Efficacy and safety of tolvaptan among patients with hyponatremia from SIADH
Article Sidebar
Main Article Content
Abstract
Hyponatremia is the most common electrolyte disorder in general practice and is associated with increased hospital mortality and prolonged length of stay. The most frequent cause of hyponatremia is the syndrome of inappropriate antidiuretic hormone (SIADH), accounting for 35 to 46% of all cases of hyponatremia. Currently, V2 receptor antagonists, especially tolvaptan, have been increasingly used to manage patients with SIADH. Evidence has shown efficacy and safety profiles. In 2009, tolvaptan was approved by the US Food and Drug Administration to treat euvolemic and hypervolemic hyponatremia and was approved by the European Medicines Agency treatment of hyponatremia from SIADH. therefore, tolvaptan has been commonly and widely used for to treat SIADH. The results from 11 studies have shown efficacy and safety profiles of tolvaptan in treating patients with SIADH. Tolvaptan has also demonstrated efficacy among patients with cancer and patients after pituitary surgery. The recommended starting dose is 15 mg daily, and may be increased to a maximum dose of 60 mg daily. Patients with SIADH and high risk of overcorrection, such as those with baseline serum sodium less than 121-125 mmol/L, blood urea nitrogen less than 10 mg/dL, low body weight or low body mass index, should be initiated with a half dose (7.5 mg daily). In terms of safety, the most common adverse events comprise dry mouth and thirst. Serious adverse events include severe vomiting, hepatitis (1 case) and arrhythmia (1 case). Overcorrection has increased, ranging from 3.2-43.8%. However, neither osmotic demyelination syndrome (ODS) nor death event from tolvaptan has been reported.
Article Details
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
This article is published under CC BY-NC-ND 4.0 license, which allows for non-commercial reuse of the published paper as long as the published paper is fully attributed. Anyone can share (copy and redistribute) the material in any medium or format without having to ask permission from the author or the Nephrology Society of Thailand.
References
Robertson GL. Regulation of Arginine Vasopressin in the Syndrome of Inappropriate Antidiuresis. Am J Med 2006;119(7):S36–42.
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 2011;119(1): c62–73.
Cuesta M, Thompson CJ. The syndrome of inappropriate antidiuresis (SIAD).Best Pract Res Clin Endocrinol Metab 2016;30(2):175–87.
Dasta JF, Chiong JR, Christian R, Friend K, Lingohr-Smith M, Lin J, et al. Update on tolvaptan for the treatment of hyponatremia. Expert Rev Pharmacoecon Outcomes Res 2012;12(4): 399–410.
Garrahy A, Thompson CJ. Vasopressin. In: Encyclopedia of Endocrine Diseases [Internet]. Elsevier;2019.p.29-35. Available from: https://linkinghub.elsevier.com/retrieve/pii/B9780128012383652169
Gargani L, Schmidt PH, Gheorghiade M. Tolvaptan for the treatment of hyponatremia secondary to the syndrome of inappropriate antidiuretic hormone secretion.Expert Rev Cardiovasc Ther 2011;9(12): 1505–13.
Schrier RW, Gross P, Gheoghiade M, Berl T, Verbalis JG, Czerwiec FS, et al.Tolvaptan,a selective oral vasopressin V2-receptor antagonist, for hyponatremia. N Engl J Med 2006; 355(20):2099-2112.
Rozen-Zvi B, Yahav D, Gheorghiade M, Korzets A, Leibovici L, Gafter U. Vasopressin Receptor Antagonists for the Treatment of Hyponatremia: Systematic Review and Meta-analysis. Am J Kidney Dis 2010; 56(2):325–37.
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 2011;124(10):977.e1-977.e9.
Bhandari S, Peri A, Cranston I, McCool R, Shaw A, Glanville J, et al. A systematic review of known interventions for the treatment of chronic nonhypovolaemic hypotonic hyponatraemia and a meta-analysis of the vaptans. Clin Endocrinol 2017;86(6):761–71.
