Efficacy and Safety of Oral Tolvaptan Therapy in Hospitalized Cirrhotic Patients with Hyponatremia
Garg, R.; Kaur, K.; Aggarwal, S.; Singh, N.
Journal of the Association of Physicians of India 66(12): 49-52
2018
ISSN/ISBN: 0004-5772 PMID: 31315326 Document Number: 694932
Tolvaptan is an orally administered, nonpeptide, selective arginine vasopressin V(2) receptor antagonist that increases free water clearance, thereby correcting and increasing the low serum sodium levels in patients of cirrhosis, where hyponatremai is am major encountered problem. Evaluate the efficacy and tolerabilty of tolvaptan in cirrhotics with symptomatic hyponatremia that resist correction with fluid restriction. Intellectual improvement assessed using Short Portable Mental Status Questionnaire (SPMSQ) pre and post therapy(on conclusion). Adverse drug reactions monitored to assess safety. Study design: Prospective, pre and post drug efficacy and safety evaluating study with permission from ethical committe. Study Population: one hundred cirrhotic patients, irrespective of etiology, with hyponatremia, who fulfill the inclusion criteria. Protocol: All enrolled patients, treated with oral Tolvaptan at doses of 15 mg once daily in addition to the concurrent treatment regimen. Tolvaptan therapy was concluded as soon as the patient reached the normal sodium levels, which were monitored daily. Our study population had a majority of Hepatitis C patients (49%). Mean sodium levels at baseline were 125.79 + 3.49 which had a significant (130.25+3.28), and highly significant (133+ 3.19) change post 48 and 72 hours. In clinical parameters, urine output was altered significantly (pre drug mean 1530.76+619.02 to post drug mean of 1783+563.01. Body weight and Abdominal girth changes were not significant.