[The efficacy and safety of tolvaptan on treating heart failure patients with hyponatremia].
OBJECTIVE
To evaluate the efficacy and safety of tolvaptan on treating congestive heart failure patients with hyponatremia.


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
Department of Cardiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China.
Ling
L
Li
Hua
H
Bai
Wen-ling
WL
Zhu
D000368:Aged; D065092:Antidiuretic Hormone Receptor Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D001552:Benzazepines / Q000009:adverse effects / Q000627:therapeutic use*; D001794:Blood Pressure; D001835:Body Weight; D004311:Double-Blind Method; D006333:Heart Failure / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D007010:Hyponatremia / Q000150:complications*; D012964:Sodium / Q000097:blood; D000077602:Tolvaptan
D065092:Antidiuretic Hormone Receptor Antagonists; D001552:Benzazepines; D000077602:Tolvaptan; D012964:Sodium