Simvastatin effects on portal hypertension in cirrhotic patients

Clinical Score: 0.950 Price: $0.50 cirrhotic portal hypertension human patients Status: proposed

What This Experiment Tests

Clinical experiment designed to assess clinical efficacy targeting N/A in human patients. Primary outcome: decrease in HVPG of at least 20% from baseline or to ≤12 mmHg

Description

A 3-month prospective, randomized, triple-blind, placebo-controlled trial evaluating the effects of simvastatin (40 mg/day) on hepatic venous pressure gradient (HVPG) and azygos vein blood flow in patients with cirrhotic portal hypertension. The study investigated whether simvastatin's pleiotropic effects could decrease intrahepatic resistance and portal hypertension. HVPG was measured directly and azygos blood flow was assessed using colour Doppler endoscopic ultrasound before and after 3 months of treatment. The trial aimed to determine if simvastatin could achieve clinically meaningful reductions in portal pressure, defined as a decrease in HVPG of at least 20% from baseline or to ≤12 mmHg. Results showed that 55% of patients in the simvastatin group achieved clinically relevant HVPG reduction compared to none in the placebo group. Patients with medium/large esophageal varices and previous variceal bleeding showed higher response rates to simvastatin treatment.

TARGET GENE
N/A
MODEL SYSTEM
human patients
ESTIMATED COST
$0
TIMELINE
0 months
PATHWAY
HMG-CoA reductase pathway/statin pleiotropic effects
SOURCE
extracted_from_pmid_26321186
PRIMARY OUTCOME
decrease in HVPG of at least 20% from baseline or to ≤12 mmHg

Scoring Dimensions

Info Gain 0.00 (25%) Feasibility 0.00 (20%) Hyp Coverage 0.00 (20%) Cost Effect. 0.00 (15%) Novelty 0.00 (10%) Ethical Safety 0.00 (10%) 0.950 composite

Protocol

3-month randomized, triple-blind, placebo-controlled trial with simvastatin 40 mg/day vs placebo. HVPG measured directly, azygos blood flow measured by colour Doppler endoscopic ultrasound before and after treatment

Expected Outcomes

reduction in portal pressure and improvement in liver function in simvastatin group compared to placebo

Success Criteria

≥20% decrease in HVPG from baseline or HVPG ≤12 mmHg after treatment

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