Role of vaptans in the management of hyponatremia

American Journal of Kidney Diseases

Volumn 62, Issue 2, 2013, Pages 364-376

  Lehrich, Ruediger W ^a   Ortiz Melo, David I ^a   Patel, Mehul B ^a   Greenberg, Arthur ^a  

^a DUKE UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

Hyponatremia; vaptans; vasopressin; vasopressin receptor antagonist

Indexed keywords

ACETYLSALICYLIC ACID; AMLODIPINE; ARGIPRESSIN; CONIVAPTAN; CREATININE; DEMECLOCYCLINE; DIURETIC AGENT; FLUOXETINE; FUROSEMIDE; HYDROCHLOROTHIAZIDE; LISINOPRIL; LIXIVAPTAN; PLACEBO; SATAVAPTAN; SIMVASTATIN; SODIUM; SODIUM CHLORIDE; TOLVAPTAN; UREA; VASOPRESSIN; VASOPRESSIN RECEPTOR ANTAGONIST; VASOPRESSIN V1A RECEPTOR; VASOPRESSIN V1B RECEPTOR; VASOPRESSIN V2 RECEPTOR;

ABDOMINAL PAIN; ACUTE HEART FAILURE; ADENOHYPOPHYSIS; ADULT; ASCITES; BRAIN EDEMA; CASE REPORT; COGNITIVE DEFECT; CONCENTRATION (PARAMETERS); CONFUSION; CONGESTIVE HEART FAILURE; CREATININE BLOOD LEVEL; DEPRESSION; DIURETIC THERAPY; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG SAFETY; EDEMA; EMERGENCY WARD; EUVOLEMIC HYPONATREMIA; EXTRACELLULAR SPACE; FATIGUE; FEVER; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; FREE WATER CLEARANCE; HALF LIFE TIME; HERNIA; HUMAN; HYPERKALEMIA; HYPERLIPIDEMIA; HYPERTENSION; HYPERVOLEMIC HYPONATREMIA; HYPOKALEMIA; HYPONATREMIA; HYPOTENSION; HYPOTHYROIDISM; HYPOVOLEMIC HYPONATREMIA; INFUSION RELATED REACTION; KIDNEY CONCENTRATING CAPACITY; KIDNEY POLYCYSTIC DISEASE; LIVER CIRRHOSIS; LIVER FUNCTION; LIVER FUNCTION TEST; LIVER INJURY; LOADING DRUG DOSE; LONG TERM SURVIVAL; LUNG SMALL CELL CANCER; MALE; MEDICAL HISTORY; MENTAL FUNCTION; MULTICENTER STUDY (TOPIC); NERVOUS SYSTEM INJURY; OSMOTIC DIURESIS; PATHOPHYSIOLOGY; PERSONAL EXPERIENCE; PHASE 1 CLINICAL TRIAL (TOPIC); PHYSICAL EXAMINATION; PLASMA OSMOLALITY; POLYDIPSIA; RANDOMIZED CONTROLLED TRIAL (TOPIC); RESPIRATORY ARREST; REVIEW; SEIZURE; SERUM OSMOLALITY; SIDE EFFECT; SMOKING; SODIUM ABSORPTION; SODIUM BLOOD LEVEL; SODIUM DEPLETION; SODIUM RESTRICTION; SODIUM URINE LEVEL; THIRST; TREATMENT DURATION; UREA NITROGEN BLOOD LEVEL; URINARY FREQUENCY; URINE FLOW RATE; URINE OSMOLALITY; WATER ABSORPTION; WATER DEPRIVATION; WATER PERMEABILITY; WATER RETENTION; WATER TRANSPORT; XEROSTOMIA;

EID: 84880576452     PISSN: 02726386     EISSN: 15236838     Source Type: Journal    
DOI: 10.1053/j.ajkd.2013.01.034     Document Type: Article

References (72)

