title: Effects of tolvaptan on volume overload in Japanese patients with heart failure: results of a phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group study.
abstract: OBJECTIVE
  Tolvaptan may reduce the signs of volume overload in heart failure (HF) patients who experience volume overload despite using conventional diuretics. In this study, we evaluated the dose-response effects of tolvaptan on weight loss, urine volume and electrolyte excretion in furosemide-treated Japanese HF patients exhibiting volume overload.
  
  
  METHODS
  In the study, 117 HF patients with volume overload on stable doses of furosemide (≥ 40 mg/day) were treated with tolvaptan (15, 30 or 45 mg) or placebo once-daily for 7 days.
  
  
  RESULTS
  The decrease in body weight from baseline to the day after the final dose with 15, 30 or 45 mg tolvaptan (-1.62 ± 1.55, -1.35 ± 1.54 and -1.85 ± 1.10 kg, respectively), was significantly greater compared with that in the placebo group (-0.53 ± 0.96 kg) (p < 0.05). However, the decrease in body weight with tolvaptan was not significantly dose-dependent. Signs of volume overload improved at all doses of tolvaptan. Tolvaptan elicited a dose-dependent increase in urine volume and a decrease in urine osmolality, but did not affect urinary sodium or potassium excretion. Adverse reactions associated with diuresis were most frequently observed at the higher doses of tolvaptan.
  
  
  CONCLUSIONS
  Once-daily tolvaptan (15, 30 or 45 mg) was effective and tolerable as an add-on treatment to furosemide therapy in Japanese HF patients with volume overload.
authors: Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan.
authors: Masunori
authors: M
authors: Matsuzaki
authors: Masatsugu
authors: M
authors: Hori
authors: Tohru
authors: T
authors: Izumi
authors: Hidetsugu
authors: H
authors: Asanoi
authors: Takayoshi
authors: T
authors: Tsutamoto
mesh_terms: D000328:Adult; D000368:Aged; D065092:Antidiuretic Hormone Receptor Antagonists; D044466:Asian People; D001552:Benzazepines / Q000494:pharmacology / Q000627:therapeutic use*; D001835:Body Weight / Q000187:drug effects; D004232:Diuretics / Q000494:pharmacology / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004489:Edema, Cardiac / Q000097:blood / Q000188:drug therapy* / Q000652:urine; D005260:Female; D005665:Furosemide / Q000494:pharmacology / Q000627:therapeutic use*; D006333:Heart Failure / Q000097:blood / Q000188:drug therapy / Q000652:urine; D006801:Humans; D008297:Male; D008875:Middle Aged; D011188:Potassium / Q000097:blood / Q000652:urine; D012964:Sodium / Q000097:blood / Q000652:urine; D000077602:Tolvaptan; D055815:Young Adult
chemical_list: D065092:Antidiuretic Hormone Receptor Antagonists; D001552:Benzazepines; D004232:Diuretics; D000077602:Tolvaptan; D005665:Furosemide; D012964:Sodium; D011188:Potassium