Treatment of hyponatremia: The role of lixivaptan

Expert Review of Clinical Pharmacology

Volumn 7, Issue 4, 2014, Pages 431-441

  Liamis, George ^a   Filippatos, Theodosios D ^a   Elisaf, Moses S ^a  

^a UNIVERSITY OF IOANNINA   (Greece)

Author keywords

antidiuretic hormone; heart failure; hyponatremia; lixivaptan; sodium; V2 receptor inhibitors; vaptans; vasopressin

Indexed keywords

AMINO TERMINAL PRO BRAIN NATRIURETIC PEPTIDE; CYTOCHROME P450; DEMECLOCYCLINE; LITHIUM; LIXIVAPTAN; LOOP DIURETIC AGENT; PLACEBO; SODIUM; SODIUM CHLORIDE; TOLVAPTAN; UREA; VASOPRESSIN; VASOPRESSIN RECEPTOR ANTAGONIST; BENZAMIDE DERIVATIVE; PYRROLE DERIVATIVE;

AREA UNDER THE CURVE; ARTICLE; BINDING AFFINITY; COGNITION; DEHYDRATION; DIURESIS; DRUG BLOOD LEVEL; DRUG EFFECT; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG TOXICITY; EUVOLEMIC HYPONATREMIA; FLUID INTAKE; FREE WATER CLEARANCE; HUMAN; HYPERVOLEMIC HYPONATREMIA; HYPONATREMIA; INAPPROPRIATE VASOPRESSIN SECRETION; LD 50; LITHIUM BLOOD LEVEL; MAXIMUM PLASMA CONCENTRATION; META ANALYSIS; MULTICENTER STUDY (TOPIC); NAUSEA; NEPHROGENIC DIABETES INSIPIDUS; NONHUMAN; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); POLYDIPSIA; SERUM OSMOLALITY; SODIUM BLOOD LEVEL; SYSTEMATIC REVIEW; URINARY TRACT INFECTION; URINE OSMOLALITY; URINE VOLUME; WATER ABSORPTION; WATER DEPRIVATION; BLOOD; RANDOMIZED CONTROLLED TRIAL (TOPIC);

ANTIDIURETIC HORMONE RECEPTOR ANTAGONISTS; BENZAMIDES; CLINICAL TRIALS, PHASE II AS TOPIC; CLINICAL TRIALS, PHASE III AS TOPIC; HUMANS; HYPONATREMIA; PYRROLES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SODIUM;

EID: 84903165001     PISSN: 17512433     EISSN: 17512441     Source Type: Journal    
DOI: 10.1586/17512433.2014.911085     Document Type: Article

References (58)

