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1. 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

2. Il Manifesto delle malattie autoinfiammatorie rare: uno strumento educazionale per promuovere la conoscenza e migliorare la gestione di queste malattie

Author

Bona G, Bergamini L, Calveri P, Cavallaro P, Celano A, Guarisco R, Maggio MC, Manessi C, Manna R, Scopinaro A, Sinigaglia L, Taverna R, Bori B, and Bona G, Bergamini L, Calveri P, Cavallaro P, Celano A, Guarisco R, Maggio MC, Manessi C, Manna R, Scopinaro A, Sinigaglia L, Taverna R, Bori B

Subjects
Settore MED/38 - Pediatria Generale E Specialistica, malattie autoinfiammatorie rare, manifesto, Rare Autoinflammatory Disease Council
Published
2021

3. Immediate Introduction of Everolimus Does Not Affect Wound Healing and Delayed Graft Function in Renal Transplant Patients: Preliminary Results From NEVERWOUND Study.: Abstract# D2430

Author

Carmellini, M., Ruggieri, G., Sforza, D., Veroux, M., Secchi, A., Todeschini, P., De Rosa, P., Sghirlanzoni, M., Fior, F., Setti, G., Iappelli, M., Silvestre, C., Taruscia, D., Minetti, E., Spagnoletti, G., Gesualdo, L., Izzo, C., Pisani, F., Piredda, G., Berloco, P., Dal Canton, A., Cappelli, G., Guarisco, R., and Caputo, F.

Published
2014

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. Impact of new DAA therapy on real clinical practice: a multicenter region-wide cohort study

Author

Lanini, Simone, Scognamiglio, Paola, Mecozzi, Alessandra, Lombardozzi, Lorella, Vullo, Vincenzo, Angelico, Mario, Gasbarrini, Antonio, Taliani, Gloria, Attili, Adolfo Francesco, Perno, Carlo Federico, De Santis, Adriano, Puro, Vincenzo, Cerqua, Fabio, D'Offizi, Gianpiero, Pellicelli, Adriano, Armignacco, Orlando, Mennini, Francesco Saverio, Siciliano, Massimo, Girardi, Enrico, Panella, Vincenzo, Ippolito, Giuseppe, Sarrecchia, C., Di Paolo, M. D., Francioso, S., Brega, A., Lenci, I., Sarmati, L., Pompili, Maurizio, Grieco, Antonio, Tamburrini, Enrica, Apaccini, R., Miele, Luca, D'Ettorre, G., Mezzaroma, I., Furlan, C., Accapezzato, D., Paoletti, F., Merili, M., Corradini, S., Sereno, S., Fimiani, C., Mastropietro, C., Labbadia, G., Gentile, Giuseppe, Pasquazzi, C., Marignani, M., Guarisco, R., Puoti, C., Spilabotti, L., Montalbano, M., Boumis, E., Visco-Comandini, U., Zaccarelli, M., Ammassari, A., Lionetti, R., Murachelli, S., Loiacono, L., Antinori, Armando, Noto, P., Palmieri, F., Cicalini, S., Cerilli, S., Sampaolesi, A., Vincenzi, L., Bellagamba, R., Galati, V., Abdeddaim, A., Iacomi, F., Iannicelli, G., Mastroianni, Chiara, Lichtner, M., Ridola, L., Coluzzi, T., Mercurio, V., Del Borgo, C., Fondacaro, L., Cerasari, G., Guarascio, P., D'Ambrosio, C., Starnini, G., Caterini, A., Villani, Emanuele Rocco, Sarracino, L., Casinelli, K., Moretti, A., Vespasiani, U., Galati, G., Cecere, R., Bonaventura, M., and Scudieri, M.

Subjects
Male, Cirrhosis, Investigational, chronic hepatitis c, clinical study, direct acting antiviral, hepatitis c virus, liver cirrhosis, liver damage, mixed effect model, multicenter cohort study, new therapy, treatment efficacy, Logistic regression, Chronic hepatitis C, Cohort Studies, 0302 clinical medicine, Clinical study, Direct acting antiviral, Hepatitis C virus, Liver cirrhosis, Liver damage, Mixed effect model, Multicenter cohort study, New therapy, Treatment efficacy, Adult, Aged, Aged, 80 and over, Antiviral Agents, Drug Therapy, Combination, Drugs, Investigational, Female, Follow-Up Studies, Hepatitis C, Chronic, Humans, Liver Cirrhosis, Middle Aged, Therapies, Investigational, 80 and over, 030212 general & internal medicine, Stage (cooking), Chronic, Confounding, Drugs, Hepatitis C, Infectious Diseases, Cohort, Combination, Settore SECS-P/03 - Scienza delle Finanze, 030211 gastroenterology & hepatology, Cohort study, Research Article, medicine.medical_specialty, Side effect, Hepatitis C virus, Chronic hepatitis C, Liver cirrhosis, Direct acting antiviral, Multicenter cohort study, Mixed effect model, Liver damage, Treatment efficacy, Clinical study, New therapy, lcsh:Infectious and parasitic diseases, 03 medical and health sciences, Drug Therapy, Internal medicine, medicine, lcsh:RC109-216, business.industry, Settore MED/09 - MEDICINA INTERNA, medicine.disease, Clinical trial, Therapies, business
Abstract

