JOURNAL READING

A Randomized, Multi-Center, Open Label

Study to Evaluate the Efficacy of
Carvedilol vs. Propanolol to Reduce Portal
Pressure in Patients with Liver Cirrhosis

FENI FARDILA

Internal Medicine Department

Medical Faculty Of Andalas University
Dr. M. Djamil Hospital Padang
2017
Introduction
Portal hypertension : hemodynamic
dearangement  variceal bleeding,
ascites, hepatic encephalopathy, and
death

Increase in resistance to portal venous

flow due to anatomical distortion of liver
architecture, vascular contraction, and
hyperdinamic systemic circulation.

Pharmacological treatment decreasing

splanchnic blood flow and lowering cardiac
output
Introduction
Reduction in hepatic venous pressure gradient
(HPVG) by 20% or < 12 mmHg unlikely to
experience esophageal variceal bleeding

Practice Guideline recommend NSBB ( non

selective β blockers) as first line prophylaxis for
esophageal variceal bleeding

A recent meta-analysis showed that carvedilol

reduces
portal pressure more eff ectively than
propranolol
AIM OF THE STUDY
Evaluate the efficacy of carvedilol for
reducing HVPG in patients with cirrhosis and
severe portal hypertension as compared with
that of propranolol.
Methods
 PATIENTS
• Cirrhosis and esophageal varix grade 2-3, from six tertiary
Randomized academic medical centers in Korea between August 2010-
Desember 2014

controlled,
open label

• Age 20-70 years

• Cirrhosis diagnosed : liver biopsy or definite radiographic

Inclusion •
•
Severe portal hypertension ( HVPG> 12 mmHg)
Esophageal varix grade 2 and 3 ( in 3 months)
• Child Pugh score < 12
Criteria • Not taking NSBB, ACE-I, nitrates, or othe vasoactive ( in 1
month)
 PATIENTS
• Systolic blood presure < 90 mmHg
• Baseline heart rate < 55 x/minutes
• Refractory ascites
• Hepatic encephalopathy
• Hepatorenal syndrome

Exclusion • Hepatocellular carcinoma

• Endoscopic variceal ligation < 3 months
• Contraindication to β blockers and α

Criteria blockers
• Bilirubin serum > 10 mg/dl
• Serum creatinine > 1.2 mg/dl
• History of shunt operation
• Insulin dependent diabetes melitus
• Pregnancy
• Unwilling to give informed consent
Study protocol and randomization
Eligible patients were assigned randomly in a 1:1 ratio to receive
either carvedilol or propanolol

Equal proportion of patients with HVPG > 20 mmHg

Carvedilol dosage 6.25 mg, increased to 12,5 mg. Propanolol dosage

20 mg titrated until 320 mg until HR decreased by 25% from baseline

The mean dosage carvedilol 11,6 mg and propanolol 152,6 mg

Follow up weekly, evaluate HR, BP, Alcohol comsumption,

development of ascites and hemorrhage, drug associated symptoms
Hemodynamic studies
To measured HVPG, patients underwent hepatic vein catherization
through a catheter, correct positioning of the ballon catheter in right
main hepatic vein was confirmed by fluoroscopy

Free hepatic venous pressure and balloon occluded wedged hepatic

venous pressured were traced for 20-30 s and 45-60 s

Measurement were performed at least in triplicate and the mean

value were used for analysis

The HVPG measurement was repeated 6 weeks after starting the first
drug administration

Respond to treatment was defined as one who achieved a decrease

of HVPG≥20% or to < 12 mmHg
Sample size calculation and statistical analysis
All analyses were conducted principally by intention to treat (ITT) and
supplemented by per-protocol (PP)

Group comparison were made with the X2 or Fisher’s exact test for
qualitative variables, and student t test or the man whitney U test for
quantitative variables.

Measurement were performed at least in triplicate and the mean

value were used for analysis

The HVPG measurement was repeated 6 weeks after starting the first
drug administration

Respond to treatment was defined as one who achieved a decrease

of HVPG≥20% or to < 12 mmHg
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