The efficacy and safety of tolvaptan on treating heart failure patients with hyponatremia / 中华心血管病杂志
Chinese Journal of Cardiology
;
(12): 936-940, 2011.
Artigo
em Chinês
| WPRIM
| ID: wpr-268282
ABSTRACT
<p><b>OBJECTIVE</b>To evaluate the efficacy and safety of tolvaptan on treating congestive heart failure patients with hyponatremia.</p><p><b>METHODS</b>This randomized double-blind placebo-controlled multicenter trial enrolled 65 patients with congestive heart failure and hyponatremia. On top of standard therapy, patients were randomized to receive either tolvaptan 15 - 60 mg daily or placebo according to the serum sodium concentration. The primary end points were the change of average daily serum sodium concentration from baseline to day 4 and to day 7 respectively. Patients' weight, urine volume, sign of heart failure, heart function, blood pressure, heart rate, and all adverse events were observed.</p><p><b>RESULTS</b>The daily serum sodium concentration increase was significantly higher in tolvaptan group than in placebo group during the first 4 days [(5.6 ± 3.5) mmol/L vs. (2.5 ± 3.4) mmol/L, P < 0.05] and 7 days [(5.9 ± 3.5) mmol/L vs. (2.8 ± 3.3) mmol/L, P < 0.05]. Moreover, urine volume increase and body weight decrease were more significant in tolvaptan group than in placebo group (all P < 0.05). The change of sign of heart failure, heart function, blood pressure and heart rate was similar between two groups (P > 0.05). There were more drug related adverse events of thirst (11.4%) and hypernatremia (5.7%) in Tolvaptan group. One patient in tolvaptan group developed agranulocytosis during therapy period and recovered post therapy.</p><p><b>CONCLUSIONS</b>Tolvaptan could effectively increase serum sodium concentration, urine volume, and improve liquid balance in heart failure patients with hyponatremia. Tolvaptan related serious adverse event was low and could be well tolerated by patients tested in this cohort.</p>
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Assunto principal:
Sódio
/
Benzazepinas
/
Sangue
/
Pressão Sanguínea
/
Peso Corporal
/
Método Duplo-Cego
/
Usos Terapêuticos
/
Tratamento Farmacológico
/
Antagonistas dos Receptores de Hormônios Antidiuréticos
/
Insuficiência Cardíaca
Tipo de estudo:
Ensaio Clínico Controlado
Limite:
Idoso
/
Humanos
Idioma:
Chinês
Revista:
Chinese Journal of Cardiology
Ano de publicação:
2011
Tipo de documento:
Artigo
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