Background Management of chronic hepatitis C (CHC) has significantly accelerated in the last few years. Currently, second generation direct acting antivirals (DAAs) promise clearance of infection in most of patients. Here we present the results of the first analysis carried out on data of Lazio clinical network for DAAs. Methods The study was designed as a multicenter cohort: a) to assess the evolution of treatment during the first 24 months of the activity of the Clinical Network; b) to report overall efficacy of treatments; c) to analyze potential factors associated with lack of virological response at 12 weeks after therapy (SVR12); d) to evaluate the variation of ALT at baseline and 12 weeks after therapy in those who achieved SVR12 in comparison to those who did not. Analyses of efficacy were carried out with multilevel mixed effect logistic regression model. ALT temporal variation was assessed by mixed effect model mixed models with random intercept at patient’s level and random slope at the level of the time; i.e. either before or after therapy. Results Between 30 December 2014 and 31 December 2016 5279 patients started a DAA treatment; of those, 5127 (in 14 clinical centers) had completed the 12-week follow-up. Overall proportion of SVR12 was 93.41% (N = 4780) with no heterogeneity between the 14 clinical centers. Interruption as the consequence of severe side effect was very low (only 23 patients). Unadjusted analysis indicates that proportion of SVR12 significantly changes according to patient’s baseline characteristics, however after adjusting for potential confounders only adherence to current guidelines, stage of liver diseases, gender, transplant and HIV status were independently associated with the response to therapy. Analysis of ALT temporal variation showed that ALT level normalized in most, but not, all patients who achieved SVR12. Conclusion Our study confirmed the extraordinary efficacy of DAAs outside clinical trials. The advantage of DAAs was particularly significant for those patients who were previously considered as difficult-to-treat and did not have treatment options before DAAs era. Intervention based on network of select centers and prioritization of patients according to diseases severity was successful. Further studies are needed to establish whether clearance of HCV after DAAs therapy can arrest or even revert liver fibrosis in non-cirrhotic patients and/or improve life quality and expectancy in those who achieve SVR12 with cirrhosis.

Published
2018
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8. Long-term use of human albumin for the treatment of ascites in patients with hepatic cirrhosis: the interim analysis of the ANSWER study

Author

Bernardi M, Riggio O, Angeli P, Alessandria C, Neri S, Foschi FG, Levantesi F, Boccia S, Airoldi A, Fagiuoli S, Svegliati Baroni G, Laffi G, Cozzolongo R, Butera G, Sangiovanni V, Toniutto P, Zocco MA, De Marco R, Morisco F, De Leonardis F, Cacciola I, Elia G, Massironi S, Guarisco R, Marin A, Piano V, Elia C, Nardelli S, Maiorca V, Neri V, Mastroianni A, Tufoni M, Simone L, Cesarini L., Magini G, Marzioni M, Romanelli R. G, Zappimbulso M, Macaluso F, Parrella G, Pugliese F, Tortora A, Cavallin M, Andrealli A, Pasquale C, Fidone F, Lanzi A, Alberti A, Salerno F, Roncadori A, Zaccherini G, Caraceni P, the ANSWER Study Group, FEDERICO, Alessandro, Bernardi, M, Riggio, O, Angeli, P, Alessandria, C, Neri, S, Foschi, Fg, Levantesi, F, Boccia, S, Airoldi, A, Fagiuoli, S, Svegliati Baroni, G, Laffi, G, Cozzolongo, R, Butera, G, Sangiovanni, V, Toniutto, P, Zocco, Ma, De Marco, R, Morisco, F, De Leonardis, F, Cacciola, I, Elia, G, Federico, Alessandro, Massironi, S, Guarisco, R, Marin, A, Piano, V, Elia, C, Nardelli, S, Maiorca, V, Neri, V, Mastroianni, A, Tufoni, M, Simone, L, Cesarini, L., Magini, G, Marzioni, M, Romanelli, R. G., Zappimbulso, M, Macaluso, F, Parrella, G, Pugliese, F, Tortora, A, Cavallin, M, Andrealli, A, Pasquale, C, Fidone, F, Lanzi, A, Alberti, A, Salerno, F, Roncadori, A, Zaccherini, G, Caraceni, P, and the ANSWER Study, Group

Published
2015

10. 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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11. Outcome Results of the Fosinopril Versus Amlodipine Cardiovascular Events Randomized Trial (FACET) in Patients With Hypertension and NIDDM

Author

Strollo G, Marco Pahor, Di Mauro P, Guarisco R, Byington Rp, Strollo F, and Tatti P

Subjects
Blood Glucose, Male, medicine.medical_specialty, Time Factors, Endocrinology, Diabetes and Metabolism, Blood lipids, Angiotensin-Converting Enzyme Inhibitors, Blood Pressure, Body Mass Index, Internal medicine, Fosinopril, Diabetes mellitus, Internal Medicine, medicine, Humans, Prospective Studies, Amlodipine, Myocardial infarction, Stroke, Antihypertensive Agents, Glycated Hemoglobin, Advanced and Specialized Nursing, business.industry, Cholesterol, HDL, Fibrinogen, Middle Aged, Calcium Channel Blockers, medicine.disease, Lipids, Surgery, Blood pressure, Diabetes Mellitus, Type 2, Hypertension, ACE inhibitor, Cardiology, Female, business, Diabetic Angiopathies, Follow-Up Studies, medicine.drug
Abstract

