title: Ezetimibe combined with low-dose statin effectively lowers LDL in protease inhibitor treated patients.
abstract: Ezetimibe (EZB) lowers cholesterol by blocking cholesterol absorption in the intestine. Data with EZB are limited in HIV-infected patients. We enrolled HIV-infected adults in this prospective, noncontrolled, single-center pilot study if their low-density lipoprotein (LDL) was not at goal despite therapy with a statin. Stable protease inhibitor (PI)-based highly active antiretroviral therapy (HAART) and a low-dose statin were required for inclusion. The primary endpoint was LDL reduction at 18 weeks. In a subgroup of patients on lopinavir/ritonavir (LPV/r), trough concentrations were obtained before and after addition of EZB. Twenty patients were enrolled; 12 (60%) men, 18 (90%) African American. HAART included ritonavir (RTV)-boosted PIs in 17 (85%) patients; 3 (15%) were on nelfinavir. Mean percent changes from baseline in LDL were -10.9%, -12.2%, and -12.4% at weeks 6, 12, and 18, respectively (p < 0.05 for each time period vs. baseline). Mean percent changes from baseline in total cholesterol (TC) were -11.1%, -9.6%, and 9.1% at weeks 6, 12, and 18, respectively (p < 0.05 at each time period vs. baseline). No significant changes in triglycerides, high-density lipoprotein, and LPV/r concentrations were seen. One patient experienced elevated creatine phosphokinase possibly related to study medication; no other adverse effects were seen. Addition of EZB to low-dose statin effectively lowers LDL and TC and appears to be safe and well tolerated.
authors.affiliation: Department of Medicine, Temple University School of Medicine, Philadelphia, Pennsylvania.
authors.forename: Mary
authors.initials: M
authors.lastname: van den Berg-Wolf
authors.forename: Olga M
authors.initials: OM
authors.lastname: Klibanov
authors.forename: John P
authors.initials: JP
authors.lastname: Gaughan
authors.forename: Ellen M
authors.initials: EM
authors.lastname: Tedaldi
mesh_terms: D000328:Adult; D000924:Anticholesteremic Agents / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D000069059:Atorvastatin; D001384:Azetidines / Q000627:therapeutic use*; D008078:Cholesterol, LDL / Q000097:blood / Q000187:drug effects*; D004334:Drug Administration Schedule; D000069438:Ezetimibe; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000097:blood* / Q000188:drug therapy; D017320:HIV Protease Inhibitors / Q000627:therapeutic use; D015497:HIV-1 / Q000187:drug effects; D006538:Heptanoic Acids / Q000008:administration & dosage*; D006801:Humans; D006937:Hypercholesterolemia / Q000097:blood / Q000188:drug therapy*; D061466:Lopinavir / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D017035:Pravastatin / Q000008:administration & dosage*; D011446:Prospective Studies; D011758:Pyrroles / Q000008:administration & dosage*; D019438:Ritonavir / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D000924:Anticholesteremic Agents; D001384:Azetidines; D008078:Cholesterol, LDL; D017320:HIV Protease Inhibitors; D006538:Heptanoic Acids; D011758:Pyrroles; D061466:Lopinavir; D000069059:Atorvastatin; D000069438:Ezetimibe; D017035:Pravastatin; D019438:Ritonavir