Reduced acute rejection and superior 1-year renal allograft survival with basiliximab in patients with diabetes mellitus
Renal allograft recipients with diabetes mellitus often demonstrate poorer clinical outcomes than nondiabetic patients. Basiliximab (Simulect super( registered )), a chimeric anti-interleukin-2 receptor monoclonal antibody, reduced the incidence of acute rejection in renal allograft recipients in 2...
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| Veröffentlicht in: | Transplantation 2000-09, Vol.70 (5), p.784-790 |
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| container_title | Transplantation |
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| creator | THISTLETHWAITE, J. Richard NASHAN, Björn HALL, Michael CHODOFF, Lawrence LIN, Tsung-Hua |
| description | Renal allograft recipients with diabetes mellitus often demonstrate poorer clinical outcomes than nondiabetic patients. Basiliximab (Simulect super( registered )), a chimeric anti-interleukin-2 receptor monoclonal antibody, reduced the incidence of acute rejection in renal allograft recipients in 2 multicenter, placebo-controlled, phase III trials. An analysis of pooled results from the 2 trials was conducted to compare the efficacy and safety of basiliximab with placebo in renal transplant recipients with and without prior diabetes. Patients received either basiliximab (20 mg on day 0 and day 4 posttransplantation) or placebo in combination with cyclosporine for microemulsion (Neoral super( registered )) and steroids. A total of 722 patients (150 diabetic, 572 nondiabetic) were eligible for intent-to-treat analysis. At 12 months, basiliximab as compared with placebo reduced the proportion of patients experiencing first acute rejection by 41% in diabetics (P |
| doi_str_mv | 10.1097/00007890-200009150-00013 |
| format | Article |
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Richard ; NASHAN, Björn ; HALL, Michael ; CHODOFF, Lawrence ; LIN, Tsung-Hua</creator><creatorcontrib>THISTLETHWAITE, J. Richard ; NASHAN, Björn ; HALL, Michael ; CHODOFF, Lawrence ; LIN, Tsung-Hua</creatorcontrib><description><![CDATA[Renal allograft recipients with diabetes mellitus often demonstrate poorer clinical outcomes than nondiabetic patients. Basiliximab (Simulect super( registered )), a chimeric anti-interleukin-2 receptor monoclonal antibody, reduced the incidence of acute rejection in renal allograft recipients in 2 multicenter, placebo-controlled, phase III trials. An analysis of pooled results from the 2 trials was conducted to compare the efficacy and safety of basiliximab with placebo in renal transplant recipients with and without prior diabetes. Patients received either basiliximab (20 mg on day 0 and day 4 posttransplantation) or placebo in combination with cyclosporine for microemulsion (Neoral super( registered )) and steroids. A total of 722 patients (150 diabetic, 572 nondiabetic) were eligible for intent-to-treat analysis. At 12 months, basiliximab as compared with placebo reduced the proportion of patients experiencing first acute rejection by 41% in diabetics (P<0.01) and by 29% in nondiabetics (P<0.001). Biopsy-confirmed rejection was reduced by 44% in diabetics (P<0.01) and by 26% in nondiabetics (P<0.01). The first acute rejection episode requiring augmented immunosuppression other than steroids was reduced by 49% in diabetics (P<0.01) and by 41% in nondiabetics (P<0.001); death, graft loss, or first rejection episode was reduced by 43% in diabetics (P=0.001) and by 22% in nondiabetics (P<0.01). Superior graft survival was maintained in diabetic recipients treated with basiliximab versus placebo (96% vs. 86%; P=0.022). There were no significant differences in safety between basiliximab and placebo in both diabetic and nondiabetic patients. Basiliximab is associated with a significant reduction in acute rejection and an excellent safety profile in renal transplant recipients with and without diabetes mellitus. Superior graft survival was evident in diabetic patients.]]