Steroid withdrawal at 3 months after kidney transplantation: a comparison of two tacrolimus‐based regimens
Summary The 6 month prospective, randomized study compared the steroid‐sparing potential of two tacrolimus‐based regimens after renal transplantation. A total of 489 patients were randomized (1:1) to receive tacrolimus/mycophenolate mofetil (MMF)/steroids (n = 243; group Tac/MMF/S) or tacrolimus/aza...
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| Veröffentlicht in: | Transplant international 2005-02, Vol.18 (2), p.157-162 |
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| creator | Wlodarczyk, Zbigniew Walaszewski, Janusz Perner, Ferenc Vitko, Stefan Ostrowski, Marek Bachleda, Petr Kokot, Franciszek Klinger, Marian Szenohradszky, Pal Studenik, Pavel Navratil, Pavel Asztalos, Laszlo Rutkowski, Boleslaw Kalmar, Karoly Nagy Hickey, David |
| description | Summary
The 6 month prospective, randomized study compared the steroid‐sparing potential of two tacrolimus‐based regimens after renal transplantation. A total of 489 patients were randomized (1:1) to receive tacrolimus/mycophenolate mofetil (MMF)/steroids (n = 243; group Tac/MMF/S) or tacrolimus/azathioprine/steroids (n = 246; group Tac/Aza/S). At 3 months, steroids were tapered off in 267 (54.6%) patients free from steroid‐resistant acute rejection and with serum creatinine concentrations |
| doi_str_mv | 10.1111/j.1432-2277.2004.00011.x |
| format | Article |
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The 6 month prospective, randomized study compared the steroid‐sparing potential of two tacrolimus‐based regimens after renal transplantation. A total of 489 patients were randomized (1:1) to receive tacrolimus/mycophenolate mofetil (MMF)/steroids (n = 243; group Tac/MMF/S) or tacrolimus/azathioprine/steroids (n = 246; group Tac/Aza/S). At 3 months, steroids were tapered off in 267 (54.6%) patients free from steroid‐resistant acute rejection and with serum creatinine concentrations <160 μmol/l. The incidence of biopsy‐confirmed acute rejection at month 3 was lower in group Tac/MMF/S compared with group Tac/Aza/S (18.1% vs. 26.0%,P = 0.035). Moreover, more patients in the Tac/MMF/S group met the criteria for steroid withdrawal than in the Tac/Aza/S group (60.5% vs. 48.8%; P < 0.01). The incidence of acute rejection during months 4–6 was low in all groups, both for patients on steroid‐free dual therapy (Tac/MMF: 2.7%, Tac/Aza: 0.8%) and for patients who continued steroid maintenance therapy (Tac/MMF/S: 3.5%, Tac/Aza/S: 7.1%). Moreover, kidney function was well preserved in steroid‐free patients with month 6 median serum creatinine levels of 119.5 μmol/l (Tac/MMF), and 115.1 μmol/l (Tac/Aza). For patients who continued to receive steroids, month 6 median creatinine levels were 130.5 μmol/l (Tac/MMF/S) and 132.8 μmol/l (Tac/Aza/S). The criteria for the selection of patients to discontinue steroids were adequate. Both tacrolimus‐based regimens allowed the safe discontinuation of steroids in low‐risk patients at month 3. The Tac/MMF combination was superior in the prevention of acute rejections and more patients met the chosen criteria for steroid withdrawal.</description><identifier>ISSN: 0934-0874</identifier><identifier>EISSN: 1432-2277</identifier><identifier>DOI: 10.1111/j.1432-2277.2004.00011.x</identifier><identifier>PMID: 15691267</identifier><language>eng</language><publisher>Oxford, UK: Munksgaard International Publishers</publisher><subject><![CDATA[acute rejection ; Adolescent ; Adult ; Aged ; azathioprine ; Azathioprine - administration & dosage ; Biological and medical sciences ; Creatinine - blood ; Female ; General aspects ; Graft Rejection - drug therapy ; Graft Rejection - prevention & control ; Humans ; Immunosuppressive Agents - administration & dosage ; kidney transplantation ; Kidney Transplantation - adverse effects ; Kidney Transplantation - pathology ; Kidney Transplantation - physiology ; Male ; Medical sciences ; Methylprednisolone - administration & dosage ; Middle Aged ; mycophenolate mofetil ; Mycophenolic Acid - administration & dosage ; Mycophenolic Acid - analogs & derivatives ; Nephrology. Urinary tract diseases ; Pharmacology. Drug treatments ; Prednisolone - administration & dosage ; Prospective Studies ; steroid withdrawal ; Steroids - administration & dosage ; tacrolimus ; Tacrolimus - administration & dosage]]></subject><ispartof>Transplant