Long-term albumin administration in decompensated cirrhosis (ANSWER): an open-label randomised trial
Evidence is scarce on the efficacy of long-term human albumin (HA) administration in patients with decompensated cirrhosis. The human Albumin for the treatmeNt of aScites in patients With hEpatic ciRrhosis (ANSWER) study was designed to clarify this issue. We did an investigator-initiated multicentr...
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| Veröffentlicht in: | The Lancet (British edition) 2018-06, Vol.391 (10138), p.2417-2429 |
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| creator | Caraceni, Paolo Riggio, Oliviero Angeli, Paolo Alessandria, Carlo Neri, Sergio Foschi, Francesco G Levantesi, Fabio Airoldi, Aldo Boccia, Sergio Svegliati-Baroni, Gianluca Fagiuoli, Stefano Romanelli, Roberto G Cozzolongo, Raffaele Di Marco, Vito Sangiovanni, Vincenzo Morisco, Filomena Toniutto, Pierluigi Tortora, Annalisa De Marco, Rosanna Angelico, Mario Cacciola, Irene Elia, Gianfranco Federico, Alessandro Massironi, Sara Guarisco, Riccardo Galioto, Alessandra Ballardini, Giorgio Rendina, Maria Nardelli, Silvia Piano, Salvatore Elia, Chiara Prestianni, Loredana Cappa, Federica Mirici Cesarini, Lucia Simone, Loredana Pasquale, Chiara Cavallin, Marta Andrealli, Alida Fidone, Federica Ruggeri, Matteo Roncadori, Andrea Baldassarre, Maurizio Tufoni, Manuel Zaccherini, Giacomo Bernardi, Mauro Domenicali, Marco Giannone, Ferdinando A Merli, Manuela Gioia, Stefania Fasolato, Silvano Sticca, Antonietta Campion, Daniela Risso, Alessandro Saracco, Giorgio M Maiorca, Daniela Rizzotto, Agostino Lanzi, Arianna Neri, Elga Visani, Anna Mastroianni, Antonio Alberti, Alberto B Mazzarelli, Chiara Vangeli, Marcello Marzioni, Marco Capretti, Francesca Kostandini, Alba Magini, Giulia Colpani, Maria Laffi, Giacomo Gabbani, Tommaso Marsico, Maria Zappimbulso, Marianna Petruzzi, Josè Calvaruso, Vincenza Parrella, Giovanni Caporaso, Nicola Auriemma, Francesco Guarino, Maria Pugliese, Fabio Gasbarrini, Antonio Leo, Pietro De Leonardis, Francesco Pecchioli, Alessandra Rossi, Piera Raimondo, Giovanni Negri, Elisa Dallio, Marcello Loguercio, Carmelina Conte, Dario Celli, Natascia Bringiotti, Roberto Castellaneta, Nicola M Salerno, Francesco |
| description | Evidence is scarce on the efficacy of long-term human albumin (HA) administration in patients with decompensated cirrhosis. The human Albumin for the treatmeNt of aScites in patients With hEpatic ciRrhosis (ANSWER) study was designed to clarify this issue.
We did an investigator-initiated multicentre randomised, parallel, open-label, pragmatic trial in 33 academic and non-academic Italian hospitals. We randomly assigned patients with cirrhosis and uncomplicated ascites who were treated with anti-aldosteronic drugs (≥200 mg/day) and furosemide (≥25 mg/day) to receive either standard medical treatment (SMT) or SMT plus HA (40 g twice weekly for 2 weeks, and then 40 g weekly) for up to 18 months. The primary endpoint was 18-month mortality, evaluated as difference of events and analysis of survival time in patients included in the modified intention-to-treat and per-protocol populations. This study is registered with EudraCT, number 2008–000625–19, and ClinicalTrials.gov, number NCT01288794.
From April 2, 2011, to May 27, 2015, 440 patients were randomly assigned and 431 were included in the modified intention-to-treat analysis. 38 of 218 patients died in the SMT plus HA group and 46 of 213 in the SMT group. Overall 18-month survival was significantly higher in the SMT plus HA than in the SMT group (Kaplan-Meier estimates 77% vs 66%; p=0·028), resulting in a 38% reduction in the mortality hazard ratio (0·62 [95% CI 0·40–0·95]). 46 (22%) patients in the SMT group and 49 (22%) in the SMT plus HA group had grade 3–4 non-liver related adverse events.
In this trial, long-term HA administration prolongs overall survival and might act as a disease modifying treatment in patients with decompensated cirrhosis.
