157
Views
11
CrossRef citations to date
0
Altmetric
Drug Profile

Update on tolvaptan for the treatment of hyponatremia

, , , , , & show all
Pages 399-410 | Published online: 09 Jan 2014

References

  • Upadhyay A, Jaber BL, Madias NE. Epidemiology of hyponatremia. Semin. Nephrol. 29(3), 227–238 (2009).
  • Anderson RJ, Chung HM, Kluge R, Schrier RW. Hyponatremia: a prospective analysis of its epidemiology and the pathogenetic role of vasopressin. Ann. Intern. Med. 102(2), 164–168 (1985).
  • Baran D, Hutchinson TA. The outcome of hyponatremia in a general hospital population. Clin. Nephrol. 22(2), 72–76 (1984).
  • Boscoe A, Paramore C, Verbalis JG. Cost of illness of hyponatremia in the United States. Cost Eff. Resour. Alloc. 4, 10 (2006).
  • Callahan MA, Do HT, Caplan DW, Yoon-Flannery K. Economic impact of hyponatremia in hospitalized patients: a retrospective cohort study. Postgrad. Med. 121(2), 186–191 (2009).
  • Zilberberg MD, Exuzides A, Spalding J et al. Epidemiology, clinical and economic outcomes of admission hyponatremia among hospitalized patients. Curr. Med. Res. Opin. 24(6), 1601–1608 (2008).
  • Vaidya C, Ho W, Freda BJ. Management of hyponatremia: providing treatment and avoiding harm. Cleve. Clin. J. Med. 77(10), 715–726 (2010).
  • Verbalis JG, Goldsmith SR, Greenberg A, Schrier RW, Sterns RH. Hyponatremia treatment guidelines 2007: expert panel recommendations. Am. J. Med. 120(11 Suppl. 1), S1–S21 (2007).
  • Esposito P, Piotti G, Bianzina S, Malul Y, Dal Canton A. The syndrome of inappropriate antidiuresis: pathophysiology, clinical management and new therapeutic options. Nephron. Clin. Pract. 119(1), c62–c73; discussion c73 (2011).
  • Hannon MJ, Thompson CJ. The syndrome of inappropriate antidiuretic hormone: prevalence, causes and consequences. Eur. J. Endocrinol. 162(Suppl. 1), S5–S12 (2010).
  • Renneboog B, Musch W, Vandemergel X, Manto MU, Decaux G. Mild chronic hyponatremia is associated with falls, unsteadiness, and attention deficits. Am. J. Med. 119(1), 71.e1–71.e8 (2006).
  • Gankam Kengne F, Andres C, Sattar L, Melot C, Decaux G. Mild hyponatremia and risk of fracture in the ambulatory elderly. QJM 101(7), 583–588 (2008).
  • Hoorn EJ, Rivadeneira F, van Meurs JB et al. Mild hyponatremia as a risk factor for fractures: the Rotterdam Study. J. Bone Miner. Res. 26(8), 1822–1828 (2011).
  • Lee WH, Packer M. Prognostic importance of serum sodium concentration and its modification by converting-enzyme inhibition in patients with severe chronic heart failure. Circulation 73(2), 257–267 (1986).
  • Chen MC, Chang HW, Cheng CI, Chen YH, Chai HT. Risk stratification of in-hospital mortality in patients hospitalized for chronic congestive heart failure secondary to non-ischemic cardiomyopathy. Cardiology 100(3), 136–142 (2003).
  • Wu CC, Yeung LK, Tsai WS et al. Incidence and factors predictive of acute renal failure in patients with advanced liver cirrhosis. Clin. Nephrol. 65(1), 28–33 (2006).
  • Jenq CC, Tsai MH, Tian YC et al. Serum sodium predicts prognosis in critically ill cirrhotic patients. J. Clin. Gastroenterol. 44(3), 220–226 (2010).
  • Cerda-Esteve M, Ruiz-González A, Gudelis M et al. Incidence of hyponatremia and its causes in neurological patients. Endocrinol. Nutr. 57(5), 182–186 (2010).
  • Doshi SM, Shah P, Lei X, Lahoti A, Salahudeen AK. Hyponatremia in hospitalized cancer patients and its impact on clinical outcomes. Am. J. Kidney Dis. 59(2), 222–228 (2012).
  • Gill G, Huda B, Boyd A et al. Characteristics and mortality of severe hyponatraemia – a hospital-based study. Clin. Endocrinol. (Oxf.) 65(2), 246–249 (2006).
  • Waikar SS, Mount DB, Curhan GC. Mortality after hospitalization with mild, moderate, and severe hyponatremia. Am. J. Med. 122(9), 857–865 (2009).
  • Dasta J, Amin A, Chiong J, Greenberg A, Hauptman P, Verbalis J. Impact of hyponatremia on readmission rates: interim results from an observational, prospective, multi-center, global registry in hypervolemic and euvolemic hyponatremic patients. Pharmacotherapy 31, 337e. (2011).
  • Kalra S, Efrati S, Arthur JM et al. Effect of loading dose and formulation on safety and efficacy of conivaptan in treatment of euvolemic and hypervolemic hyponatremia. Am. J. Health. Syst. Pharm. 68(7), 590–598 (2011).
