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STOPAH
OVMC LANDMARK TRIALS SERIES
Thursz MR, et al. "Prednisolone or pentoxifylline for
alcoholic hepatitis". The New England Journal of Medicine.
2015. 372(17):1619-1628.
Steroids or Pentoxifylline for Alcoholic Hepatitis (STOPAH)
BACKGROUND
 Alcoholic hepatitis is a clinical syndrome:
characteristics features include jaundice and
liver failure
 Severity is defined by Maddrey’s discriminant
function (a score of 32 or higher for
discriminant function, threshold used for most
other alcoholic hepatitis trials)
 Prior to the STOPAH study, there were some
trials that showed benefit of prednisolone and
pentoxifylline in patients with alcoholic
hepatitis, but studies were still limited
CLINICAL QUESTION
In patients with severe alcoholic hepatitis (discriminate function >32), does treatment
with prednisolone OR pentoxifylline improve survival?
DESIGN
 Analysis: Intention-to-treat
 Trial Design: Prospective multicenter randomized, double-blind 2-by-2 factorial design trial
 N=1,092 (5,234 screened)
 Placebo-placebo (n=272)
 Prednisolone-placebo (n=274)
 Pentoxifylline-placebo (n=273)
 Prednisolone-pentoxifylline (n=273)
 Setting: 65 hospitals across the United Kingdom
 Follow-up: 12 months (primary outcome at 28 days)
 Primary outcome: All-cause mortality at 28 days
POPULATION
Inclusion Criteria
 Age ≥18
 Clinical diagnosis of alcoholic hepatitis
 Average alcohol consumption of:
 >80 g/day for males
 >60 g/day for females
 Serum bilirubin >80 μmol/L (4.7 mg/dL)
 Maddrey's discriminant function ≥32
Exclusion Criteria
 Jaundice for >3 months
 Cessation of alcohol consumption >2 months
prior to randomization
 Other causes of liver disease
 Serum AST >500 IU/L or ALT >300 IU/L
 Development of renal failure, active GI
bleeding, untreated sepsis or requirement of
inotrope support, unless it becomes stable in
the first week of admission
INTERVENTIONS
 Participants were randomized to a group:
 Placebo-placebo
 Prednisolone-placebo
 Pentoxifylline-placebo
 Prednisolone-pentoxifylline
 Medications doses:
 Prednisone 40 mg daily
 Pentoxifylline 400 mg TID
 Study medications were continued for 28 days
CRITICISMS/LIMITATIONS/FUNDING
 Lower mortality rates in STOPAH compared to other similarly designed trials
 Likely attributable to:
 Participants were younger and rate of encephalopathy lower (both of which influence mortality)
 Lower incidence of AKI and infections
 Liver biopsy for histologic confirmation was not performed so misdiagnosis of alcoholic
steatohepatitis could occur
 Alcohol consumption data difficult to collect
 No taper in the prednisolone may have resulted in harm to the patients upon medication
withdrawal
FUNDING
 National Institute for Health Research (NIHR) Health Technology Assessment program
BOTTOM LINE
Among patients with severe alcoholic
hepatitis, NEITHER prednisolone nor
pentoxifylline reduces all-cause mortality at
28 days.
Prednisolone was associated with a non-
significant mortality benefit at 28 days but
no benefit at 90 days or 1 year. Further use
was associated with increased infections
BOARD-LIKE QUESTION
29 yo alcoholic male is evaluated for 6month
history of progressive jaundice and weight loss.
Patient’s fiancé says after being terminated from
his job, he started drink 2 packs of beer a day. He
watches TV all day and often does not eat
regular meals.
Physical exam:
T 37, HR 80, BP 108/54, RR 16. BMI 18.
Gen: NAD, thin, muscle wasting, jaundice
Abdomen: B+, tender in RUQ, hepatomegaly
noted
Neuro: confused, A&Ox2 asterixis
Labs:
Hg 11, MCV 77, Ferritin 5
ALT 140, AST 310, Alk phos 135, Albumin 2, T bili
3
FOBT negative
What is the first line treatment for this patient?
A. Oral prednisone
B. Oral pentoxifylline
C. Gluten free diet
D. Refer to GI for treatment of hepatitis
E. Advise alcohol cessation
BOARD-LIKE QUESTION
ANSWER
What is the first line treatment for this patient?
A. Oral prednisone
B. Oral pentoxifylline
C. Gluten free diet
D. Refer to GI for treatment of hepatitis
E. Advise alcohol cessation
Educational Objective:
Identify patients with alcoholic hepatitis and
calculate MDF (Maddrey discriminant function)
Key Point:
MDF = 4.6 (prothrombin time [s] – control prothrombin time
[s]) + total bilirubin (mg/dL)
Patients with hepatic encephalopathy or MDF score of 32 or
greater have high risk of death and warrant treatment with
Prednisone (1st line) or Pentoxifylline (2nd line)
- Prednisone is 1st line and contraindicated in infection,
variceal hemorrhage, or AKI. D/C after day 7 if serum
bilirubin does not improve
- Changing therapy to pentoxifylline thereafter is not
beneficial.
REFERENCES
 Thursz MR, et al. "Prednisolone or pentoxifylline
for alcoholic hepatitis". The New England
Journal of Medicine. 2015. 372(17):1619-1628.