Italian Medicine Agency. |
| doi_str_mv | 10.1016/S0140-6736(18)30840-7 |
| format | Article |
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Riggio, Oliviero ; Angeli, Paolo ; Alessandria, Carlo ; Neri, Sergio ; Foschi, Francesco G ; Levantesi, Fabio ; Airoldi, Aldo ; Boccia, Sergio ; Svegliati-Baroni, Gianluca ; Fagiuoli, Stefano ; Romanelli, Roberto G ; Cozzolongo, Raffaele ; Di Marco, Vito ; Sangiovanni, Vincenzo ; Morisco, Filomena ; Toniutto, Pierluigi ; Tortora, Annalisa ; De Marco, Rosanna ; Angelico, Mario ; Cacciola, Irene ; Elia, Gianfranco ; Federico, Alessandro ; Massironi, Sara ; Guarisco, Riccardo ; Galioto, Alessandra ; Ballardini, Giorgio ; Rendina, Maria ; Nardelli, Silvia ; Piano, Salvatore ; Elia, Chiara ; Prestianni, Loredana ; Cappa, Federica Mirici ; Cesarini, Lucia ; Simone, Loredana ; Pasquale, Chiara ; Cavallin, Marta ; Andrealli, Alida ; Fidone, Federica ; Ruggeri, Matteo ; Roncadori, Andrea ; Baldassarre, Maurizio ; Tufoni, Manuel ; Zaccherini, Giacomo ; Bernardi, Mauro ; Domenicali, Marco ; Giannone, Ferdinando A ; Merli, Manuela ; Gioia, Stefania ; Fasolato, Silvano ; Sticca, Antonietta ; Campion, Daniela ; Risso, Alessandro ; Saracco, Giorgio M ; Maiorca, Daniela ; Rizzotto, Agostino ; Lanzi, Arianna ; Neri, Elga ; Visani, Anna ; Mastroianni, Antonio ; Alberti, Alberto B ; Mazzarelli, Chiara ; Vangeli, Marcello ; Marzioni, Marco ; Capretti, Francesca ; Kostandini, Alba ; Magini, Giulia ; Colpani, Maria ; Laffi, Giacomo ; Gabbani, Tommaso ; Marsico, Maria ; Zappimbulso, Marianna ; Petruzzi, Josè ; Calvaruso, Vincenza ; Parrella, Giovanni ; Caporaso, Nicola ; Auriemma, Francesco ; Guarino, Maria ; Pugliese, Fabio ; Gasbarrini, Antonio ; Leo, Pietro ; De Leonardis, Francesco ; Pecchioli, Alessandra ; Rossi, Piera ; Raimondo, Giovanni ; Negri, Elisa ; Dallio, Marcello ; Loguercio, Carmelina ; Conte, Dario ; Celli, Natascia ; Bringiotti, Roberto ; Castellaneta, Nicola M ; Salerno, Francesco</creator><creatorcontrib>Caraceni, Paolo ; Riggio, Oliviero ; Angeli, Paolo ; Alessandria, Carlo ; Neri, Sergio ; Foschi, Francesco G ; Levantesi, Fabio ; Airoldi, Aldo ; Boccia, Sergio ; Svegliati-Baroni, Gianluca ; Fagiuoli, Stefano ; Romanelli, Roberto G ; Cozzolongo, Raffaele ; Di Marco, Vito ; Sangiovanni, Vincenzo ; Morisco, Filomena ; Toniutto, Pierluigi ; Tortora, Annalisa ; De Marco, Rosanna ; Angelico, Mario ; Cacciola, Irene ; Elia, Gianfranco ; Federico, Alessandro ; Massironi, Sara ; Guarisco, Riccardo ; Galioto, Alessandra ; Ballardini, Giorgio ; Rendina, Maria ; Nardelli, Silvia ; Piano, Salvatore ; Elia, Chiara ; Prestianni, Loredana ; Cappa, Federica Mirici ; Cesarini, Lucia ; Simone, Loredana ; Pasquale, Chiara ; Cavallin, Marta ; Andrealli, Alida ; Fidone, Federica ; Ruggeri, Matteo ; Roncadori, Andrea ; Baldassarre, Maurizio ; Tufoni, Manuel ; Zaccherini, Giacomo ; Bernardi, Mauro ; Domenicali, Marco ; Giannone, Ferdinando A ; Merli, Manuela ; Gioia, Stefania ; Fasolato, Silvano ; Sticca, Antonietta ; Campion, Daniela ; Risso, Alessandro ; Saracco, Giorgio M ; Maiorca, Daniela ; Rizzotto, Agostino ; Lanzi, Arianna ; Neri, Elga ; Visani, Anna ; Mastroianni, Antonio ; Alberti, Alberto B ; Mazzarelli, Chiara ; Vangeli, Marcello ; Marzioni, Marco ; Capretti, Francesca ; Kostandini, Alba ; Magini, Giulia ; Colpani, Maria ; Laffi, Giacomo ; Gabbani, Tommaso ; Marsico, Maria ; Zappimbulso, Marianna ; Petruzzi, Josè ; Calvaruso, Vincenza ; Parrella, Giovanni ; Caporaso, Nicola ; Auriemma, Francesco ; Guarino, Maria ; Pugliese, Fabio ; Gasbarrini, Antonio ; Leo, Pietro ; De Leonardis, Francesco ; Pecchioli, Alessandra ; Rossi, Piera ; Raimondo, Giovanni ; Negri, Elisa ; Dallio, Marcello ; Loguercio, Carmelina ; Conte, Dario ; Celli, Natascia ; Bringiotti, Roberto ; Castellaneta, Nicola M ; Salerno, Francesco ; ANSWER Study Investigators</creatorcontrib><description>Evidence is scarce on the efficacy of long-term human albumin (HA) administration in patients with decompensated cirrhosis. The human Albumin for the treatmeNt of aScites in patients With hEpatic ciRrhosis (ANSWER) study was designed to clarify this issue.
We did an investigator-initiated multicentre randomised, parallel, open-label, pragmatic trial in 33 academic and non-academic Italian hospitals. We randomly assigned patients with cirrhosis and uncomplicated ascites who were treated with anti-aldosteronic drugs (≥200 mg/day) and furosemide (≥25 mg/day) to receive either standard medical treatment (SMT) or SMT plus HA (40 g twice weekly for 2 weeks, and then 40 g weekly) for up to 18 months. The primary endpoint was 18-month mortality, evaluated as difference of events and analysis of survival time in patients included in the modified intention-to-treat and per-protocol populations. This study is registered with EudraCT, number 2008–000625–19, and ClinicalTrials.gov, number NCT01288794.
From April 2, 2011, to May 27, 2015, 440 patients were randomly assigned and 431 were included in the modified intention-to-treat analysis. 38 of 218 patients died in the SMT plus HA group and 46 of 213 in the SMT group. Overall 18-month survival was significantly higher in the SMT plus HA than in the SMT group (Kaplan-Meier estimates 77% vs 66%; p=0·028), resulting in a 38% reduction in the mortality hazard ratio (0·62 [95% CI 0·40–0·95]). 46 (22%) patients in the SMT group and 49 (22%) in the SMT plus HA group had grade 3–4 non-liver related adverse events.
In this trial, long-term HA administration prolongs overall survival and might act as a disease modifying treatment in patients with decompensated cirrhosis.
Italian Medicine Agency.</description><identifier>ISSN: 0140-6736</identifier><identifier>EISSN: 1474-547X</identifier><identifier>DOI: 10.1016/S0140-6736(18)30840-7</identifier><identifier>PMID: 29861076</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Aged ; Albumin ; Albumins - therapeutic use ; Ascites ; Ascites - etiology ; Ascites - therapy ; Bacterial infections ; Cirrhosis ; Clinical trials ; Cost analysis ; Diuretics - administration & dosage ; Diuretics - adverse effects ; Drug Therapy, Combination ; Evidence-based medicine ; Female ; Furosemide ; Furosemide - administration & dosage ; Furosemide - adverse effects ; Hospitals ; Humans ; Hyperkalemia - chemically induced ; Hyponatremia - chemically induced ; Kaplan-Meier Estimate ; Liver ; Liver cirrhosis ; Liver Cirrhosis - complications ; Liver Cirrhosis - drug therapy ; Liver Cirrhosis - physiopathology ; Male ; Medical prognosis ; Medical treatment ; Middle Aged ; Mineralocorticoid Receptor Antagonists - therapeutic use ; Mortality ; Motivation ; Paracentesis ; Patients ; Population studies ; Quality of Life ; Quality-Adjusted Life Years ; Randomization ; Survival ; Survival Rate ; Time Factors</subject><ispartof>The Lancet (British edition), 2018-06, Vol.391 (10138), p.2417-2429</ispartof><rights>2018 Elsevier Ltd</rights><rights>Copyright © 2018 Elsevier Ltd. All rights reserved.