High versus standard dose methylprednisolone in the acute phase of idiopathic thrombotic thrombocytopenic purpura: a randomized study
Therapeutic plasma exchange (PE) is the accepted therapy for thrombotic thrombocytopenic purpura (TTP). Because not all patients achieve remission, other treatment modalities have been used in addition to PE, but no randomized clinical trial evaluated their efficacy. The aim of this multicentric stu...
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Veröffentlicht in: | Annals of hematology 2010-06, Vol.89 (6), p.591-596 |
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creator | Balduini, Carlo L Gugliotta, Luigi Luppi, Mario Laurenti, Luca Klersy, Catherine Pieresca, Carla Quintini, Gerlando Iuliano, Francesco Re, Rossana Spedini, Pierangelo Vianelli, Nicola Zaccaria, Alfonso Pogliani, Enrico Maria Musso, Roberto Bobbio Pallavicini, Enrico Quarta, Giovanni Galieni, Piero Fragasso, Alberto Casella, Gianluca Noris, Patrizia Ascari, Edoardo |
description | Therapeutic plasma exchange (PE) is the accepted therapy for thrombotic thrombocytopenic purpura (TTP). Because not all patients achieve remission, other treatment modalities have been used in addition to PE, but no randomized clinical trial evaluated their efficacy. The aim of this multicentric study was to compare the effectiveness of standard- versus high-dose methylprednisolone as an adjunctive treatment to PE in the acute phase of TTP. Sixty patients with idiopathic TTP were randomized to receive methylprednisolone 1 mg/kg/die intravenous or 10 mg/kg/die for 3 days, thereafter, 2.5 mg/kg/die in addition to PE. Both dosages of steroids were well tolerated. At the end of induction therapy (day 23), the percentage of patients failing to achieve complete remission was significantly higher in the standard dose (16 of 30) than in the high-dose group (seven of 30). Also, the number of cases without a good response at day 9 and the number of deaths were higher in the standard-dose arm, but the differences did not reach the statistical significance. Results of present study indicate that the association of PE with high-dose instead of standard-dose steroids reduces the percentage of TTP patients that fail to achieve complete remission. |
doi_str_mv | 10.1007/s00277-009-0877-5 |
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Because not all patients achieve remission, other treatment modalities have been used in addition to PE, but no randomized clinical trial evaluated their efficacy. The aim of this multicentric study was to compare the effectiveness of standard- versus high-dose methylprednisolone as an adjunctive treatment to PE in the acute phase of TTP. Sixty patients with idiopathic TTP were randomized to receive methylprednisolone 1 mg/kg/die intravenous or 10 mg/kg/die for 3 days, thereafter, 2.5 mg/kg/die in addition to PE. Both dosages of steroids were well tolerated. At the end of induction therapy (day 23), the percentage of patients failing to achieve complete remission was significantly higher in the standard dose (16 of 30) than in the high-dose group (seven of 30). Also, the number of cases without a good response at day 9 and the number of deaths were higher in the standard-dose arm, but the differences did not reach the statistical significance. Results of present study indicate that the association of PE with high-dose instead of standard-dose steroids reduces the percentage of TTP patients that fail to achieve complete remission.</description><identifier>ISSN: 0939-5555</identifier><identifier>EISSN: 1432-0584</identifier><identifier>DOI: 10.1007/s00277-009-0877-5</identifier><identifier>PMID: 20033409</identifier><language>eng</language><publisher>Berlin/Heidelberg: Berlin/Heidelberg : Springer-Verlag</publisher><subject>Acute-Phase Reaction - drug therapy ; Acute-Phase Reaction - mortality ; Adult ; Anti-Inflammatory Agents - administration & dosage ; Dose-Response Relationship, Drug ; Female ; Hematology ; Humans ; Male ; Medicine ; Medicine & Public Health ; Methylprednisolone - administration & dosage ; Middle Aged ; Oncology ; Original Article ; Purpura, Thrombocytopenic, Idiopathic - drug therapy ; Purpura, Thrombocytopenic, Idiopathic - immunology ; Purpura, Thrombocytopenic, Idiopathic - mortality ; Survival