></description><identifier>ISSN: 0041-1337</identifier><identifier>EISSN: 1534-6080</identifier><identifier>DOI: 10.1097/00007890-200009150-00013</identifier><identifier>CODEN: TRPLAU</identifier><language>eng</language><publisher>Hagerstown, MD: Lippincott</publisher><subject>basiliximab ; Biological and medical sciences ; Immunomodulators ; Medical sciences ; Pharmacology. Drug treatments</subject><ispartof>Transplantation, 2000-09, Vol.70 (5), p.784-790</ispartof><rights>2001 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=1117248$$DView record in Pascal Francis$$Hfree_for_read</backlink></links><search><creatorcontrib>THISTLETHWAITE, J. Richard</creatorcontrib><creatorcontrib>NASHAN, Björn</creatorcontrib><creatorcontrib>HALL, Michael</creatorcontrib><creatorcontrib>CHODOFF, Lawrence</creatorcontrib><creatorcontrib>LIN, Tsung-Hua</creatorcontrib><title>Reduced acute rejection and superior 1-year renal allograft survival with basiliximab in patients with diabetes mellitus</title><title>Transplantation</title><description><![CDATA[Renal allograft recipients with diabetes mellitus often demonstrate poorer clinical outcomes than nondiabetic patients. Basiliximab (Simulect super( registered )), a chimeric anti-interleukin-2 receptor monoclonal antibody, reduced the incidence of acute rejection in renal allograft recipients in 2 multicenter, placebo-controlled, phase III trials. An analysis of pooled results from the 2 trials was conducted to compare the efficacy and safety of basiliximab with placebo in renal transplant recipients with and without prior diabetes. Patients received either basiliximab (20 mg on day 0 and day 4 posttransplantation) or placebo in combination with cyclosporine for microemulsion (Neoral super( registered )) and steroids. A total of 722 patients (150 diabetic, 572 nondiabetic) were eligible for intent-to-treat analysis. At 12 months, basiliximab as compared with placebo reduced the proportion of patients experiencing first acute rejection by 41% in diabetics (P<0.01) and by 29% in nondiabetics (P<0.001). Biopsy-confirmed rejection was reduced by 44% in diabetics (P<0.01) and by 26% in nondiabetics (P<0.01). The first acute rejection episode requiring augmented immunosuppression other than steroids was reduced by 49% in diabetics (P<0.01) and by 41% in nondiabetics (P<0.001); death, graft loss, or first rejection episode was reduced by 43% in diabetics (P=0.001) and by 22% in nondiabetics (P<0.01). Superior graft survival was maintained in diabetic recipients treated with basiliximab versus placebo (96% vs. 86%; P=0.022). There were no significant differences in safety between basiliximab and placebo in both diabetic and nondiabetic patients. Basiliximab is associated with a significant reduction in acute rejection and an excellent safety profile in renal transplant recipients with and without diabetes mellitus. Superior graft survival was evident in diabetic patients.]]></description><subject>basiliximab</subject><subject>Biological and medical sciences</subject><subject>Immunomodulators</subject><subject>Medical sciences</subject><subject>Pharmacology. Drug treatments</subject><issn>0041-1337</issn><issn>1534-6080</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2000</creationdate><recordtype>article</recordtype><recordid>eNotj09PwzAMxSMEEmPwHXJA3AJ20y7tEU38kyYhIThXbutCpq4tSTq2b0-mzT48y7-nJ1sIiXCPUJgHiGXyAlRymArMQEVFfSZmmOlULSCHczEDSFGh1uZSXHm_jpZMGzMTuw9uppobSfUUWDpecx3s0EvqG-mnkZ0dnES1Z3KR9tRJ6rrh21EbIndbu42rPxt-ZEXednZnN1RJ28uRguU--CNsLFUc2MsNd50Nk78WFy11nm9OOhdfz0-fy1e1en95Wz6u1JigDgphkVdZVtRFS4AJZClUh2Zi3TSQVWgw5dqkLeRs0obBJHlmIAEmMMx6Lu6OuaMbfif2odxYX8cjqOdh8iUak4DWSTTenozka-paR31tfTm6-JDbl4hokjTX_wUob80</recordid><startdate>20000915</startdate><enddate>20000915</enddate><creator>THISTLETHWAITE, J. Richard</creator><creator>NASHAN, Björn</creator><creator>HALL, Michael</creator><creator>CHODOFF, Lawrence</creator><creator>LIN, Tsung-Hua</creator><general>Lippincott</general><scope>IQODW</scope><scope>7T5</scope><scope>H94</scope></search><sort><creationdate>20000915</creationdate><title>Reduced acute rejection and superior 1-year renal allograft survival with basiliximab in patients with diabetes