Tolvaptan Increases Serum Sodium in Pediatric Patients With Heart Failure

Abstract

This study aimed to evaluate the use of tolvaptan in a consecutive series of pediatric patients with heart failure. Patients 18 years of age or younger with heart failure prescribed tolvaptan between January 2009 and October 2011 were retrospectively identified at Children's Medical Center Dallas. Laboratory parameters, urine output, fluid balance, and concurrent medications were recorded at baseline and at specified intervals after a single dose of tolvaptan. The 28 patients in the study had a median age of 2 years (range 1 month-18 years). The median tolvaptan dose administered was 0.3 mg/kg (range 0.1-1.3 mg/kg). The study patients had a median baseline serum sodium concentration of 127 mmol/L, and the increases in sodium were 2.5 mmol/L at 12 h, 5 mmol/L at 24 h, 4 mmol/L at 48 h, and 5 mmol/L at 72 h (all p < 0.001). Urine output was increased at 24 h (p < 0.001) and 48 h (p = 0.03), and fluid balance changes were significantly different at 24 h (p = 0.004). The changes in potassium, blood urea nitrogen, and serum creatinine were not significant at any interval. When controlling for traditional diuretic therapy, increases in serum sodium concentration and urine output remained statistically significant. A single dose of tolvaptan increased serum sodium concentrations for the majority in this small series of pediatric patients with heart failure. These results suggest that tolvaptan can be safely and effectively administered to pediatric patients. Prospective, randomized controlled trials are needed to evaluate the safety and efficacy of its use further.

Tolvaptan use during hyperhydration in paediatric intracranial lymphoma with SIADH

“…Tolvaptan has been reported in a case series of 28 paediatric patients with heart failure (8), a patient with restrictive cardiomyopathy (9) and a patient with massive oedema due to nephrotic syndrome (10). In these paediatric case reports and case series, tolvaptan was well tolerated and considered to be a safe treatment.…”

Pediatric Cardiac Intensive Care Society 2014 Consensus Statement

“…Experience with vaptans is limited in children. In a single-center, retrospective, uncontrolled study in 28 pediatric heart failure patients hospitalized with heart failure, treatment with tolvaptan was associated with increased serum sodium levels and greater urine output (158). More data are needed to determine the safety and efficacy of vaptans in pediatric cardiac patients.…”

Experts’ recommendations for the management of cardiogenic shock in children

“…Other studies have shown that the continuous perfusion of 0.01–0.03 µg/kg/min nesiritide improves echocardiogram variables (heart rate, left ventricular ejection fraction) and laboratory values (decreased creatinine, BNP and aldosterone levels) after 72 h [ 26 ]. In a retrospective series of 28 children with heart failure and hyponatremia, tolvaptan, a selective non-peptide antagonist the arginine vasopressin receptors (V2), improved, when used orally at a dose of 0.3 mg/kg, both diuresis and sodium levels after 72 h [ 27 ].…”