Abstract | BACKGROUND & AIMS: METHODS: Inclusion criteria were as follows: Child-Pugh A viral pre-ascitic cirrhosis, with either F1 esophageal varices or no varices, but endoscopic and/or ultrasound evidence of portal hypertension. Thirteen Italian Liver Units prospectively enrolled 120 patients randomized to receive double-blind either Kcanrenoate (100 mg/day; 66 patients) or placebo (54 patients). Endoscopy and sonography were performed at entry and at 52 weeks unless the patient developed ascites earlier, whereas laboratory examinations were performed at entry and every 3 months thereafter. An intention-to-treat analysis was performed, with each end point assessed by the Fisher exact test; the cumulative risk for the appearance of any end point was analyzed by the adjusted log-rank test (Tarone-Ware), with censoring for drop-outs. RESULTS: The progression of variceal status or appearance of ascites, analyzed independently, was not significantly more frequent on placebo (24.1% and 9.2%, respectively) than on Kcanrenoate (12.1% and 1.5%, respectively), whereas the cumulative occurrence of end points was decreased on Kcanrenoate (17.6% vs 38.3% with placebo; P < .05, Tarone-Ware test). The incidence of adverse events was negligible and did not differ between groups. CONCLUSIONS: This preliminary study shows that 100 mg/day of Kcanrenoate is well tolerated and does not reduce the individual incidence of ascites and/or the appearance or progression of esophageal varices in preascitc cirrhosis, but may decrease their 1-year cumulative occurrence.
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Authors | Luigi Bolondi, Fabio Piscaglia, Angelo Gatta, Francesco Salerno, Mauro Bernardi, Antonio Ascione, Oscar Ferraù, David Sacerdoti, Stefania Visentin, Franco Trevisani, Roberto Mazzanti, Gabriele Donati, Umberto Arena, Paolo Gentilini, DOC (Decrease Of Complications in cirrhosis) Study Group |
Journal | Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association
(Clin Gastroenterol Hepatol)
Vol. 4
Issue 11
Pg. 1395-402
(Nov 2006)
ISSN: 1542-3565 [Print] United States |
PMID | 16931172
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Mineralocorticoid Receptor Antagonists
- Canrenoic Acid
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Topics |
- Aged
- Ascites
(epidemiology, etiology, prevention & control)
- Canrenoic Acid
(administration & dosage, therapeutic use)
- Disease Progression
- Double-Blind Method
- Esophageal and Gastric Varices
(etiology, physiopathology, prevention & control)
- Female
- Humans
- Incidence
- Kidney Function Tests
- Liver Cirrhosis
(complications, physiopathology)
- Male
- Middle Aged
- Mineralocorticoid Receptor Antagonists
(administration & dosage, therapeutic use)
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