Analysis ; Treatment Outcome</subject><ispartof>Annals of hematology, 2010-06, Vol.89 (6), p.591-596</ispartof><rights>Springer-Verlag 2009</rights><rights>Springer-Verlag 2010</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c537t-9285156ebb764956f7fc8868a89fbacfe50238e51618516eec72730ec32275573</citedby><cites>FETCH-LOGICAL-c537t-9285156ebb764956f7fc8868a89fbacfe50238e51618516eec72730ec32275573</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00277-009-0877-5$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00277-009-0877-5$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>230,314,776,780,881,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20033409$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://hal.science/hal-00494349$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Balduini, Carlo L</creatorcontrib><creatorcontrib>Gugliotta, Luigi</creatorcontrib><creatorcontrib>Luppi, Mario</creatorcontrib><creatorcontrib>Laurenti, Luca</creatorcontrib><creatorcontrib>Klersy, Catherine</creatorcontrib><creatorcontrib>Pieresca, Carla</creatorcontrib><creatorcontrib>Quintini, Gerlando</creatorcontrib><creatorcontrib>Iuliano, Francesco</creatorcontrib><creatorcontrib>Re, Rossana</creatorcontrib><creatorcontrib>Spedini, Pierangelo</creatorcontrib><creatorcontrib>Vianelli, Nicola</creatorcontrib><creatorcontrib>Zaccaria, Alfonso</creatorcontrib><creatorcontrib>Pogliani, Enrico Maria</creatorcontrib><creatorcontrib>Musso, Roberto</creatorcontrib><creatorcontrib>Bobbio Pallavicini, Enrico</creatorcontrib><creatorcontrib>Quarta, Giovanni</creatorcontrib><creatorcontrib>Galieni, Piero</creatorcontrib><creatorcontrib>Fragasso, Alberto</creatorcontrib><creatorcontrib>Casella, Gianluca</creatorcontrib><creatorcontrib>Noris, Patrizia</creatorcontrib><creatorcontrib>Ascari, Edoardo</creatorcontrib><creatorcontrib>Italian TTP Study Group</creatorcontrib><creatorcontrib>The Italian TTP Study Group</creatorcontrib><title>High versus standard dose methylprednisolone in the acute phase of idiopathic thrombotic thrombocytopenic purpura: a randomized study</title><title>Annals of hematology</title><addtitle>Ann Hematol</addtitle><addtitle>Ann Hematol</addtitle><description>Therapeutic plasma exchange (PE) is the accepted therapy for thrombotic thrombocytopenic purpura (TTP). Because not all patients achieve remission, other treatment modalities have been used in addition to PE, but no randomized clinical trial evaluated their efficacy. The aim of this multicentric study was to compare the effectiveness of standard- versus high-dose methylprednisolone as an adjunctive treatment to PE in the acute phase of TTP. Sixty patients with idiopathic TTP were randomized to receive methylprednisolone 1 mg/kg/die intravenous or 10 mg/kg/die for 3 days, thereafter, 2.5 mg/kg/die in addition to PE. Both dosages of steroids were well tolerated. At the end of induction therapy (day 23), the percentage of patients failing to achieve complete remission was significantly higher in the standard dose (16 of 30) than in the high-dose group (seven of 30). Also, the number of cases without a good response at day 9 and the number of deaths were higher in the standard-dose arm, but the differences did not reach the statistical significance. Results of present study indicate that the association of PE with high-dose instead of standard-dose steroids reduces the percentage of TTP patients that fail to achieve complete remission.</description><subject>Acute-Phase Reaction - drug therapy</subject><subject>Acute-Phase Reaction - mortality</subject><subject>Adult</subject><subject>Anti-Inflammatory Agents - administration & dosage</subject><subject>Dose-Response Relationship, Drug</subject><subject>Female</subject><subject>Hematology</subject><subject>Humans</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Methylprednisolone - administration & dosage</subject><subject>Middle Aged</subject><subject>Oncology</subject><subject>Original Article</subject><subject>Purpura, Thrombocytopenic, Idiopathic - drug therapy</subject><subject>Purpura, Thrombocytopenic, Idiopathic - immunology</subject><subject>Purpura, Thrombocytopenic, Idiopathic - mortality</subject><subject>Survival Analysis</subject><subject>Treatment