</rights><rights>Copyright Elsevier Limited Jun 16, 2018</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c492t-f2e411b0d58e7be0a3dea98fea8b046007033576b70f8c90ff7c0a9c83b728103</citedby><cites>FETCH-LOGICAL-c492t-f2e411b0d58e7be0a3dea98fea8b046007033576b70f8c90ff7c0a9c83b728103</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0140673618308407$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65534</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29861076$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Caraceni, Paolo</creatorcontrib><creatorcontrib>Riggio, Oliviero</creatorcontrib><creatorcontrib>Angeli, Paolo</creatorcontrib><creatorcontrib>Alessandria, Carlo</creatorcontrib><creatorcontrib>Neri, Sergio</creatorcontrib><creatorcontrib>Foschi, Francesco G</creatorcontrib><creatorcontrib>Levantesi, Fabio</creatorcontrib><creatorcontrib>Airoldi, Aldo</creatorcontrib><creatorcontrib>Boccia, Sergio</creatorcontrib><creatorcontrib>Svegliati-Baroni, Gianluca</creatorcontrib><creatorcontrib>Fagiuoli, Stefano</creatorcontrib><creatorcontrib>Romanelli, Roberto G</creatorcontrib><creatorcontrib>Cozzolongo, Raffaele</creatorcontrib><creatorcontrib>Di Marco, Vito</creatorcontrib><creatorcontrib>Sangiovanni, Vincenzo</creatorcontrib><creatorcontrib>Morisco, Filomena</creatorcontrib><creatorcontrib>Toniutto, Pierluigi</creatorcontrib><creatorcontrib>Tortora, Annalisa</creatorcontrib><creatorcontrib>De Marco, Rosanna</creatorcontrib><creatorcontrib>Angelico, Mario</creatorcontrib><creatorcontrib>Cacciola, Irene</creatorcontrib><creatorcontrib>Elia, Gianfranco</creatorcontrib><creatorcontrib>Federico, Alessandro</creatorcontrib><creatorcontrib>Massironi, Sara</creatorcontrib><creatorcontrib>Guarisco, Riccardo</creatorcontrib><creatorcontrib>Galioto, Alessandra</creatorcontrib><creatorcontrib>Ballardini, Giorgio</creatorcontrib><creatorcontrib>Rendina, Maria</creatorcontrib><creatorcontrib>Nardelli, Silvia</creatorcontrib><creatorcontrib>Piano, Salvatore</creatorcontrib><creatorcontrib>Elia, Chiara</creatorcontrib><creatorcontrib>Prestianni, Loredana</creatorcontrib><creatorcontrib>Cappa, Federica Mirici</creatorcontrib><creatorcontrib>Cesarini, Lucia</creatorcontrib><creatorcontrib>Simone, Loredana</creatorcontrib><creatorcontrib>Pasquale, Chiara</creatorcontrib><creatorcontrib>Cavallin, Marta</creatorcontrib><creatorcontrib>Andrealli, Alida</creatorcontrib><creatorcontrib>Fidone, Federica</creatorcontrib><creatorcontrib>Ruggeri, Matteo</creatorcontrib><creatorcontrib>Roncadori, Andrea</creatorcontrib><creatorcontrib>Baldassarre, Maurizio</creatorcontrib><creatorcontrib>Tufoni, Manuel</creatorcontrib><creatorcontrib>Zaccherini, Giacomo</creatorcontrib><creatorcontrib>Bernardi, Mauro</creatorcontrib><creatorcontrib>Domenicali, Marco</creatorcontrib><creatorcontrib>Giannone, Ferdinando A</creatorcontrib><creatorcontrib>Merli, Manuela</creatorcontrib><creatorcontrib>Gioia, Stefania</creatorcontrib><creatorcontrib>Fasolato, Silvano</creatorcontrib><creatorcontrib>Sticca, Antonietta</creatorcontrib><creatorcontrib>Campion, Daniela</creatorcontrib><creatorcontrib>Risso, Alessandro</creatorcontrib><creatorcontrib>Saracco, Giorgio M</creatorcontrib><creatorcontrib>Maiorca, Daniela</creatorcontrib><creatorcontrib>Rizzotto, Agostino</creatorcontrib><creatorcontrib>Lanzi, Arianna</creatorcontrib><creatorcontrib>Neri, Elga</creatorcontrib><creatorcontrib>Visani, Anna</creatorcontrib><creatorcontrib>Mastroianni, Antonio</creatorcontrib><creatorcontrib>Alberti, Alberto