Maria Stepanova1, Fatema Nader1, Christophe Bureau2, Danielle Adebayo3, Laure Elkrief4, Dominique Valla4, Markus Peck-Radosavljevic5, Anne McCune6, Victor Vargas7, Macarena Simon-Talero7, Juan Cordoba7, Paolo Angeli8, Silvia Rossi8, Stewart MacDonald3, Jeroen Capel9, Rajiv Jalan3, Zobair M Younossi10,11. 1. Center for Outcomes Research in Liver Diseases, Washington, DC, USA. 2. Service d'hépato-gastroentérologie, CHU Toulouse, Toulouse, France. 3. UCL Institute of Hepatology, Royal Free Hospital, University College London, London, UK. 4. DHU UNITY, Service d'hépatologie, Hôpital Beaujon, Clichy, and Université Paris Diderot and Inserm U1149, Paris, France. 5. Department of Gastroenterology/Hepatology, Endocrinology and Nephrology, Klinikum Klagenfurt am Wörthersee, Klagenfurt, Austria. 6. Department of Hepatology, Bristol Royal Infirmary, Bristol, UK. 7. Liver Unit, Department of Internal Medicine, Hospital Universitari Vall d´Hebron, VHIR, Universitat Autònoma de Barcelona, CIBERehd, Barcelona, Spain. 8. Facoltà di Medicina e Chirurgia, Università degli Studi di Padova, Padova, Italy. 9. Sequana Medical AG, Zurich, Switzerland. 10. Department of Medicine, Inova Fairfax Hospital, Falls Church, VA, USA. zobair.younossi@inova.org. 11. Betty and Guy Beatty Center for Integrated Research, Claude Moore Health Education and Research Building, 3300 Gallows Road, Falls Church, VA, 22042, USA. zobair.younossi@inova.org.
Abstract
BACKGROUND: 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 withalfapump® versus LVP. METHODS: 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. RESULTS: 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). CONCLUSION: 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.
RCT Entities:
BACKGROUND: 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. METHODS: The data were collected in a multicenter open-label randomized controlled trial (clinicaltrials.gov #NCT01528410). Subjects with cirrhosisChild-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. RESULTS: 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). CONCLUSION: 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.
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