OBJECTIVE ACE inhibitors and calcium antagonists may favorably affect serum lipids and glucose metabolism. The primary aim of the Fosinopril Versus Amlodipine Cardiovascular Events Randomized Trial (FACET) was to compare the effects of fosinopril and amlodipine on serum lipids and diabetes control in NIDDM patients with hypertension. Prospectively defined cardiovascular events were assessed as secondary outcomes. RESEARCH DESIGN AND METHODS Inclusion criteria included a diagnosis of NIDDM and hypertension (systolic blood pressure of >140 mmHg or diastolic blood pressure of >90 mmHg). Exclusion criteria included a history of coronary heart disease or stroke, serum creatinine >1.5 mg/dl, albuminuria >40 μg/min, and use of lipid-lowering drugs, aspirin, or antihypertensive agents other than beta-blockers or diuretics. A total of 380 hypertensive diabetics were randomly assigned to open-label fosinopril (20 mg/day) or amlodipine (10 mg/day) and followed for up to 3.5 years. If blood pressure was not controlled, the other study drug was added. RESULTS Both treatments were effective in lowering blood pressure. At the end of followup, between the two groups there was no significant difference in total serum cholesterol, HDL cholesterol, HbA1c, fasting serum glucose, or plasma insulin. The patients receiving fosinopril had a significantly lower risk of the combined outcome of acute myocardial infarction, stroke, or hospitalized angina than those receiving amlodipine (14/189 vs. 27/191; hazards ratio = 0.49, 95% CI = 0.26–0.95). CONCLUSIONS Fosinopril and amlodipine had similar effects on biochemical measures, but the patients randomized to fosinopril had a significantly lower risk of major vascular events, compared with the patients randomized to amlodipine.

Published
1998
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12. Long-term use of human albumin for the treatment of ascites in patients with hepatic cirrhosis: The interim analysis of the ANSWER study

Author

Bernardi, M., primary, Riggio, O., additional, Angeli, P., additional, Alessandria, C., additional, Neri, S., additional, Foschi, F.G., additional, Levantesi, F., additional, Boccia, S., additional, Airoldi, A., additional, Fagiuoli, S., additional, Svegliati-Baroni, G., additional, Laffi, G., additional, Cozzolongo, R., additional, Butera, G., additional, Sangiovanni, V., additional, Toniutto, P., additional, Zocco, M.A., additional, De Marco, R., additional, Morisco, F., additional, De Leonardis, F., additional, Cacciola, I., additional, Elia, G., additional, Federico, A., additional, Massironi, S., additional, Guarisco, R., additional, Marin, A., additional, Piano, S., additional, Elia, C., additional, Nardelli, S., additional, Maiorca, D., additional, Neri, E., additional, Mastroianni, A., additional, Tufoni, M., additional, Simone, L., additional, Cesarini, L., additional, Magini, G., additional, Marzioni, M., additional, Romanelli, R.G., additional, Zappimbulso, M., additional, Macaluso, F., additional, Parrella, G., additional, Pugliese, F., additional, Tortora, A., additional, Cavallin, M., additional, Andrealli, A., additional, Pasquale, C., additional, Fidone, F., additional, Lanzi, A., additional, Alberti, A., additional, Salerno, F., additional, Roncadori, A., additional, Zaccherini, G., additional, and Caraceni, P., additional

Published
2015
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13. 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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14. Immediate Introduction of Everolimus Does Not Affect Wound Healing and Delayed Graft Function in Renal Transplant Patients: Preliminary Results From NEVERWOUND Study.

Author

Carmellini, M., primary, Ruggieri, G., additional, Sforza, D., additional, Veroux, M., additional, Secchi, A., additional, Todeschini, P., additional, De Rosa, P., additional, Sghirlanzoni, M., additional, Fior, F., additional, Setti, G., additional, Iappelli, M., additional, Silvestre, C., additional, Taruscia, D., additional, Minetti, E., additional, Spagnoletti, G., additional, Gesualdo, L., additional, Izzo, C., additional, Pisani, F., additional, Piredda, G., additional, Berloco, P., additional, Dal Canton, A., additional, Cappelli, G., additional, Guarisco, R., additional, and Caputo, F., additional

Published
2014
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15. Safety of Early Everolimus in De Novo Heart Transplant Recipients: Interim Analysis of the Randomized Study EVERHEART

Author

Potena, L., primary, Barberini, F., additional, Boffini, M., additional, Amarelli, C., additional, Pellegrini, C., additional, Livi, U., additional, Masciocco, G., additional, Faggian, G., additional, Gerosa, G., additional, Lilla, P., additional, Marraudino, N., additional, Porcu, M., additional, Guarisco, R., additional, and Maccherini, M., additional

Published
2013
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21. OC3.10.3 ANTIVIRAL TREATMENT OF HCV CARRIERS WITH NORMAL ALT

Author

Puoti, C., primary, Pellicelli, A.M., additional, Romano, M., additional, Mecenate, F., additional, Barbarini, G., additional, Mazzoni, E., additional, Barlattani, A., additional, Picardi, A., additional, Nosotti, L., additional, Paffetti, A., additional, Bonaventura, M.E., additional, Villani, R., additional, Guarisco, R., additional, Bellis, L., additional, Nicodemo, S., additional, Spilabotti, L., additional, and Soccorsi, F., additional

Published
2008
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22. 826 ANTIVIRAL TREATMENT OF HCV CARRIERS WITH NORMAL ALT

Author

Puoti, C., primary, Pellicelli, A.M., additional, Romano, M., additional, Guarisco, R., additional, Mecenate, F., additional, Barbarini, G., additional, Mazzoni, E., additional, Barlattani, A., additional, Picardi, A., additional, Paffetti, A., additional, Nosotti, L., additional, Bonaventura, M.E, additional, Villani, R., additional, Bellis, L., additional, Nicodemo, S., additional, Spilabotti, L., additional, and Soccorsi, F., additional

Published
2008
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23. An Unsuspected Factor Contributing to Pizza Hyperglycemia

Author

Guarisco R, Tatti P, and Di Mauro P

Subjects
Advanced and Specialized Nursing, medicine.medical_specialty, Endocrinology, business.industry, Endocrinology, Diabetes and Metabolism, Diabetes mellitus, Internal medicine, Internal Medicine, medicine, medicine.disease, business, Dietary Carbohydrates
Published
1993
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27. Immediate Introduction of Everolimus Does Not Affect Wound Healing and Delayed Graft Function in Renal Transplant Patients: Preliminary Results From NEVERWOUND Study

Author

Carmellini, M., Ruggieri, G., Sforza, D., Veroux, M., Secchi, A., Todeschini, P., Rosa, P., Sghirlanzoni, M., Fior, F., Setti, G., Iappelli, M., Silvestre, C., Taruscia, D., Minetti, E., Spagnoletti, G., Gesualdo, L., Izzo, C., Pisani, F., Piredda, G., Berloco, P., Dal Canton, A., Gianni Cappelli, Guarisco, R., and Caputo, F.

