{"id":5167,"date":"2018-03-20T08:34:21","date_gmt":"2018-03-20T07:34:21","guid":{"rendered":"https:\/\/www.sequanamedical.com\/sequana-medical-announces-publication-results-multicentre-randomized-controlled-study\/"},"modified":"2022-07-07T14:27:42","modified_gmt":"2022-07-07T12:27:42","slug":"sequana-medical-announces-publication-results-multicentre-randomized-controlled-study","status":"publish","type":"post","link":"https:\/\/www.sequanamedical.com\/nl\/persberichten\/sequana-medical-announces-publication-results-multicentre-randomized-controlled-study\/","title":{"rendered":"Sequana Medical Announces Publication of Results of Multicentre Randomized Controlled Study"},"content":{"rendered":"

Zurich, SWITZERLAND \u2013 19. March 2018 — Sequana Medical AG (\u201cSequana Medical\u201d), a commercial stage medical device company and an innovator in the management of liver disease, announces the
\npublication of a multicentre, randomized controlled study in Quality of Life Research (https:\/\/link.springer.com\/journal\/11136<\/a>). <\/p>\n

The study demonstrated that patients with refractory ascites treated with alfa<\/strong>pump\u00ae system have better health-related quality of life as compared to those treated with large volume paracentesis.<\/p>\n

In this multicentre, open-label randomized controlled trial, subjects were randomised to receive the alfa<\/strong>pump\u00ae (AP) or large volume Paracentesis (LVP) (27 AP, 31 SoC). The SF-36v2 and CLDQ scores were compared between the two treatment arms at screening and monthly during treatment<\/p>\n

At baseline, no differences were seen between the treatment arms (all p\u2009>\u20090.05): age 61.9\u2009\u00b1\u20098.4, 79.3% male, MELD scores 11.7\u2009\u00b1\u20093.3, 85.2% Child\u2013Pugh class B, 70.7% had alcoholic cirrhosis. The mean number of LVP events\/subject was lower in alfa<\/strong>pump\u00ae than LVP (1.1 vs. 8.6, in 6 months after treatment; p\u2009<\u20090.001). The health-related quality of life (HRQL) scores showed a moderate improvement from the baseline levels in subjects treated with alfa<\/strong>pump\u00ae (p\u2009<\u20090.05 for abdominal and activity scores of CLDQ) but not with LVP (all one-sided p\u2009>\u20090.05) in the first 3 months. Subjects with refractory ascites who were treated with LVP continued to worsen their HRQL and experience no HRQL benefit. In contrast, subjects with refractory ascites who were treated with alfa<\/strong>pump\u00ae system did experience improvement of HRQL as early as 1 month after treatment initiation. In fact, this improvement continued with longer follow-up of those subjects, and clinically meaningful HRQL superiority was noted in multiple domains related to bodily pain, other systemic symptoms, and fatigue. It is also important to note that the superiority of HRQL in patients treated with alfa<\/strong>pump\u00ae remained significant even after controlling for other known predictors of HRQL scores. This supports HRQL-related benefits of alfa<\/strong>pump\u00ae system over LVP.<\/p>\n

Download the full press release<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"

Zurich, SWITZERLAND \u2013 19. March 2018 — Sequana Medical AG (\u201cSequana Medical\u201d), a commercial stage medical device company and an innovator in the management of liver disease, announces the publication of a multicentre, randomized controlled study in Quality of Life Research (https:\/\/link.springer.com\/journal\/11136). The study demonstrated that patients with refractory ascites treated with alfapump\u00ae system have […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[74],"tags":[94],"class_list":["post-5167","post","type-post","status-publish","format-standard","hentry","category-persberichten","tag-niet-gereglementeerd"],"acf":[],"yoast_head":"\nSequana Medical Announces Publication of Results of Multicentre Randomized Controlled Study - Sequana Medical<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.sequanamedical.com\/nl\/persberichten\/sequana-medical-announces-publication-results-multicentre-randomized-controlled-study\/\" \/>\n<meta property=\"og:locale\" content=\"nl_NL\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Sequana Medical Announces Publication of Results of Multicentre Randomized Controlled Study - Sequana Medical\" \/>\n<meta property=\"og:description\" content=\"Zurich, SWITZERLAND \u2013 19. March 2018 — Sequana Medical AG (\u201cSequana Medical\u201d), a commercial stage medical device company and an innovator in the management of liver disease, announces the publication of a multicentre, randomized controlled study in Quality of Life Research (https:\/\/link.springer.com\/journal\/11136). 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