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1. Long-term albumin improves the outcomes of patients with decompensated cirrhosis and diabetes mellitus: Post hoc analysis of the ANSWER trial

Author

Pompili, E, Baldassarre, M, Iannone, G, Tedesco, G, Nardelli, S, Piano, S, Alessandria, C, Neri, S, Foschi, F, Levantesi, F, Caraceni, P, Bernardi, M, Zaccherini, G, Domenicali, M, Giannone, F, Antognoli, A, Riggio, O, Merli, M, Pasquale, C, Gioia, S, Angeli, P, Fasolato, S, Sticca, A, Cavallin, M, Campion, D, Risso, A, Andrealli, A, Saracco, G, Prestianni, L, Fidone, F, Maiorca, D, Rizzotto, A, Cappa, F, Lanzi, A, Neri, E, Visani, A, Mastroianni, A, Airoldi, A, Perricone, G, Alberti, A, Cesarini, L, Mazzarelli, C, Vangeli, M, Vigano, R, Svegliati-Baroni, G, Marzioni, M, Capretti, F, Kostandini, A, Fagiuoli, S, Magini, G, Colpani, M, Laffi, G, Gabbani, T, Marsico, M, Cozzolongo, R, Zappimbulso, M, Petruzzi, J, Di Marco, V, Calvaruso, V, Sangiovanni, V, Parrella, G, Caporaso, N, Morisco, F, Auriemma, F, Guarino, M, Toniutto, P, Pugliese, F, Gasbarrini, A, Tortora, A, Leo, P, De Marco, R, Angelico, M, De Leonardis, F, Pecchioli, A, Rossi, P, Raimondo, G, Cacciola, I, Elia, G, Negri, E, Dallio, M, Loguercio, C, Federico, A, Conte, D, Massironi, S, Ballardini, G, Celli, N, Rendina, M, Bringiotti, R, Castellaneta, N, Salerno, F, Boccia, S, Simone, L, Guarisco, R, Galioto, A, Pompili E., Baldassarre M., Iannone G., Tedesco G., Nardelli S., Piano S., Alessandria C., Neri S., Foschi F. G., Levantesi F., Caraceni P., Bernardi M., Zaccherini G., Domenicali M., Giannone F. A., Antognoli A., Riggio O., Merli M., Pasquale C., Gioia S., Angeli P., Fasolato S., Sticca A., Cavallin M., Campion D., Risso A., Andrealli A., Saracco G. M., Prestianni L., Fidone F., Maiorca D., Rizzotto A., Cappa F. M., Lanzi A., Neri E., Visani A., Mastroianni A., Airoldi A., Perricone G., Alberti A. B., Cesarini L., Mazzarelli C., Vangeli M., Vigano R., Svegliati-Baroni G., Marzioni M., Capretti F., Kostandini A., Fagiuoli S., Magini G., Colpani M., Laffi G., Gabbani T., Marsico M., Cozzolongo R., Zappimbulso M., Petruzzi J., Di Marco V., Calvaruso V., Sangiovanni V., Parrella G., Caporaso N., Morisco F., Auriemma F., Guarino M., Toniutto P., Pugliese F., Gasbarrini A., Tortora A., Leo P., De Marco R., Angelico M., De Leonardis F., Pecchioli A., Rossi P., Raimondo G., Cacciola I., Elia G., Negri E., Dallio M., Loguercio C., Federico A., Conte D., Massironi S., Ballardini G., Celli N., Rendina M., Bringiotti R., Castellaneta N. M., Salerno F., Boccia S., Simone L., Guarisco R., Galioto A., Pompili, E, Baldassarre, M, Iannone, G, Tedesco, G, Nardelli, S, Piano, S, Alessandria, C, Neri, S, Foschi, F, Levantesi, F, Caraceni, P, Bernardi, M, Zaccherini, G, Domenicali, M, Giannone, F, Antognoli, A, Riggio, O, Merli, M, Pasquale, C, Gioia, S, Angeli, P, Fasolato, S, Sticca, A, Cavallin, M, Campion, D, Risso, A, Andrealli, A, Saracco, G, Prestianni, L, Fidone, F, Maiorca, D, Rizzotto, A, Cappa, F, Lanzi, A, Neri, E, Visani, A, Mastroianni, A, Airoldi, A, Perricone, G, Alberti, A, Cesarini, L, Mazzarelli, C, Vangeli, M, Vigano, R, Svegliati-Baroni, G, Marzioni, M, Capretti, F, Kostandini, A, Fagiuoli, S, Magini, G, Colpani, M, Laffi, G, Gabbani, T, Marsico, M, Cozzolongo, R, Zappimbulso, M, Petruzzi, J, Di Marco, V, Calvaruso, V, Sangiovanni, V, Parrella, G, Caporaso, N, Morisco, F, Auriemma, F, Guarino, M, Toniutto, P, Pugliese, F, Gasbarrini, A, Tortora, A, Leo, P, De Marco, R, Angelico, M, De Leonardis, F, Pecchioli, A, Rossi, P, Raimondo, G, Cacciola, I, Elia, G, Negri, E, Dallio, M, Loguercio, C, Federico, A, Conte, D, Massironi, S, Ballardini, G, Celli, N, Rendina, M, Bringiotti, R, Castellaneta, N, Salerno, F, Boccia, S, Simone, L, Guarisco, R, Galioto, A, Pompili E., Baldassarre M., Iannone G., Tedesco G., Nardelli S., Piano S., Alessandria C., Neri S., Foschi F. G., Levantesi F., Caraceni P., Bernardi M., Zaccherini G., Domenicali M., Giannone F. A., Antognoli A., Riggio O., Merli M., Pasquale C., Gioia S., Angeli P., Fasolato S., Sticca A., Cavallin M., Campion D., Risso A., Andrealli A., Saracco G. M., Prestianni L., Fidone F., Maiorca D., Rizzotto A., Cappa F. M., Lanzi A., Neri E., Visani A., Mastroianni A., Airoldi A., Perricone G., Alberti A. B., Cesarini L., Mazzarelli C., Vangeli M., Vigano R., Svegliati-Baroni G., Marzioni M., Capretti F., Kostandini A., Fagiuoli S., Magini G., Colpani M., Laffi G., Gabbani T., Marsico M., Cozzolongo R., Zappimbulso M., Petruzzi J., Di Marco V., Calvaruso V., Sangiovanni V., Parrella G., Caporaso N., Morisco F., Auriemma F., Guarino M., Toniutto P., Pugliese F., Gasbarrini A., Tortora A., Leo P., De Marco R., Angelico M., De Leonardis F., Pecchioli A., Rossi P., Raimondo G., Cacciola I., Elia G., Negri E., Dallio M., Loguercio C., Federico A., Conte D., Massironi S., Ballardini G., Celli N., Rendina M., Bringiotti R., Castellaneta N. M., Salerno F., Boccia S., Simone L., Guarisco R., and Galioto A.

