Efficacy and safety of a 14-day administration of tolvaptan in the treatment of patients with ascites in hepatic oedema

Journal of International Medical Research

Volumn 41, Issue 3, 2013, Pages 835-847

  Sakaida, Isao ^a   Yamashita, Satoyoshi ^b   Kobayashi, Tomoo ^c   Komatsu, Masafumi ^d   Sakai, Terufumi ^e   Komorizono, Yasuji ^f   Okada, Mitsuru ^g   Okita, Kiwamu ^h  

^a YAMAGUCHI UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^b Shimonoseki Kosei Hospital   (Japan)

^c TOHOKU ROSAI HOSPITAL   (Japan)

^d AKITA CITY HOSPITAL   (Japan)

^e ST MARY S HOSPITAL   (Japan)

^f Nanpuh Hospital   (Japan)

^g OTSUKA PHARMACEUTICAL CO LTD   (Japan)

^h Social Insurance Alliance Shimonoseki Kohsei Hospital   (Japan)

Author keywords

aquaretic effect; Ascites; body weight; diuretic; hepatic oedema; liver cirrhosis; tolvaptan

Indexed keywords

ALDOSTERONE ANTAGONIST; DIURETIC AGENT; FUROSEMIDE; LOOP DIURETIC AGENT; SPIRONOLACTONE; TOLVAPTAN;

ABDOMINAL DISTENSION; ADULT; AGED; ARTICLE; ASCITES; BLOOD PRESSURE; CONSTIPATION; CREATININE BLOOD LEVEL; DISEASE MARKER; DIURETIC ACTIVITY; DIURETIC THERAPY; DIZZINESS; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG SAFETY; EDEMA; ESOPHAGUS HEMORRHAGE; ESOPHAGUS VARICES; FEMALE; FEVER; HEPATIC EDEMA; HEPATIC ENCEPHALOPATHY; HERNIA; HUMAN; HYPOTENSION; INSOMNIA; JAPANESE; LIVER CIRRHOSIS; MAJOR CLINICAL STUDY; MALAISE; MALE; MULTICENTER STUDY; PHARYNGITIS; PHASE 3 CLINICAL TRIAL; POTASSIUM BLOOD LEVEL; SIDE EFFECT; SOMNOLENCE; THIRST; TREATMENT DURATION; TREATMENT RESPONSE; UREA BLOOD LEVEL; WEIGHT CHANGE; WEIGHT REDUCTION;

AQUARETIC EFFECT; ASCITES; BODY WEIGHT; DIURETIC; HEPATIC OEDEMA; LIVER CIRRHOSIS; TOLVAPTAN;

AGED; ASCITES; BENZAZEPINES; BODY WEIGHT; DIURETICS; DRUG ADMINISTRATION SCHEDULE; EDEMA; FEMALE; HUMANS; LIVER; LIVER CIRRHOSIS; MALE; MIDDLE AGED; PROTECTIVE AGENTS; SODIUM; TREATMENT OUTCOME;

EID: 84887385576     PISSN: 03000605     EISSN: 14732300     Source Type: Journal    
DOI: 10.1177/0300060513480089     Document Type: Article

References (29)

