>England</cop><pub>Oxford University Press</pub><pmid>15814549</pmid><doi>10.1093/ndt/gfh1081</doi><oa>free_for_read</oa></addata></record>
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source MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Oxford University Press Journals All Titles (1996-Current); Alma/SFX Local Collection
subjects Biopsy
corticosteroid withdrawal
cyclosporin microemulsion
Cyclosporine - therapeutic use
Diabetes Mellitus, Type 1 - complications
Diabetes Mellitus, Type 1 - surgery
Diabetic Nephropathies - complications
Diabetic Nephropathies - surgery
Drug Therapy, Combination
Europe
Feasibility Studies
Follow-Up Studies
Glucocorticoids - adverse effects
Glucocorticoids - therapeutic use
Graft Rejection - pathology
Graft Rejection - prevention & control
Humans
Immunosuppressive Agents - therapeutic use
Israel
Kidney Failure, Chronic - etiology
Kidney Failure, Chronic - surgery
Kidney Transplantation
Mycophenolic Acid - analogs & derivatives
Mycophenolic Acid - therapeutic use
Pancreas Transplantation
Prospective Studies
rejection
Safety
simultaneous pancreas–kidney transplantation
tacrolimus
Tacrolimus - therapeutic use
Time Factors
Treatment Outcome
Withholding Treatment
title A large, prospective, randomized, open-label, multicentre study of corticosteroid withdrawal in SPK transplantation: a 3-year report
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