Tolerability and Efficacy of Multidose Epoetin Beta (Reco-Pen®) for Subcutaneous Administration in Patients with Anemia due to Renal Failure
Aims: To assess the tolerability, safety and efficacy of the epoetin beta multidose cartridge formulation, self-administered subcutaneously via a pen device (Reco-Pen ® ), in adult patients with renal anemia. Methods: Patients receiving maintenance epoetin therapy were switched to the subcutaneous (...
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| Veröffentlicht in: | Kidney & blood pressure research 2003-01, Vol.26 (3), p.192-198 |
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| creator | Kleophas, W. Kult, J. Kreusser, W. Piper, C. Plache, H. Wunderle, P. Fiegel, V. Härtl, W. |
| description | Aims: To assess the tolerability, safety and efficacy of the epoetin beta multidose cartridge formulation, self-administered subcutaneously via a pen device (Reco-Pen ® ), in adult patients with renal anemia. Methods: Patients receiving maintenance epoetin therapy were switched to the subcutaneous (SC) multidose formulation of epoetin beta (NeoRecormon ® ). The frequency of adverse events, local tolerability, and changes in blood pressure and laboratory variables were recorded. Hematologic parameters, transfusion requirements and epoetin beta dosage were also assessed. Results: A total of 406 patients were entered in the intention-to-treat analysis. Mean treatment duration was 82.3 days. Fifty patients (12.3%) withdrew from the study; 14 (3.4%) discontinued because of adverse events. Treatment was well tolerated, with adverse events considered probably related to treatment in only 5 cases, and 1 case of local intolerability. There were no clinically significant changes in blood pressure or laboratory variables, and no changes in hematologic parameters or transfusion requirements. Unexpectedly, the epoetin beta dose was reduced by almost one-third in patients previously maintained on SC epoetin. Conclusion: SC administration of this multidose epoetin beta formulation with the Reco-Pen ® device was well tolerated and effective. It is possible that the improved capacity to individualize dose may have contributed to the considerable reduction in SC epoetin beta dosage requirement. |
| doi_str_mv | 10.1159/000071885 |
| format | Article |
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Methods: Patients receiving maintenance epoetin therapy were switched to the subcutaneous (SC) multidose formulation of epoetin beta (NeoRecormon ® ). The frequency of adverse events, local tolerability, and changes in blood pressure and laboratory variables were recorded. Hematologic parameters, transfusion requirements and epoetin beta dosage were also assessed. Results: A total of 406 patients were entered in the intention-to-treat analysis. Mean treatment duration was 82.3 days. Fifty patients (12.3%) withdrew from the study; 14 (3.4%) discontinued because of adverse events. Treatment was well tolerated, with adverse events considered probably related to treatment in only 5 cases, and 1 case of local intolerability. There were no clinically significant changes in blood pressure or laboratory variables, and no changes in hematologic parameters or transfusion requirements. Unexpectedly, the epoetin beta dose was reduced by almost one-third in patients previously maintained on SC epoetin. Conclusion: SC administration of this multidose epoetin beta formulation with the Reco-Pen ® device was well tolerated and effective. It is possible that the improved capacity to individualize dose may have contributed to the considerable reduction in SC epoetin beta dosage requirement.</description><identifier>ISSN: 1420-4096</identifier><identifier>EISSN: 1423-0143</identifier><identifier>DOI: 10.1159/000071885</identifier><identifier>PMID: 12886047</identifier><identifier>CODEN: RPBIEL</identifier><language>eng</language><publisher>Basel, Switzerland: S. Karger AG</publisher><subject>Adult ; Aged ; Anemia - blood ; Anemia - drug therapy ; Anemia - etiology ; Blood Transfusion ; Erythropoietin - administration & dosage ; Erythropoietin - adverse effects ; Erythropoietin - therapeutic use ; Female ; Hematocrit ; Hemoglobins - metabolism ; Humans ; Injections, Intravenous ; Injections, Subcutaneous ; Male ; Middle Aged ; Original Paper ; Recombinant Proteins ; Renal Insufficiency - complications ; Self Administration</subject><ispartof>Kidney & blood pressure research, 2003-01, Vol.26 (3), p.192-198</ispartof><rights>2003 S. Karger AG, Basel</rights><rights>Copyright 2003 S. Karger AG, Basel</rights><rights>Copyright S. Karger AG 2003</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c355t-21bc7ca53086688f533519af0ee31ec4e5e122d752427f4906ddfa3b5f541e83</citedby><cites>FETCH-LOGICAL-c355t-21bc7ca53086688f533519af0ee31ec4e5e122d752427f4906ddfa3b5f541e83</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,2423,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/12886047$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kleophas, W.