Abstract

Type-2 diabetes mellitus is a frequent comorbidity of cirrhosis independently associated with cirrhosis-related complications and mortality. This post hoc analysis of the ANSWER trial database assessed the effects of long-term human albumin (HA) administration on top of the standard medical treatment (SMT) on the clinical outcomes of a subgroup of 85 outpatients with liver cirrhosis, uncomplicated ascites and insulin-treated diabetes mellitus type 2 (ITDM). Compared to patients in the SMT arm, the SMT + HA group showed a better overall survival (86% vs. 57%, p =.016) and lower incidence rates of paracenteses, overt hepatic encephalopathy, bacterial infections, renal dysfunction and electrolyte disorders. Hospital admissions did not differ between the two arms, but the number of days spent in hospital was lower in the SMT + HA group. In conclusion, in a subgroup of ITDM outpatients with decompensated cirrhosis and ascites, long-term HA administration was associated with better survival and a lower incidence of cirrhosis-related complications.

Published
2024

2. On-treatment serum albumin level can guide long-term treatment in patients with cirrhosis and uncomplicated ascites

Author

Caraceni, P, Tufoni, M, Zaccherini, G, Riggio, O, Angeli, P, Alessandria, C, Neri, S, Foschi, F, Levantesi, F, Airoldi, A, Simone, L, Svegliati-Baroni, G, Fagiuoli, S, Laffi, G, Cozzolongo, R, Di Marco, V, Sangiovanni, V, Morisco, F, Toniutto, P, Gasbarrini, A, De Marco, R, Piano, S, Nardelli, S, Elia, C, Roncadori, A, Baldassarre, M, Bernardi, M, Domenicali, M, Giannone, F, Antognoli, A, Merli, M, Pasquale, C, Gioia, S, Fasolato, S, Sticca, A, Campion, D, Risso, A, Saracco, G, Prestianni, L, Fidone, F, Maiorca, D, Rizzotto, A, Cappa, F, Lanzi, A, Neri, E, Visani, A, Mastroianni, A, Perricone, G, Alberti, A, Cesarini, L, Mazzarelli, C, Vangeli, M, Vigano, R, Marzioni, M, Capretti, F, Kostandini, A, Magini, G, Colpani, M, Gabbani, T, Marsico, M, Zappimbulso, M, Petruzzi, J, Calvaruso, V, Parrella, G, Caporaso, N, Auriemma, F, Guarino, M, Pugliese, F, Tortora, A, Leo, P, Angelico, M, De Leonardis, F, Pecchioli, A, Rossi, P, Raimondo, G, Cacciola, I, Elia, G, Negri, E, Dallio, M, Loguercio, C, Federico, A, Conte, D, Massironi, S, Natascia Celli, G, Rendina, M, Bringiotti, R, Castellaneta, N, Salerno, F, Boccia, S, Guarisco, R, Galioto, A, Cavallin, M, Andrealli, A, Caraceni P., Tufoni M., Zaccherini G., Riggio O., Angeli P., Alessandria C., Neri S., Foschi F. G., Levantesi F., Airoldi A., Simone L., Svegliati-Baroni G., Fagiuoli S., Laffi G., Cozzolongo R., Di Marco V., Sangiovanni V., Morisco F., Toniutto P., Gasbarrini A., De Marco R., Piano S., Nardelli S., Elia C., Roncadori A., Baldassarre M., Bernardi M., Domenicali M., Giannone F. A., Antognoli A., Merli M., Pasquale C., Gioia S., Fasolato S., Sticca A., Campion D., Risso A., Saracco G. M., Prestianni L., Fidone F., Maiorca D., Rizzotto A., Cappa F. M., Lanzi A., Neri E., Visani A., Mastroianni A., Perricone G., Alberti A. B., Cesarini L., Mazzarelli C., Vangeli M., Vigano R., Marzioni M., Capretti F., Kostandini A., Magini G., Colpani M., Gabbani T., Marsico M., Zappimbulso M., Petruzzi J., Calvaruso V., Parrella G., Caporaso N., Auriemma F., Guarino M., Pugliese F., Tortora A., Leo P., Angelico M., De Leonardis F., Pecchioli A., Rossi P., Raimondo G., Cacciola I., Elia G., Negri E., Dallio M., Loguercio C., Federico A., Conte D., Massironi S., Natascia Celli G. B., Rendina M., Bringiotti R., Castellaneta N. M., Salerno F., Boccia S., Guarisco R., Galioto A., Cavallin M., Andrealli A., Caraceni, P, Tufoni, M, Zaccherini, G, Riggio, O, Angeli, P, Alessandria, C, Neri, S, Foschi, F, Levantesi, F, Airoldi, A, Simone, L, Svegliati-Baroni, G, Fagiuoli, S, Laffi, G, Cozzolongo, R, Di Marco, V, Sangiovanni, V, Morisco, F, Toniutto, P, Gasbarrini, A, De Marco, R, Piano, S, Nardelli, S, Elia, C, Roncadori, A, Baldassarre, M, Bernardi, M, Domenicali, M, Giannone, F, Antognoli, A, Merli, M, Pasquale, C, Gioia, S, Fasolato, S, Sticca, A, Campion, D, Risso, A, Saracco, G, Prestianni, L, Fidone, F, Maiorca, D, Rizzotto, A, Cappa, F, Lanzi, A, Neri, E, Visani, A, Mastroianni, A, Perricone, G, Alberti, A, Cesarini, L, Mazzarelli, C, Vangeli, M, Vigano, R, Marzioni, M, Capretti, F, Kostandini, A, Magini, G, Colpani, M, Gabbani, T, Marsico, M, Zappimbulso, M, Petruzzi, J, Calvaruso, V, Parrella, G, Caporaso, N, Auriemma, F, Guarino, M, Pugliese, F, Tortora, A, Leo, P, Angelico, M, De Leonardis, F, Pecchioli, A, Rossi, P, Raimondo, G, Cacciola, I, Elia, G, Negri, E, Dallio, M, Loguercio, C, Federico, A, Conte, D, Massironi, S, Natascia Celli, G, Rendina, M, Bringiotti, R, Castellaneta, N, Salerno, F, Boccia, S, Guarisco, R, Galioto, A, Cavallin, M, Andrealli, A, Caraceni P., Tufoni M., Zaccherini G., Riggio O., Angeli P., Alessandria C., Neri S., Foschi F. G., Levantesi F., Airoldi A., Simone L., Svegliati-Baroni G., Fagiuoli S., Laffi G., Cozzolongo R., Di Marco V., Sangiovanni V., Morisco F., Toniutto P., Gasbarrini A., De Marco R., Piano S., Nardelli S., Elia C., Roncadori A., Baldassarre M., Bernardi M., Domenicali M., Giannone F. A., Antognoli A., Merli M., Pasquale C., Gioia S., Fasolato S., Sticca A., Campion D., Risso A., Saracco G. M., Prestianni L., Fidone F., Maiorca D., Rizzotto A., Cappa F. M., Lanzi A., Neri E., Visani A., Mastroianni A., Perricone G., Alberti A. B., Cesarini L., Mazzarelli C., Vangeli M., Vigano R., Marzioni M., Capretti F., Kostandini A., Magini G., Colpani M., Gabbani T., Marsico M., Zappimbulso M., Petruzzi J., Calvaruso V., Parrella G., Caporaso N., Auriemma F., Guarino M., Pugliese F., Tortora A., Leo P., Angelico M., De Leonardis F., Pecchioli A., Rossi P., Raimondo G., Cacciola I., Elia G., Negri E., Dallio M., Loguercio C., Federico A., Conte D., Massironi S., Natascia Celli G. B., Rendina M., Bringiotti R., Castellaneta N. M., Salerno F., Boccia S., Guarisco R., Galioto A., Cavallin M., and Andrealli A.

