Table 2.
Study | Event | Tolvaptan 30 mg | Placebo | p value |
---|---|---|---|---|
ACTIV in CHF | Death | 13/239 (5.4%) | 7/80 (8.7%) | 0.18 |
Rehospitalization | 44/239 (18.4%) | 14/80 (17.5%) | >0.99 | |
Worsening CHF | 64/239 (26.7%) | 22/80 (27.5%) | 0.88 | |
EVEREST | All-cause mortality | 537/2063 (25.9%) | 543/2055 (26.3%) | 0.68 |
CV death or hospitalization for CHF | 871/2063 (42.0%) | 829/2055 (40.2%) | 0.55 | |
Effect of tolvaptan on LV dilation | Death | 6/120 (5%) | 11/120 (9%) | 0.03 |
CHF-related hospitalizations | 21/120 (18%) | 34/120 (28%) | ||
Post-LVEDI | 1.78 ± 10.7 | 0.04 ± 10.0 | 0.21 |
Duration: ACTIV in CHF study: 60 days; EVEREST study: 9.9 months; and Udelson’s Effect of Tolvaptan on LV Dilation and Function: 52 weeks.
Abbreviations: CHF, congestive heart failure; CV, cardiovascular; LVEDVI, left ventricular end diastolic volume index.