Arginine vasopressin antagonist tolvaptan in the treatment of heart failure: a meta-analysis of randomized controlled trials.

ABSTRACT

BACKGROUND: Tolvaptan can promote water clearance without a deterioration of serum electrolytes in HF patients, but its efficacy and safety were unclear. We performed a meta-analysis of randomized controlled trials (RCTs) to investigate the efficacy and safety of tolvaptan in the treatment of patients hospitalized for heart failure (HF). METHODS: In Oct 2014, a literature search was started and found all studies conducted from 2000 to 2014. We systematically searched the literature through the MEDLINE database and EMBASE database. Quality assessments were evaluated with Jadad quality scale. Data were extracted considering the characteristics of efficacy and safety designs. RESULT: Eight RCTs enrolling 13453 participants satisfying the inclusion criteria were finally analyzed. There were significant decreases of body weight (MD=-0.87, 95% CI=-0.94 to -0.80, P<0.001) among all subgroups. Significant increase of serum sodium was found between tolvaptan and placebo groups at day 1 (MD=2.93, 95% CI=2.70 to 3.16, P<0.001) and at day 7 or discharge (MD=3.10, 95% CI=2.78 to 3.42, P<0.001). There were significant differences between the day 1 subgroup and day 7 or discharge subgroup (MD=2.99, 95% CI=2.80 to 3.18, P<0.001). A statistical significant improve in dyspnea (RR=1.10, 95% CI=1.07 to 1.13, P<0.001) and edema (RR=1.05, 95% CI=1.02 to 1.08, P<0.001) occurred, whereas there was no difference in rales (RR=2.38, 95% CI=0.89 to 6.38, P=0.08) and pulmonary congestion (RR=1.02, 95% CI=0.71 to 1.45, P=0.93). Pooled effect measure in the outcome of common adverse event (RR=1.08, 95% CI=0.99 to 1.18, P=0.08) and serious adverse (RR=0.96, 95% CI=0.88 to 1.04, P=0.29) event both show no significant occurrence. CONCLUSION: Tolvaptan decreases body weight, increases serum sodium, and improves congestion without significant increasing adverse events in HF patients.