Abstract

Background & Aims: The ANSWER study reported that long-term albumin administration in patients with cirrhosis and uncomplicated ascites improves survival. During treatment, serum albumin increased within a month and remained stable thereafter. In this post hoc analysis, we aimed to determine whether on-treatment serum albumin levels could guide therapy. Methods: Logistic regression was used to assess the association between baseline serum albumin and mortality, as well as to determine on-treatment factors associated with mortality and to predict the achievement of a given on-treatment serum albumin level. Survival was assessed by Kaplan-Meier estimates and second-order polynomial regression. Patients whose on-treatment serum albumin remained below normal were compared with a subset of patients from the control arm matched by principal score. Results: Baseline serum albumin was closely associated with 18-month mortality in untreated patients; albumin treatment almost effaced this relationship. On-treatment serum albumin and MELD-Na at month 1 were the sole independent variables associated with mortality. Second-order polynomial regression revealed that survival improved in parallel with increased 1-month on-treatment serum albumin. Kaplan-Meier estimations showed that any value of 1-month on-treatment serum albumin (0.1 g/dl intervals) in the range 2.5–4.5 g/dl discriminated patient survival. In the normal range of serum albumin, the best discriminant value was 4.0 g/dl. Compared to untreated patients, survival even improved in patients whose on-treatment serum albumin remained below normal. Conclusion: Baseline serum albumin per se should not guide the decision to start albumin therapy. Conversely, 1-month on-treatment serum albumin levels are strongly associated with outcomes and could guide the use of albumin – 4.0 g/dl being the target threshold. However, even patients whose serum albumin remains below normal benefit from long-term albumin administration. Lay

