Dose-finding trial of tolvaptan in liver cirrhosis patients with hepatic edema: A randomized, double-blind, placebo-controlled trial

Hepatology Research

Volumn 44, Issue 1, 2014, Pages 83-91

  Okita, Kiwamu ^a   Kawazoe, Seiji ^b   Hasebe, Chitomi ^c   Kajimura, Kozo ^d   Kaneko, Akira ^e   Okada, Mitsuru ^f   Sakaida, Isao ^g   Inoue, Atsuo ^h   Yoshihara, Harumasa ⁱ   Kumada, Hiromitsu ^j   Ikeda, Kenji ^j   Kohno, Hiroshi ^k   Hidaka, Hisashi ^l   Moriwaki, Hisataka ^m   Inoue, Junichi ⁿ   Nakatsuka, Katsuhisa ^o   Chayama, Kazuaki ^p   Katayama, Kazuhiro ^q   Fujimura, Kazuyo ^r   Tsuji, Keiji ^s   Kumamoto, Masafumi ^t   Yamazaki, Masaharu ^u   Kawaguchi, Masanori ^v   Yoneda, Masashi ^w   Tanaka, Masatoshi ^x   Kato, Michio ^y   Kitamoto, Mikiya ^z   Endo, Ryujin ^aa   Suzuki, Satoko ^ab   Watanabe, Sumio ^ab   Kaneda, Satoru ^ac   Yamashita, Satoyoshi ^ad   Nakayama, Seiichi ^ae   Kokubu, Shigehiro ^af   Tanaka, Shin ^ag   Katsushima, Shinji ^ah   Aimitsu, Shiomi ^ai   Terai, Shuji ^aj   Kawata, Sumio ^ak   Saito, Takafumi ^ak   Ueki, Toshiharu ^al   Nouchi, Toshihiko ^am   Ohnishi, Yoshifumi ^an   Nishigaki, Youichi ^ao   more..

^a Social Insurance Alliance Shimonoseki Kohsei Hospital   (Japan)

^b Saga Medical School   (Japan)

^c Yoshida Hospital   (Japan)

^d Kishiwada City Hospital   (Japan)

^e OSAKA POLICE HOSPITAL   (Japan)

^f Otsuka Pharmaceutical   (Japan)

^g YAMAGUCHI UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^h OSAKA GENERAL MEDICAL CENTER   (Japan)

ⁱ OSAKA ROSAI HOSPITAL   (Japan)

^j TORANOMON HOSPITAL   (Japan)

^k NHO Kure Medical Center   (Japan)

^l KITASATO UNIVERSITY HOSPITAL   (Japan)

^m GIFU UNIVERSITY HOSPITAL   (Japan)

ⁿ Hiroshima Teishin Hospital   (Japan)

^o NIPPON MEDICAL SCHOOL HOSPITAL   (Japan)

^p HIROSHIMA UNIVERSITY HOSPITAL   (Japan)

^q OSAKA KOSEI NENKIN HOSPITAL   (Japan)

^r Nara Social Insurance Hospital   (Japan)

^s HIROSHIMA CITY ASA HOSPITAL   (Japan)

^t KURUME UNIVERSITY HOSPITAL   (Japan)

^u NARA MEDICAL UNIVERSITY HOSPITAL   (Japan)

^v Saiseikai Wakayama Hospital   (Japan)

^w AICHI MEDICAL UNIVERSITY HOSPITAL   (Japan)

^x KURUME UNIVERSITY MEDICAL CENTER   (Japan)

^y NHO Osaka Medical Center   (Japan)

^z HIROSHIMA PREFECTURAL HOSPITAL   (Japan)

^aa IWATE MEDICAL UNIVERSITY   (Japan)

^ab JUNTENDO UNIVERSITY HOSPITAL   (Japan)

^ac NATIONAL HOSPITAL ORGANIZATION CHIBA MEDICAL CENTER   (Japan)

^ad Shimonoseki Kosei Hospital   (Japan)

^ae National Hospital Organization   (Japan)

^af JUNTENDO UNIVERSITY NERIMA HOSPITAL   (Japan)

^ag NATIONAL HOSPITAL ORGANIZATION TOKYO MEDICAL CENTER   (Japan)

^ah NATIONAL HOSPITAL ORGANIZATION KYOTO MEDICAL CENTER   (Japan)

^ai ATOMIC BOMB SURVIVORS HOSPITAL   (Japan)

^aj YAMAGUCHI UNIVERSITY HOSPITAL   (Japan)

^ak YAMAGATA UNIVERSITY HOSPITAL   (Japan)

^al FUKUOKA UNIVERSITY   (Japan)

^am Showa General Hospital   (Japan)

^an SHIZUOKA MEDICAL CENTER   (Japan)

^ao Gifu Municipal Hospital   (Japan)

more..