29. 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

30. 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

31. Factors Enhancing Treatment of Hepatitis C Virus-Infected Italian People Who Use Drugs: The CLEO-GRECAS Experience

Author

Giuseppe Cariti, Valerio Rosato, Giustino Parruti, Luca Rinaldi, Maria Antonietta Di Rosolini, Valeria Morbiducci, Lucio Cosco, Maria D'Antò, Emanuela Ciracì, Giovanni Garrucciu, Giorgio Barbarini, Massimo De Luca, Rodolfo Sacco, Riccardo Nevola, Pietro Gatti, Antonio Ascione, F. Benanti, Cecilia Cangiano, Paolo Maggi, Paolo Tundo, Gianpiero D'Offizi, Riccardo Guarisco, Giancarlo Gimignani, Michele Imparato, Fabio Bulla, Vincenzo Messina, G. Scifo, Ilaria Luzzitelli, Valeria Pace Palitti, Vito Di Marco, Francesco Di Lorenzo, Ernesto Claar, Antonio Izzi, Mariano Quartini, Tommaso Lupia, Umberto Vespasiani Gentilucci, Vincenzo Iovinella, Marco Di Stefano, Federica Sozio, Antonio Craxì, Rinaldi, Luca, Messina, Vincenzo, Di Marco, Vito, Iovinella, Vincenzo, Claar, Ernesto, Cariti, Giuseppe, Sacco, Rodolfo, De Luca, Massimo, Scifo, Gaetano, Gatti, Pietro, Barbarini, Giorgio, Pace Palitti, Valeria, Quartini, Mariano, Tundo, Paolo, D'Offizi, Gianpiero, Parruti, Giustino, di Rosolini, Maria Antonietta, Garrucciu, Giovanni, Cosco, Lucio, Benanti, Francesco, Gimignani, Giancarlo, Vespasiani Gentilucci, Umberto, Di Lorenzo, Francesco, D'Antò, Maria, Nevola, Riccardo, Lupia, Tommaso, Rosato, Valerio, Morbiducci, Valeria, Luzzitelli, Ilaria, Sozio, Federica, Di Stefano, Marco, Ciraci, Emanuela, Bulla, Fabio, Guarisco, Riccardo, Cangiano, Cecilia, Imparato, Michele, Maggi, Paolo, Ascione, Antonio, Craxì, Antonio, Izzi, Antonio, Rinaldi L., Messina V., Di Marco V., Iovinella V., Claar E., Cariti G., Sacco R., de Luca M., Scifo G., Gatti P., Barbarini G., Palitti V.P., Quartini M., Tundo P., D'Offizi G., Parruti G., di Rosolini M.A., Garrucciu G., Cosco L., Benanti F., Gimignani G., Gentilucci U.V., Di Lorenzo F., D'Anto M., Nevola R., Lupia T., Rosato V., Morbiducci V., Luzzitelli I., Sozio F., Di Stefano M., Ciraci E., Bulla F., Guarisco R., Cangiano C., Imparato M., Maggi P., Ascione A., Craxi A., and Izzi A.

Subjects
Adult, Male, Elbasvir, medicine.medical_specialty, Sofosbuvir, Sustained Virologic Response, Intention to Treat Analysi, Substance-Related Disorders, Hepatitis C virus, medicine.disease_cause, Antiviral Agents, Medication Adherence, 03 medical and health sciences, 0302 clinical medicine, Retrospective Studie, Internal medicine, medicine, Humans, Prospective Studies, Retrospective Studies, Antiviral Agent, Hepatology, business.industry, Gastroenterology, virus diseases, Glecaprevir, Odds ratio, Hepatitis C, Chronic, Middle Aged, Substance-Related Disorder, Pibrentasvir, digestive system diseases, Intention to Treat Analysis, Prospective Studie, Grazoprevir, Italy, 030220 oncology & carcinogenesis, Cohort, 030211 gastroenterology & hepatology, Female, business, medicine.drug, Human
Abstract

INTRODUCTION: We assessed the performance of direct-acting antivirals (DAAs) in hepatitis C virus (HCV)-infected people who use drugs (PWUDs) in terms of sustained virological response (SVR) and adherence rates in comparison to a location-matched cohort of non-PWUD HCV patients. METHODS: All consecutive HCV RNA-positive PWUDs were enrolled between 2015 and 2019. All subjects underwent DAA treatment according to international guidelines and then followed, at least, up to 12 weeks after the end of treatment (SVR12). The SVR and adherence to treatment was compared with that of non-PWUD HCV patients observed at hepatological units of the CLEO platform. Intention-to-treat analysis was performed. RESULTS: A total of 1,786 PWUDs who were followed up were available for assessment. Most PWUDs (85.4%) were managed inside the specialized outpatient addiction clinics (SerDs). The overall SVR rate was 95.4%. The SerDs group achieved an SVR rate of 96.2% compared with 91.6% of the non-SerDs group (P < 0.001). Comparison with the non-SerDs group and the control HCV group showed a significant difference in the dropout rate (0.6% in the SerDs group versus 2.8% in the non-SerDs group and 1.2% in the control group; P < 0.001). At multivariate analysis, factors independently associated with SVR were use of the most recent regimens (elbasvir/grazoprevir, glecaprevir/pibrentasvir, and sofosbuvir/ velpatasvir; odds ratio: 3.126; P 5 0.000) and belonging to the SerDs group (odds ratio: 2.356; P 5 0.002). DISCUSSION: The performance of DAAs in PWUD is excellent, if 2 conditions are met: (i) that the latest generation drugs are used and (ii) that the patients are managed within the SerDs.