Published
2021

4. Long-term albumin administration in decompensated cirrhosis (ANSWER): an open-label randomised trial

Author

Caraceni, P, Riggio, O, Angeli, P, Alessandria, C, Neri, S, Foschi, F, Levantesi, F, Airoldi, A, Boccia, S, Svegliati-Baroni, G, Fagiuoli, S, Romanelli, R, Cozzolongo, R, Di Marco, V, Sangiovanni, V, Morisco, F, Toniutto, P, Tortora, A, De Marco, R, Angelico, M, Cacciola, I, Elia, G, Federico, A, Massironi, S, Guarisco, R, Galioto, A, Ballardini, G, Rendina, M, Nardelli, S, Piano, S, Elia, C, Prestianni, L, Cappa, F, Cesarini, L, Simone, L, Pasquale, C, Cavallin, M, Andrealli, A, Fidone, F, Ruggeri, M, Roncadori, A, Baldassarre, M, Tufoni, M, Zaccherini, G, Bernardi, M, Domenicali, M, Giannone, F, Merli, M, Gioia, S, Fasolato, S, Sticca, A, Campion, D, Risso, A, Saracco, G, Maiorca, D, Rizzotto, A, Lanzi, A, Neri, E, Visani, A, Mastroianni, A, Alberti, A, Mazzarelli, C, Vangeli, M, Marzioni, M, Capretti, F, Kostandini, A, Magini, G, Colpani, M, Laffi, G, Gabbani, T, Marsico, M, Zappimbulso, M, Petruzzi, J, Calvaruso, V, Parrella, G, Caporaso, N, Auriemma, F, Guarino, M, Pugliese, F, Gasbarrini, A, Leo, P, De Leonardis, F, Pecchioli, A, Rossi, P, Raimondo, G, Negri, E, Dallio, M, Loguercio, C, Conte, D, Celli, N, Bringiotti, R, Castellaneta, N, Salerno, F, Caraceni P., Riggio O., Angeli P., Alessandria C., Neri S., Foschi F. G., Levantesi F., Airoldi A., Boccia S., Svegliati-Baroni G., Fagiuoli S., Romanelli R. G., Cozzolongo R., Di Marco V., Sangiovanni V., Morisco F., Toniutto P., Tortora A., De Marco R., Angelico M., Cacciola I., Elia G., Federico A., Massironi S., Guarisco R., Galioto A., Ballardini G., Rendina M., Nardelli S., Piano S., Elia C., Prestianni L., Cappa F. M., Cesarini L., Simone L., Pasquale C., Cavallin M., Andrealli A., Fidone F., Ruggeri M., Roncadori A., Baldassarre M., Tufoni M., Zaccherini G., Bernardi M., Domenicali M., Giannone F. A., Merli M., Gioia S., Fasolato S., Sticca A., Campion D., Risso A., Saracco G. M., Maiorca D., Rizzotto A., Lanzi A., Neri E., Visani A., Mastroianni A., Alberti A. B., Mazzarelli C., Vangeli M., Marzioni M., Capretti F., Kostandini A., Magini G., Colpani M., Laffi G., Gabbani T., Marsico M., Zappimbulso M., Petruzzi J., Calvaruso V., Parrella G., Caporaso N., Auriemma F., Guarino M., Pugliese F., Gasbarrini A., Leo P., De Leonardis F., Pecchioli A., Rossi P., Raimondo G., Negri E., Dallio M., Loguercio C., Conte D., Celli N., Bringiotti R., Castellaneta N. M., Salerno F., Caraceni, P, Riggio, O, Angeli, P, Alessandria, C, Neri, S, Foschi, F, Levantesi, F, Airoldi, A, Boccia, S, Svegliati-Baroni, G, Fagiuoli, S, Romanelli, R, Cozzolongo, R, Di Marco, V, Sangiovanni, V, Morisco, F, Toniutto, P, Tortora, A, De Marco, R, Angelico, M, Cacciola, I, Elia, G, Federico, A, Massironi, S, Guarisco, R, Galioto, A, Ballardini, G, Rendina, M, Nardelli, S, Piano, S, Elia, C, Prestianni, L, Cappa, F, Cesarini, L, Simone, L, Pasquale, C, Cavallin, M, Andrealli, A, Fidone, F, Ruggeri, M, Roncadori, A, Baldassarre, M, Tufoni, M, Zaccherini, G, Bernardi, M, Domenicali, M, Giannone, F, Merli, M, Gioia, S, Fasolato, S, Sticca, A, Campion, D, Risso, A, Saracco, G, Maiorca, D, Rizzotto, A, Lanzi, A, Neri, E, Visani, A, Mastroianni, A, Alberti, A, Mazzarelli, C, Vangeli, M, Marzioni, M, Capretti, F, Kostandini, A, Magini, G, Colpani, M, Laffi, G, Gabbani, T, Marsico, M, Zappimbulso, M, Petruzzi, J, Calvaruso, V, Parrella, G, Caporaso, N, Auriemma, F, Guarino, M, Pugliese, F, Gasbarrini, A, Leo, P, De Leonardis, F, Pecchioli, A, Rossi, P, Raimondo, G, Negri, E, Dallio, M, Loguercio, C, Conte, D, Celli, N, Bringiotti, R, Castellaneta, N, Salerno, F, Caraceni P., Riggio O., Angeli P., Alessandria C., Neri S., Foschi F. G., Levantesi F., Airoldi A., Boccia S., Svegliati-Baroni G., Fagiuoli S., Romanelli R. G., Cozzolongo R., Di Marco V., Sangiovanni V., Morisco F., Toniutto P., Tortora A., De Marco R., Angelico M., Cacciola I., Elia G., Federico A., Massironi S., Guarisco R., Galioto A., Ballardini G., Rendina M., Nardelli S., Piano S., Elia C., Prestianni L., Cappa F. M., Cesarini L., Simone L., Pasquale C., Cavallin M., Andrealli A., Fidone F., Ruggeri M., Roncadori A., Baldassarre M., Tufoni M., Zaccherini G., Bernardi M., Domenicali M., Giannone F. A., Merli M., Gioia S., Fasolato S., Sticca A., Campion D., Risso A., Saracco G. M., Maiorca D., Rizzotto A., Lanzi A., Neri E., Visani A., Mastroianni A., Alberti A. B., Mazzarelli C., Vangeli M., Marzioni M., Capretti F., Kostandini A., Magini G., Colpani M., Laffi G., Gabbani T., Marsico M., Zappimbulso M., Petruzzi J., Calvaruso V., Parrella G., Caporaso N., Auriemma F., Guarino M., Pugliese F., Gasbarrini A., Leo P., De Leonardis F., Pecchioli A., Rossi P., Raimondo G., Negri E., Dallio M., Loguercio C., Conte D., Celli N., Bringiotti R., Castellaneta N. M., and Salerno F.

Abstract

Background: 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. Methods: 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. Findings: 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. Interpretation: In this trial, long-term HA administration prolongs overall survival and might act as a disease modifying treatment in patients with decompensated cirrhosis. Funding: Italian Medicine Agency.

