Clinical trial: short-term effects of combination of satavaptan, a selective vasopressin V2receptor antagonist, and diuretics on ascites in patients with cirrhosis without hyponatremia - a randomized, double-blind, placebo-controlled study
| Autor: | Ginès P, Wong F, Watson H, Terg R, Bruha R, Zarski JP, Dudley F, NormoCAT study investigators: Angeli P, Angus P, Bilic A, Bronowicki JP, Chira C, Dobru D, Doffoel M, Fleig W, Fraticiu A, Gadano A, Gerbes A, Gheorge L, Goldis A, Grigorescu M, Horsmans Y, Hulek P, Lata J, Lonovics J, Manns M, Masliah C, Morichaut Beauchant M, Olteanu D, Pascu O, Planas R, Ramdani M, Ruiz del Arbol L, Siahmed SN, Stoica V, Ujszaszy L, Voiosu M.R., BERNARDI, MAURO |
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| Přispěvatelé: | Ginès P, Wong F, Watson H, Terg R, Bruha R, Zarski JP, Dudley F, NormoCAT study investigators: Angeli P, Angus P, Bernardi M, Bilic A, Bronowicki JP, Chira C, Dobru D, Doffoel M, Fleig W, Fraticiu A, Gadano A, Gerbes A, Gheorge L, Goldis A, Grigorescu M, Horsmans Y, Hulek P, Lata J, Lonovics J, Manns M, Masliah C, Morichaut-Beauchant M, Olteanu D, Pascu O, Planas R, Ramdani M, Ruiz del Arbol L, Siahmed SN, Stoica V, Ujszaszy L, Voiosu MR. |
| Rok vydání: | 2010 |
| Předmět: |
Liver Cirrhosis
Male medicine.medical_specialty Cirrhosis Morpholines VASOPRESSIN V2 RECEPTORS medicine.medical_treatment Placebo-controlled study Spironolactone Placebo Gastroenterology chemistry.chemical_compound Double-Blind Method Furosemide Internal medicine Ascites Humans Medicine Spiro Compounds Pharmacology (medical) Prospective Studies Diuretics CIRRHOSIS SATAVAPTAN Aged HYPONATREMIA Hepatology business.industry Body Weight Middle Aged medicine.disease Surgery Drug Combinations Satavaptan Treatment Outcome chemistry Female ASCITES Diuretic medicine.symptom business Hyponatremia Antidiuretic Hormone Receptor Antagonists |
| Zdroj: | Alimentary Pharmacology & Therapeutics. |
| ISSN: | 1365-2036 0269-2813 |
| DOI: | 10.1111/j.1365-2036.2010.04236.x |
| Popis: | Aliment Pharmacol Ther 31, 834–845 Summary Background There is little information on the effects of vaptans in patients with cirrhosis. Aim To investigate the short-term effects of satavaptan, a selective vasopressin V2 receptor antagonist on ascites in cirrhosis without hyponatraemia. Methods A total of 148 patients with cirrhosis, ascites and serum sodium >130 mmol/L were included in a multicentre, double-blind, randomized, controlled study of 14 days comparing three fixed doses of satavaptan (5 mg, 12.5 mg or 25 mg once daily) vs. placebo. Average MELD scores were: 13.4, 12.3, 13.8 and 13.1 respectively. All patients received spironolactone 100 mg/day plus furosemide 20–25 mg/day. Results Satavaptan treatment was associated with a decrease in ascites (mean change in body weight was −0.36 kg (±3.03) for placebo vs. −2.46 kg (±3.11), −2.08 kg (±4.17) and −2.28 kg (±3.24) for the 5 mg, 12.5 mg and 25 mg doses respectively; P = 0.036, P = 0.041 and P = 0.036 for satavaptan 5, 12.5 and 25 mg/day vs. placebo respectively). Thirst and slight increases in serum sodium were more common in patients treated with satavaptan compared with placebo, while other adverse events were similar. Conclusions The administration satavaptan for a 14-day period is associated with reduction in ascites in patients with moderately severe cirrhosis without hyponatraemia under diuretic treatment. |
| Databáze: | OpenAIRE |
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