Bo Lively, Mercer University College of Pharmacy 2015
Alcoholic hepatitis is a disease characterized by inflammation of the liver that occurs after fatty liver has developed. Alcoholic hepatitis can progress to chronic hepatitis with fibrosis, or cirrhosis. The current guidelines provided by the American Association for the Study of Liver Diseases (AASLD) state that prednisolone or pentoxifylline should be used in the treatment of severe alcoholic hepatitis.1
|Title: Prednisolone or Pentoxifylline for Alcoholic Hepatitis2|
|Design||Multicenter, double-blind, randomized trial. 1092 participants.|
|Objective||Determine if prednisolone or pentoxifylline administered for a 28-day period reduced short-term and medium-term mortality of patients admitted to a hospital with severe alcoholic hepatitis|
|Study Groups||Patients diagnosed with alcoholic hepatitis were randomly assigned to one of four groups.
Group 1 (n=272) placebo
Group 2 (n=274) prednisolone-placebo
Group 3 (n=273) pentoxifylline-placebo
Group 4 (n=273) prednisolone-pentoxifylline
|Methods||Treatment duration of 28 days. The four groups received the following treatment regimens.
Placebo-placebo three times daily (Group 1).
Placebo or 40 mg of prednisolone daily (Group 2).
Placebo or 400 mg of pentoxifylline three times daily (Group 3).
Prednisolone 40 mg daily and pentoxifylline 400mg three times daily (Group 4).
|Duration||12 months or until death|
|Primary Outcome Measure||Mortality at 28 days.|
|Baseline Characteristics||Treatment groups were well matched.
-17% mortality at 28 days, no other data supplied
-14% mortality at 28 days, OR of 0.72 (95% confidence interval (CI),0.52 to 1.01; P=0.06)
-19% mortality at 28 days, OR of 1.07 (95% CI, 0.77 to 1.49; P=0.69)
-13% mortality at 28 days, no other data supplied
|Adverse Events||Common Adverse Events: Information not supplied.|
|Serious Adverse Events: Reported in 42% of the patients, 20% of serious adverse events resulted in death. Infection occurred in 13% of the patients receiving prednisolone compared with 7% who did not receive prednisolone.
-GI disorder 9%, hepatobiliary disorder 10%, infection 8%, renal or urinary disorder 4%
– GI disorder 15%, hepatobiliary disorder 10%, infection 15%, renal or urinary disorder 4%
– GI disorder 15%, hepatobiliary disorder 9%, infection 6%, renal or urinary disorder 5%
– GI disorder 15%, hepatobiliary disorder 8%, infection 11%, renal or urinary disorder 3%
|Percentage that Discontinued due to Adverse Events: Information not supplied.|
|Study Author Conclusions||Results showed that after 28 days, neither prednisolone nor pentoxifylline showed a significant influence on mortality. 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.
This study found no reduction in mortality in the pentoxifylline treatment group, but a reduction in mortality using prednisolone treatment was observed. The reduction in mortality seen with prednisolone treatment failed to reach statistical significance.
1) O’Shea RS, Dasarathy S, McCullough AJ, Practice Guideline Committee of the American Association for the Study of Liver Diseases, Practice Parameters Committee of the American College of Gastroenterology. Alcoholic liver disease. Hepatology. 2010 Jan;51(1):307-28
2) Thursz MR, Richardson P, Allison M, et al. Prednisolone or pentoxifylline for alcoholic hepatitis. N Engl J Med. 2015;372(17):1619-28.