Published
2018

5. Long-term albumin administration improves survival in patients with decompensated cirrhosis: final results of the “ANSWER” study

Author

Caraceni, P., primary, Riggio, O., additional, Angeli, P., additional, Alessandria, C., additional, Neri, S., additional, Foschi, F.G., additional, Levantesi, F., additional, Airoldi, A., additional, Boccia, S., additional, Baroni, G.S., additional, Fagiuoli, S., additional, Laffi, G., additional, Cozzolongo, R., additional, Di Marco, V., additional, Sangiovanni, V., additional, Morisco, F., additional, Toniutto, P., additional, Gasbarrini, A., additional, De Marco, R., additional, De Leonardis, F., additional, Cacciola, I., additional, Elia, G., additional, Federico, A., additional, Massironi, S., additional, Guarisco, R., additional, Marin, G., additional, Ballardini, G., additional, Rendina, M., additional, Nardelli, S., additional, Piano, S., additional, Elia, C., additional, Prestianni, L., additional, Neri, E., additional, Mastroianni, A., additional, Cesarini, L., additional, Simone, L., additional, Marzioni, M., additional, Magini, G., additional, Romanelli, R.G., additional, Zappimbulso, M., additional, Calvaruso, V., additional, Parrella, G., additional, Caporaso, N., additional, Pugliese, F., additional, Tortora, A., additional, Pasquale, C., additional, Cavallin, M., additional, Andrealli, A., additional, Fidone, F., additional, Lanzi, A., additional, Vangeli, M., additional, Salerno, F., additional, Roncadori, A., additional, Tufoni, M., additional, Zaccherini, G., additional, and Bernardi, M., additional

Published
2017
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7. LBO-08 - Long-term albumin administration improves survival in patients with decompensated cirrhosis: final results of the “ANSWER” study

Author

Caraceni, P., Riggio, O., Angeli, P., Alessandria, C., Neri, S., Foschi, F.G., Levantesi, F., Airoldi, A., Boccia, S., Baroni, G.S., Fagiuoli, S., Laffi, G., Cozzolongo, R., Di Marco, V., Sangiovanni, V., Morisco, F., Toniutto, P., Gasbarrini, A., De Marco, R., De Leonardis, F., Cacciola, I., Elia, G., Federico, A., Massironi, S., Guarisco, R., Marin, G., Ballardini, G., Rendina, M., Nardelli, S., Piano, S., Elia, C., Prestianni, L., Neri, E., Mastroianni, A., Cesarini, L., Simone, L., Marzioni, M., Magini, G., Romanelli, R.G., Zappimbulso, M., Calvaruso, V., Parrella, G., Caporaso, N., Pugliese, F., Tortora, A., Pasquale, C., Cavallin, M., Andrealli, A., Fidone, F., Lanzi, A., Vangeli, M., Salerno, F., Roncadori, A., Tufoni, M., Zaccherini, G., and Bernardi, M.

Published
2017
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8. On-treatment serum albumin level can guide long-term treatment in patients with cirrhosis and uncomplicated ascites