Outcome</subject><issn>0939-5555</issn><issn>1432-0584</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp9kU1v1DAQhiMEokvhB3ABiwvqITD-im1uVQVdpJU4QM-WN5lsXCVxsJNKy53_jVcprcQBy5JHM8_Ma_stitcUPlAA9TEBMKVKAFOCzoF8Umyo4KwEqcXTYgOGm1LmdVa8SOkWgDIt2PPijAFwLsBsit9bf-jIHca0JJJmNzYuNqQJCcmAc3fsp4jN6FPow4jEj2TukLh6mZFMnctUaIlvfJjc3Pk6V2MY9mF-DOvjHCYcc2JaYt7uE3EkZp0w-F_YZM2lOb4snrWuT_jq_jwvbr58_nG1LXffrr9eXe7KWnI1l4ZpSWWF-72qhJFVq9pa60o7bdq9q1uUwLhGSSuawQqxVkxxwJozpqRU_Ly4WOd2rrdT9IOLRxuct9vLnT3lAIQRXJg7mtn3KzvF8HPBNNvBpxr73o0YlmQV59oAoyyT7_4hb8MSx_wQy6hhUghhMkRXqI4hpYjtgz4Fe3LTrm7mKxh7ctPK3PPmfvCyH7B56PhrXwbYCqRcGg8YH5X_N_Xt2tS6YN0h-mRvvjOgHKhmRuQf-wP9t7RV</recordid><startdate>20100601</startdate><enddate>20100601</enddate><creator>Balduini, Carlo L</creator><creator>Gugliotta, Luigi</creator><creator>Luppi, Mario</creator><creator>Laurenti, Luca</creator><creator>Klersy, Catherine</creator><creator>Pieresca, Carla</creator><creator>Quintini, Gerlando</creator><creator>Iuliano, Francesco</creator><creator>Re, Rossana</creator><creator>Spedini, Pierangelo</creator><creator>Vianelli, Nicola</creator><creator>Zaccaria, Alfonso</creator><creator>Pogliani, Enrico Maria</creator><creator>Musso, Roberto</creator><creator>Bobbio Pallavicini, Enrico</creator><creator>Quarta, Giovanni</creator><creator>Galieni, Piero</creator><creator>Fragasso, Alberto</creator><creator>Casella, Gianluca</creator><creator>Noris, Patrizia</creator><creator>Ascari, Edoardo</creator><general>Berlin/Heidelberg : Springer-Verlag</general><general>Springer-Verlag</general><general>Springer Nature B.V</general><general>Springer Verlag</general><scope>FBQ</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>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>1XC</scope><scope>VOOES</scope></search><sort><creationdate>20100601</creationdate><title>High versus standard dose methylprednisolone in the acute phase of idiopathic thrombotic thrombocytopenic purpura: a randomized study</title><author>Balduini, Carlo L ; Gugliotta, Luigi ; Luppi, Mario ; Laurenti, Luca ; Klersy, Catherine ; Pieresca, Carla ; Quintini, Gerlando ; Iuliano, Francesco ; Re, Rossana ; Spedini, Pierangelo ; Vianelli, Nicola ; Zaccaria, Alfonso ; Pogliani, Enrico Maria ; Musso, Roberto ; Bobbio Pallavicini, Enrico ; Quarta, Giovanni ; Galieni, Piero ; Fragasso, Alberto ; Casella, Gianluca ; Noris, Patrizia ; Ascari, Edoardo</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c537t-9285156ebb764956f7fc8868a89fbacfe50238e51618516eec72730ec32275573</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Acute-Phase Reaction - 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Because not all patients achieve remission, other treatment modalities have been used in addition to PE, but no randomized clinical trial evaluated their efficacy. The aim of this multicentric study was to compare the effectiveness of standard- versus high-dose methylprednisolone as an adjunctive treatment to PE in the acute phase of TTP. Sixty patients with idiopathic TTP were randomized to receive methylprednisolone 1 mg/kg/die intravenous or 10 mg/kg/die for 3 days, thereafter, 2.5 mg/kg/die in addition to PE. Both dosages of steroids were well tolerated. At the end of induction therapy (day 23), the percentage of patients failing to achieve complete remission was significantly higher in the standard dose (16 of 30) than in the high-dose group (seven of 30). Also, the number of cases without a good response at day 9 and the number of deaths were higher in the standard-dose arm, but the differences did not reach the statistical significance. 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subjects | Acute-Phase Reaction - drug therapy Acute-Phase Reaction - mortality Adult Anti-Inflammatory Agents - administration & dosage Dose-Response Relationship, Drug Female Hematology Humans Male Medicine Medicine & Public Health Methylprednisolone - administration & dosage Middle Aged Oncology Original Article Purpura, Thrombocytopenic, Idiopathic - drug therapy Purpura, Thrombocytopenic, Idiopathic - immunology Purpura, Thrombocytopenic, Idiopathic - mortality Survival Analysis Treatment Outcome |
title | High versus standard dose methylprednisolone in the acute phase of idiopathic thrombotic thrombocytopenic purpura: a randomized study |
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