Table 1.
Study | Treatment | Weight loss (kg) | Weight loss (kg) | Urine output (L/day) | Urine osmolality (mOsm/kg) | Change in Sna (meq/L) | Change in Sna (meq/L) |
---|---|---|---|---|---|---|---|
Day 1 | Day 7 | Day 1 | Day 1 | Day 1 | Day 7 | ||
Tolvaptan in patients with CHF | Tolvaptan | ||||||
30 mg | 0.79 ± 0.99 | 3.9 ± 0.6 | 15.5 ± 190 | ||||
45 mg | 0.96 ± 0.93 | 4.2 ± 0.9 | 52.4 ± 165 | ||||
60 mg | 0.84 ± 0.02 | 4.6 ± 0.4 | 118.8 ± 132 | ||||
Placebo | +0.32 ± 0.46 | 2.3 ± 0.2 | +135.8 ± 189 | ||||
ACTIV in CHF | Tolvaptan | ||||||
30 mg | 1.80 (−3.85 to −0.5) | +2.77 | |||||
60 mg | 2.10 (−3.1 to −0.85) | +3.38 | |||||
90 mg | 2.05 (−2.80 to −0.6) | +3.50 | |||||
Placebo | 0.60 (−1.60 to 0) | 0.20 | |||||
EVEREST | Tolvaptan | ||||||
30 mg | |||||||
Trial A | 1.71 ± 1.8 | 3.35 ± 3.3 | +3.28 | +2.07 | |||
Trial B | 1.82 ± 2.01 | 3.77 ± 3.6 | |||||
Placebo A | 0.99 ± 1.83 | 2.73 ± 3.3 | 0.41 | 1.06 | |||
Placebo B | 0.95 ± 1.85 | 2.79 ± 3.5 |
All above comparisons of tolvaptan versus placebo are statistically significant (p < 0.05).
Abbreviation: CHF, congestive heart failure.