title: Efficacy and safety of tolvaptan in heart failure patients with volume overload despite the standard treatment with conventional diuretics: a phase III, randomized, double-blind, placebo-controlled study (QUEST study).
abstract: OBJECTIVE
  Diuretics are recommended to treat volume overload with heart failure (HF), however, they may cause serum electrolyte imbalance, limiting their use. Moreover, patients with advanced HF could poorly respond to these diuretics. In this study, we evaluated the efficacy and safety of Tolvaptan, a competitive vasopressin V2-receptor antagonist developed as a new drug to treat volume overload in HF patients.
  
  
  METHODS
  A phase III, multicenter, randomized, double-blind, placebo-controlled parallel study was performed to assess the efficacy and safety of tolvaptan in treating HF patients with volume overload despite the use of conventional diuretics. One hundred and ten patients were randomly assigned to receive either placebo or 15 mg/day tolvaptan for 7 consecutive days.
  
  
  RESULTS
  Compared with placebo, tolvaptan administered for 7 days significantly reduced body weight and improved symptoms associated with volume overload. The safety profile of tolvaptan was considered acceptable for clinical use with minimal adverse effects.
  
  
  CONCLUSIONS
  Tolvaptan reduced volume overload and improved congestive symptoms associated with HF by a potent water diuresis (aquaresis).
authors: Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine, Ube, Japan.
authors: Masunori
authors: M
authors: Matsuzaki
authors: Masatsugu
authors: M
authors: Hori
authors: Tohru
authors: T
authors: Izumi
authors: Masatake
authors: M
authors: Fukunami
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D065092:Antidiuretic Hormone Receptor Antagonists; D001127:Arginine Vasopressin / Q000097:blood; D001552:Benzazepines / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D001835:Body Weight / Q000187:drug effects; D004232:Diuretics / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D004311:Double-Blind Method; D004489:Edema, Cardiac / Q000097:blood / Q000188:drug therapy*; D005260:Female; D006333:Heart Failure / Q000097:blood / Q000188:drug therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D011188:Potassium / Q000097:blood; D012964:Sodium / Q000097:blood; D000077602:Tolvaptan
chemical_list: D065092:Antidiuretic Hormone Receptor Antagonists; D001552:Benzazepines; D004232:Diuretics; D001127:Arginine Vasopressin; D000077602:Tolvaptan; D012964:Sodium; D011188:Potassium