Efficacy and Safety of Simvastatin in the Treatment of Portal Hypertension

Hospital Clinic of Barcelona

Status and phase: Completed; Phase 2

Conditions: Portal Hypertension; Cirrhosis

Treatments: Drug: Simvastatin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00594191

AEM 03-0434

SIMV-HTP2003

Details and patient eligibility

About

The purpose of this study is to evaluate the effects of continuous simvastatin administration on the hepatic venous pressure gradient (HVPG), as a surrogate marker of prognosis, and its safety in patients with cirrhosis and portal hypertension.

Full description

Statins exert beneficial vascular effects independently of cholesterol reduction by improving endothelial dysfunction. In cirrhosis sinusoidal endothelial dysfunction further increases intrahepatic resistance and portal pressure. Previous studies have shown that statins improve hepatic endothelial dysfunction in cirrhosis, suggesting that statins could be an effective therapy for portal hypertension (PHT). This randomized controlled trial evaluated the effects of continuous simvastatin administration on the hepatic venous pressure gradient (HVPG), as a surrogate marker of prognosis, and its safety in patients with cirrhosis and PHT.

Enrollment: 59 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age between 18 and 75.
2. Clinical, analytical, ultrasound or pathological criteria of cirrhosis.
3. Severe sinusoidal portal hypertension (HVPG >12 mmHg)
4. Signed informed consent

Exclusion criteria

1. Pregnancy or lactation
2. Advanced liver disease defined as one of the following: Prothrombin rate <40%, Bilirubin >5 mg/dl, hepatic encephalopathy > grade I or Child-Pugh score >12).
3. Portal vein thrombosis
4. Multinodular hepatocellular carcinoma or single hepatocellular carcinoma > 5 cm.
5. Heart, renal or respiratory failure
6. Previous portal-systemic shunt
7. Treatment with organic nitrates
8. Hypersensitivity to HMG-CoA reductase inhibitors
9. Previous treatment with HMG-CoA reductase inhibitors
10. Treatment with calcium channel blockers

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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59 participants in 2 patient groups, including a placebo group

A

Placebo Comparator group

Description:

Placebo treatment

Treatment:

Drug: Placebo

B

Experimental group

Treatment:

Drug: Simvastatin