title: Simvastatin added to ursodeoxycholic acid does not enhance disappearance of gallstone fragments after shock wave therapy.
abstract: Inhibitors of the HMG-CoA reductase have been shown to further reduce the biliary cholesterol saturation in patients treated with oral bile acids for cholesterol gallbladder stones. It was the aim of our study to evaluate the efficacy of simvastatin in addition to ursodeoxycholic acid in the dissolution of gallstone fragments after shock wave lithotripsy and adjuvant bile acid dissolution therapy. Eighteen patients with a single radiolucent gallbladder stone and a serum cholesterol of more than 250 mg/dl were randomly assigned to receive either ursodeoxycholic acid alone (750 mg per day, group A, n = 9) or in combination with simvastatin (20 mg per day, group B, n = 9) for the dissolution of the gallstone fragments generated by extracorporeal shock wave lithotripsy. The two groups were well matched regarding their baseline characteristics. At the primary end point of the study 6 months after lithotripsy, there was no difference between the groups in the rate of gallstone disappearance with 4 of 9 patients being stone free in each group. As evaluated by life table analysis, even further follow-up showed no significant difference between the groups (P = 0.8). In group B, serum cholesterol levels decreased by 22% at 3 months (P = 0.01 vs. baseline) and by 24% at six months (P = 0.02) during treatment while no significant change was observed in group A. With both regiments, no adverse effects were observed. While simvastatin added to ursodeoxycholic acid resulted in a decrease of elevated serum cholesterol levels in gallstone patients, it did not enhance stone disappearance after shock wave lithotripsy and adjuvant bile acid dissolution therapy.
authors.affiliation: Dept of Medicine II, University of Munich, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Sackmann
authors.forename: R
authors.initials: R
authors.lastname: Koelbl
authors.forename: J
authors.initials: J
authors.lastname: Pauletzki
authors.forename: P
authors.initials: P
authors.lastname: Cremer
authors.forename: U G
authors.initials: UG
authors.lastname: Klueppelberg
authors.forename: C
authors.initials: C
authors.lastname: von Ritter
authors.forename: G
authors.initials: G
authors.lastname: Sauter
authors.forename: J
authors.initials: J
authors.lastname: Holl
authors.forename: D
authors.initials: D
authors.lastname: Seidel
authors.forename: G
authors.initials: G
authors.lastname: Paumgartner
mesh_terms: D000924:Anticholesteremic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002756:Cholagogues and Choleretics / Q000008:administration & dosage* / Q000009:adverse effects; D002769:Cholelithiasis / Q000628:therapy*; D002784:Cholesterol / Q000097:blood; D003131:Combined Modality Therapy; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D006801:Humans; D008096:Lithotripsy; D008148:Lovastatin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D019821:Simvastatin; D014580:Ursodeoxycholic Acid / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000924:Anticholesteremic Agents; D002756:Cholagogues and Choleretics; D014580:Ursodeoxycholic Acid; D002784:Cholesterol; D008148:Lovastatin; D019821:Simvastatin