1. A. Upadhyay, B.L. Jaber, N.E. Madias Incidence and prevalence of hyponatremia Am J Med 119 7 suppl 1 2006 S30 S35
2. R.C. Hawkins Age and gender as risk factors for hyponatremia and hypernatremia Clin Chim Acta 337 1-2 2003 169 172
3. R.J. Anderson, H.M. Chung, R. Kluge, R.W. Schrier Hyponatremia: a prospective analysis of its epidemiology and the pathogenetic role of vasopressin Ann Intern Med 102 2 1985 164 168
4. S. Kinsella, S. Moran, M.O. Sullivan, M.G. Molloy, J.A. Eustace Hyponatremia independent of osteoporosis is associated with fracture occurrence Clin J Am Soc Nephrol 5 2 2010 275 280
5. B. Renneboog, W. Musch, X. Vandemergel, M.U. Manto, G. Decaux Mild chronic hyponatremia is associated with falls, unsteadiness, and attention deficits Am J Med 119 1 2006 71 e71-e78
6. M. Gheorghiade, J.S. Rossi, W. Cotts Characterization and prognostic value of persistent hyponatremia in patients with severe heart failure in the ESCAPE trial Arch Intern Med 167 18 2007 1998 2005
7. W.R. Kim, S.W. Biggins, W.K. Kremers Hyponatremia and mortality among patients on the liver-transplant waiting list N Engl J Med 359 10 2008 1018 1026
8. A.M. Shea, B.G. Hammill, L.H. Curtis, L.A. Szczech, K.A. Schulman Medical costs of abnormal serum sodium levels J Am Soc Nephrol 19 4 2008 764 770
9. W.H. Lee, M. Packer Prognostic importance of serum sodium concentration and its modification by converting-enzyme inhibition in patients with severe chronic heart failure Circulation 73 2 1986 257 267
10. R. Wald, B.L. Jaber, L.L. Price, A. Upadhyay, N.E. Madias Impact of hospital-associated hyponatremia on selected outcomes Arch Intern Med 170 3 2010 294 302
11. S.S. Waikar, D.B. Mount, G.C. Curhan Mortality after hospitalization with mild, moderate, and severe hyponatremia Am J Med 122 9 2009 857 865
12. M.D. Zilberberg, A. Exuzides, J. Spalding Hyponatremia and hospital outcomes among patients with pneumonia: a retrospective cohort study BMC Pulm Med 8 2008 16
13. Hoorn EJ, Zietse R. Hyponatremia and mortality: moving beyond associations [published online ahead of print January 7, 2013]. Am J Kidney Dis. http://dx.doi.org/10.1053/j.ajkd.2012.09.019
14. B.D. Rose New approach to disturbances in the plasma sodium concentration Am J Med 81 6 1986 1033 1040
15. G.L. Robertson Regulation of arginine vasopressin in the syndrome of inappropriate antidiuresis Am J Med 119 7 suppl 1 2006 S36 S42
16. H.J. Adrogue, N.E. Madias Hyponatremia N Engl J Med 342 21 2000 1581 1589
17. R.W. Schrier Pathogenesis of sodium and water retention in high-output and low-output cardiac failure, nephrotic syndrome, cirrhosis, and pregnancy (1) N Engl J Med 319 16 1988 1065 1072
18. G. Decaux Is asymptomatic hyponatremia really asymptomatic? Am J Med 119 7 suppl 1 2006 S79 S82
19. B. Renneboog, W. Musch, X. Vandemergel, M.U. Manto, G. Decaux Mild chronic hyponatremia is associated with falls, unsteadiness, and attention deficits Am J Med 119 1 2006 71 e71-e78
20. E.J. Hoorn, R. Zietse Hyponatremia and mortality: how innocent is the bystander? Clin J Am Soc Nephrol 6 5 2011 951 953
21. A.I. Arieff, F. Llach, S.G. Massry Neurological manifestations and morbidity of hyponatremia: correlation with brain water and electrolytes Medicine (Baltimore) 55 2 1976 121 129
22. J.G. Verbalis Brain volume regulation in response to changes in osmolality Neuroscience 168 4 2010 862 870
23. R.H. Sterns, J.D. Cappuccio, S.M. Silver, E.P. Cohen Neurologic sequelae after treatment of severe hyponatremia: a multicenter perspective J Am Soc Nephrol 4 8 1994 1522 1530
24. J.G. Verbalis Hyponatremia and hypoosmolar disorders A. Greenberg, A.K. Cheung, Primer on Kidney Diseases 5th ed. 2009 Saunders/Elsevier: National Kidney Foundation Philadelphia, PA 52 59
25. B.J. Feldman, S.M. Rosenthal, G.A. Vargas Nephrogenic syndrome of inappropriate antidiuresis N Engl J Med 352 18 2005 1884 1890
26. T. Berl, A. Rastegar A patient with severe hyponatremia and hypokalemia: osmotic demyelination following potassium repletion Am J Kidney Dis 55 4 2010 742 748
27. J.G. Verbalis, S.R. Goldsmith, A. Greenberg, R.W. Schrier, R.H. Sterns Hyponatremia treatment guidelines 2007: expert panel recommendations Am J Med 120 11 suppl 1 2007 S1 S21
