Human albumin infusions improve mortality in patients with persistent ascites (ANSWER)

Reference

Caraceni P, Riggio O, Angeli P, et al, for the ANSWER Study Investigators. Long-term albumin administration in decompensated cirrhosis (ANSWER): an open-label randomised trial. Lancet 2018;391(10138):2417-2429.

Synopsis

These researchers identified adults with persistent ascites due to hepatic cirrhosis in 33 Italian hospitals and randomized them to receive standard medical therapy alone (spironolactone and furosemide; n = 213) or standard medical therapy in combination with human albumin infusions (20% albumin 40 g twice weekly for the first 2 weeks, followed by 40 g weekly; n = 218). There was no sham or placebo infusion. The researchers evaluated the patients every month. After 18 months, 46 (22%) patients treated with standard medical therapy died from any cause compared with 38 (17%) who received human albumin infusions (number needed to treat = 24). Although quality-of-life scores declined over the study period for patients receiving standard medical therapy, the scores for the patients treated with albumin remained steady. The proportion of patients undergoing liver transplant or transjugular intrahepatic portosystemic shunt was the same in each group. Nearly 25% of patients in both groups experienced nonhepatic adverse events (eg, cardiac events, procedural complications, gastrointestinal disorders, and so forth). The authors report that the albumin infusions cost an additional 2500 euros per year ($2900 US), but the cost was outweighed by cost savings.