The DOI matches its Crossref record; 6 of the 6 references it cites were found in a registry or an index.
Long-term albumin administration in decompensated cirrhosis (ANSWER): an open-label randomised trial
Open accessAbstract
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.
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The Cochrane Collaboration's tool for assessing risk of bias in randomised trials
Higgins, J. P. T., Altman, D. G., Gotzsche, P. C., Juni, P., Moher, D., Oxman, A. D., Savovic, J., Schulz, K. F., Weeks, L., Sterne, J. A. C., et al. (2011) · BMJ · doi:10.1136/bmj.d5928 · Cited by 33,817
Moher, D., Hopewell, S., Schulz, K. F., Montori, V., Gotzsche, P. C., Devereaux, P. J., Elbourne, D., Egger, M., & Altman, D. G. (2010) · BMJ · doi:10.1136/bmj.c869 · Cited by 8,883
Vos, T., Allen, C., Arora, M., Barber, R. M., Bhutta, Z. A., Brown, A., Carter, A., Casey, D. C., Charlson, F. J., Chen, A. Z., et al. (2016) · The Lancet · doi:10.1016/s0140-6736(16)31678-6 · Cited by 7,253
Ford, I., & Norrie, J. (2016) · New England Journal of Medicine · doi:10.1056/nejmra1510059 · Cited by 1,405
Moeller, C., Fleischmann, C., Thomas-Rueddel, D., Vlasakov, V., Rochwerg, B., Theurer, P., Gattinoni, L., Reinhart, K., & Hartog, C. S. (2016) · Journal of Critical Care · doi:10.1016/j.jcrc.2016.04.011 · Cited by 159
Italian population-based values of EQ-5D health states
Scalone, L., Cortesi, P. A., Ciampichini, R., Belisari, A., D’Angiolella, L. S., Cesana, G., & Mantovani, L. G. (2013) · Value in Health · doi:10.1016/j.jval.2013.04.008 · Cited by 145
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Ginès, P., Krag, A., Abraldes, J. G., Solà, E., Fabrellas, N., & Kamath, P. S. (2021) · The Lancet · doi:10.1016/s0140-6736(21)01374-x · Cited by 1,663
Guidelines on the management of ascites in cirrhosis
Aithal, G. P., Palaniyappan, N., China, L., Härmälä, S., Macken, L., Ryan, J. M., Wilkes, E. A., Moore, K., Leithead, J. A., Hayes, P. C., et al. (2021) · Gut · doi:10.1136/gutjnl-2020-321790 · Cited by 680
Hypoalbuminemia as Surrogate and Culprit of Infections
Wiedermann, C. J. (2021) · International Journal of Molecular Sciences · doi:10.3390/ijms22094496 · Cited by 394
Nutrition in Patients with Type 2 Diabetes: Present Knowledge and Remaining Challenges
Petroni, M. L., Brodosi, L., Marchignoli, F., Sasdelli, A. S., Caraceni, P., Marchesini, G., & Ravaioli, F. (2021) · Nutrients · doi:10.3390/nu13082748 · Cited by 116
Self-citationSolà, E., Pose, E., Campion, D., Piano, S., Roux, O., Simon-Talero, M., Uschner, F., de Wit, K., Zaccherini, G., Alessandria, C., et al. (2021) · Journal of Hepatology · doi:10.1016/j.jhep.2020.08.009 · Cited by 41
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Metadata
- Authors
- 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.
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2018-06
- Volume
- 391
- Issue
- 10138
- Pages
- 2417-2429
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W2806141881
- Cited by
- 536
- References
- 6
- FWCI
- 26.53
- Type
- journal article
- Language
- en
- Open access
- bronze
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- 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., . . . Salerno, F. (2018). Long-term albumin administration in decompensated cirrhosis (ANSWER): an open-label randomised trial. The Lancet. https://doi.org/10.1016/s0140-6736(18)30840-7
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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