28. L. Bankir Antidiuretic action of vasopressin: quantitative aspects and interaction between V1a and V2 receptor-mediated effects Cardiovasc Res 51 3 2001 372 390
29. M. Birnbaumer Vasopressin receptors Trends Endocrinol Metab 11 10 2000 406 410
30. G. Decaux, A. Soupart, G. Vassart Non-peptide arginine-vasopressin antagonists: the vaptans Lancet 371 9624 2008 1624 1632
31. C.L. Holmes, D.W. Landry, J.T. Granton Science review: vasopressin and the cardiovascular system part 1 - receptor physiology Crit Care 7 6 2003 427 434
32. S. Nielsen, J. Frokiaer, D. Marples, T.H. Kwon, P. Agre, M.A. Knepper Aquaporins in the kidney: from molecules to medicine Physiol Rev 82 1 2002 205 244
33. L.B. Kinter, W.F. Huffman, F.L. Stassen Antagonists of the antidiuretic activity of vasopressin Am J Physiol 254 2, pt 2 1988 F165 F177
34. F.A. Laszlo, F. Laszlo Jr, D. De Wied Pharmacology and clinical perspectives of vasopressin antagonists Pharmacol Rev 43 1 1991 73 108
35. M. Manning, B. Lammek, A.M. Kolodziejczyk, J. Seto, W.H. Sawyer Synthetic antagonists of in vivo antidiuretic and vasopressor responses to arginine-vasopressin J Med Chem 24 6 1981 701 706
36. Y. Yamamura, H. Ogawa, H. Yamashita Characterization of a novel aquaretic agent, OPC-31260, as an orally effective, nonpeptide vasopressin V2 receptor antagonist Br J Pharmacol 105 4 1992 787 791
37. J.G. Verbalis Vasopressin V2 receptor antagonists J Mol Endocrinol 29 1 2002 1 9
38. A. Ohnishi, Y. Orita, R. Okahara Potent aquaretic agent A novel nonpeptide selective vasopressin 2 antagonist (OPC-31260) in men J Clin Invest 92 6 1993 2653 2659
39. T. Saito, S. Ishikawa, K. Abe Acute aquaresis by the nonpeptide arginine vasopressin (AVP) antagonist OPC-31260 improves hyponatremia in patients with syndrome of inappropriate secretion of antidiuretic hormone (SIADH) J Clin Endocrinol Metab 82 4 1997 1054 1057
40. R.W. Lehrich, A. Greenberg Hyponatremia and the use of vasopressin receptor antagonists in critically ill patients J Intensive Care Med 27 4 2012 207 218
41. G. Decaux Long-term treatment of patients with inappropriate secretion of antidiuretic hormone by the vasopressin receptor antagonist conivaptan, urea, or furosemide Am J Med 110 7 2001 582 584
42. D. Annane, G. Decaux, N. Smith Efficacy and safety of oral conivaptan, a vasopressin-receptor antagonist, evaluated in a randomized, controlled trial in patients with euvolemic or hypervolemic hyponatremia Am J Med Sci 337 1 2009 28 36
43. J.K. Ghali, M.J. Koren, J.R. Taylor Efficacy and safety of oral conivaptan: a V1A/V2 vasopressin receptor antagonist, assessed in a randomized, placebo-controlled trial in patients with euvolemic or hypervolemic hyponatremia J Clin Endocrinol Metab 91 6 2006 2145 2152
44. D. Zeltser, S. Rosansky, H. van Rensburg, J.G. Verbalis, N. Smith Assessment of the efficacy and safety of intravenous conivaptan in euvolemic and hypervolemic hyponatremia Am J Nephrol 27 5 2007 447 457
45. Y. Yamamura, S. Nakamura, S. Itoh 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 287 3 1998 860 867
46. S.E. Shoaf, Z. Wang, P. Bricmont, S. Mallikaarjun Pharmacokinetics, pharmacodynamics, and safety of tolvaptan, a nonpeptide AVP antagonist, during ascending single-dose studies in healthy subjects J Clin Pharmacol 47 12 2007 1498 1507
47. R.W. Schrier, P. Gross, M. Gheorghiade Tolvaptan, a selective oral vasopressin V2-receptor antagonist, for hyponatremia N Engl J Med 355 20 2006 2099 2112
48. T. Berl, F. Quittnat-Pelletier, J.G. Verbalis Oral tolvaptan is safe and effective in chronic hyponatremia J Am Soc Nephrol 21 4 2010 705 712
49. V.E. Torres, A.B. Chapman, O. Devuyst Tolvaptan in patients with autosomal dominant polycystic kidney disease N Engl J Med 367 25 2012 2407 2418
50. Samsca Tolvaptan Drug Warning - Potential Risk of Liver Injury Posted 1/25/2013 http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm336669.htm Accessed January 31, 2013
51. F. Wong, A.T. Blei, L.M. Blendis, P.J. Thuluvath A vasopressin receptor antagonist (VPA-985) improves serum sodium concentration in patients with hyponatremia: a multicenter, randomized, placebo-controlled trial Hepatology 37 1 2003 182 191