 Brain, P. STOPAH.
https://www.wikijournalclub.org/wiki/STOPAH

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STOPAH

  • 1. STOPAH OVMC LANDMARK TRIALS SERIES Thursz MR, et al. "Prednisolone or pentoxifylline for alcoholic hepatitis". The New England Journal of Medicine. 2015. 372(17):1619-1628.
  • 2. Steroids or Pentoxifylline for Alcoholic Hepatitis (STOPAH)
  • 3. BACKGROUND  Alcoholic hepatitis is a clinical syndrome: characteristics features include jaundice and liver failure  Severity is defined by Maddrey’s discriminant function (a score of 32 or higher for discriminant function, threshold used for most other alcoholic hepatitis trials)  Prior to the STOPAH study, there were some trials that showed benefit of prednisolone and pentoxifylline in patients with alcoholic hepatitis, but studies were still limited
  • 4. CLINICAL QUESTION In patients with severe alcoholic hepatitis (discriminate function >32), does treatment with prednisolone OR pentoxifylline improve survival?
  • 5. DESIGN  Analysis: Intention-to-treat  Trial Design: Prospective multicenter randomized, double-blind 2-by-2 factorial design trial  N=1,092 (5,234 screened)  Placebo-placebo (n=272)  Prednisolone-placebo (n=274)  Pentoxifylline-placebo (n=273)  Prednisolone-pentoxifylline (n=273)  Setting: 65 hospitals across the United Kingdom  Follow-up: 12 months (primary outcome at 28 days)  Primary outcome: All-cause mortality at 28 days
  • 6. POPULATION Inclusion Criteria  Age ≥18  Clinical diagnosis of alcoholic hepatitis  Average alcohol consumption of:  >80 g/day for males  >60 g/day for females  Serum bilirubin >80 μmol/L (4.7 mg/dL)  Maddrey's discriminant function ≥32 Exclusion Criteria  Jaundice for >3 months  Cessation of alcohol consumption >2 months prior to randomization  Other causes of liver disease  Serum AST >500 IU/L or ALT >300 IU/L  Development of renal failure, active GI bleeding, untreated sepsis or requirement of inotrope support, unless it becomes stable in the first week of admission
  • 7. INTERVENTIONS  Participants were randomized to a group:  Placebo-placebo  Prednisolone-placebo  Pentoxifylline-placebo  Prednisolone-pentoxifylline  Medications doses:  Prednisone 40 mg daily  Pentoxifylline 400 mg TID  Study medications were continued for 28 days
  • 8. CRITICISMS/LIMITATIONS/FUNDING  Lower mortality rates in STOPAH compared to other similarly designed trials  Likely attributable to:  Participants were younger and rate of encephalopathy lower (both of which influence mortality)  Lower incidence of AKI and infections  Liver biopsy for histologic confirmation was not performed so misdiagnosis of alcoholic steatohepatitis could occur  Alcohol consumption data difficult to collect  No taper in the prednisolone may have resulted in harm to the patients upon medication withdrawal FUNDING  National Institute for Health Research (NIHR) Health Technology Assessment program
  • 9. BOTTOM LINE Among patients with severe alcoholic hepatitis, NEITHER prednisolone nor pentoxifylline reduces all-cause mortality at 28 days. Prednisolone was associated with a non- significant mortality benefit at 28 days but no benefit at 90 days or 1 year. Further use was associated with increased infections
  • 10. BOARD-LIKE QUESTION 29 yo alcoholic male is evaluated for 6month history of progressive jaundice and weight loss. Patient’s fiancé says after being terminated from his job, he started drink 2 packs of beer a day. He watches TV all day and often does not eat regular meals. Physical exam: T 37, HR 80, BP 108/54, RR 16. BMI 18. Gen: NAD, thin, muscle wasting, jaundice Abdomen: B+, tender in RUQ, hepatomegaly noted Neuro: confused, A&Ox2 asterixis Labs: Hg 11, MCV 77, Ferritin 5 ALT 140, AST 310, Alk phos 135, Albumin 2, T bili 3 FOBT negative What is the first line treatment for this patient? A. Oral prednisone B. Oral pentoxifylline C. Gluten free diet D. Refer to GI for treatment of hepatitis E. Advise alcohol cessation
  • 11. BOARD-LIKE QUESTION ANSWER What is the first line treatment for this patient? A. Oral prednisone B. Oral pentoxifylline C. Gluten free diet D. Refer to GI for treatment of hepatitis E. Advise alcohol cessation Educational Objective: Identify patients with alcoholic hepatitis and calculate MDF (Maddrey discriminant function) Key Point: MDF = 4.6 (prothrombin time [s] – control prothrombin time [s]) + total bilirubin (mg/dL) Patients with hepatic encephalopathy or MDF score of 32 or greater have high risk of death and warrant treatment with Prednisone (1st line) or Pentoxifylline (2nd line) - Prednisone is 1st line and contraindicated in infection, variceal hemorrhage, or AKI. D/C after day 7 if serum bilirubin does not improve - Changing therapy to pentoxifylline thereafter is not beneficial.
  • 12. REFERENCES  Thursz MR, et al. "Prednisolone or pentoxifylline for alcoholic hepatitis". The New England Journal of Medicine. 2015. 372(17):1619-1628.  Brain, P. STOPAH. https://www.wikijournalclub.org/wiki/STOPAH