Author

Alessandro Federico, M. Colpani, Paolo Caraceni, Marco Domenicali, Manuel Tufoni, L. Simone, A Alberti, Giovanni Raimondo, A. Risso, Antonietta Sticca, Salvatore Piano, Anna Visani, Francesco Salerno, Giacomo Laffi, Piera Rossi, Paolo Angeli, F. Fidone, Pierluigi Toniutto, Vincenza Calvaruso, Silvia Nardelli, Aldo Airoldi, Sara Massironi, Stefania Gioia, A. Roncadori, Marco Marzioni, Nicola Caporaso, N.M. Castellaneta, Stefano Fagiuoli, Francesco Giuseppe Foschi, Raffaele Cozzolongo, Maria Rendina, Irene Cacciola, Oliviero Riggio, Sergio Neri, Raffaella Viganò, Ferdinando Giannone, Chiara Mazzarelli, Maria Marsico, Giovanni Parrella, Riccardo Guarisco, Chiara Elia, F. Levantesi, M. Cavallin, Alida Andrealli, A. Pecchioli, Loredana Prestianni, Rosanna De Marco, T Gabbani, Elga Neri, S. Boccia, Arianna Lanzi, Giacomo Zaccherini, Marcello Dallio, Giovanni Perricone, Giorgio Ballardini Natascia Celli, Francesco Auriemma, Federica Mirici Cappa, Agnese Antognoli, Annalisa Tortora, Gianfranco Elia, R. Bringiotti, Francesco De Leonardis, Marcello Vangeli, Agostino Rizzotto, Dario Conte, Manuela Merli, Francesca Capretti, Mauro Bernardi, Chiara Pasquale, Pietro Leo, D. Maiorca, M. Zappimbulso, Filomena Morisco, Vincenzo Sangiovanni, Maurizio Baldassarre, Lucia Cesarini, Gianluca Svegliati-Baroni, Maria Guarino, Carmelina Loguercio, Alessandra Galioto, Antonio Mastroianni, Giorgio Maria Saracco, Antonio Gasbarrini, G. Magini, Alba Kostandini, Carlo Alessandria, Josè Petruzzi, Vito Di Marco, Silvano Fasolato, Elisa Negri, Fabio Pugliese, Mario Angelico, Daniela Campion, Caraceni P., Tufoni M., Zaccherini G., Riggio O., Angeli P., Alessandria C., Neri S., Foschi F.G., Levantesi F., Airoldi A., Simone L., Svegliati-Baroni G., Fagiuoli S., Laffi G., Cozzolongo R., Di Marco V., Sangiovanni V., Morisco F., Toniutto P., Gasbarrini A., De Marco R., Piano S., Nardelli S., Elia C., Roncadori A., Baldassarre M., Bernardi M., Domenicali M., Giannone F.A., Antognoli A., Merli M., Pasquale C., Gioia S., Fasolato S., Sticca A., Campion D., Risso A., Saracco G.M., Prestianni L., Fidone F., Maiorca D., Rizzotto A., Cappa F.M., Lanzi A., Neri E., Visani A., Mastroianni A., Perricone G., Alberti A.B., Cesarini L., Mazzarelli C., Vangeli M., Vigano R., Marzioni M., Capretti F., Kostandini A., Magini G., Colpani M., Gabbani T., Marsico M., Zappimbulso M., Petruzzi J., Calvaruso V., Parrella G., Caporaso N., Auriemma F., Guarino M., Pugliese F., Tortora A., Leo P., Angelico M., De Leonardis F., Pecchioli A., Rossi P., Raimondo G., Cacciola I., Elia G., Negri E., Dallio M., Loguercio C., Federico A., Conte D., Massironi S., Natascia Celli G.B., Rendina M., Bringiotti R., Castellaneta N.M., Salerno F., Boccia S., Guarisco R., Galioto A., Cavallin M., Andrealli A., Caraceni, P., Tufoni, M., Zaccherini, G., Riggio, O., Angeli, P., Alessandria, C., Neri, S., Foschi, F. G., Levantesi, F., Airoldi, A., Simone, L., Svegliati-Baroni, G., Fagiuoli, S., Laffi, G., Cozzolongo, R., Di Marco, V., Sangiovanni, V., Morisco, F., Toniutto, P., Gasbarrini, A., De Marco, R., Piano, S., Nardelli, S., Elia, C., Roncadori, A., Baldassarre, M., Bernardi, M., Domenicali, M., Giannone, F. A., Antognoli, A., Merli, M., Pasquale, C., Gioia, S., Fasolato, S., Sticca, A., Campion, D., Risso, A., Saracco, G. M., Prestianni, L., Fidone, F., Maiorca, D., Rizzotto, A., Cappa, F. M., Lanzi, A., Neri, E., Visani, A., Mastroianni, A., Perricone, G., Alberti, A. B., Cesarini, L., Mazzarelli, C., Vangeli, M., Vigano, R., Marzioni, M., Capretti, F., Kostandini, A., Magini, G., Colpani, M., Gabbani, T., Marsico, M., Zappimbulso, M., Petruzzi, J., Calvaruso, V., Parrella, G., Caporaso, N., Auriemma, F., Guarino, M., Pugliese, F., Tortora, A., Leo, P., Angelico, M., De Leonardis, F., Pecchioli, A., Rossi, P., Raimondo, G., Cacciola, I., Elia, G., Negri, E., Dallio, M., Loguercio, C., Federico, A., Conte, D., Massironi, S., Natascia Celli, G. B., Rendina, M., Bringiotti, R., Castellaneta, N. M., Salerno, F., Boccia, S., Guarisco, R., Galioto, A., Cavallin, M., Andrealli, A., Caraceni, P, Tufoni, M, Zaccherini, G, Riggio, O, Angeli, P, Alessandria, C, Neri, S, Foschi, F, Levantesi, F, Airoldi, A, Simone, L, Svegliati-Baroni, G, Fagiuoli, S, Laffi, G, Cozzolongo, R, Di Marco, V, Sangiovanni, V, Morisco, F, Toniutto, P, Gasbarrini, A, De Marco, R, Piano, S, Nardelli, S, Elia, C, Roncadori, A, Baldassarre, M, Bernardi, M, Domenicali, M, Giannone, F, Antognoli, A, Merli, M, Pasquale, C, Gioia, S, Fasolato, S, Sticca, A, Campion, D, Risso, A, Saracco, G, Prestianni, L, Fidone, F, Maiorca, D, Rizzotto, A, Cappa, F, Lanzi, A, Neri, E, Visani, A, Mastroianni, A, Perricone, G, Alberti, A, Cesarini, L, Mazzarelli, C, Vangeli, M, Vigano, R, Marzioni, M, Capretti, F, Kostandini, A, Magini, G, Colpani, M, Gabbani, T, Marsico, M, Zappimbulso, M, Petruzzi, J, Calvaruso, V, Parrella, G, Caporaso, N, Auriemma, F, Guarino, M, Pugliese, F, Tortora, A, Leo, P, Angelico, M, De Leonardis, F, Pecchioli, A, Rossi, P, Raimondo, G, Cacciola, I, Elia, G, Negri, E, Dallio, M, Loguercio, C, Federico, A, Conte, D, Massironi, S, Natascia Celli, G, Rendina, M, Bringiotti, R, Castellaneta, N, Salerno, F, Boccia, S, Guarisco, R, Galioto, A, Cavallin, M, and Andrealli, A

Subjects
Male, 0301 basic medicine, Cirrhosis, ascites, complications, liver cirrhosis, serum albumin, survival, Serum albumin, Survival, Logistic regression, Gastroenterology, Biomarkers, Pharmacological, Ascites, Complications, 0302 clinical medicine, Medicine, biology, Middle Aged, Intention to Treat Analysis, Treatment Outcome, Ascite, Female, 030211 gastroenterology & hepatology, Drug Monitoring, medicine.symptom, medicine.medical_specialty, Settore MED/12 - GASTROENTEROLOGIA, Serum Albumin, Human, 03 medical and health sciences, Serum albumin level, Predictive Value of Tests, Internal medicine, Post-hoc analysis, Humans, In patient, Biological Products, Cirrhosi, Hepatology, business.industry, Albumin, medicine.disease, Long-Term Care, Survival Analysis, 030104 developmental biology, biology.protein, business, Complication
Abstract