52. W.T. Abraham, G. Decaux, R.C. Josiassen Oral lixivaptan effectively increases serum sodium concentrations in outpatients with euvolemic hyponatremia Kidney Int 82 11 2012 1215 1222
53. W.T. Abraham, J. Hensen, P.A. Gross Lixivaptan safely and effectively corrects serum sodium concentrations in hospitalized patients with euvolemic hyponatremia Kidney Int 82 11 2012 1223 1230
54. J.G. Verbalis, S. Adler, R.W. Schrier, T. Berl, Q. Zhao, F.S. Czerwiec Efficacy and safety of oral tolvaptan therapy in patients with the syndrome of inappropriate antidiuretic hormone secretion Eur J Endocrinol 164 5 2011 725 732
55. EMA CHMP Assessment Report For Samsca Procedure No. EMEA/H/C/000980 http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Public-assessment- report/human/000980/WC500048715.pdf 2009 Accessed December 9, 2012
56. A. Soupart, P. Gross, J.J. Legros Successful long-term treatment of hyponatremia in syndrome of inappropriate antidiuretic hormone secretion with satavaptan (SR121463B), an orally active nonpeptide vasopressin V2-receptor antagonist Clin J Am Soc Nephrol 1 6 2006 1154 1160
57. K. Yamaguchi, N. Shijubo, T. Kodama Clinical implication of the antidiuretic hormone (ADH) receptor antagonist mozavaptan hydrochloride in patients with ectopic ADH syndrome Jpn J Clin Oncol 41 1 2011 148 152
58. M. Gheorghiade, W.T. Abraham, N.M. Albert Relationship between admission serum sodium concentration and clinical outcomes in patients hospitalized for heart failure: an analysis from the OPTIMIZE-HF registry Eur Heart J 28 8 2007 980 988
59. M. Gheorghiade, M.A. Konstam, J.C. Burnett Jr Short-term clinical effects of tolvaptan, an oral vasopressin antagonist, in patients hospitalized for heart failure: the EVEREST Clinical Status Trials Jama 297 12 2007 1332 1343
60. M.A. Konstam, M. Gheorghiade, J.C. Burnett Jr Effects of oral tolvaptan in patients hospitalized for worsening heart failure: the EVEREST Outcome Trial JAMA 297 12 2007 1319 1331
61. J. Rossi, M. Bayram, J.E. Udelson Improvement in hyponatremia during hospitalization for worsening heart failure is associated with improved outcomes: insights from the Acute and Chronic Therapeutic Impact of a Vasopressin Antagonist in Chronic Heart Failure (ACTIV in CHF) trial Acute Card Care 9 2 2007 82 86
62. D. Bichet, V. Szatalowicz, C. Chaimovitz, R.W. Schrier Role of vasopressin in abnormal water excretion in cirrhotic patients Ann Intern Med 96 4 1982 413 417
63. A.L. Gerbes, V. Gulberg, P. Gines Therapy of hyponatremia in cirrhosis with a vasopressin receptor antagonist: a randomized double-blind multicenter trial Gastroenterology 124 4 2003 933 939
64. P. Gines, F. Wong, H. Watson, S. Milutinovic, L.R. del Arbol, D. Olteanu Effects of satavaptan, a selective vasopressin V(2) receptor antagonist, on ascites and serum sodium in cirrhosis with hyponatremia: a randomized trial Hepatology 48 1 2008 204 213
65. A. Cardenas, P. Gines, P. Marotta Tolvaptan, an oral vasopressin antagonist, in the treatment of hyponatremia in cirrhosis J Hepatol 56 3 2012 571 578
66. A. Krag, S. Moller, E.B. Pedersen, J.H. Henriksen, N.H. Holstein-Rathlou, F. Bendtsen Impaired free water excretion in child C cirrhosis and ascites: relations to distal tubular function and the vasopressin system Liver Int 30 9 2010 1364 1370
67. R.W. Lehrich, A. Greenberg When is it appropriate to use vasopressin receptor antagonists? J Am Soc Nephrol 19 6 2008 1054 1058
68. A. Greenberg, R.W. Lehrich Treatment of chronic hyponatremia: now we know how, but do we know when or if? J Am Soc Nephrol 21 4 2010 552 555
69. Data on File: SAM-098 2012 Otsuka America Pharmaceutical; Inc Rockville, MD
70. A. Boscoe, C. Paramore, J.G. Verbalis Cost of illness of hyponatremia in the United States Cost Eff Resour Alloc 4 2006 10
71. A. Greenberg, J.G. Verbalis Vasopressin receptor antagonists Kidney Int 69 2006 2124 2130
72. US Food and Drug Administration Samsca (tolvaptan): drug safety communication - FDA limits duration and usage due to possible liver injury leading to organ transplant or death http://www.fda.gov/Safety/MedWatch/ SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm350185.htm?source= govdelivery Accessed April 30, 2013