international, 2005-02, Vol.18 (2), p.157-162</ispartof><rights>2006 INIST-CNRS</rights><rights>Copyright Blackwell Publishing Ltd. Feb 2005</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4231-1613ba8fa41f93fc3ed3a6c1c220c9083a38e5b43375f169b4f78061bfb199c93</citedby><cites>FETCH-LOGICAL-c4231-1613ba8fa41f93fc3ed3a6c1c220c9083a38e5b43375f169b4f78061bfb199c93</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%2Fj.1432-2277.2004.00011.x$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fj.1432-2277.2004.00011.x$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=17351113$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/15691267$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Wlodarczyk, Zbigniew</creatorcontrib><creatorcontrib>Walaszewski, Janusz</creatorcontrib><creatorcontrib>Perner, Ferenc</creatorcontrib><creatorcontrib>Vitko, Stefan</creatorcontrib><creatorcontrib>Ostrowski, Marek</creatorcontrib><creatorcontrib>Bachleda, Petr</creatorcontrib><creatorcontrib>Kokot, Franciszek</creatorcontrib><creatorcontrib>Klinger, Marian</creatorcontrib><creatorcontrib>Szenohradszky, Pal</creatorcontrib><creatorcontrib>Studenik, Pavel</creatorcontrib><creatorcontrib>Navratil, Pavel</creatorcontrib><creatorcontrib>Asztalos, Laszlo</creatorcontrib><creatorcontrib>Rutkowski, Boleslaw</creatorcontrib><creatorcontrib>Kalmar, Karoly Nagy</creatorcontrib><creatorcontrib>Hickey, David</creatorcontrib><title>Steroid withdrawal at 3 months after kidney transplantation: a comparison of two tacrolimus‐based regimens</title><title>Transplant international</title><addtitle>Transpl Int</addtitle><description>Summary
The 6 month prospective, randomized study compared the steroid‐sparing potential of two tacrolimus‐based regimens after renal transplantation. A total of 489 patients were randomized (1:1) to receive tacrolimus/mycophenolate mofetil (MMF)/steroids (n = 243; group Tac/MMF/S) or tacrolimus/azathioprine/steroids (n = 246; group Tac/Aza/S). At 3 months, steroids were tapered off in 267 (54.6%) patients free from steroid‐resistant acute rejection and with serum creatinine concentrations <160 μmol/l. The incidence of biopsy‐confirmed acute rejection at month 3 was lower in group Tac/MMF/S compared with group Tac/Aza/S (18.1% vs. 26.0%,P = 0.035). Moreover, more patients in the Tac/MMF/S group met the criteria for steroid withdrawal than in the Tac/Aza/S group (60.5% vs. 48.8%; P < 0.01). The incidence of acute rejection during months 4–6 was low in all groups, both for patients on steroid‐free dual therapy (Tac/MMF: 2.7%, Tac/Aza: 0.8%) and for patients who continued steroid maintenance therapy (Tac/MMF/S: 3.5%, Tac/Aza/S: 7.1%). Moreover, kidney function was well preserved in steroid‐free patients with month 6 median serum creatinine levels of 119.5 μmol/l (Tac/MMF), and 115.1 μmol/l (Tac/Aza). For patients who continued to receive steroids, month 6 median creatinine levels were 130.5 μmol/l (Tac/MMF/S) and 132.8 μmol/l (Tac/Aza/S). The criteria for the selection of patients to discontinue steroids were adequate. Both tacrolimus‐based regimens allowed the safe discontinuation of steroids in low‐risk patients at month 3. The Tac/MMF combination was superior in the prevention of acute rejections and more patients met the chosen criteria for steroid withdrawal.</description><subject>acute rejection</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>azathioprine</subject><subject>Azathioprine - administration & dosage</subject><subject>Biological and medical sciences</subject><subject>Creatinine - blood</subject><subject>Female</subject><subject>General aspects</subject><subject>Graft Rejection - drug therapy</subject><subject>Graft Rejection - prevention & control</subject><subject>Humans</subject><subject>Immunosuppressive Agents - administration & dosage</subject><subject>kidney transplantation</subject><subject>Kidney Transplantation - adverse effects</subject><subject>Kidney Transplantation - pathology</subject><subject>Kidney Transplantation - physiology</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Methylprednisolone - administration & dosage</subject><subject>Middle Aged</subject><subject>mycophenolate mofetil</subject><subject>Mycophenolic Acid - administration & dosage</subject><subject>Mycophenolic Acid - analogs & derivatives</subject><subject>Nephrology. Urinary tract diseases</subject><subject>Pharmacology. Drug