Zhang X, Zhao M, Du W, Zu D, Sun Y, Xiang R, et al. Efficacy and Safety of Vasopressin Receptor Antagonists for Euvolemic or Hypervolemic Hyponatremia: A Meta-Analysis. Medicine 2016;95 (15):e3310.
Li B, Fang D, Qian C, Feng H, Wang Y. The Efficacy and Safety of Tolvaptan in Patients with Hyponatremia: A Meta-Analysis of Randomized Controlled Trials. Clin Drug Investig 2017;37(4):327–42.
Verbalis JG, Adler S, Schrier RW, Berl T, Zhao Q, Czerwiec FS, et al. Efficacy and safety of oral tolvaptan therapy in patients with the syndrome of inappropriate antidiuretic hormone secretion. Eur J Endocrinol 2011;164(5):725–32.
Chen S, Zhao J-J, Tong N-W, Guo X-H, Qiu M-C, Yang G-Y, et al. Randomized, double blinded, placebo-controlled trial to evaluate the efficacy and safety of tolvaptan in Chinese patients with hyponatremia caused by SIADH. J Clin Pharmacol 2014;54(12):1362–7.
Gralla RJ, Ahmad F, Blais JD, Chiodo J, Zhou W, Glaser LA, et al. Tolvaptan use in cancer patients with hyponatremia due to the syndrome of inappropriate antidiuretic hormone: a post hoc analysis of the SALT-1 and SALT-2 trials. Cancer Med 2017;6(4):723–9.
Kleindienst A, Georgiev S, Schlaffer SM, Buchfelder M. Tolvaptan Versus Fluid Restriction in the Treatment of Hyponatremia Resulting from SIADH Following Pituitary Surgery. J Endocr Soc. 2020 Jun 9;4(7):bvaa068.
Han SW, Yi JH, Kang KP, Kim HY, Kim SW, Choi HY, et al. Safety and Efficacy of Tolvaptan in Korean Patients with Hyponatremia Caused by the Syndrome of Inappropriate Antidiuretic Hormone. J Korean Med Sci 2018;33(15):e112.
Arima H, Goto K, Motozawa T, Mouri M, Watanabe R, Hirano T, et al. Open-label, multicenter, dose-titration study to determine the efficacy and safety of tolvaptan in Japanese patients with hyponatremia secondary to syndrome of inappropriate secretion of antidiuretic hormone. Endocr J. 2021; 68(1):17-29.
Morris JH, Bohm NM, Nemecek BD, Crawford R, Kelley D, Bhasin B, et al. Rapidity of Correction of Hyponatremia Due to Syndrome of Inappropriate Secretion of Antidiuretic Hormone Following Tolvaptan. Am J Kidney Dis 2018;71(6):772–82.
Park GH, Lee CM, Song JW, Jung MC, Kim JK, Song YR, et al. Comparison of tolvaptan treatment between patients with the SIADH and congestive heart failure: a single-center experience. Korean J Intern Med 2018;33(3):561–7.
Hanna RM, Velez JC, Rastogi A, Nguyen MK, Kamgar MK, Moe K, et al. Equivalent Efficacy and Decreased Rate of Overcorrection in Patients With Syndrome of Inappropriate Secretion of Antidiuretic Hormone Given Very Low-Dose Tolvaptan. Kidney Medicine 2020;2(1):20–8.
Bilgetekin I, Erturk I, Basal FB, Karacin C, Karadurmus N, Oksuzoglu B, Demirci U. Tolvaptan treatment in hyponatremia due to the syndrome of inappropriate secretion of antidiuretic hormone (SIADH): effects on survival in patients with cancer. Int Urol Nephrol. 2021; 53(2):301-307.
Humayun MA,Cranston IC. In-patient Tolvaptan use in SIADH: care audit, therapy observation and outcome analysis. BMC Endocr Disord 2017;17(1):69.