Sponsored: Human albumin: Liver Disease SE Asia - Page 12

TABLE 1
Summary of studies of long-term albumin infusion 1
Study
Design and follow up ( n )
Study population
Length of infusion ( days )
Intervention
Control
Wilkinson and
Sherlock 21
Nonrandomised , single centre trial ; 22 months ; n = 16
Patients with cirrhosis and ascites , despite dietary and diuretic therapy
616 Albumin 25 – 100g until serum colloid oncotic pressure 38 – 40cm of water
Standard medical therapy ( SMT )
Gentilini et al 22
Single centre randomised , controlled trial ( RCT ); 3 years ; n = 126
Adult patients with cirrhosis 1095 Albumin 12.5g / day SMT
Romanelli et al 23
Single centre RCT ; 84 months ; n = 100
Adult patients with cirrhosis and new-onset clinically significant ascites
1440 Albumin 25g / week in the first year , 25g every two weeks thereafter
SMT
Sola-Vera et al ( MACHT ) 24
Multicentre RCT ; 1 year ; n = 196
Patients with cirrhosis and ascites on liver transplant waiting list
365 Midodrine 15 – 30mg / day and albumin 40g / 15 days for 1 year
SMT
Caraceni et al ( ANSWER trial ) 25
Multicentre RCT ; 18 months ; n = 431
Adult patients with medically controlled uncomplicated ascites
540 Albumin 40g twice weekly for 2 weeks ; and 40g / week up to 18 months
SMT
Di Pascoli et al 26
Nonrandomised , prospective study ; mean 408 days ; n = 70
Adult patients with cirrhosis and refractory ascites
720
Albumin 20g twice per week
SMT and large-volume paracentesis if indicated
China et al Multicentre ( ATTIRE ) 27 RCT ; 6 months ; n = 828
Adult patients with cirrhosis hospitalised with acute decompensation and hypoalbuminaemia ( serum albumin < 30g / l )
14 Albumin 20 – 80g / day until serum albumin levels ≥35g / l
SMT
Hepatorenal syndrome ( HRS ) HRS is the functional renal failure secondary to intra-renal vasoconstriction in patients with decompensated cirrhosis or acute liver failure . 12 The combination of albumin ( 20 – 40g / day ) and terlipressin infusion has been shown to reverse renal impairment in up to 56 % of patients with type-1 HRS ( also known as HRS-acute kidney injury ( HRS-AKI )). 12
Hepatic encephalopathy ( HE ) HE is a neuropsychiatric manifestation associated with poor prognosis in decompensated cirrhosis resulting from the complex interplay between effective circulatory volume , ammonia , systemic inflammation and portosystemic shunting . As albumin is known to improve systemic circulatory dysfunction and oxidative stress-mediated tissue injury , there has been growing interest in using albumin to treat or prevent HE . 16 A meta-analysis suggests albumin infusion might be useful for treatment and prevention of HE . 17 Dedicated studies are required to investigate the optional regimen and patient population that would best benefit from human albumin before it can be adopted into routine practice .
Acute-on-chronic liver failure ( ACLF ) ACLF is a distinct clinical entity characterised by systemic inflammation associated with multiorgan failure and high short-term mortality among decompensated cirrhosis patients . 18 A randomised trial showed that patients in the albumin group experienced resolution of ACLF ( 82.3 % vs 33.3 %) even though the overall mortality was similar to patients receiving antibiotics alone . 19 More data are also awaited from an ongoing randomised trial investigating the efficacy of albumin infusion in ACLF ( the ASIA trial ). 20
Long-term albumin infusion in decompensated cirrhosis Since Wilkinson and Sherlock first described the role of long-term albumin infusion in the 1960s , 21 there has been an increasing interest in its use in decompensated cirrhosis . Table 1 summarises the main studies that have been carried out .
12 | hospitalpharmacyeurope . com