  • EMA. Press release. sanofi-aventis withdraws its marketing authorization application for Aquilda (satavaptan). Procedure No. EMEA/CHMP/277714/2008. EMA, London, UK (2008).
  • Ghali JK, Zmily HD, Farah JO, Daifallah S. Lixivaptan, a non-peptide vasopressin V2 receptor antagonist for the potential oral treatment of hyponatremia. IDrugs 13(11), 782–792 (2010).
  • Yamaguchi K, Shijubo N, Kodama T et al.; Ectopic ADH Syndrome Therapeutic Research Group. Clinical implication of the antidiuretic hormone (ADH) receptor antagonist mozavaptan hydrochloride in patients with ectopic ADH syndrome. Jpn. J. Clin. Oncol. 41(1), 148–152 (2011).
  • Kondo K, Ogawa H, Yamashita H et al. 7-chloro-5-hydroxy-1-[2-methyl-4-(2-methylbenzoyl-amino)benzoyl]-2,3,4,5-tetrahydro-1H-1-benzazepine (OPC-41061): a potent, orally active nonpeptide arginine vasopressin V2 receptor antagonist. Bioorg. Med. Chem. 7(8), 1743–1754 (1999).
  • Miyazaki T, Fujiki H, Yamamura Y, Nakamura S, Mori T. Tolvaptan, an orally active vasopressin V(2)-receptor antagonist – pharmacology and clinical trials. Cardiovasc. Drug Rev. 25(1), 1–13 (2007).
  • Shoaf SE, Bramer SL, Bricmont P, Zimmer CA. Pharmacokinetic and pharmacodynamic interaction between tolvaptan, a non-peptide AVP antagonist, and furosemide or hydrochlorothiazide. J. Cardiovasc. Pharmacol. 50(2), 213–222 (2007).
  • 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. 73(4), 579–587 (2012).
  • Shoaf SE, Elizari MV, Wang Z et al. Tolvaptan administration does not affect steady state amiodarone concentrations in patients with cardiac arrhythmias. J. Cardiovasc. Pharmacol. Ther. 10(3), 165–171 (2005).
  • EMA. CHMP Assessment Report for Samsca. Procedure No. EMEA/H/C/000980. EMA, London, UK (2009).
  • Schrier RW, Gross P, Gheorghiade M et al.; SALT Investigators. Tolvaptan, a selective oral vasopressin V2-receptor antagonist, for hyponatremia. N. Engl. J. Med. 355(20), 2099–2112 (2006).
  • Berl T, Quittnat-Pelletier F, Verbalis JG et al.; SALTWATER Investigators. Oral tolvaptan is safe and effective in chronic hyponatremia. J. Am. Soc. Nephrol. 21(4), 705–712 (2010).
  • Goldsmith SR, Gheorghiade M. Vasopressin antagonism in heart failure. J. Am. Coll. Cardiol. 46(10), 1785–1791 (2005).
  • Gheorghiade M, Gottlieb SS, Udelson JE et al.; Tolvaptan Investigators. Vasopressin V(2) receptor blockade with tolvaptan versus fluid restriction in the treatment of hyponatremia. Am. J. Cardiol. 97(7), 1064–1067 (2006).
  • Gheorghiade M, Gattis WA, O’Connor CM et al.; Acute and Chronic Therapeutic Impact of a Vasopressin Antagonist in Congestive Heart Failure (ACTIV in CHF) Investigators. Effects of tolvaptan, a vasopressin antagonist, in patients hospitalized with worsening heart failure: a randomized controlled trial. JAMA 291(16), 1963–1971 (2004).
  • Rossi J, Bayram M, Udelson JE et al. 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), 82–86 (2007).
  • Udelson JE, Orlandi C, Ouyang J et al. Acute hemodynamic effects of tolvaptan, a vasopressin V2 receptor blocker, in patients with symptomatic heart failure and systolic dysfunction: an international, multicenter, randomized, placebo-controlled trial. J. Am. Coll. Cardiol. 52(19), 1540–1545 (2008).
  • Konstam MA, Gheorghiade M, Burnett JC Jr et al.; Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study With Tolvaptan (EVEREST) Investigators. Effects of oral tolvaptan in patients hospitalized for worsening heart failure: the EVEREST outcome trial. JAMA 297(12), 1319–1331 (2007).
  • Jaber BL, Almarzouqi L, Borgi L, Seabra VF, Balk EM, Madias NE. Short-term efficacy and safety of vasopressin receptor antagonists for treatment of hyponatremia. Am. J. Med. 124(10), 977.e1–977.e9 (2011).
  • Nemerovski C, Hutchinson DJ. Treatment of hypervolemic or euvolemic hyponatremia associated with heart failure, cirrhosis, or the syndrome of inappropriate antidiuretic hormone with tolvaptan: a clinical review. Clin. Ther. 32(6), 1015–1032 (2010).
  • Fukunami M, Matsuzaki M, Hori M, Izumi T. Efficacy and safety of tolvaptan in heart failure patients with sustained volume overload despite the use of conventional diuretics: a Phase III open-label study. Cardiovasc. Drugs Ther. 25(Suppl. 1), 47–56 (2011).