</creatorcontrib><creatorcontrib>Kult, J.</creatorcontrib><creatorcontrib>Kreusser, W.</creatorcontrib><creatorcontrib>Piper, C.</creatorcontrib><creatorcontrib>Plache, H.</creatorcontrib><creatorcontrib>Wunderle, P.</creatorcontrib><creatorcontrib>Fiegel, V.</creatorcontrib><creatorcontrib>Härtl, W.</creatorcontrib><creatorcontrib>Collaborative Study Group</creatorcontrib><title>Tolerability and Efficacy of Multidose Epoetin Beta (Reco-Pen®) for Subcutaneous Administration in Patients with Anemia due to Renal Failure</title><title>Kidney & blood pressure research</title><addtitle>Kidney Blood Press Res</addtitle><description>Aims: To assess the tolerability, safety and efficacy of the epoetin beta multidose cartridge formulation, self-administered subcutaneously via a pen device (Reco-Pen ® ), in adult patients with renal anemia. Methods: Patients receiving maintenance epoetin therapy were switched to the subcutaneous (SC) multidose formulation of epoetin beta (NeoRecormon ® ). The frequency of adverse events, local tolerability, and changes in blood pressure and laboratory variables were recorded. Hematologic parameters, transfusion requirements and epoetin beta dosage were also assessed. Results: A total of 406 patients were entered in the intention-to-treat analysis. Mean treatment duration was 82.3 days. Fifty patients (12.3%) withdrew from the study; 14 (3.4%) discontinued because of adverse events. Treatment was well tolerated, with adverse events considered probably related to treatment in only 5 cases, and 1 case of local intolerability. There were no clinically significant changes in blood pressure or laboratory variables, and no changes in hematologic parameters or transfusion requirements. Unexpectedly, the epoetin beta dose was reduced by almost one-third in patients previously maintained on SC epoetin. Conclusion: SC administration of this multidose epoetin beta formulation with the Reco-Pen ® device was well tolerated and effective. It is possible that the improved capacity to individualize dose may have contributed to the considerable reduction in SC epoetin beta dosage requirement.</description><subject>Adult</subject><subject>Aged</subject><subject>Anemia - blood</subject><subject>Anemia - drug therapy</subject><subject>Anemia - etiology</subject><subject>Blood Transfusion</subject><subject>Erythropoietin - administration & dosage</subject><subject>Erythropoietin - adverse effects</subject><subject>Erythropoietin - therapeutic use</subject><subject>Female</subject><subject>Hematocrit</subject><subject>Hemoglobins - metabolism</subject><subject>Humans</subject><subject>Injections, Intravenous</subject><subject>Injections, Subcutaneous</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Original Paper</subject><subject>Recombinant Proteins</subject><subject>Renal Insufficiency - complications</subject><subject>Self Administration</subject><issn>1420-4096</issn><issn>1423-0143</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2003</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNpt0c1u1DAQB3ALgWgpHDgjIasHRA8BfybOcVttAVFEtew9cuwxuCTx4g-hfYi-Sh-CJyPtLkVC-OKR_JvRWH-EnlPyhlLZviXzaahS8gE6pILxilDBH97VpBKkrQ_Qk5SuZiUJYY_RAWVK1UQ0h-h6HQaIuveDz1usJ4uXznmjzRYHhz-VIXsbEuDlJkD2Ez6FrPHrFZhQXcL06-YEuxDxl9KbkvUEoSS8sKOffMpRZx8mPDddzhVMOeGfPn_DiwlGr7EtgHPAK5j0gM-1H0qEp-iR00OCZ_v7CK3Pl-uz99XF53cfzhYXleFS5orR3jRGS05UXSvlJOeSttoRAE7BCJBAGbONZII1TrSkttZp3ksnBQXFj9Cr3dhNDD8KpNyNPhkYht0PuoZLomR9C4__gVehxHnh1DEmKKlp287oZIdMDClFcN0m-lHHbUdJd5tPd5_PbF_uB5Z-BPtX7gOZwYsd-K7jV4j34E_78X9fP56u7kC3sY7_BvZMn68</recordid><startdate>20030101</startdate><enddate>20030101</enddate><creator>Kleophas, W.</creator><creator>Kult, J.</creator><creator>Kreusser, W.</creator><creator>Piper, C.</creator><creator>Plache, H.</creator><creator>Wunderle, P.</creator><creator>Fiegel, V.</creator><creator>Härtl, W.</creator><general>S. 