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Open-labeled randomized controlled trial to compare diuretic therapy with recombinant human serum albumin and diuretic therapy for therapeutic treatment of ascites in patients with advanced liver cirrhosis: an exploratory trial.


Hepatol Res. 2013 Apr 22;


Authors: Nakamura T, Sata M, Suzuki K, Moriwaki H, Fukui H, Fujiyama S, Imawari M


Abstract

AIM: There were only a few trials demonstrated additional effects of human serum albumin (HSA) on diuretic therapy in patients with cirrhotic ascites. We aimed to evaluate the safety and efficacy of recombinant HSA, KD-294, treatment in patients with cirrhotic ascites. METHODS: The inclusion criteria were patients 20 to 75 years of age, with cirrhotic ascites, and a serum albumin concentration of less than 3.0 g/dL. Eighty five patients were registered and 71 patients underwent randomization. Enrolled patients received oral spironolactone at 50 mg/day and intravenous furosemide at 20 mg/day in addition to low-sodium diet. They were divided randomly into KD-294 treatment group (n=35) or non-treatment control group (n=36). Patients in KD-294 group received KD-294 at 25 g/day for up to 5 days and those in control group continued the diuretic therapy. They were followed up for 5 weeks. RESULTS: KD-294 was well tolerated. A correlation between the increases in serum albumin and decreases in body weight was not shown (r=-0.116, P=0.355). However, changes of plasma renin concentration (PRC) showed a significant decrease in KD-294 group compared with control group (geometric mean fold change ratio: -0.2818, 95%CI: -0.4288 - -0.1349, Log-transformed data). As a result of this exploratory analysis, patients with high PRC showed a significant correlation between increases in serum albumin and decreases in body weight (r=-0.440, P=0.036). CONCLUSION: The present data don't show efficacy in all patients with cirrhotic ascites, however, suggest that additional effects of HSA on diuretic therapy were expected in high PRC patients.

PMID: 23607459 [PubMed - as supplied by publisher]