Background & Aims: The ANSWER study reported that long-term albumin administration in patients with cirrhosis and uncomplicated ascites improves survival. During treatment, serum albumin increased within a month and remained stable thereafter. In this post hoc analysis, we aimed to determine whether on-treatment serum albumin levels could guide therapy. Methods: Logistic regression was used to assess the association between baseline serum albumin and mortality, as well as to determine on-treatment factors associated with mortality and to predict the achievement of a given on-treatment serum albumin level. Survival was assessed by Kaplan-Meier estimates and second-order polynomial regression. Patients whose on-treatment serum albumin remained below normal were compared with a subset of patients from the control arm matched by principal score. Results: Baseline serum albumin was closely associated with 18-month mortality in untreated patients; albumin treatment almost effaced this relationship. On-treatment serum albumin and MELD-Na at month 1 were the sole independent variables associated with mortality. Second-order polynomial regression revealed that survival improved in parallel with increased 1-month on-treatment serum albumin. Kaplan-Meier estimations showed that any value of 1-month on-treatment serum albumin (0.1 g/dl intervals) in the range 2.5–4.5 g/dl discriminated patient survival. In the normal range of serum albumin, the best discriminant value was 4.0 g/dl. Compared to untreated patients, survival even improved in patients whose on-treatment serum albumin remained below normal. Conclusion: Baseline serum albumin per se should not guide the decision to start albumin therapy. Conversely, 1-month on-treatment serum albumin levels are strongly associated with outcomes and could guide the use of albumin – 4.0 g/dl being the target threshold. However, even patients whose serum albumin remains below normal benefit from long-term albumin administration. Lay summary: The ANSWER study has shown that long-term albumin administration improves survival and prevents the occurrence of major complications in patients with cirrhosis and ascites. This study shows that the achievement of these beneficial effects is related to a significant increase in serum albumin concentration. Even though the best results follow the achievement of a serum albumin concentration of 4 g/dl, a survival benefit is also achieved in patients who fail to normalise serum albumin.

Published
2020

9. Long-term albumin administration in decompensated cirrhosis (ANSWER): an open-label randomised trial

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, ANSWER Study Investigators, 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, Caraceni P1, Riggio O2, Angeli P3, Alessandria C4, Neri S5, Foschi FG6, Levantesi F7, Airoldi A8, Boccia S9, Svegliati-Baroni G10, Fagiuoli S11, Romanelli RG12, Cozzolongo R13, Di Marco Vito, Sangiovanni V15, Morisco F16, Toniutto P17, Tortora A18, De Marco R19, Angelico M20, Cacciola I21, Elia G22, Federico A23, Massironi S24, Guarisco R25, Galioto A26, Ballardini G27, Rendina M28, Nardelli S2, Piano S3, Elia C4, Prestianni L5, Cappa FM6, Cesarini L8, Simone L9, Pasquale C2, Cavallin M3, Andrealli A4, Fidone F5, Ruggeri M29, Roncadori A30, Baldassarre M1, Tufoni M1, Zaccherini G1, Bernardi M31, Domenicali M, Giannone FA, Merli M, Gioia S, Fasolato S, Sticca A, Campion D, Risso A, Saracco GM, Maiorca D, Rizzotto A, Lanzi A, Neri E, Visani A, Mastroianni A, Alberti AB, Mazzarelli C, Vangeli M, Marzioni M, Capretti F, Kostandini A, Magini G, Colpani M, Laffi G, Gabbani T, Marsico M, Zappimbulso M, Petruzzi J, Calvaruso Vincenza, Parrella G, Caporaso N, Auriemma F, Guarino M, Pugliese F, Gasbarrini A, Leo P, De Leonardis F, Pecchioli A, Rossi P, Raimondo G, Negri E, Dallio M, Loguercio C, Conte D, Celli N, Bringiotti R, Castellaneta NM, Salerno F., Caraceni P, Riggio O, Angeli P, Alessandria C, Neri S, Foschi FG, Levantesi F, Airoldi A, Boccia S, Svegliati-Baroni G, Fagiuoli S, Romanelli RG, Cozzolongo R, Di Marco V, Sangiovanni V, Morisco F, Toniutto P, Tortora A, De Marco R, Angelico M, Cacciola I, Elia G, Federico A, Massironi S, Guarisco R, Galioto A, Ballardini G, Rendina M, Nardelli S, Piano S, Elia C, Prestianni L, Cappa FM, Cesarini L, Simone L, Pasquale C, Cavallin M, Andrealli A, Fidone F, Ruggeri M, Roncadori A, Baldassarre M, Tufoni M, Zaccherini G, Bernardi M, Domenicali M, Giannone FA, Merli M, Gioia S, Fasolato S, Sticca A, Campion D, Risso A, Saracco GM, Maiorca D, Rizzotto A, Lanzi A, Neri E, Visani A, Mastroianni A, Alberti AB, Mazzarelli C, Vangeli M, Marzioni M, Capretti F, Kostandini A, Magini G, Colpani M, Laffi G, Gabbani T, Marsico M, Zappimbulso M, Petruzzi J, Calvaruso V, Parrella G, Caporaso N, Auriemma F, Guarino M, Pugliese F, Gasbarrini A, Leo P, De Leonardis F, Pecchioli A, Rossi P, Raimondo G, Negri E, Dallio M, Loguercio C, Conte D, Celli N, Bringiotti R, Castellaneta NM, Salerno F., Caraceni, P, Riggio, O, Angeli, P, Alessandria, C, Neri, S, Foschi, F, Levantesi, F, Airoldi, A, Boccia, S, Svegliati-Baroni, G, Fagiuoli, S, Romanelli, R, Cozzolongo, R, Di Marco, V, Sangiovanni, V, Morisco, F, Toniutto, P, Tortora, A, De Marco, R, Angelico, M, Cacciola, I, Elia, G, Federico, A, Massironi, S, Guarisco, R, Galioto, A, Ballardini, G, Rendina, M, Nardelli, S, Piano, S, Elia, C, Prestianni, L, Cappa, F, Cesarini, L, Simone, L, Pasquale, C, Cavallin, M, Andrealli, A, Fidone, F, Ruggeri, M, Roncadori, A, Baldassarre, M, Tufoni, M, Zaccherini, G, Bernardi, M, Domenicali, M, Giannone, F, Merli, M, Gioia, S, Fasolato, S, Sticca, A, Campion, D, Risso, A, Saracco, G, Maiorca, D, Rizzotto, A, Lanzi, A, Neri, E, Visani, A, Mastroianni, A, Alberti, A, Mazzarelli, C, Vangeli, M, Marzioni, M, Capretti, F, Kostandini, A, Magini, G, Colpani, M, Laffi, G, Gabbani, T, Marsico, M, Zappimbulso, M, Petruzzi, J, Calvaruso, V, Parrella, G, Caporaso, N, Auriemma, F, Guarino, M, Pugliese, F, Gasbarrini, A, Leo, P, De Leonardis, F, Pecchioli, A, Rossi, P, Raimondo, G, Negri, E, Dallio, M, Loguercio, C, Conte, D, Celli, N, Bringiotti, R, Castellaneta, N, and Salerno, F