mellitus</title><author>THISTLETHWAITE, J. Richard ; NASHAN, Björn ; HALL, Michael ; CHODOFF, Lawrence ; LIN, Tsung-Hua</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p213t-1068b559c9fa0120540b0b0beae3dd05b1714ec74f08e74de072857020ea07ee3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2000</creationdate><topic>basiliximab</topic><topic>Biological and medical sciences</topic><topic>Immunomodulators</topic><topic>Medical sciences</topic><topic>Pharmacology. Drug treatments</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>THISTLETHWAITE, J. Richard</creatorcontrib><creatorcontrib>NASHAN, Björn</creatorcontrib><creatorcontrib>HALL, Michael</creatorcontrib><creatorcontrib>CHODOFF, Lawrence</creatorcontrib><creatorcontrib>LIN, Tsung-Hua</creatorcontrib><collection>Pascal-Francis</collection><collection>Immunology Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><jtitle>Transplantation</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>THISTLETHWAITE, J. Richard</au><au>NASHAN, Björn</au><au>HALL, Michael</au><au>CHODOFF, Lawrence</au><au>LIN, Tsung-Hua</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Reduced acute rejection and superior 1-year renal allograft survival with basiliximab in patients with diabetes mellitus</atitle><jtitle>Transplantation</jtitle><date>2000-09-15</date><risdate>2000</risdate><volume>70</volume><issue>5</issue><spage>784</spage><epage>790</epage><pages>784-790</pages><issn>0041-1337</issn><eissn>1534-6080</eissn><coden>TRPLAU</coden><abstract><![CDATA[Renal allograft recipients with diabetes mellitus often demonstrate poorer clinical outcomes than nondiabetic patients. Basiliximab (Simulect super( registered )), a chimeric anti-interleukin-2 receptor monoclonal antibody, reduced the incidence of acute rejection in renal allograft recipients in 2 multicenter, placebo-controlled, phase III trials. An analysis of pooled results from the 2 trials was conducted to compare the efficacy and safety of basiliximab with placebo in renal transplant recipients with and without prior diabetes. Patients received either basiliximab (20 mg on day 0 and day 4 posttransplantation) or placebo in combination with cyclosporine for microemulsion (Neoral super( registered )) and steroids. A total of 722 patients (150 diabetic, 572 nondiabetic) were eligible for intent-to-treat analysis. At 12 months, basiliximab as compared with placebo reduced the proportion of patients experiencing first acute rejection by 41% in diabetics (P<0.01) and by 29% in nondiabetics (P<0.001). Biopsy-confirmed rejection was reduced by 44% in diabetics (P<0.01) and by 26% in nondiabetics (P<0.01). The first acute rejection episode requiring augmented immunosuppression other than steroids was reduced by 49% in diabetics (P<0.01) and by 41% in nondiabetics (P<0.001); death, graft loss, or first rejection episode was reduced by 43% in diabetics (P=0.001) and by 22% in nondiabetics (P<0.01). Superior graft survival was maintained in diabetic recipients treated with basiliximab versus placebo (96% vs. 86%; P=0.022). There were no significant differences in safety between basiliximab and placebo in both diabetic and nondiabetic patients. Basiliximab is associated with a significant reduction in acute rejection and an excellent safety profile in renal transplant recipients with and without diabetes mellitus. Superior graft survival was evident in diabetic patients.]]></abstract><cop>Hagerstown, MD</cop><pub>Lippincott</pub><doi>10.1097/00007890-200009150-00013</doi><tpages>7</tpages></addata></record> |
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| ispartof | Transplantation, 2000-09, Vol.70 (5), p.784-790 |
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| language | eng |
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| source | Journals@Ovid Complete |
| subjects | basiliximab Biological and medical sciences Immunomodulators Medical sciences Pharmacology. Drug treatments |
| title | Reduced acute rejection and superior 1-year renal allograft survival with basiliximab in patients with diabetes mellitus |
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