Therapy of hyponatremia in cirrhosis with a vasopressin receptor antagonist: A randomized double-blind multicenter trial

Gastroenterology

Volumn 124, Issue 4, 2003, Pages 933-939

  Gerbes, Alexander L ^a,f   Gülberg, Veit ^a   Ginès, Pere ^b   Decaux, Guy ^c   Gross, Peter ^d   Gandjini, Hassan ^e   Djian, Jacques ^e   Azizi, M ^g   Bendtsen, F ^g   Cales, P ^g   Eichler, H G ^g   Gatta, A ^g   Gouerou, H ^g   Guyader, D ^g   Hartmann, A ^g   Hensen, J ^g   Kantola, I ^g   Norbiato, G ^g   Vilstrup, H ^g   Wikstrom B ^g  

^a LUDWIG MAXIMILIANS UNIVERSITY   (Germany)

^b UNIVERSITY OF BARCELONA   (Spain)

^c ERASME HOSPITAL   (Belgium)

^d DRESDEN UNIVERSITY OF TECHNOLOGY   (Germany)

^e Searle European Clinical R and D   (France)

^f UNIVERSITY OF MUNICH   (Germany)

^g NONE

Author keywords

[No Author keywords available]

Indexed keywords

LIXIVAPTAN; SODIUM; VASOPRESSIN;

ADULT; ARTICLE; ASCITES; BODY WEIGHT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEHYDRATION; DOUBLE BLIND PROCEDURE; FEMALE; FLUID RESTRICTION; GASTROINTESTINAL HEMORRHAGE; HUMAN; HYPONATREMIA; KIDNEY DISEASE; LIVER CIRRHOSIS; LIVER DYSFUNCTION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PERITONITIS; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SODIUM BLOOD LEVEL; STATISTICAL ANALYSIS; THIRST; URINE OSMOLALITY; VASOPRESSIN RELEASE; WATER METABOLISM; WATER RETENTION;

EID: 0344806948     PISSN: 00165085     EISSN: None     Source Type: Journal    
DOI: 10.1053/gast.2003.50143     Document Type: Article

References (26)