Subjects
Liver Cirrhosis, Male, Time Factors, Cirrhosis, Kaplan-Meier Estimate, law.invention, ascites, 0302 clinical medicine, Hepatorenal syndrome, Randomized controlled trial, Furosemide, law, Ascites, Clinical endpoint, Paracentesis, Diuretics, albumin, decompensated cirrhosi, Mineralocorticoid Receptor Antagonists, Settore MED/12 - Gastroenterologia, Medicine (all), Hazard ratio, General Medicine, Middle Aged, Survival Rate, 030220 oncology & carcinogenesis, Drug Therapy, Combination, Female, 030211 gastroenterology & hepatology, Quality-Adjusted Life Years, medicine.symptom, Hyponatremia, medicine.medical_specialty, 03 medical and health sciences, Albumins, Internal medicine, medicine, Humans, Survival rate, albumin, Aged, business.industry, cirrhosis, medicine.disease, Clinical trial, albumin, cirrhosis, ascites, liver decompensation, Quality of Life, Hyperkalemia, business, Esophagus Varices, Portal Hypertension, Varicosis
Abstract

Background 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. Methods 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. Findings 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. Interpretation In this trial, long-term HA administration prolongs overall survival and might act as a disease modifying treatment in patients with decompensated cirrhosis. Funding Italian Medicine Agency. Copyright © 2018 Elsevier Ltd. All rights reserved.

Published
2018

10. Synthesis and Characterization of Quercetin-Iron Complex Nanoparticles for Overcoming Drug Resistance.

Author

Prestianni L, Espinal ER, Hathcock SF, Vollmuth N, Wang P, Holler RA, Liu S, Kim BJ, and Bao Y

Abstract

Quercetin, one of the major natural flavonoids, has demonstrated great pharmacological potential as an antioxidant and in overcoming drug resistance. However, its low aqueous solubility and poor stability limit its potential applications. Previous studies suggest that the formation of quercetin-metal complexes could increase quercetin stability and biological activity. In this paper, we systematically investigated the formation of quercetin-iron complex nanoparticles by varying the ligand-to-metal ratios with the goal of increasing the aqueous solubility and stability of quercetin. It was found that quercetin-iron complex nanoparticles could be reproducibly synthesized with several ligand-to-iron ratios at room temperature. The UV-Vis spectra of the nanoparticles indicated that nanoparticle formation greatly increased the stability and solubility of quercetin. Compared to free quercetin, the quercetin-iron complex nanoparticles exhibited enhanced antioxidant activities and elongated effects. Our preliminary cellular evaluation suggests that these nanoparticles had minimal cytotoxicity and could effectively block the efflux pump of cells, indicating their potential for cancer treatment.

Published
2023
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11. Long-term albumin administration in decompensated cirrhosis (ANSWER): an open-label randomised trial.

Author

Caraceni P, Riggio O, Angeli P, Alessandria C, Neri S, Foschi FG, Levantesi F, Airoldi A, Boccia S, Svegliati-Baroni G, Fagiuoli S, Romanelli RG, Cozzolongo R, Di Marco V, Sangiovanni V, Morisco F, Toniutto P, Tortora A, De Marco R, Angelico M, Cacciola I, Elia G, Federico A, Massironi S, Guarisco R, Galioto A, Ballardini G, Rendina M, Nardelli S, Piano S, Elia C, Prestianni L, Cappa FM, Cesarini L, Simone L, Pasquale C, Cavallin M, Andrealli A, Fidone F, Ruggeri M, Roncadori A, Baldassarre M, Tufoni M, Zaccherini G, and Bernardi M

Subjects
Aged, Ascites etiology, Diuretics administration & dosage, Diuretics adverse effects, Drug Therapy, Combination, Female, Furosemide administration & dosage, Furosemide adverse effects, Humans, Hyperkalemia chemically induced, Hyponatremia chemically induced, Kaplan-Meier Estimate, Liver Cirrhosis complications, Liver Cirrhosis physiopathology, Male, Middle Aged, Mineralocorticoid Receptor Antagonists therapeutic use, Paracentesis, Quality of Life, Quality-Adjusted Life Years, Survival Rate, Time Factors, Albumins therapeutic use, Ascites therapy, Liver Cirrhosis drug therapy
Abstract

Background: 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., Methods: 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., Findings: 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., Interpretation: In this trial, long-term HA administration prolongs overall survival and might act as a disease modifying treatment in patients with decompensated cirrhosis., Funding: Italian Medicine Agency., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Published
2018
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12. Healthcare Utilizing Deliberate Discussion Linking Events (HUDDLE): A Systematic Review.

Author

Glymph DC, Olenick M, Barbera S, Brown EL, Prestianni L, and Miller C

Subjects
Communication, Humans, Nursing Staff, Hospital, Operating Room Technicians, Physicians, Anesthesiology methods, Cooperative Behavior, Interprofessional Relations, Patient Care Planning organization & administration, Patient Care Team organization & administration, Patient Safety, Preoperative Care methods
Abstract

The phenomenon, "huddle moments," can be described as a preparatory briefing among healthcare providers for the purpose of collaborating, exchanging information, and bringing awareness to patient safety concerns. A historical background of huddle communication is described and a systematic literature review was conducted on preoperative briefing and huddle communication. The article also describes a need for increased interprofessional collaboration education in anesthesia and a need for leadership to support initiatives that improve patient safety. The purpose of this article is to provide a systematic review of huddle communication and give future evidence-based recommendations on how the huddle can be used in healthcare as well as how to roll out use of the HUDDLE acronym: Healthcare, Utilizing, Deliberate, Discussion, Linking, Events.

Published
2015

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