B</creatorcontrib><creatorcontrib>Mazzarelli, Chiara</creatorcontrib><creatorcontrib>Vangeli, Marcello</creatorcontrib><creatorcontrib>Marzioni, Marco</creatorcontrib><creatorcontrib>Capretti, Francesca</creatorcontrib><creatorcontrib>Kostandini, Alba</creatorcontrib><creatorcontrib>Magini, Giulia</creatorcontrib><creatorcontrib>Colpani, Maria</creatorcontrib><creatorcontrib>Laffi, Giacomo</creatorcontrib><creatorcontrib>Gabbani, Tommaso</creatorcontrib><creatorcontrib>Marsico, Maria</creatorcontrib><creatorcontrib>Zappimbulso, Marianna</creatorcontrib><creatorcontrib>Petruzzi, Josè</creatorcontrib><creatorcontrib>Calvaruso, Vincenza</creatorcontrib><creatorcontrib>Parrella, Giovanni</creatorcontrib><creatorcontrib>Caporaso, Nicola</creatorcontrib><creatorcontrib>Auriemma, Francesco</creatorcontrib><creatorcontrib>Guarino, Maria</creatorcontrib><creatorcontrib>Pugliese, Fabio</creatorcontrib><creatorcontrib>Gasbarrini, Antonio</creatorcontrib><creatorcontrib>Leo, Pietro</creatorcontrib><creatorcontrib>De Leonardis, Francesco</creatorcontrib><creatorcontrib>Pecchioli, Alessandra</creatorcontrib><creatorcontrib>Rossi, Piera</creatorcontrib><creatorcontrib>Raimondo, Giovanni</creatorcontrib><creatorcontrib>Negri, Elisa</creatorcontrib><creatorcontrib>Dallio, Marcello</creatorcontrib><creatorcontrib>Loguercio, Carmelina</creatorcontrib><creatorcontrib>Conte, Dario</creatorcontrib><creatorcontrib>Celli, Natascia</creatorcontrib><creatorcontrib>Bringiotti, Roberto</creatorcontrib><creatorcontrib>Castellaneta, Nicola M</creatorcontrib><creatorcontrib>Salerno, Francesco</creatorcontrib><creatorcontrib>ANSWER Study Investigators</creatorcontrib><title>Long-term albumin administration in decompensated cirrhosis (ANSWER): an open-label randomised trial</title><title>The Lancet (British edition)</title><addtitle>Lancet</addtitle><description>Evidence is scarce on the efficacy of long-term human albumin (HA) administration in patients with decompensated cirrhosis. The human Albumin for the treatmeNt of aScites in patients With hEpatic ciRrhosis (ANSWER) study was designed to clarify this issue.
We did an investigator-initiated multicentre randomised, parallel, open-label, pragmatic trial in 33 academic and non-academic Italian hospitals. We randomly assigned patients with cirrhosis and uncomplicated ascites who were treated with anti-aldosteronic drugs (≥200 mg/day) and furosemide (≥25 mg/day) to receive either standard medical treatment (SMT) or SMT plus HA (40 g twice weekly for 2 weeks, and then 40 g weekly) for up to 18 months. The primary endpoint was 18-month mortality, evaluated as difference of events and analysis of survival time in patients included in the modified intention-to-treat and per-protocol populations. This study is registered with EudraCT, number 2008–000625–19, and ClinicalTrials.gov, number NCT01288794.
From April 2, 2011, to May 27, 2015, 440 patients were randomly assigned and 431 were included in the modified intention-to-treat analysis. 38 of 218 patients died in the SMT plus HA group and 46 of 213 in the SMT group. Overall 18-month survival was significantly higher in the SMT plus HA than in the SMT group (Kaplan-Meier estimates 77% vs 66%; p=0·028), resulting in a 38% reduction in the mortality hazard ratio (0·62 [95% CI 0·40–0·95]). 46 (22%) patients in the SMT group and 49 (22%) in the SMT plus HA group had grade 3–4 non-liver related adverse events.
In this trial, long-term HA administration prolongs overall survival and might act as a disease modifying treatment in patients with decompensated cirrhosis.
