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.
Article
en Zh
| WPRIM
| ID: wpr-268282
Biblioteca responsable:
WPRO
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:
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Base de datos:
WPRIM
Asunto principal:
Sodio
/
Benzazepinas
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Sangre
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Presión Sanguínea
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Peso Corporal
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Método Doble Ciego
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Usos Terapéuticos
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Quimioterapia
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Antagonistas de los Receptores de Hormonas Antidiuréticas
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Insuficiencia Cardíaca
Tipo de estudio:
Clinical_trials
Límite:
Aged
/
Humans
Idioma:
Zh
Revista:
Chinese Journal of Cardiology
Año:
2011
Tipo del documento:
Article