Published
2020

32. Factors Enhancing Treatment of Hepatitis C Virus-Infected Italian People Who Use Drugs: The CLEO-GRECAS Experience.

Author

Rinaldi L, Messina V, Di Marco V, Iovinella V, Claar E, Cariti G, Sacco R, De Luca M, Scifo G, Gatti P, Barbarini G, Pace Palitti V, Quartini M, Tundo P, D'Offizi G, Parruti G, di Rosolini MA, Garrucciu G, Cosco L, Benanti F, Gimignani G, Vespasiani Gentilucci U, Di Lorenzo F, D'Antò M, Nevola R, Lupia T, Rosato V, Morbiducci V, Luzzitelli I, Sozio F, Di Stefano M, Ciraci E, Bulla F, Guarisco R, Cangiano C, Imparato M, Maggi P, Ascione A, Craxì A, and Izzi A

Subjects
Adult, Female, Hepatitis C, Chronic epidemiology, Humans, Intention to Treat Analysis, Italy, Male, Middle Aged, Prospective Studies, Retrospective Studies, Substance-Related Disorders epidemiology, Sustained Virologic Response, Antiviral Agents therapeutic use, Hepatitis C, Chronic drug therapy, Medication Adherence, Substance-Related Disorders complications
Abstract

Introduction: We assessed the performance of direct-acting antivirals (DAAs) in hepatitis C virus (HCV)-infected people who use drugs (PWUDs) in terms of sustained virological response (SVR) and adherence rates in comparison to a location-matched cohort of non-PWUD HCV patients., Methods: All consecutive HCV RNA-positive PWUDs were enrolled between 2015 and 2019. All subjects underwent DAA treatment according to international guidelines and then followed, at least, up to 12 weeks after the end of treatment (SVR12). The SVR and adherence to treatment was compared with that of non-PWUD HCV patients observed at hepatological units of the CLEO platform. Intention-to-treat analysis was performed., Results: A total of 1,786 PWUDs who were followed up were available for assessment. Most PWUDs (85.4%) were managed inside the specialized outpatient addiction clinics (SerDs). The overall SVR rate was 95.4%. The SerDs group achieved an SVR rate of 96.2% compared with 91.6% of the non-SerDs group (P < 0.001). Comparison with the non-SerDs group and the control HCV group showed a significant difference in the dropout rate (0.6% in the SerDs group versus 2.8% in the non-SerDs group and 1.2% in the control group; P < 0.001). At multivariate analysis, factors independently associated with SVR were use of the most recent regimens (elbasvir/grazoprevir, glecaprevir/pibrentasvir, and sofosbuvir/velpatasvir; odds ratio: 3.126; P = 0.000) and belonging to the SerDs group (odds ratio: 2.356; P = 0.002)., Discussion: The performance of DAAs in PWUD is excellent, if 2 conditions are met: (i) that the latest generation drugs are used and (ii) that the patients are managed within the SerDs., (Copyright © 2021 by The American College of Gastroenterology.)

Published
2021
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33. 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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35. HCV carriers with normal alanine aminotransferase levels: healthy persons or severely ill patients? Dealing with an everyday clinical problem.

Author

Puoti C, Bellis L, Guarisco R, Dell' Unto O, Spilabotti L, and Costanza OM

Subjects
Disease Progression, Female, Fibrosis, Hepacivirus, Hepatitis C pathology, Humans, Liver pathology, Male, Alanine Transaminase blood, Carrier State enzymology, Hepatitis C enzymology
Abstract

Approximately 30% of patients with chronic HCV infection show persistently normal ALT levels. Although formerly referred to as 'healthy' or 'asymptomatic' HCV carriers, and thus historically excluded from antiviral treatment, it has now become clear that the majority of these patients have some degree of histological liver damage that may be significant in up to 20% of patients and might progress toward a more severe degree of liver fibrosis. A significant proportion of patients (> or =20%) experience periods of increased serum ALT (flare) associated with enhanced disease progression. However, controversies still exist in clinical practice regarding the definition of 'persistent' ALT normality, the virological and histological features of these subjects, the need for liver biopsy, the role of non invasive tools for the assessment of liver fibrosis (transient hepatic elastography, fibroscan), and the natural history and optimal management of chronic hepatitis C with normal ALT. The advent of new therapeutic options (pegylated interferons plus ribavirin) has shifted treatment targets toward eradication of underlying infection, with therapy decision based on age, severity of disease and likelihood of response rather than on aminotransferase levels. This review does approach the main unresolved issues on this topic in the form of a dialog between a hepatologist and a patient with HCV infection but normal alanine aminotransferase levels, trying to give evidence-based answers to the more frequently asked questions from patients and their physicians., (Copyright 2009 Elsevier B.V. All rights reserved.)

Published
2010
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36. Quantitation of tissue polypeptide antigen (TPA) in hepatic and systemic circulation in patients with chronic liver diseases.