treatments</subject><subject>Prednisolone - administration & dosage</subject><subject>Prospective Studies</subject><subject>steroid withdrawal</subject><subject>Steroids - administration & dosage</subject><subject>tacrolimus</subject><subject>Tacrolimus - administration & dosage</subject><issn>0934-0874</issn><issn>1432-2277</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2005</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkd9qFDEYxYModq2-ggRB72bMv5nMiDelaFsoCFqvwzeZxGadmaxJhu3eFXwBn7FP0kx3seCVuUkgv-_k5ByEMCUlzev9uqSCs4IxKUtGiCgJIZSWN0_Q6u_FU7QiLRcFaaQ4Qi9iXGeINRV5jo5oVbeU1XKFpm_JBO96vHXpug-whQFDwvzu9vfop3QdMdhM4J-un8wOpwBT3AwwJUjOTx8wYO3HDQQX_YS9xWnrcQId_ODGOd7d_ukgmh4H88ONZoov0TMLQzSvDvsx-v7509XpeXH55ezi9OSy0IJxWtCa8g4aC4LallvNTc-h1lQzRnRLGg68MVUnOJeVpXXbCSsbUtPOdrRtdcuP0bu97ib4X7OJSY0uajNk58bPUdVSECFlncE3_4BrP4cpe1OMtnXWbHiGmj2U_xVjMFZtghsh7BQlailErdWSu1pyV0sh6qEQdZNHXx_05240_ePgoYEMvD0AEDUMNgesXXzkJK_yA4uHj3tu6waz-28D6urrRT7wew13qIc</recordid><startdate>200502</startdate><enddate>200502</enddate><creator>Wlodarczyk, Zbigniew</creator><creator>Walaszewski, Janusz</creator><creator>Perner, Ferenc</creator><creator>Vitko, Stefan</creator><creator>Ostrowski, Marek</creator><creator>Bachleda, Petr</creator><creator>Kokot, Franciszek</creator><creator>Klinger, Marian</creator><creator>Szenohradszky, Pal</creator><creator>Studenik, Pavel</creator><creator>Navratil, Pavel</creator><creator>Asztalos, Laszlo</creator><creator>Rutkowski, Boleslaw</creator><creator>Kalmar, Karoly Nagy</creator><creator>Hickey, David</creator><general>Munksgaard International Publishers</general><general>Blackwell Publishing</general><general>Blackwell Publishing Ltd</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>7QO</scope><scope>7T5</scope><scope>8FD</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>P64</scope><scope>7X8</scope></search><sort><creationdate>200502</creationdate><title>Steroid withdrawal at 3 months after kidney transplantation: a comparison of two tacrolimus‐based regimens</title><author>Wlodarczyk, Zbigniew ; Walaszewski, Janusz ; Perner, Ferenc ; Vitko, Stefan ; Ostrowski, Marek ; Bachleda, Petr ; Kokot, Franciszek ; Klinger, Marian ; Szenohradszky, Pal ; Studenik, Pavel ; Navratil, Pavel ; Asztalos, Laszlo ; Rutkowski, Boleslaw ; Kalmar, Karoly Nagy ; Hickey, David</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4231-1613ba8fa41f93fc3ed3a6c1c220c9083a38e5b43375f169b4f78061bfb199c93</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2005</creationdate><topic>acute rejection</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>azathioprine</topic><topic>Azathioprine - administration & dosage</topic><topic>Biological and medical sciences</topic><topic>Creatinine - blood</topic><topic>Female</topic><topic>General aspects</topic><topic>Graft Rejection - drug therapy</topic><topic>Graft Rejection - prevention & control</topic><topic>Humans</topic><topic>Immunosuppressive Agents - administration & dosage</topic><topic>kidney transplantation</topic><topic>Kidney Transplantation - adverse effects</topic><topic>Kidney Transplantation - pathology</topic><topic>Kidney Transplantation - physiology</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Methylprednisolone - administration & dosage</topic><topic>Middle Aged</topic><topic>mycophenolate mofetil</topic><topic>Mycophenolic Acid - administration & dosage</topic><topic>Mycophenolic Acid - analogs & derivatives</topic><topic>Nephrology. Urinary tract diseases</topic><topic>Pharmacology. Drug treatments</topic><topic>Prednisolone - administration & dosage</topic><topic>Prospective Studies</topic><topic>steroid withdrawal</topic><topic>Steroids - administration & dosage</topic><topic>tacrolimus</topic><topic>Tacrolimus - administration & dosage</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Wlodarczyk, Zbigniew</creatorcontrib><creatorcontrib>Walaszewski, Janusz</creatorcontrib><creatorcontrib>Perner, Ferenc</creatorcontrib><creatorcontrib>Vitko, Stefan</creatorcontrib><creatorcontrib>Ostrowski, Marek</creatorcontrib><creatorcontrib>Bachleda, Petr</creatorcontrib><creatorcontrib>Kokot, Franciszek</creatorcontrib><creatorcontrib>Klinger, Marian</creatorcontrib><creatorcontrib>Szenohradszky, Pal</creatorcontrib><creatorcontrib>Studenik, Pavel</creatorcontrib><creatorcontrib>Navratil, Pavel</creatorcontrib><creatorcontrib>Asztalos, Laszlo</creatorcontrib><creatorcontrib>Rutkowski, Boleslaw</creatorcontrib><creatorcontrib>Kalmar, Karoly