Title |
Patients with refractory ascites treated with alfapump® system have better health-related quality of life as compared to those treated with large volume paracentesis: the results of a multicenter randomized controlled study
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Published in |
Quality of Life Research, February 2018
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DOI | 10.1007/s11136-018-1813-8 |
Pubmed ID | |
Authors |
Maria Stepanova, Fatema Nader, Christophe Bureau, Danielle Adebayo, Laure Elkrief, Dominique Valla, Markus Peck-Radosavljevic, Anne McCune, Victor Vargas, Macarena Simon-Talero, Juan Cordoba, Paolo Angeli, Silvia Rossi, Stewart MacDonald, Jeroen Capel, Rajiv Jalan, Zobair M. Younossi |
Abstract |
Refractory ascites (RA) is a complication of cirrhosis which is treated with large volume paracentesis (LVP) as the standard of care. Alfapump® system is a fully implantable pump system which reduces the need for LVP. The aim was to assess health-related quality of life (HRQL) in patients treated with alfapump® versus LVP. The data were collected in a multicenter open-label randomized controlled trial (clinicaltrials.gov #NCT01528410). Subjects with cirrhosis Child-Pugh class B or C accompanied by RA were randomized to receive alfapump® or LVP. The SF-36v2 and CLDQ scores were compared between the two treatment arms at screening and monthly during treatment. Of 60 subjects randomized, HRQL data were available for 58 (N = 27 received alfapump® and N = 31 received LVP only). At baseline, no differences were seen between the treatment arms (all p > 0.05): age 61.9 ± 8.4, 79.3% male, MELD scores 11.7 ± 3.3, 85.2% Child-Pugh class B, 70.7% had alcoholic cirrhosis. The mean number of LVP events/subject was lower in alfapump® than LVP (1.1 vs. 8.6, p < 0.001). The HRQL scores showed a moderate improvement from the baseline levels in subjects treated with alfapump® (p < 0.05 for abdominal and activity scores of CLDQ) but not with LVP (all one-sided p > 0.05) in the first 3 months. Multivariate analysis showed that treatment with alfapump® was independently associated with better HRQL at 3 months (total CLDQ score: beta = 0.67 ± 0.33, p = 0.05). As compared to LVP, the use of alfapump® system is associated with both a reduction in the number of LVP events and improvement of health-related quality of life. |
X Demographics
Geographical breakdown
Country | Count | As % |
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Spain | 1 | 33% |
Unknown | 2 | 67% |
Demographic breakdown
Type | Count | As % |
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Members of the public | 2 | 67% |
Practitioners (doctors, other healthcare professionals) | 1 | 33% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
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Unknown | 59 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
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Student > Master | 9 | 15% |
Researcher | 5 | 8% |
Other | 5 | 8% |
Professor | 5 | 8% |
Student > Postgraduate | 3 | 5% |
Other | 9 | 15% |
Unknown | 23 | 39% |
Readers by discipline | Count | As % |
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Medicine and Dentistry | 28 | 47% |
Unspecified | 2 | 3% |
Social Sciences | 2 | 3% |
Agricultural and Biological Sciences | 1 | 2% |
Pharmacology, Toxicology and Pharmaceutical Science | 1 | 2% |
Other | 2 | 3% |
Unknown | 23 | 39% |