March 25, 2007JAMA
Short-term Clinical Effects of Tolvaptan, an Oral Vasopressin Antagonist, in Patients Hospitalized for Heart Failure<SUBTITLE>The EVEREST Clinical Status Trials</SUBTITLE>
Why the study?
Does tolvaptan improve short-term clinical status and body weight in patients hospitalized with heart failure and congestion?
Population
4,133 patients hospitalized with heart failure and congestion, multinational.
Comparison
Tolvaptan 30 mg/d oral added to standard… vs Matching placebo added to standard therapy.
Design
RCT, randomized, double-blind, placebo-controlled
Follow-up
day 7 or discharge if earlier
Authors
Discussion
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Implication
Supports tolvaptan addition for short-term congestion relief in hospitalized HF; confirms vasopressin antagonism benefit on clinical status.
Key Points
- To evaluate the short-term effects of tolvaptan added to standard therapy in hospitalized heart failure patients.
- Two identical prospective, randomized, double-blind, placebo-controlled trials conducted across 359 sites
- A total of 2048 (trial A) and 2085 (trial B) patients with heart failure and congestion
- Patients randomized to tolvaptan (30 mg/d) or matching placebo within 48 hours of admission.
- Tolvaptan showed greater improvement in primary end point vs placebo (P<.001)
- Mean body weight reduction was greater with tolvaptan on day 1 and day 7 or discharge in both trials (P<.001)
- Significant improvement in dyspnea at day 1 for tolvaptan group vs placebo (P<.001)
Structured PICO
Does tolvaptan improve short-term clinical status and body weight in patients hospitalized with heart failure and congestion?
P
Population
4,133 patients (2,048 in trial A, 2,085 in trial B) hospitalized with heart failure and congestion, multinational (North America, South America, and Europe).
I
Intervention
Tolvaptan 30 mg/d oral added to standard therapy, initiated within 48 hours of admission.
C
Comparator
Matching placebo added to standard therapy.
O
Outcome
Composite of changes in global clinical status based on a visual analog scale and body weight at day 7 or discharge if earlier.composite
In patients hospitalized with heart failure, the addition of oral tolvaptan to standard therapy significantly improved short-term signs and symptoms of congestion, including body weight and dyspnea, without increasing serious adverse events.
Cite This Study
Mihai Gheorghiade (2007) studied this question.