NEW YORK (Reuters Health) – A large new phase-3 study is questioning the widespread use of albumin to treat deadly decompensated cirrhosis, especially when the long-trusted therapy may pose a risk of significant side effects.
Dr. Alastair O’Brien of University College London, senior author of the ATTIRE study, noted that liver specialists have used the treatment for 70 years “with great enthusiasm” despite limited evidence of its effectiveness.
But in the wake of the new findings, doctors should think twice before they prescribe albumin and ask themselves, “‘Are you doing the right thing for your patients?'” Dr. O’Brien told Reuters Health in a telephone interview.
The trial of 777 U.K. volunteers, published in the New England Journal of Medicine, involved patients with a serum albumin level of less than 30 g/L. Half got a 20% human albumin solution daily for up to 14 days. Ninety percent of the patients had alcohol-related liver disease.
While 29.7% in the albumin group – who received a median of 200 g – developed a new infection, kidney dysfunction or death between three and 15 days after the initiation of treatment, the rate was 30.2% in the control group (P=0.87), which received a median of 20 g to drain ascites or for renal failure. Half the patients in the standard-care group received no albumin at all.
When the research team looked at individual elements of the primary endpoint, they found no significant differences either.
The rates of new infections were 20.8% with albumin versus 17.9% with standard care, a non-significant difference.
Rates of kidney dysfunction were 10.5% and 14.4% respectively. Death occurred in 7.9% of the experimental group and 8.3% of the control group.
“Giving lots of albumin made no difference,” said Dr. O’Brien, clinical director of the university’s comprehensive clinical-trials unit.
Pulmonary edema and fluid overload were the chief adverse effects that were severe or life-threatening. One or the other was seen in 23 of the albumin patients compared with eight in the standard-care group.
Fifteen patients in the albumin group developed pulmonary edema versus four who got standard care.
“Despite the targeted regimen to increase the serum albumin level to 30 per liter or more, there were no apparent benefits of the intervention with respect to the primary end point in any of the subgroups analyzed,” the researchers write. “There were no significant between-group differences in the incidence of death at 28 days, 3 months, and 6 months.”
“There may be some backlash” among doctors who strongly believe in the therapy, said Dr. O’Brien. “But I hope it changes practice.”
Because the survival rate is so poor – one third of the patients admitted to the hospital were dead within six months and treatment made no difference – “I think at this stage of advanced liver disease, what we do in hospital doesn’t make much difference,” he said. “I think we need to go upstream to primary prevention and get people to stop drinking alcohol to excess.”
And with so many people confined by the COVID-19 pandemic, “a lot of people have drunk more and eaten more and exercised less. I’m concerned we’ll see a surge in liver disease over the next few years.”
SOURCE: https://bit.ly/3rbDVjv The New England Journal of Medicine, online March 3, 2021.
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