Vasopressin v(2) receptor blockade with tolvaptan versus fluid restriction in the treatment of hyponatremia.
Hyponatremia is common and is associated with a poor prognosis. Traditional management with fluid restriction is difficult to maintain, and it is often ineffective. The objective of this study was to determine the effect of tolvaptan versus fluid restriction on serum sodium concentration. The study was a prospective, multicenter, randomized, active-controlled, open-label trial. Twenty-eight hospitalized subjects with serum sodium <135 mmol/L were enrolled in the study. After a 2-day run-in period, subjects were randomized 2:1 to tolvaptan alone (n = 17) or fluid restriction (1,200 ml/day) plus placebo (n = 11). Oral tolvaptan was started at 10 mg/day and increased to 60 mg/day as needed. Treatment was continued for up to 27 days, and follow-up continued for up to 65 days. The primary end point was the normalization of serum sodium, defined as >135 mmol/L or a > or =10% increase from baseline. At the last inpatient visit, serum sodium had increased by 5.7 +/- 3.2 mmol/L in the tolvaptan group and 1.0 +/- 4.7 mmol/L in the fluid restriction group (p = 0.0065). No differences in adverse events were observed between the groups. In conclusion, tolvaptan appears to be more effective than fluid restriction at correcting hyponatremia in hospitalized subjects, without an increase in adverse events.
Northwestern University, Feinberg School of Medicine, Chicago, Illinois, USA. m-gheorghiade@northwestern.edu
Mihai
M
Gheorghiade
Stephen S
SS
Gottlieb
James E
JE
Udelson
Marvin A
MA
Konstam
Frank
F
Czerwiec
John
J
Ouyang
Cesare
C
Orlandi
D000368:Aged; D065092:Antidiuretic Hormone Receptor Antagonists; D001552:Benzazepines / Q000627:therapeutic use*; D005260:Female; D005440:Fluid Therapy; D005500:Follow-Up Studies; D006801:Humans; D007010:Hyponatremia / Q000097:blood / Q000628:therapy* / Q000652:urine; D008297:Male; D008875:Middle Aged; D011188:Potassium / Q000097:blood / Q000652:urine; D011446:Prospective Studies; D012964:Sodium / Q000097:blood / Q000652:urine; D000077602:Tolvaptan; D016896:Treatment Outcome
D065092:Antidiuretic Hormone Receptor Antagonists; D001552:Benzazepines; D000077602:Tolvaptan; D012964:Sodium; D011188:Potassium