1. Upadhyay A, Jaber BL, Madias NE. Incidence and prevalence of hyponatremia. Am J Med 2006;119(7 Suppl 1):S30-5
2. Liamis G, Rodenburg EM, Hofman A, et al. Electrolyte disorders in community subjects: Prevalence and risk factors. Am J Med 2013;126(3):256-63
3. Filippatos TD, Elisaf MS. Hyponatremia in patients with heart failure. World J Cardiol 2013;5(9):317-28
4. Adrogue HJ, Madias NE. Hyponatremia. N Engl J Med 2000;342(21):1581-9
5. Karp BI, Laureno R. Pontine and extrapontine myelinolysis: A neurologic disorder following rapid correction of hyponatremia. Medicine (Baltimore) 1993; 72(6):359-73 (Pubitemid 23345633
6. Kumar S, Fowler M, Gonzalez-Toledo E, Jaffe SL. Central pontine myelinolysis, an update. Neurol Res 2006;28(3):360-6 (Pubitemid 43765125
7. Graff-Radford J, Fugate JE, Kaufmann TJ, et al. Clinical and radiologic correlations of central pontine myelinolysis syndrome. Mayo Clin Proc 2011;86(11):1063-7
8. Hart BL, Eaton RP. Osmotic Myelinolysis. N Engl J Med 1995;333(19):1259
9. Lauriat SM, Berl T. The hyponatremic patient: Practical focus on therapy. J Am Soc Nephrol 1997;8(10):1599-607 (Pubitemid 27496480
10. Borroni G, Maggi A, Sangiovanni A, et al. Clinical relevance of hyponatraemia for the hospital outcome of cirrhotic patients. Dig Liver Dis 2000;32(7):605-10
11. Waikar SS, Mount DB, Curhan GC. Mortality after hospitalization with mild, moderate, and severe hyponatremia. Am J Med 2009;122(9):857-65
12. Renneboog B, Musch W, Vandemergel X, et al. Mild chronic hyponatremia is associated with falls, unsteadiness, and attention Deficits. Am J Med 2006;119(1): 71. e1-8
13. Shea AM, Hammill BG, Curtis LH, et al. Medical costs of abnormal serum sodium levels. J Am Soc Nephrol 2008;19(4): 764-70
14. Milionis HJ, Liamis GL, Elisaf MS. The hyponatremic patient: A systematic approach to laboratory diagnosis. CMAJ 2002;166(8): 1056-62 (Pubitemid 34304651
15. Liamis G, Milionis HJ, Elisaf M. Endocrine disorders: Causes of hyponatremia not to neglect. Ann Med 2011;43(3):179-87
16. Sterns RH, Silver SM. Cerebral salt wasting versus SIADH: What difference?. J Am Soc Nephrol 2008;19(2):194-6 (Pubitemid 351240639
17. Liamis G, Christidis D, Alexandridis G, et al. Uric acid homeostasis in the evaluation of diuretic-induced hyponatremia. J Investig Med 2007;55(1): 36-44 (Pubitemid 46512740
18. Smith D, Moore K, Tormey W, et al. Downward resetting of the osmotic threshold for thirst in patients with SIADH. Am J Physiol Endocrinol Metab 2004; 287(5):E1019-23
19. Chow KM, Szeto CC, Wong TY, et al. Risk factors for thiazide-induced hyponatraemia. QJM 2003;96(12):911-17
20. Decaux G. Treatment of the syndrome of inappropriate secretion of antidiuretic hormone by long loop diuretics. Nephron 1983;35(2):82-8 (Pubitemid 13033726
21. Dzau VJ, Hollenberg NK. Renal response to captopril in severe heart failure: Role of furosemide in natriuresis and reversal of hyponatremia. Ann Intern Med 1984; 100(6):777-82 (Pubitemid 14121584
22. Elisaf M, Theodorou J, Pappas C, Siamopoulos K. Successful treatment of hyponatremia with angiotensin-converting enzyme inhibitors in patients with congestive heart failure. Cardiology 1995; 86(6):477-80
23. Greenberg A. Diuretic complications. Am J Med Sci 2000;319(1):10-24 (Pubitemid 30367871
24. Decaux G. Long-Term treatment of patients with inappropriate secretion of antidiuretic hormone by the vasopressin receptor antagonist conivaptan, urea, or furosemide. Am J Med 2001;110(7):582-4
25. Liamis G, Milionis HJ, Elisaf M. A review of drug-induced hypernatraemia. NDT Plus 2009;2(5):339-46
26. Thibonnier M, Conarty DM, Preston JA, et al. Molecular pharmacology of human vasopressin receptors. Adv Exp Med Biol 1998;449251-76
27. Nakamura Y, Haneda T, Osaki J, et al. Hypertrophic growth of cultured neonatal rat heart cells mediated by vasopressin V (1A) receptor. Eur J Pharmacol 2000; 391(1-2):39-48 (Pubitemid 30138078
28. Fukuzawa J, Haneda T, Kikuchi K. Arginine vasopressin increases the rate of protein synthesis in isolated perfused adult rat heart via the V1 receptor. Mol Cell Biochem 1999;195(1-2):93-8 (Pubitemid 29259773
29. Howl J, Ismail T, Strain AJ, et al. Characterization of the human liver vasopressin receptor. Profound differences between human and rat vasopressin-receptor-mediated responses suggest only a minor role for vasopressin in regulating human hepatic function. Biochem J 1991;276(Pt 1):189-95
30. Tanoue A, Ito S, Honda K, et al. The vasopressin V1b receptor critically regulates hypothalamic-pituitary-Adrenal axis activity under both stress and resting conditions. J Clin Invest 2004;113(2):302-9 (Pubitemid 38544214
31. Xu DL, Martin PY, Ohara M, et al. Upregulation of aquaporin-2 water channel expression in chronic heart failure rat. J Clin Invest 1997;99(7):1500-5 (Pubitemid 27163800
32. Kwon TH, Hager H, Nejsum LN, et al. Physiology and pathophysiology of renal aquaporins. Semin Nephrol 2001;21(3): 231-8 (Pubitemid 32390914