Italian Medicine Agency.</description><subject>Aged</subject><subject>Albumin</subject><subject>Albumins - therapeutic use</subject><subject>Ascites</subject><subject>Ascites - etiology</subject><subject>Ascites - therapy</subject><subject>Bacterial infections</subject><subject>Cirrhosis</subject><subject>Clinical trials</subject><subject>Cost analysis</subject><subject>Diuretics - administration & dosage</subject><subject>Diuretics - adverse effects</subject><subject>Drug Therapy, Combination</subject><subject>Evidence-based medicine</subject><subject>Female</subject><subject>Furosemide</subject><subject>Furosemide - administration & dosage</subject><subject>Furosemide - adverse effects</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Hyperkalemia - chemically induced</subject><subject>Hyponatremia - chemically induced</subject><subject>Kaplan-Meier Estimate</subject><subject>Liver</subject><subject>Liver cirrhosis</subject><subject>Liver Cirrhosis - complications</subject><subject>Liver Cirrhosis - drug therapy</subject><subject>Liver Cirrhosis - physiopathology</subject><subject>Male</subject><subject>Medical prognosis</subject><subject>Medical treatment</subject><subject>Middle Aged</subject><subject>Mineralocorticoid Receptor Antagonists - therapeutic use</subject><subject>Mortality</subject><subject>Motivation</subject><subject>Paracentesis</subject><subject>Patients</subject><subject>Population studies</subject><subject>Quality of Life</subject><subject>Quality-Adjusted Life Years</subject><subject>Randomization</subject><subject>Survival</subject><subject>Survival Rate</subject><subject>Time 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albumin administration in decompensated cirrhosis (ANSWER): an open-label randomised trial</title><author>Caraceni, Paolo ; Riggio, Oliviero ; Angeli, Paolo ; Alessandria, Carlo ; Neri, Sergio ; Foschi, Francesco G ; Levantesi, Fabio ; Airoldi, Aldo ; Boccia, Sergio ; Svegliati-Baroni, Gianluca ; Fagiuoli, Stefano ; Romanelli, Roberto G ; Cozzolongo, Raffaele ; Di Marco, Vito ; Sangiovanni, Vincenzo ; Morisco, Filomena ; Toniutto, Pierluigi ; Tortora, Annalisa ; De Marco, Rosanna ; Angelico, Mario ; Cacciola, Irene ; Elia, Gianfranco ; Federico, Alessandro ; Massironi, Sara ; Guarisco, Riccardo ; Galioto, Alessandra ; Ballardini, Giorgio ; Rendina, Maria ; Nardelli, Silvia ; Piano, Salvatore ; Elia, Chiara ; Prestianni, Loredana ; Cappa, Federica Mirici ; Cesarini, Lucia ; Simone, Loredana ; Pasquale, Chiara ; Cavallin, Marta ; Andrealli, Alida ; Fidone, Federica ; Ruggeri, Matteo ; Roncadori, Andrea ; Baldassarre, Maurizio ; Tufoni, Manuel ; Zaccherini, Giacomo ; Bernardi, Mauro ; Domenicali, Marco ; Giannone, Ferdinando A ; Merli, Manuela ; Gioia, Stefania ; Fasolato, Silvano ; Sticca, Antonietta ; Campion, Daniela ; Risso, Alessandro ; Saracco, Giorgio M ; Maiorca, Daniela ; Rizzotto, Agostino ; Lanzi, Arianna ; Neri, Elga ; Visani, Anna ; Mastroianni, Antonio ; Alberti, Alberto B ; Mazzarelli, Chiara ; Vangeli, Marcello ; Marzioni, Marco ; Capretti, Francesca ; Kostandini, Alba ; Magini, Giulia ; Colpani, Maria ; Laffi, Giacomo ; Gabbani, Tommaso ; Marsico, Maria ; Zappimbulso, Marianna ; Petruzzi, Josè ; Calvaruso, Vincenza ; Parrella, Giovanni ; Caporaso, Nicola ; Auriemma, Francesco ; Guarino, Maria ; Pugliese, Fabio ; Gasbarrini, Antonio ; Leo, Pietro ; De Leonardis, Francesco ; Pecchioli, Alessandra ; Rossi, Piera ; Raimondo, Giovanni ; Negri, Elisa ; Dallio, Marcello ; Loguercio, Carmelina ; Conte, Dario ; Celli, Natascia ; Bringiotti, Roberto ; Castellaneta, Nicola M ; Salerno, Francesco</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c492t-f2e411b0d58e7be0a3dea98fea8b046007033576b70f8c90ff7c0a9c83b728103</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Aged</topic><topic>Albumin</topic><topic>Albumins - therapeutic use</topic><topic>Ascites</topic><topic>Ascites - etiology</topic><topic>Ascites - therapy</topic><topic>Bacterial infections</topic><topic>Cirrhosis</topic><topic>Clinical trials</topic><topic>Cost analysis</topic><topic>Diuretics - administration & dosage</topic><topic>Diuretics - adverse effects</topic><topic>Drug Therapy, Combination</topic><topic>Evidence-based medicine</topic><topic>Female</topic><topic>Furosemide</topic><topic>Furosemide - administration & dosage</topic><topic>Furosemide - adverse effects</topic><topic>Hospitals</topic><topic>Humans</topic><topic>Hyperkalemia - chemically induced</topic><topic>Hyponatremia - chemically induced</topic><topic>Kaplan-Meier Estimate</topic><topic>Liver</topic><topic>Liver cirrhosis</topic><topic>Liver Cirrhosis - complications</topic><topic>Liver Cirrhosis - drug therapy</topic><topic>Liver Cirrhosis - physiopathology</topic><topic>Male</topic><topic>Medical prognosis</topic><topic>Medical treatment</topic><topic>Middle Aged</topic><topic>Mineralocorticoid Receptor Antagonists - therapeutic use</topic><topic>Mortality</topic><topic>Motivation</topic><topic>Paracentesis</topic><topic>Patients</topic><topic>Population studies</topic><topic>Quality of Life</topic><topic>Quality-Adjusted Life Years</topic><topic>Randomization</topic><topic>Survival</topic><topic>Survival Rate</topic><topic>Time Factors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Caraceni, Paolo</creatorcontrib><creatorcontrib>Riggio, Oliviero</creatorcontrib><creatorcontrib>Angeli, Paolo</creatorcontrib><creatorcontrib>Alessandria, 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Basic</collection><collection>SIRS Editorial</collection><collection>MEDLINE - Academic</collection><jtitle>The Lancet (British edition)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Caraceni, Paolo</au><au>Riggio, Oliviero</au><au>Angeli, Paolo</au><au>Alessandria, Carlo</au><au>Neri, Sergio</au><au>Foschi, Francesco G</au><au>Levantesi, Fabio</au><au>Airoldi, Aldo</au><au>Boccia, Sergio</au><au>Svegliati-Baroni, Gianluca</au><au>Fagiuoli, Stefano</au><au>Romanelli, Roberto G</au><au>Cozzolongo, Raffaele</au><au>Di Marco, Vito</au><au>Sangiovanni, Vincenzo</au><au>Morisco, Filomena</au><au>Toniutto, Pierluigi</au><au>Tortora, Annalisa</au><au>De Marco, Rosanna</au><au>Angelico, Mario</au><au>Cacciola, Irene</au><au>Elia, Gianfranco</au><au>Federico, Alessandro</au><au>Massironi, Sara</au><au>Guarisco, Riccardo</au><au>Galioto, Alessandra</au><au>Ballardini, Giorgio</au><au>Rendina, Maria</au><au>Nardelli, Silvia</au><au>Piano, Salvatore</au><au>Elia, Chiara</au><au>Prestianni, Loredana</au><au>Cappa, Federica Mirici</au><au>Cesarini, Lucia</au><au>Simone, Loredana</au><au>Pasquale, Chiara</au><au>Cavallin, Marta</au><au>Andrealli, Alida</au><au>Fidone, Federica</au><au>Ruggeri, Matteo</au><au>Roncadori, Andrea</au><au>Baldassarre, Maurizio</au><au>Tufoni, Manuel</au><au>Zaccherini, Giacomo</au><au>Bernardi, Mauro</au><au>Domenicali, Marco</au><au>Giannone, Ferdinando A</au><au>Merli, Manuela</au><au>Gioia, Stefania</au><au>Fasolato, Silvano</au><au>Sticca, Antonietta</au><au>Campion, Daniela</au><au>Risso, Alessandro</au><au>Saracco, Giorgio M</au><au>Maiorca, Daniela</au><au>Rizzotto, Agostino</au><au>Lanzi, Arianna</au><au>Neri, Elga</au><au>Visani, Anna</au><au>Mastroianni, Antonio</au><au>Alberti, Alberto B</au><au>Mazzarelli, Chiara</au><au>Vangeli, Marcello</au><au>Marzioni, Marco</au><au>Capretti, Francesca</au><au>Kostandini, Alba</au><au>Magini, Giulia</au><au>Colpani, Maria</au><au>Laffi, Giacomo</au><au>Gabbani, Tommaso</au><au>Marsico, Maria</au><au>Zappimbulso, Marianna</au><au>Petruzzi, Josè</au><au>Calvaruso, Vincenza</au><au>Parrella, Giovanni</au><au>Caporaso, Nicola</au><au>Auriemma, Francesco</au><au>Guarino, Maria</au><au>Pugliese, Fabio</au><au>Gasbarrini, Antonio</au><au>Leo, Pietro</au><au>De