Clinical and laboratory data

Clinical and laboratory data

chronic liver disease (CLD)

Liver fibrosis progression is a major factor in prognostication of chronic liver disease (CLD). The main treatment of liver fibrosis is the causal treatment. However, certain CLD causes have not yet specific treatment, especially non-alcoholic fatty liver disease (NAFLD) and alcoholic liver disease (ALD). Angiotensin II is one of the main profibrotic factors [1]. Therefore, a lot of studies have evaluated the effects of angiotensin II receptor blockers (ARB) against fibrosis from cardiac, renal of liver origin. Thus, ARBs are indicated in the protection from diabetic nephropathy. Concerning liver fibrosis, several controlled studies performed in animal models, one of them from our group , have shown an improvement by ARB.

Characteristics

Patients were included into two groups: control and telmisartan. Inclusion criteria were CLD and age between 18 and 75 years. CLD etiology was NAFLD or chronic hepatitis C or alcohol or mixed previous causes. ARB administration prior to inclusion was permitted in the telmisartan group but not in the control group. Indeed, as telmisartan is not reimbursed for this indication in France, telmisartan administration often was a conversion of a previous ARB prescribed for another indication, mainly AHT. However, previous administration of telmisartan was not permitted in any group. Prior ARB was prescribed in 18 included patients: irbesartan: 7, candesartan: 4, valsartan: 3, losartan: 1 and olmesartan: 1. Patients should have non-invasive fibrosis test at inclusion and end of follow-up. Minimal follow-up duration was one year. Censoring date was the date of second non-invasive fibrosis test that was planned at the beginning of the second year.

Multivariate analysis

The independent predictors of the primary judgement criterion were evaluated by backward stepwise selection of variables including treatment group (forced entry), all significantly different variables at baseline or those during follow-up having a clinical impact on fibrosis (e.g. treatment). These variables included significant predictors of the primary judgement criterion as well as those significantly different between groups for adjustment. Independent predictors of VCTE change ≤ -10% were, at baseline: increased alcohol intake, previous ARB, severe fibrosis, treatment group; and during follow-up: longer follow-up duration and decrease in AST or waist circumference, anti-diabetics (absence) . Surprisingly, telmisartan was a negative predictor of the primary judgement criterion. However, there was a significant interaction between previous ARB and telmisartan (p=0.074).

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Table des matières

ABSTRACT
INTRODUCTION
PATIENTS AND METHODS
1. Patients
1.1. Characteristics
1.2. Flow chart of patients
2. Methods
2.1. Clinical and laboratory data
2.2. Telmisartan administration
2.3. Judgement criteria
2.4. Statistics
RESULTS
1. Baseline characteristics
2. Follow up
3. Judgement criteria
3.1. Validation
3.2. Univariate analysis
3.3. Multivariate analysis
3.4. ARB subgroup comparison
4. Side effects
DISCUSSION
REFERENCES
TABLES
FIGURES
SUPPLEMENTAL MATERIAL