33. Fushimi K, Uchida S, Hara Y, et al. Cloning and expression of apical membrane water channel of rat kidney collecting tubule. Nature 1993;361(6412):549-52 (Pubitemid 23055619
34. Greenberg A, Verbalis JG. Vasopressin receptor antagonists. Kidney Int 2006; 69(12):2124-30 (Pubitemid 43882098
35. Ghali JK, Farah JO, Daifallah S, et al. Conivaptan and its role in the treatment of hyponatremia. Drug Des Devel Ther 2009; 3253-68
36. Tolvaptan monograph. Available from: Http://samsca.ca/assets/doc/ monograph-en. pdf [Last accessed 9 February 2014]
37. FDA drug safety communication -FDA Limits duration and usage due to possible liver injury leading to organ transplant or death. Available from: Www. fda.gov/Safety/MedWatch/Safety Information/SafetyAlertsforHumanMedical Products/ucm350185.htm [Last accessed 12 February 2014]
38. Li-Ng M, Verbalis JG. Conivaptan: Evidence supporting its therapeutic use in hyponatremia. Core Evid 2010;483-92
39. Schrier RW, Gross P, Gheorghiade M, et al. Tolvaptan, a selective oral vasopressin V2-receptor antagonist, for hyponatremia. N Engl J Med 2006;355(20):2099-112 (Pubitemid 44749318
40. Verbalis JG, Goldsmith SR, Greenberg A, et al. Hyponatremia treatment guidelines 2007: Expert panel recommendations. Am J Med 2007;120(11 Suppl 1):S1-21
41. Albright JD, Reich MF, Delos Santos EG, et al. 5-Fluoro-2-methyl-N-[4- (5H-pyrrolo [2,1-c]-[1, 4]benzodiazepin-10(11H)-ylcarbonyl)-3-chlorophenyl] benzamide (VPA-985): An orally active arginine vasopressin antagonist with selectivity for V2 receptors. J Med Chem 1998;41(14): 2442-4
42. Guyader D, Patat A, Ellis-Grosse EJ, Orczyk GP. Pharmacodynamic effects of a nonpeptide antidiuretic hormone V2 antagonist in cirrhotic patients with ascites. Hepatology 2002;36(5):1197-205 (Pubitemid 35253436
43. Lixivaptan. FDA Briefing Document for the Cardiovascular and Renal Drugs advisory (CRDAC). Available from: Www.fda.gov/ downloads/advisorycommittees/ committeesmeetingmaterials/drugs/ cardiovascularandrenaldrugsadvisory committee/ucm318867.pdf. [Last accessed 8 February 2014]
44. Martin PY, Abraham WT, Lieming X, et al. Selective V2-receptor vasopressin antagonism decreases urinary aquaporin-2 excretion in patients with chronic heart failure. J Am Soc Nephrol 1999;10(10):2165-70 (Pubitemid 29453494
45. 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(1): 18-21 (Pubitemid 32589198
46. Wong F, Blei AT, Blendis LM, Thuluvath PJ. A vasopressin receptor antagonist (VPA-985) improves serum sodium concentration in patients with hyponatremia: A multicenter, randomized, placebo-controlled trial. Hepatology 2003; 37(1):182-91 (Pubitemid 36042159
47. Gerbes AL, Gulberg V, Gines P, et al. Therapy of hyponatremia in cirrhosis with a vasopressin receptor antagonist: A randomized double-blind multicenter trial. Gastroenterology 2003;124(4):933-9 (Pubitemid 36389796
48. Ghali JK, Orlandi C, Abraham WT; Investigators C-LS. The efficacy and safety of lixivaptan in outpatients with heart failure and volume overload: Results of a multicentre, randomized, double-blind, placebo-controlled, parallel-group study. Eur J Heart Fail 2012;14(6):642-51
49. Abraham WT, Hensen J, Gross PA, et al. Lixivaptan safely and effectively corrects serum sodium concentrations in hospitalized patients with euvolemic hyponatremia. Kidney Int 2012;82(11):1223-30
50. Abraham WT, Decaux G, Josiassen RC, et al. Oral lixivaptan effectively increases serum sodium concentrations in outpatients with euvolemic hyponatremia. Kidney Int 2012;82(11):1215-2
51. Abraham WT, Aranda JM, Boehmer JP, et al. Rationale and design of the treatment of hyponatremia based on lixivaptan in NYHA class III/IV cardiac patient evaluation (THE BALANCE) study. Clin Transl Sci 2010;3(5):249-53
52. Shoaf SE, Bricmont P, Mallikaarjun S. Effects of CYP3A4 inhibition and induction on the pharmacokinetics and pharmacodynamics of tolvaptan, a non-peptide AVP antagonist in healthy subjects. Br J Clin Pharmacol 2012;73(4): 579-87
53. Siegel AJ. Hyponatremia in psychiatric patients: Update on evaluation and management. Harv Rev Psychiatry 2008; 16(1):13-24 (Pubitemid 351317185
54. Josiassen RC, Goldman M, Jessani M, et al. Double-blind, placebo-controlled, multicenter trial of a vasopressin V2-receptor antagonist in patients with schizophrenia and hyponatremia. Biol Psychiatry 2008;64(12):1097-100
55. Josiassen RC, Curtis J, Filmyer DM, et al. Tolvaptan: A new tool for the effective treatment of hyponatremia in psychotic disorders. Expert Opin Pharmacother 2010; 11(4):637-48
56. FDA. Cardiovascular and Renal Drugs Advisory Committee meeting announcement. Available from: Www.fda. gov/AdvisoryCommittees/Calendar/ ucm313273.htm [Last accessed 14 February 2014]
57. FDA Panel Rejects Lixivaptan for CHF. Available from: Www.medpagetoday.com/ Washington-Watch/FDAGeneral/34753 [Last accessed 24 March 2014]
58. FDA panel votes against Cornerstone's lixivaptan. Available from: Www. pharmatimes.com/article/12-09-14/ FDA-panel-votes-against- Cornerstone-s- lixivaptan.aspx [Last accessed 24 March 2014]