  • Matsuzaki M, Hori M, Izumi T, Fukunami M. Efficacy and safety of tolvaptan in heart failure patients with volume overload despite the standard treatment with conventional diuretics: a Phase III, randomized, double-blind, placebo-controlled study (QUEST Study). Cardiovasc. Drugs Ther. 25(Suppl. 1), S33–S45 (2011).
  • Pang PS, Gheorghiade M, Dihu J et al. Effects of tolvaptan on physician-assessed symptoms and signs in patients hospitalized with acute heart failure syndromes: analysis from the efficacy of vasopressin antagonism in heart failure outcome study with tolvaptan (EVEREST) trials. Am. Heart J. 161(6), 1067–1072 (2011).
  • Pang PS, Konstam MA, Krasa HB et al.; Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study with Tolvaptan (EVEREST) Investigators. Effects of tolvaptan on dyspnoea relief from the EVEREST trials. Eur. Heart J. 30(18), 2233–2240 (2009).
  • Shea AM, Hammill BG, Curtis LH, Szczech LA, Schulman KA. Medical costs of abnormal serum sodium levels. J. Am. Soc. Nephrol. 19(4), 764–770 (2008).
  • Shorr AF, Tabak YP, Johannes RS, Gupta V, Saltzberg MT, Costanzo MR. Burden of sodium abnormalities in patients hospitalized for heart failure. Congest. Heart Fail. 17(1), 1–7 (2011).
  • Cyr PL, Slawsky KA, Olchanski N et al. Effect of serum sodium concentration and tolvaptan treatment on length of hospitalization in patients with heart failure. Am. J. Health. Syst. Pharm. 68(4), 328–333 (2011).
  • Verbalis JG, Adler S, Schrier RW, Berl T, Zhao Q, Czerwiec FS; SALT Investigators. Efficacy and safety of oral tolvaptan therapy in patients with the syndrome of inappropriate antidiuretic hormone secretion. Eur. J. Endocrinol. 164(5), 725–732 (2011).
  • Chiong JR, Kim S, Lin J, Christian R, Dasta JF. Evaluation of costs associated with tolvaptan-mediated length of stay reduction among heart failure patients with hyponatremia in the US, based on the EVEREST Trial. J. Med. Econ. 15(2), 276–284 (2012).
  • Dasta JF, Chiong JR, Christian R, Lin J. Evaluation of costs associated with tolvaptan-mediated hospital length of stay reduction among US patients with the syndrome of inappropriate antidiuretic hormone secretion, based on SALT-1 and SALT-2 trials. Hosp. Pract. (Minneap.) 40(1), 7–14 (2012).
  • Fenske W, Allolio B. The syndrome of inappropriate secretion of antidiuretic hormone: diagnostic and therapeutic advances. Horm. Metab. Res. 42(10), 691–702 (2010).
  • Movig KL, Leufkens HG, Lenderink AW, Egberts AC. Validity of hospital discharge International Classification of Diseases (ICD) codes for identifying patients with hyponatremia. J. Clin. Epidemiol. 56(6), 530–535 (2003).
  • Shea AM, Curtis LH, Szczech LA, Schulman KA. Sensitivity of International Classification of Diseases codes for hyponatremia among commercially insured outpatients in the United States. BMC Nephrol. 9, 5 (2008).
  • Wald R, Jaber BL, Price LL, Upadhyay A, Madias NE. Impact of hospital-associated hyponatremia on selected outcomes. Arch. Intern. Med. 170(3), 294–302 (2010).
  • Testani JM, Cappola TP, Brensinger CM, Shannon RP, Kimmel SE. Interaction between loop diuretic-associated mortality and blood urea nitrogen concentration in chronic heart failure. J. Am. Coll. Cardiol. 58(4), 375–382 (2011).
  • Chiong JR, Cheung RJ. Loop diuretic therapy in heart failure: the need for solid evidence on a fluid issue. Clin. Cardiol. 33(6), 345–352 (2010).
  • Lloyd-Jones D, Adams RJ, Brown TM et al.; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics – 2010 update: a report from the American Heart Association. Circulation 121(7), 948–954 (2010).
  • Scherz N, Labarère J, Méan M, Ibrahim SA, Fine MJ, Aujesky D. Prognostic importance of hyponatremia in patients with acute pulmonary embolism. Am. J. Respir. Crit. Care Med. 182(9), 1178–1183 (2010).
  • Gheorghiade M, Rossi JS, Cotts W et al. Characterization and prognostic value of persistent hyponatremia in patients with severe heart failure in the ESCAPE trial. Arch. Intern. Med. 167(18), 1998–2005 (2007).

Websites

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.