Author

Puoti C, Bellis L, Guarisco R, Costanza OM, Felici R, Spilabotti L, Paglia F, Galossi A, and Dell' Unto O

Subjects
Aged, Biomarkers blood, Carcinoma, Hepatocellular immunology, Female, Hepatic Veins physiopathology, Hepatitis B, Chronic immunology, Hepatitis C, Chronic immunology, Humans, Hypertension, Portal physiopathology, Liver Cirrhosis immunology, Liver Diseases complications, Liver Diseases physiopathology, Liver Neoplasms immunology, Male, Middle Aged, Predictive Value of Tests, Prospective Studies, Severity of Illness Index, Venous Pressure, Hypertension, Portal immunology, Liver Circulation, Liver Diseases immunology, Tissue Polypeptide Antigen blood
Abstract

Background and Aim: Abnormal serum tissue polypeptide antigen (TPA) values are commonly found in patients with chronic liver damage and liver cirrhosis even in the absence of malignancies. The aim of this study was to compare serum TPA levels in patients with cirrhosis, to examine correlations between TPA levels and the degree of portal hypertension, and to evaluate TPA concentrations in paired hepatic and peripheral blood samples., Methods: A total of 128 patients with chronic liver disease of various severity were studied prospectively. TPA concentrations in hepatic vein and peripheral blood were determined, and Hepatic Vein Pressure Gradient (HVPG) was measured., Results: TPA levels were significantly higher in patients with cirrhosis than in those with chronic hepatitis, and in systemic circulation than in hepatic vein blood. Peripheral but not hepatic TPA levels did correlate with the HVPG. Subjects with clinically significant portal hypertension (HVPG > 10 mmHg) showed significantly higher peripheral TPA levels than those with HVPG < 10 mmHg., Conclusions: Our data suggest that the increased TPA levels observed in cirrhotic patients and the high systemic-to-hepatic blood TPA gradient are probably due to the presence of portal-systemic shunts rather than to hepatic necro-inflammatory activity. In clinical practice, TPA determination could help us to identify and to follow up cirrhotic patients with more severe portal hypertension.

Published
2009
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37. Treatment of hepatitis C virus carriers with persistently normal alanine aminotransferase levels with peginterferon alpha-2a and ribavirin: a multicentric study.

Author

Puoti C, Pellicelli AM, Romano M, Mecenate F, Guarisco R, Barbarini G, Mazzoni E, Spilabotti L, Bellis L, Paglia F, Barlattani A, Picardi A, Paffetti A, Bonaventura ME, Nosotti L, Mitidieri O, Dell'Unto O, Villani R, Dell'Unto C, Morrone A, and Soccorsi F

Subjects
Adult, Carrier State pathology, Carrier State virology, Drug Therapy, Combination, Female, Hepatitis C pathology, Hepatitis C virology, Humans, Interferon alpha-2, Liver pathology, Male, Middle Aged, RNA, Viral blood, Recombinant Proteins, Alanine Transaminase blood, Antiviral Agents administration & dosage, Carrier State drug therapy, Hepatitis C drug therapy, Interferon-alpha administration & dosage, Polyethylene Glycols administration & dosage, Ribavirin administration & dosage
Abstract

Background/aims: To evaluate, in clinical practice, the efficacy and safety of combined antiviral treatment in hepatitis C virus (HCV) carriers with normal alanine aminotransferase (ALT) levels., Methods: Eighty-eight HCV carriers with persistently normal ALT levels were enrolled. All patients received peginterferon (PEG-IFN) alpha-2a 180 microg once weekly plus ribavirin (RBV) 800 mg/day for 24 weeks (HCV-2 and -3) or 1000-1200 mg/day for 48 weeks (HCV-1)., Results: Rapid virological response (RVR) was seen in 66/88 patients (75%): 19/32 HCV-1 (59%), 40/46 HCV-2 (87%) and 7/10 HCV-3 patients. Younger patients, leaner subjects and patients with non-1 genotype or lower baseline HCV RNA levels were more likely to achieve an RVR. Sustained virological response (SVR) was seen in 69/88 patients (78%): 20/32 HCV-1 patients (62%), 41/46 HCV-2 patients (89%) and 8/10 (80%) HCV-3 patients. The overall SVR rate was 88% in patients with RVR (58/66) and 50% in those without RVR., Conclusions: The combination of PEG-IFN alpha-2a and RBV produces, in patients with normal ALT, virological response rates that are comparable or even higher than those obtained in patients with elevated ALT levels. Thus, we suggest that in selected cases immediate therapy might be preferred to a 'wait-and-see' policy.

Published
2009
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40. Antiviral treatment of HCV carriers with persistently normal ALT levels.

Author

Puoti C, Bellis L, Galossi A, Guarisco R, Nicodemo S, Spilabotti L, and Unto OD

Subjects
Antiviral Agents pharmacology, Carrier State virology, Hepacivirus drug effects, Hepacivirus physiology, Hepatitis C, Chronic genetics, Hepatitis C, Chronic virology, Humans, Alanine Transaminase metabolism, Antiviral Agents therapeutic use, Carrier State drug therapy, Carrier State enzymology, Hepatitis C, Chronic drug therapy, Hepatitis C, Chronic enzymology
Abstract