Nagy</creatorcontrib><creatorcontrib>Hickey, David</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>Biotechnology Research Abstracts</collection><collection>Immunology Abstracts</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Transplant international</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Wlodarczyk, Zbigniew</au><au>Walaszewski, Janusz</au><au>Perner, Ferenc</au><au>Vitko, Stefan</au><au>Ostrowski, Marek</au><au>Bachleda, Petr</au><au>Kokot, Franciszek</au><au>Klinger, Marian</au><au>Szenohradszky, Pal</au><au>Studenik, Pavel</au><au>Navratil, Pavel</au><au>Asztalos, Laszlo</au><au>Rutkowski, Boleslaw</au><au>Kalmar, Karoly Nagy</au><au>Hickey, David</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Steroid withdrawal at 3 months after kidney transplantation: a comparison of two tacrolimus‐based regimens</atitle><jtitle>Transplant international</jtitle><addtitle>Transpl Int</addtitle><date>2005-02</date><risdate>2005</risdate><volume>18</volume><issue>2</issue><spage>157</spage><epage>162</epage><pages>157-162</pages><issn>0934-0874</issn><eissn>1432-2277</eissn><abstract>Summary
The 6 month prospective, randomized study compared the steroid‐sparing potential of two tacrolimus‐based regimens after renal transplantation. A total of 489 patients were randomized (1:1) to receive tacrolimus/mycophenolate mofetil (MMF)/steroids (n = 243; group Tac/MMF/S) or tacrolimus/azathioprine/steroids (n = 246; group Tac/Aza/S). At 3 months, steroids were tapered off in 267 (54.6%) patients free from steroid‐resistant acute rejection and with serum creatinine concentrations <160 μmol/l. The incidence of biopsy‐confirmed acute rejection at month 3 was lower in group Tac/MMF/S compared with group Tac/Aza/S (18.1% vs. 26.0%,P = 0.035). Moreover, more patients in the Tac/MMF/S group met the criteria for steroid withdrawal than in the Tac/Aza/S group (60.5% vs. 48.8%; P < 0.01). The incidence of acute rejection during months 4–6 was low in all groups, both for patients on steroid‐free dual therapy (Tac/MMF: 2.7%, Tac/Aza: 0.8%) and for patients who continued steroid maintenance therapy (Tac/MMF/S: 3.5%, Tac/Aza/S: 7.1%). Moreover, kidney function was well preserved in steroid‐free patients with month 6 median serum creatinine levels of 119.5 μmol/l (Tac/MMF), and 115.1 μmol/l (Tac/Aza). For patients who continued to receive steroids, month 6 median creatinine levels were 130.5 μmol/l (Tac/MMF/S) and 132.8 μmol/l (Tac/Aza/S). The criteria for the selection of patients to discontinue steroids were adequate. Both tacrolimus‐based regimens allowed the safe discontinuation of steroids in low‐risk patients at month 3. The Tac/MMF combination was superior in the prevention of acute rejections and more patients met the chosen criteria for steroid withdrawal.</abstract><cop>Oxford, UK</cop><pub>Munksgaard International Publishers</pub><pmid>15691267</pmid><doi>10.1111/j.1432-2277.2004.00011.x</doi><tpages>6</tpages></addata></record> |
| fulltext | fulltext |
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| ispartof | Transplant international, 2005-02, Vol.18 (2), p.157-162 |
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| language | eng |
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| source | MEDLINE; EZB-FREE-00999 freely available EZB journals; Wiley Online Library All Journals |
| subjects | acute rejection Adolescent Adult Aged azathioprine Azathioprine - administration & dosage Biological and medical sciences Creatinine - blood Female General aspects Graft Rejection - drug therapy Graft Rejection - prevention & control Humans Immunosuppressive Agents - administration & dosage kidney transplantation Kidney Transplantation - adverse effects Kidney Transplantation - pathology Kidney Transplantation - physiology Male Medical sciences Methylprednisolone - administration & dosage Middle Aged mycophenolate mofetil Mycophenolic Acid - administration & dosage Mycophenolic Acid - analogs & derivatives Nephrology. Urinary tract diseases Pharmacology. Drug treatments Prednisolone - administration & dosage Prospective Studies steroid withdrawal Steroids - administration & dosage tacrolimus Tacrolimus - administration & dosage |
| title | Steroid withdrawal at 3 months after kidney transplantation: a comparison of two tacrolimus‐based regimens |
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