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

PURPOSE:

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: Masunori Matsuzaki, Masatsugu Hori, Tohru Izumi, Hidetsugu Asanoi, Takayoshi Tsutamoto, Tolvaptan Investigators
• Journal: Cardiovascular drugs and therapy (Cardiovasc Drugs Ther) Vol. 25 Suppl 1 Pg. S19-31 (Dec 2011) ISSN: 1573-7241 [Electronic] United States
• PMID: 22120091 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Antidiuretic Hormone Receptor Antagonists
• Benzazepines
• Diuretics
• Tolvaptan
• Furosemide
• Sodium
• Potassium

Topics

• Adult
• Aged
• Antidiuretic Hormone Receptor Antagonists
• Asian People
• Benzazepines (pharmacology, therapeutic use)
• Body Weight (drug effects)
• Diuretics (pharmacology, therapeutic use)
• Double-Blind Method
• Drug Therapy, Combination
• Edema, Cardiac (blood, drug therapy, urine)
• Female
• Furosemide (pharmacology, therapeutic use)
• Heart Failure (blood, drug therapy, urine)
• Humans
• Male
• Middle Aged
• Potassium (blood, urine)
• Sodium (blood, urine)
• Tolvaptan
• Young Adult