PRESENTER: QUYNH VU, PGY-2 UCLA-OLIVE VIEW INTERNAL MEDICINE

PRESENTER: QUYNH VU, PGY-2 UCLA-OLIVE VIEW INTERNAL MEDICINE

PRESENTER: QUYNH VU, PGY-2 UCLA-OLIVE VIEW INTERNAL MEDICINE C/O VASIF MAYAN NEW ENGLAND JOURNAL OF MEDICINE, APRIL, 2015 STeroids Or Pentoxifylline for Alcoholic Hepatitis to determine whether prednisolone or pentoxifylline

administered for a 28-day period reduced short-term and medium-term mortality among patients admitted with severe alcoholic hepatitis BACKGROUND Alcoholic hepatitis is a distinct manifestation of alcoholic liver disease that is characterized by jaundice and liver

failure in a patient with history of prolonged and heavy alcohol use. The severity of alcoholic hepatitis is conventionally defined by Maddreys discriminant function [4.6 (difference in PT) + serum bilirubin level ( mg/dl)] >32 indicates severe alcoholic hepatitis that carries an adverse prognosis 20 to 30% mortality within 1 month after presentation

METHODS Study Design and Oversight Multicenter Randomized double-blind trial

INCLUSION CRITERIA 18 years or older clinical diagnosis of alcoholic hepatitis

average alcohol consumption of more than 80 g per day for men and more than 60 g per day for women, Serum bilirubin level >80 mol/L (4.7 mg/dL)mol/L (4.7 mg/dL)

Discriminant function of 32 or higher EXCLUSION CRITERIA Cessation of alcohol consumption for more than 2 months before randomization

Duration Serum Other of jaundice > 3 months AST>500 or ALT>300

causes of liver disease including: Evidence Biliary of chronic viral hepatitis (Hepatitis B or C) obstruction

Hepatocellular carcinoma TREATMENT PROTOCOL prednisolone 40mg qday pentoxifylline 400mg tid

x 28 days x 28 days CRITIQUE BREAK Clinically sensible intervention? Any contamination of controls?

Any co-interventions for the treated? END POINTS Primary end point: all-cause mortality at 28 days

Secondary end points: all-cause mortality or liver transplantation at 90 days and at 1 year Evaluations During and After Treatment Treatment

Day 7, 14, 21, and 28 On discharge from hospital 3 months 1 year INDICATORS USED Maddreys discriminant function

MELD score Glasgow alcoholic hepatitis score Lille score CRITIQUE BREAK Blinded results?

Would you have chosen the same outcomes? 28-DAY MORTALITY GROUP PLACEBO PLACEBO PREDNISOLONE PLACEBO PENTOXIFYLLINE PLACEBO PREDNSIOLONE PENTOXIFYLLINE

MORTALITY 17 14 19 13 Pentoxifylline

Prednisolone P value 0.06 Infections were nearly twice as common in the

prednisolone group ADVERSE EFFECTS Prednisolone Groups [ group infection rate

without prednisolone 13% 7% p value 0.002] 95%

deaths during the study were due to liver related causes 24% were due to infections No

clear mortality benefit for Pentoxifyllin e Uncertainity persists

regarding Prednisolone DISCUSSION Controversy over the use of glucocorticoids in severe alcoholic hepatitis has persisted for many years

In the study, the reduction in 28-day mortality observed among patients treated with prednisolone did not reach the conventional threshold of statistical significance No significant differences were observed in

90-day or 12-month outcomes Significant advantage with respect to 28-day mortality was seen with prednisolone In

summary, in the STOPAH trial, pentoxifylline did not improve outcomes in patients with alcoholic hepatitis The findings suggest that the administration of 40 mg of prednisolone daily for 1 month may have a beneficial effect on short term mortality but not on the medium-term or long-term outcome of alcoholic hepatitis

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