Approximately 30% of patients with chronic HCV infection show persistently normal alanine aminotransferase levels (PNAL). The prevalence of HCV carriers with normal liver seems to be very low (less than 15-20%). Liver disease is usually minimal/mild and fibrosis is generally absent or minimal, although the association of normal alanine aminotransferase (ALT) with cirrhosis or with liver cancer has been reported. In all studies, liver histology was, on average, significantly less severe in subjects with PNAL than with abnormal ALT. Although the majority of data seem to show that HCV carriers with normal ALT have mild and stable disease, with a favourable prognosis, several studies reported a significant progression of fibrosis in approximately 20-30% of the patients with ALT normality, and the development of HCC in some cases has been described, despite persistent ALT normality. Sudden worsening of disease with ALT increase and histological deterioration has been described after up to 15 years of follow-up, in particular in patients harboring genotype 2. As to antiviral treatment, it has been clearly stated that it no longer seems reasonable to affirm that sustained response rates for patients with normal ALT levels are any different than those for patients with elevated ALT levels when the combination of pegylated interferon (IFN) and ribavirin is used. The issue at hand is whether or not patients with mild disease should be treated. There are numerous other factors which impact on this decision, including genotype, histology, patients motivation, symptoms, co-morbid illness, and the age of the patient.

Published
2008
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41. Hepatic venous pressure gradient does not correlate with the presence and the severity of portal hypertensive gastropathy in patients with liver cirrhosis.

Author

Bellis L, Nicodemo S, Galossi A, Guarisco R, Spilabotti L, Durola L, Dell'Unto O, and Puoti C

Subjects
Aged, Data Interpretation, Statistical, Esophageal and Gastric Varices epidemiology, Esophageal and Gastric Varices etiology, Female, Humans, Hypertension, Portal complications, Liver Cirrhosis complications, Male, Middle Aged, Portal Pressure physiology, Prevalence, Venous Pressure physiology, Esophageal and Gastric Varices physiopathology, Hepatic Veins physiology, Hypertension, Portal physiopathology, Liver Cirrhosis physiopathology, Stomach Diseases etiology
Abstract

Background and Aims: To evaluate whether the hepatic venous pressure gradient (HVPG) differs between cirrhotic patients with severe portal hypertensive gastropathy (PHG) and those with mild or absent PHG., Methods: 59 cirrhotic patients with portal hypertension underwent hepatic vein catheterisation. 44 patients (76%) had PHG (16 mild and 28 severe)., Setting: tertiary care setting (Liver Unit, Internal Medicine)., Results: HVPG values did not differ between the patients without PHG (21.6 +/- 10.1 mmHg) and those with PHG (18.6 +/- 9.1 mmHg), nor between those with mild (19.3 +/- 4.3 mmHg) or severe PHG (17.7 +/- 4.6 mmHg; p = 0.26). The overall prevalence of PHG and the proportion of patients with severe PHG did not differ regarding the Child Pugh classification. The etiology of the cirrhosis did not influence the HVPG. No correlations were found between HVPG values and Child Pugh score, age, platelet count, prothrombin time, bilirubin levels and ALT values. The HVPG did not differ between patients with small, medium or large esophageal varices, nor between subjects with or without gastric varices., Conclusions: Our data show that PHG does not correlate with the degree of portal pressure, and that the prevalence and the severity of this condition are not influenced by the severity of underlying liver disease or by the size of varices.

Published
2007

42. Extrahepatic manifestations of chronic HCV infection.

Author

Galossi A, Guarisco R, Bellis L, and Puoti C

Subjects
Humans, Hepatitis C, Chronic complications
Abstract

Several extrahepatic manifestations have been reported in the natural history of hepatitis C virus infection (HCV). Up to 40-74% of patients infected with HCV might develop at least one extrahepatic manifestation during the course of their disease. Mixed Cryoglobulinemia (MC) is the most known and studied syndrome associated with HCV infection. It is a systemic vasculitis that may involve the skin, kidney and nervous system. A frequent reported association is that between HCV infection and non-Hodgkin lymphoma. The cryoglobulinemia may be the intermediary disorder, in fact some persistent forms of cyoglobulinemia can switch over to a more aggressive haematologic disorder. As compared to cutaneous vasculitis described in MC, HCV infection has been associated with dermatological disorders such as porphyria cutanea tarda and lichen planus. Thyroid disease (usually hypothyroidism) is commonly seen in people with HCV. Up to 25% have thyroid antibodies. Several studies described a correlation between HCV and lympho-cytic sialoadenitis, similar to sialoadenitis associated with idiopathic Sjögren syndrome, but we can define as "pseudo- Sjögren syndrome" the one associated with HCV infection, because it shows several differences in the idiopathic form. In the course of chronic HCV infection, a common obser-vation are rheumatological symptoms such as polyarthritis. The clinical pattern of joint involvement in the course of HCV infection varies from a rheumatoid arthritis-like form (very rare), to a non erosive oligoarthritis involving the large-sized and middle joints.

Published
2007

44. Surveillance of patients with chronic hepatitis C not on antiviral therapy: a practical approach.

Author

Puoti C, Bellis L, Martellino F, Durola L, Galossi A, Guarisco R, and Dell' Unto O

Subjects
Antiviral Agents therapeutic use, Hepatitis C, Chronic diagnosis, Hepatitis C, Chronic epidemiology, Humans, Risk Factors, Hepatitis C, Chronic therapy, Outcome Assessment, Health Care, Population Surveillance methods
Abstract

Surveillance of patients with HCV-related chronic liver disease (CHC) not on antiviral therapy is mandatory, because of the risk of worsening of the disease and progression to cirrhosis and its lethal complications. Unfortunately, data from the literature are scarce, and sometimes there are differences among experts and discrepancies between recommendations. Furthermore, the wide range of diagnostic tests and the continuous development of new diagnostic tools not rarely results in expensive, redundant and not justified surveillance programs. The identification of the optimal frequency of follow-ups constitutes another source of difficulties for the physicians. The purpose of this article is to provide practicing physicians with published criteria for performing a cost-effective and adequate surveillance program for patients with CHC not on antiviral treatment. On the basis of randomized controlled trials (RCTs), metanalysis, and international guide-lines and Consensus Conference statements we have attempted to outline a cost-effective surveillance program for HCV carriers with normal aminotransferases (ALT), for responders to previous interferon (IFN) treatment and for patients with CHC non-eligible for antiviral therapy. This surveillance strategy relies upon the judicious use of un-expensive and widely available tests.