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blood</topic><topic>Anemia - drug therapy</topic><topic>Anemia - etiology</topic><topic>Blood Transfusion</topic><topic>Erythropoietin - administration & dosage</topic><topic>Erythropoietin - adverse effects</topic><topic>Erythropoietin - therapeutic use</topic><topic>Female</topic><topic>Hematocrit</topic><topic>Hemoglobins - metabolism</topic><topic>Humans</topic><topic>Injections, Intravenous</topic><topic>Injections, Subcutaneous</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Original Paper</topic><topic>Recombinant Proteins</topic><topic>Renal Insufficiency - complications</topic><topic>Self Administration</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kleophas, W.</creatorcontrib><creatorcontrib>Kult, J.</creatorcontrib><creatorcontrib>Kreusser, W.</creatorcontrib><creatorcontrib>Piper, C.</creatorcontrib><creatorcontrib>Plache, H.</creatorcontrib><creatorcontrib>Wunderle, P.</creatorcontrib><creatorcontrib>Fiegel, V.</creatorcontrib><creatorcontrib>Härtl, W.</creatorcontrib><creatorcontrib>Collaborative Study Group</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Technology Research Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>ProQuest Central (New)</collection><collection>ProQuest One Academic (New)</collection><collection>ProQuest Health & Medical Research Collection</collection><collection>ProQuest One Academic Middle East (New)</collection><collection>ProQuest One Health & Nursing</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>SIRS Editorial</collection><collection>MEDLINE - Academic</collection><jtitle>Kidney & blood pressure research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kleophas, W.</au><au>Kult, J.</au><au>Kreusser, W.</au><au>Piper, C.</au><au>Plache, H.</au><au>Wunderle, P.</au><au>Fiegel, V.</au><au>Härtl, W.</au><aucorp>Collaborative Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Tolerability and Efficacy of Multidose Epoetin Beta (Reco-Pen®) for Subcutaneous Administration in Patients with Anemia due to Renal Failure</atitle><jtitle>Kidney & blood pressure research</jtitle><addtitle>Kidney Blood Press Res</addtitle><date>2003-01-01</date><risdate>2003</risdate><volume>26</volume><issue>3</issue><spage>192</spage><epage>198</epage><pages>192-198</pages><issn>1420-4096</issn><eissn>1423-0143</eissn><coden>RPBIEL</coden><abstract>Aims: To assess the tolerability, safety and efficacy of the epoetin beta multidose cartridge formulation, self-administered subcutaneously via a pen device (Reco-Pen ® ), in adult patients with renal anemia. Methods: Patients receiving maintenance epoetin therapy were switched to the subcutaneous (SC) multidose formulation of epoetin beta (NeoRecormon ® ). The frequency of adverse events, local tolerability, and changes in blood pressure and laboratory variables were recorded. Hematologic parameters, transfusion requirements and epoetin beta dosage were also assessed. Results: A total of 406 patients were entered in the intention-to-treat analysis. Mean treatment duration was 82.3 days. Fifty patients (12.3%) withdrew from the study; 14 (3.4%) discontinued because of adverse events. Treatment was well tolerated, with adverse events considered probably related to treatment in only 5 cases, and 1 case of local intolerability. There were no clinically significant changes in blood pressure or laboratory variables, and no changes in hematologic parameters or transfusion requirements. Unexpectedly, the epoetin beta dose was reduced by almost one-third in patients previously maintained on SC epoetin. Conclusion: SC administration of this multidose epoetin beta formulation with the Reco-Pen ® device was well tolerated and effective. It is possible that the improved capacity to individualize dose may have contributed to the considerable reduction in SC epoetin beta dosage requirement.</abstract><cop>Basel, Switzerland</cop><pub>S. Karger AG</pub><pmid>12886047</pmid><doi>10.1159/000071885</doi><tpages>7</tpages></addata></record> |
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| source | Karger Journals; MEDLINE |
| subjects | Adult Aged Anemia - blood Anemia - drug therapy Anemia - etiology Blood Transfusion Erythropoietin - administration & dosage Erythropoietin - adverse effects Erythropoietin - therapeutic use Female Hematocrit Hemoglobins - metabolism Humans Injections, Intravenous Injections, Subcutaneous Male Middle Aged Original Paper Recombinant Proteins Renal Insufficiency - complications Self Administration |
| title | Tolerability and Efficacy of Multidose Epoetin Beta (Reco-Pen®) for Subcutaneous Administration in Patients with Anemia due to Renal Failure |
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