[Effect of ursodeoxycholic acid combined with statins in hypercholesterolemia treatment: a prospective clinical trial].
BACKGROUND
A possible synergistic effect of the combination treatment with statins and ursodeoxycholic acid (UDCA) for reduction of total cholesterol and LDL cholesterol plasma levels has been suggested.


METHODS
Random prospective clinical trial in 48 patients with primary or family hypercholesterolemia nonrespondent to simvastatin or atorvastatin treatment. The patients were assigned to a double statin dose group or to a group of combined treatment with simvastatin or atorvastatin and ursodeoxycholic acid for 4 months. Total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides plasma levels were evaluated.


RESULTS
The administration of simvastatin 20 mg/day + UDCA 300 mg/day yielded significantly greater reduction of LDL cholesterol plasma levels compared with the group of patients treated with simvastatin 40 mg/day (118.8 +/- 8.6 vs 154.8 +/- 12.2, respectively; p = 0.0034). Moreover, addition of atorvastatin 20 mg/day to UDCA 300 mg/day was more effective that atorvastatin 40 mg/day in single-dose for LDL cholesterol reduction after 4 months of treatment (94.6 +/- 6.1 versus 138.7 +/- 9.0, respectively; p = 0.0037). No significant adverse effects were observed in any of the analyzed groups.


CONCLUSIONS
Our results suggest the effectiveness of combination therapy with statins at low doses and UDCA in the treatment of patients with primary or family hypercholesterolemia initially nonrespondent to low doses of simvastatin or atorvastatin.
Cabezas Gelabert
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Servicio de Medicina Interna, Hospital Sant Pau, Barcelona.
D000924:Anticholesteremic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002756:Cholagogues and Choleretics / Q000008:administration & dosage* / Q000009:adverse effects; D002784:Cholesterol / Q000097:blood; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D006937:Hypercholesterolemia / Q000097:blood / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome; D014580:Ursodeoxycholic Acid / Q000008:administration & dosage* / Q000009:adverse effects
D000924:Anticholesteremic Agents; D002756:Cholagogues and Choleretics; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D014580:Ursodeoxycholic Acid; D002784:Cholesterol