Published
2005

45. Oxerutins (Venoruton): efficacy in chronic venous insufficiency--a double-blind, randomized, controlled study.

Author

Petruzzellis V, Troccoli T, Candiani C, Guarisco R, Lospalluti M, Belcaro G, and Dugall M

Subjects
Adult, Chronic Disease, Double-Blind Method, Edema drug therapy, Edema physiopathology, Female, Humans, Leg blood supply, Leg pathology, Male, Microcirculation, Middle Aged, Pain drug therapy, Pain physiopathology, Pain Measurement, Plethysmography methods, Plethysmography, Impedance, Thermography, Treatment Outcome, Venous Insufficiency physiopathology, Anticoagulants therapeutic use, Hydroxyethylrutoside analogs & derivatives, Hydroxyethylrutoside therapeutic use, Venous Insufficiency drug therapy
Abstract

The aim of this study was to confirm the clinical efficacy of oxerutins by evaluation of venous parietal tone and microvascular perfusion in a double-blind, randomized, placebo-controlled study. The study included 60 patients. Venous tone was evaluated by air-plethysmography (APG) in patients with venous insufficiency (CVI). Forty patients were treated with oxerutins and 20 with placebo for 4 weeks. The dose of the first 2 weeks was higher than that of the following 2 weeks. The age range was between 18 and 65 years. Randomized patients received treatment (oxerutins or placebo) according to the grade of CVI. Patients with grade I CVI received 2 g/day in the first 2 weeks of treatment and 1 g/day in the following weeks. Patients with grade II CVI received 3 g/day in the first 2 weeks and 2 g/day in the following 2 weeks. Visits were scheduled at baseline time (visit 1), at 2 weeks (visit 2) and at 4 weeks (visit 3). They were assessed with the following: (1) APG; (2) light reflection rheography (LRR); (3) capillaroscopy; (4) liquid crystals thermography. CVI signs/symptoms--heavy legs, edema, paresthesia, and cramps--were evaluated following a 4-point rating scale (0 = no symptom; 3 = severe symptoms). At visit 3 a final opinion on efficacy was provided by both patients and investigators, based on a 4-point scale (none, fairly good, good, excellent). The two groups were homogeneous for age, sex, and clinical distribution. The changes in venous capacity, were significant (p<0.01) in the oxerutins group at visits 2 and 3; values in the placebo group remained unchanged. The changes in LRR were significant in the treatment group at visits 2 (p<0.05) and 3 (p<0.01); values in the placebo group remained unchanged. Changes in temperature were significant in the oxerutins group at visits 2 (p<0.05) and 3 (p<0.01); changes in the placebo group were not significant at the end of the study. Capillaroscopy showed an improvement in patients treated with oxerutins. The results of the analysis of signs/symptoms favored active treatment. The overall effects of oxerutins were significantly better than the effects of placebo. Considering both noninvasive tests and clinical evaluation, oxerutins is effective in controlling chronic venous hypertension, without side effect, and with good tolerability.

Published
2002
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46. [Partially hydrolyzed guar gum: a fiber as coadjuvant in the irritable colon syndrome].

Author

Giaccari S, Grasso G, Tronci S, Allegretta L, Sponziello G, Montefusco A, Siciliano IG, Guarisco R, Candiani C, and Chiri S

Subjects
Adolescent, Adult, Aged, Female, Humans, Hydrolysis, Male, Middle Aged, Plant Gums, Colonic Diseases, Functional diet therapy, Dietary Fiber therapeutic use, Galactans therapeutic use, Mannans therapeutic use
Abstract

Purpose: Partially hydrolyzed guar gum (PHGG) is a water-soluble dietary fiber, possessing non-gelling properties. The objective of this clinical experience was to evaluate the progress of symptoms and the modifications in the frequency of evacuation in subjects affected by IBS and regularly taking PHGG., Patients and Methods: The group was made up of 134 out-patients of both sexes, average age 43.12, suffering from IBS, both obese and of normal weigh, with a mean number of weekly evacuations between 2 and 35. The subjects, divided in 2 groups on the basis of Body Mass Index (BMI), were submitted for 24 weeks to a balanced, low or normal calorie diet supplemented by 5 g a day of PHGG. The following information was gathered: number of weekly evacuation, typical symptoms of IBS, cholesterol, triglycerides and glucose levels. In a few subjects (n. = 34) also the plasmatic electrolyte levels, before and during PHGG intake, were evaluated., Results: Both groups showed positive results in the evacuation frequency (p < 0.01 at 12th week) and a decrease, after 3 weeks of PHGG intake, in frequency of IBS symptoms such as flatulence (-55.6%), abdominal tension (-4.7%) and abdominal spasm (-35%). On the other hand an increased number of subjects showed normal levels of cholesterol (+12.2%), lipids (+26.9%) and glucose (+16%). Concentrations of plasmatic electrolytes didn't change during PHGG intake, except for a marked increase of selenium levels, compared to pre-intake levels., Conclusions: The observations obtained from this clinical experience reassert that dietary fiber supplementation is useful in cases of altered intestinal motility. PHGG, due to its water-solubility and non-gelling properties, can be useful also in IBS.

Published
2001

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