Author keywords

Aquaretic action; Ascites; Diuretics; Hepatic edema; Liver cirrhosis; Tolvaptan

Indexed keywords

CREATININE; DIURETIC AGENT; FUROSEMIDE; SODIUM; SPIRONOLACTONE; TOLVAPTAN;

ADD ON THERAPY; ADULT; AGED; ARTICLE; ASCITES; CHRONIC LIVER DISEASE; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DIURETIC THERAPY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; GASTROINTESTINAL HEMORRHAGE; HEMORRHAGIC SHOCK; HEPATIC EDEMA; HEPATIC ENCEPHALOPATHY; HUMAN; KIDNEY DYSFUNCTION; LIVER CIRRHOSIS; LIVER DISEASE; LIVER FAILURE; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MULTICENTER STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SODIUM BLOOD LEVEL; THIRST; TREATMENT RESPONSE; WAIST CIRCUMFERENCE; WEIGHT REDUCTION; YOUNG ADULT;

EID: 84891776986     PISSN: 13866346     EISSN: 1872034X     Source Type: Journal    
DOI: 10.1111/hepr.12099     Document Type: Article

References (24)

1. Schuppan D, Afdhal NH. Liver cirrhosis. Lancet 2008; 371: 838-851.
2. Kotoh K, Nakamuta M, Fukushima M etal. High relative fat-free mass is important for maintaining serum albumin levels in patients with compensated liver cirrhosis. World J Gastroenterol 2005; 11: 1356-1360.
3. Ginès P, Cárdenas A, Arroyo V etal. Management of cirrhosis and ascites. N Engl J Med 2004; 350: 1646-1654.
4. European Association for the Study of the Liver. EASL clinical practice guidelines on the management of ascites, spontaneous bacterial peritonitis, and hepatorenal syndrome in cirrhosis. J Hepatol 2010; 53: 397-417.
5. Wong F. Management of ascites in cirrhosis. J Gastroenterol Hepatol 2012; 27: 11-20.
6. Felker GM, Lee KL, Bull DA etal. Diuretic strategies in patients with acute decompensated heart failure. N Engl J Med 2011; 364: 797-805.
7. Gross P. Treatment of hyponatremia. Intern Med 2008; 47: 885-891.
8. Butler J, Forman DE, Abraham WT etal. Relationship between heart failure treatment and development of worsening renal function among hospitalized patients. Am Heart J 2004; 147: 331-338.
9. Ireland R. Hyponatremia: prolonged use of the vasopressin antagonist tolvaptan is a safe and effective treatment for hyponatremia. Nat Rev Nephrol 2010; 6: 315.
10. Decaux G, Soupart A, Vassart G. Non-peptide arginine-vasopressin antagonists: the vaptans. Lancet 2008; 371: 1624-1632.
11. Yamamura Y, Nakamura S, Itoh S etal. 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.
12. Gassanov N, Semmo N, Semmo M, Nia AM, Fuhr U, Er F. Arginine vasopressin (AVP) and treatment with arginine vasopressin receptor antagonists (vaptans) in congestive heart failure, liver cirrhosis and syndrome of inappropriate antidiuretic hormone secretion (SIADH). Eur J Clin Pharmacol 2011; 67: 333-346.
13. Schrier RW, Gross P, Gheorghiade M etal. Tolvaptan, a selective oral vasopressin V2-receptor antagonist, for hyponatremia. N Engl J Med 2006; 355: 2099-2112.
14. Yi JH, Shin HJ, Kim HJ. V2 receptor antagonist; tolvaptan. Electrolyte Blood Press 2011; 9: 50-54.
15. Zmily HD, Daifallah S, Ghali JK. Tolvaptan, hyponatremia, and heart failure. Int J Nephrol Renovasc Dis 2011; 4: 57-71.
16. Okita K, Sakaida I, Okada M etal. 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.
17. Giordano S. The 2008 Declaration of Helsinki: some reflections. J Med Ethics 2010; 36: 598-603.
18. Uemura M, Matsumoto M, Tsujii T etal. Effects of "body compression" on parameters related to ascites formation: therapeutic trial in cirrhotic patients. J Gastroenterol 1999; 34: 75-82.
19. Mochida S, Takikawa Y, Nakayama Y etal. Diagnostic criteria of acute liver failure. A report by the Intractable Hepato-Biliary Diseases Study Group of Japan. Hepatol Res 2011; 41: 805-812.
20. Yang YY, Lin HC, Lee WP etal. Association of the G-protein and α2-adrenergic receptor gene and plasma norepinephrine level with clonidine improvement of the effects of diuretics in patients with cirrhosis with refractory ascites: a randomised clinical trial. Gut 2010; 59: 1545-1553.
21. Senousy BE, Draganov PV. Evaluation and management of patients with refractory ascites. World J Gastroenterol 2009; 15: 67-80.
22. Inomata T, Izumi T, Matsuzaki M etal. Phase III clinical pharmacology study of tolvaptan. Cardiovasc Drugs Ther 2011; 25 (Suppl 1): S57-65.
23. Kim SR, Hasunuma T, Sato O etal. Pharmacokinetics, pharmacodynamics and safety of tolvaptan, a novel, oral, selective nonpeptide AVP V2-receptor antagonist: results of single- and multiple-dose studies in healthy Japanese male volunteers. Cardiovasc Drugs Ther 2011; 25 (Suppl 1): S5-17.
24. Rangasetty UC, Gheorghiade M, Uretsky BF etal. Tolvaptan: a selective vasopressin type 2 receptor antagonist in congestive heart failure. Expert Opin Investig Drugs 2006; 15: 533-540.