Leonardis, Francesco</au><au>Pecchioli, Alessandra</au><au>Rossi, Piera</au><au>Raimondo, Giovanni</au><au>Negri, Elisa</au><au>Dallio, Marcello</au><au>Loguercio, Carmelina</au><au>Conte, Dario</au><au>Celli, Natascia</au><au>Bringiotti, Roberto</au><au>Castellaneta, Nicola M</au><au>Salerno, Francesco</au><aucorp>ANSWER Study Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Long-term albumin administration in decompensated cirrhosis (ANSWER): an open-label randomised trial</atitle><jtitle>The Lancet (British edition)</jtitle><addtitle>Lancet</addtitle><date>2018-06-16</date><risdate>2018</risdate><volume>391</volume><issue>10138</issue><spage>2417</spage><epage>2429</epage><pages>2417-2429</pages><issn>0140-6736</issn><eissn>1474-547X</eissn><abstract>Evidence is scarce on the efficacy of long-term human albumin (HA) administration in patients with decompensated cirrhosis. The human Albumin for the treatmeNt of aScites in patients With hEpatic ciRrhosis (ANSWER) study was designed to clarify this issue.
We did an investigator-initiated multicentre randomised, parallel, open-label, pragmatic trial in 33 academic and non-academic Italian hospitals. We randomly assigned patients with cirrhosis and uncomplicated ascites who were treated with anti-aldosteronic drugs (≥200 mg/day) and furosemide (≥25 mg/day) to receive either standard medical treatment (SMT) or SMT plus HA (40 g twice weekly for 2 weeks, and then 40 g weekly) for up to 18 months. The primary endpoint was 18-month mortality, evaluated as difference of events and analysis of survival time in patients included in the modified intention-to-treat and per-protocol populations. This study is registered with EudraCT, number 2008–000625–19, and ClinicalTrials.gov, number NCT01288794.
From April 2, 2011, to May 27, 2015, 440 patients were randomly assigned and 431 were included in the modified intention-to-treat analysis. 38 of 218 patients died in the SMT plus HA group and 46 of 213 in the SMT group. Overall 18-month survival was significantly higher in the SMT plus HA than in the SMT group (Kaplan-Meier estimates 77% vs 66%; p=0·028), resulting in a 38% reduction in the mortality hazard ratio (0·62 [95% CI 0·40–0·95]). 46 (22%) patients in the SMT group and 49 (22%) in the SMT plus HA group had grade 3–4 non-liver related adverse events.
In this trial, long-term HA administration prolongs overall survival and might act as a disease modifying treatment in patients with decompensated cirrhosis.
Italian Medicine Agency.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>29861076</pmid><doi>10.1016/S0140-6736(18)30840-7</doi><tpages>13</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0140-6736 |
| ispartof | The Lancet (British edition), 2018-06, Vol.391 (10138), p.2417-2429 |
| issn | 0140-6736 1474-547X |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2049936002 |
| source | MEDLINE; Elsevier ScienceDirect Journals Complete |
| subjects | Aged Albumin Albumins - therapeutic use Ascites Ascites - etiology Ascites - therapy Bacterial infections Cirrhosis Clinical trials Cost analysis Diuretics - administration & dosage Diuretics - adverse effects Drug Therapy, Combination Evidence-based medicine Female Furosemide Furosemide - administration & dosage Furosemide - adverse effects Hospitals Humans Hyperkalemia - chemically induced Hyponatremia - chemically induced Kaplan-Meier Estimate Liver Liver cirrhosis Liver Cirrhosis - complications Liver Cirrhosis - drug therapy Liver Cirrhosis - physiopathology Male Medical prognosis Medical treatment Middle Aged Mineralocorticoid Receptor Antagonists - therapeutic use Mortality Motivation Paracentesis Patients Population studies Quality of Life Quality-Adjusted Life Years Randomization Survival Survival Rate Time Factors |
| title | Long-term albumin administration in decompensated cirrhosis (ANSWER): an open-label randomised trial |
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