A pilot trial of fenofibrate for the treatment of non-alcoholic fatty liver disease.
BACKGROUND
Dyslipidaemia and insulin resistance are two important risk factors for non-alcoholic fatty liver disease. Both factors can improve with fenofibrate.


OBJECTIVE
To evaluate the effect of fenofibrate on the clinical, analytical and histological evolution of patients with non-alcoholic fatty liver disease.


METHODS
Sixteen consecutive patients with biopsy-confirmed non-alcoholic fatty liver disease were treated with 200mg/day of fenofibrate for 48 weeks. A clinical and biochemical follow-up was done every 3 months. A new liver biopsy was performed in all patients at the end of therapy.


RESULTS
All patients completed 48 weeks of therapy with fenofibrate, without adverse events. At the end of the study, a significant decrease in triglyceride, glucose, alkaline phosphatase and gamma-glutamyl transpeptidase and an increase of apolipoprotein A1 levels were found. Insulin levels and insulin resistance showed a trend to decrease. Moreover, a reduction in the proportion of patients with abnormal aminotransferase levels (>45IU/L) was observed (alanine aminotransferase: 93.7% vs. 62.5%, p=0.02; aspartate aminotransferase: 50% vs. 18.7%, p=0.02). The body mass index did not show any significant change, but the proportion of patients with metabolic syndrome decreased significantly (43.7% vs. 18.7%, p=0.04). A control biopsy after treatment revealed a decrease in the grade of hepatocellular ballooning degeneration (p=0.03), but the grade of steatosis, lobular inflammation, fibrosis or non-alcoholic fatty liver disease activity score did not change significantly.


CONCLUSIONS
In patients with non-alcoholic fatty liver disease, treatment with fenofibrate is safe and improves metabolic syndrome, glucose and liver tests. However, its effects on liver histology are minimal.
Fernández-Miranda
C
C
Services of Internal Medicine (Lipid and Atherosclerosis Unit), Servicio de Medicina Interna, Hospital Universitario 12 de Octubre, Avda. de Córdoba s/n, 28041 Madrid, Spain. cfmiranda@telefonica.net
Pérez-Carreras
M
M
Colina
F
F
López-Alonso
G
G
Vargas
C
C
Solís-Herruzo
J A
JA
D000328:Adult; D000469:Alkaline Phosphatase / Q000097:blood; D016632:Apolipoprotein A-I / Q000097:blood; D001707:Biopsy, Needle; D004305:Dose-Response Relationship, Drug; D005234:Fatty Liver / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology; D005260:Female; D011345:Fenofibrate / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D000960:Hypolipidemic Agents / Q000627:therapeutic use*; D008099:Liver / Q000187:drug effects / Q000378:metabolism / Q000473:pathology; D008297:Male; D010865:Pilot Projects; D012189:Retrospective Studies; D000637:Transaminases / Q000097:blood; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood; D005723:gamma-Glutamyltransferase / Q000097:blood
D016632:Apolipoprotein A-I; D000960:Hypolipidemic Agents; D014280:Triglycerides; D005723:gamma-Glutamyltransferase; D000637:Transaminases; D000469:Alkaline Phosphatase; D011345:Fenofibrate