1. Adrogue HJ, Madias NE. Hyponatremia. N Engl J Med 2000;342: 1581-1589.
2. Shear L, Hall PW, Gabuzda GJ. Renal failure in patients with cirrhosis of the liver. II. Factors influencing maximal urinary flow rate. Am J Med 1966;42:199-209.
3. Arroyo V, Rodés J, Gutiérrez-Lizárraga MA, Revert L. Prognostic value of spontaneous hyponatremia in cirrhosis with ascites. Am J Dig Dis 1976;21:249-256.
4. Llach J, Gines P, Arroyo V, Rimola A, Tito L, Badalamenti S, Jimenez W, Gaya J, Rivera F, Rodes J. Prognostic value of arterial pressure, endogenous vasoactive systems, and renal function in cirrhotic patients admitted to the hospital for the treatment of ascites. Gastroenterology 1988;94:482-487.
5. Cosby RL, Yee B, Schrier RW. New classification with prognostic value in cirrhotic patients. Miner Electrolyte Metab 1989;15: 261-266.
6. Ginés A, Escorsell A, Ginés P, Saló J, Jiménez W, Inglada L, Navasa M, Clària J, Rimola A, Arroyo V, et al. Incidence, predictive factors, and prognosis of the hepatorenal syndrome in cirrhosis with ascites. Gastroenterology 1993;105:229-236.
7. Fernandez-Esparrach G, Sanchez-Fueyo A, Gines P, Uriz J, Quinto L, Ventura PJ, Cardenas A, Guevara M, Sort P, Jimenez W, Bataller R, Arroyo V, Rodes J. A prognostic model for predicting survival in cirrhosis with ascites. J Hepatol 2001;34:46-52.
8. Borroni G, Maggi A, Sangiovanni A, Cazzaniga M, Salerno F. Clinical relevance of hyponatraemia for the hospital outcome of cirrhotic patients. Dig Liver Dis 2000;32:605-610.
9. Gines P, Berl T, Bernardi M, Bichet DG, Hamon G, Jimenez W, Liard JF, Martin PY, Schrier RW. Hyponatremia in cirrhosis. From pathogenesis to treatment. Hepatology 1998;28:851-864.
10. Gerbes AL. Medical treatment of ascites. J Hepatol 1993; 17(Suppl 2):S4-S9.
11. Gross P, Wehrle R, Bussemaker E. Hyponatremia: pathophysiology, differential diagnosis and new aspects of treatment. Clin Nephrol 1996;46:273-276.
12. Ginès P, Jiménez W. Aquaretic agents: a new potential treatment of dilutional hyponatremia in cirrhosis. J Hepatol 1996;24:506-512.
13. Yamamura Y, Ogawa H, Yamashita H, Chihara T, Miyamoto H, Nakamura S, Onogawa T, Yamashita T, Hosokawa T, Mori T. Characterization of a novel aquaretic agent, OPC-31260, as an effective, nonpeptide vasopressin V2 receptor antagonist. Br J Pharmacol 1992;105:787-791.
14. Ohnishi A, Orita Y, Okahara R, Fujihara H, Inoue T, Yamamura Y, Yabuuchi Y, Tanaka T. Potent aquaretic agent. A novel nonpeptide selective vasopressin 2 antagonist (OPC-31260) in men. J Clin Invest 1993;92:2653-2659.
15. Ohnishi A, Orita Y, Takagi N, Fujita T, Toyoki T, Ihara Y, Yamamura Y, Inoue T, Tanaka T. Aquaretic effect of a potent, orally active, nonpeptide V2 antagonist in men. J Pharmacol Exp Ther 1995; 272:546-551.
16. Shimizu K. Aquaretic effects of the nonpeptide V2 antagonist OPC-31260 in hydropenic humans. Kidney Intern 1995;48:220-226.
17. Chan PS, Coupet J, Park HC, Lai F, Hartupee D, Cervoni P, Dusza JP, Albright JD, Ru X, Mazandarani H, Tanikella T, Shepherd C, Ochalski L, Bailey T, Lock TY, Ning X, Taylor JR, Spinelli W. VPA-985, a nonpeptide orally active and selective vasopressin V2 receptor antagonist. Adv Exp Med Biol 1998;449:439-443.
18. Martin PY, Abraham WT, Lieming X, Olson BR, Oren RM, Ohara M, Schrier RW. Selective V2-receptor vasopressin antagonism decreases urinary aquaporin-2 excretion in patients with chronic heart failure. J Am Soc Nephrol 1999;10:2165-2170.
19. Guyader D, Palat A, Ellis-Grosse EJ, Orczyk GP. Pharmacodynamic I effects of a nonpeptide antidiuretic hormone V2 antagonist in cirrhotic patients with ascites. Hepatology 2002;36:1197-1205.
20. Decaux G. Difference in solute excretion during correction of hyponatremic patients with cirrhosis or syndrome of inappropriate secretion of antidiuretic hormone by oral vasopressin V2 receptor antagonist VPA-985. J Lab Clin Med 2001;138:18-21.
21. Gross P, Decaux G, Gerbes AL, Djian J. Double blind, placebo-controlled study of the activity and tolerance of two doses of VPA-985 in patients with hyponatremia. J Am Soc Nephrol 1999; 10:121A (abstr).
22. Inoue T, Ohnishi A, Matsuo A, Kawai B, Kunihiro N, Tada Y, Koizumi F, Chau T, Okada K, Yamamura Y, Tanaka T. Therapeutic and diagnostic potential of a vasopressin-2 antagonist for impaired water handling in cirrhosis. Clin Pharmacol Ther 1998;63: 561-570.
23. Saito T, Ishikawa SE, Sasaki S, Nakamura T, Rokkaku K, Kawakami A, Honda K, Marumo F, Saito T. Acute aquaresis by nonpeptide arginine vasopressin (AVP) antagonist OPC-31260 improves hyponatremia in patients with syndrome of inappropriate secretion of antidiuretic hormone (SIADH). J Clin Endocrinol Metab 1997;82:1054-1057.
24. Bosch-Marcé M, Poo JL, Jimenez W, Bordas N, Leivas A, Morales-Ruiz M, Munoz RM, Perez M, Arroyo V, Rivera F, Rodes J. Comparison of two aquaretic drugs (niravoline and OPC-31260) in cirrhotic rats with ascites and water retention. J Pharmacol Exp Ther 1999;289:194-201.
25. Jiménez W, Serradeil-Le Gal CS, Ros J, Cano C, Cejudo P, Morales-Ruiz M, Arroyo V, Pascal M, Rivera F, Maffrand JP, Rodes J. Long-term efficacy of a selective nonpeptide V2-vasopressin receptor antagonist, SR121463, in cirrhotic rats. J Pharmacol Exp Ther 2000;295:83-90.
26. Ginès P, Cárdenas A, Schrier RW. Liver disease and the kidney. In: Schrier RW, ed. Diseases of the kidney and urinary tract. 7th ed. Philadelphia, PA: Lippincott Williams and Wilkins, 2001: 2167-2204.