1. Ginès P,Cárdenas A,Arroyo V,et al.Management of cirrhosis and ascites.N Engl J Med. 2004;350:1646-1654.
2. Moore KP,Wong F,Gines P,et al.The management of ascites in cirrhosis: report on the consensus conference of the International Ascites Club.Hepatology. 2003;38:258-266.
3. Cárdenas A,Arroyo V.Refractory ascites.Dig Dis. 2005;23:30-38.
4. Ginès P,Angeli P,Lenz K,et al.EASL clinical practice guidelines on the management of ascites, spontaneous bacterial peritonitis, and hepatorenal syndrome in cirrhosis.J Hepatol. 2010;53:397-417.
5. Management of adult patients with ascites due to cirrhosis: an update.Hepatology. 2009;49:2087-2107.
6. Wong F.Management of ascites in cirrhosis.J Gastroenterol Hepatol. 2012;27:11-20.
7. Felker GM,Lee KL,Bull DA,et al.Diuretic strategies in patients with acute decompensated heart failure.N Engl J Med. 2011;364:797-805.
8. Gross P.Treatment of hyponatremia.Intern Med. 2008;47:885-891.
9. Kuiper JJ,de Man RA,van Buuren HR.Review article: management of ascites and associated complications in patients with cirrhosis.Aliment Pharmacol Ther. 2007;26:183-193.
10. Kuiper JJ,van Buuren HR,de Man RA.Ascites in cirrhosis: a review of management and complications.Neth J Med. 2007;65:283-288.
11. Decaux G,Soupart A,Vassart G.Non-peptide arginine-vasopressin antagonists: the vaptans.Lancet. 2008;371:1624-1632.
12. Yamamura Y,Nakamura S,Itoh S,et al.OPC-41061, a highly potent human vasopressin V2-receptor antagonist: pharmacological profile and aquaretic effect by single and multiple oral dosing in rats.J Pharmacol Exp Ther. 1998;287:860-867.
13. Vaidya C,Ho W,Freda BJ.Management of hyponatremia: providing treatment and avoiding harm.Cleve Clin J Med. 2010;77:715-726.
14. Orlandi C,Zimmer CA,Gheorghiade M.Tolvaptan for the treatment of hyponatremia and congestive heart failure.Future Cardiol. 2006;2:627-634.
15. Doggrell SA.Tolvaptan (Otsuka).Curr Opin Investig Drugs. 2004;5:977-983.
16. Gheorghiade M,Konstam MA,Burnett JC,et al.Short-term clinical effects of tolvaptan, an oral vasopressin antagonist, in patients hospitalized for heart failure: the EVEREST Clinical Status Trials.JAMA. 2007;297:1332-1343.
17. Veeraveedu PT,Watanabe K,Ma M,et al.Effects of nonpeptide vasopressin V2 antagonist tolvaptan in rats with heart failure.Biochem Pharmacol. 2007;74:1466-1475.
18. Gheorghiade M,Orlandi C,Burnett JC,et al.Rationale and design of the multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy of vasopressin antagonism in heart failure: outcome study with tolvaptan (EVEREST).J Card Fail. 2005;11:260-269.
19. Yi JH,Shin HJ,Kim HJ.V2 receptor antagonist; tolvaptan.Electrolyte Blood Press. 2011;9:50-54.
20. Sakaida I,Yanase M,Kobayashi Y,et al.The pharmacokinetics and pharmacodynamics of tolvaptan in patients with liver cirrhosis with insufficient response to conventional diuretics: a multicentre, double-blind, parallel-group, phase III study.J Int Med Res. 2012;40:2381-2393.
21. Sakaida I, Kawazoe S, Hasebe C,et al.Dose-finding trial of tolvaptan in liver cirrhosis patients with increased body fluid. Hepatol Res 2013; In press.
22. Okita K,Sakaida I,Okada M,et al.A multicenter, open-label, dose-ranging study to exploratively evaluate the efficacy, safety, and dose-response of tolvaptan in patients with decompensated liver cirrhosis.J Gastroenterol. 2010;45:979-987.
23. Mochida S,Takikawa Y,Nakayama Y,et al.Diagnostic criteria of acute liver failure: a report by the Intractable Hepato-Biliary diseases study group of Japan.Hepatol Res. 2011;43:805-812.
24. Giordano S.The 2008 Declaration of Helsinki: some reflections.J Med Ethics. 2010;36:598-603.
25. Flear CT,Gill GV,Burn J.Hyponatraemia: mechanisms and management.Lancet. 1981;318:26-31.
26. Miller M.Hyponatremia and arginine vasopressin dysregulation: mechanisms, clinical consequences, and management.J Am Geriatr Soc. 2006;54:345-353.
27. Madan K,Mehta A.Management of renal failure and ascites in patients with cirrhosis.Int J Hepatol. 2011;2011:790232-790232.
28. Rai A,Whaley-Connell A,McFarlane S,et al.Hyponatremia, arginine vasopressin dysregulation, and vasopressin receptor antagonism.Am J Nephrol. 2006;26:579-589.
29. Durand F,Valla D.Assessment of prognosis in cirrhosis.Semin Liver Dis. 2008;28:110-122.