title: Dyslipidemia in HIV-positive patients: a randomized, controlled, prospective study on ezetimibe+fenofibrate versus pravastatin monotherapy.
abstract: BACKGROUND
  We designed a randomized, controlled prospective study aimed at comparing efficacy and tolerability of ezetimibe+fenofibrate treatment versus pravastatin monotherapy in dyslipidemic HIV-positive (HIV+) patients treated with protease inhibitors (PIs).
  
  
  METHODS
  We consecutively enrolled 42 HIV+ dyslipidemic patients on stable PIs therapy (LDL cholesterol >130 mg/dl or triglycerides 200-500 mg/dl with non-HDL cholesterol >160 mg/dl). After basal evaluation, patients were randomized to a six-month treatment with ezetimibe 10 mg/day+fenofibrate 200 mg/day or with pravastatin 40 mg/day. Both at the basal evaluation and after the six-month treatment, the patients underwent blood tests for lipid parameters, and muscle and liver enzymes.
  
  
  RESULTS
  At baseline, the two groups (21 patients each) were similar with regards to gender, age, BMI, blood pressure and virologic and metabolic parameters. After the six-month therapy, total cholesterol, LDL cholesterol and non-HDL cholesterol decreased significantly (p<0.01) in both groups. high-density lipoprotein (HDL) cholesterol increased (44 ± 10 to 53 ± 12 mg/dl, p<0.005) and triglycerides decreased (from 265 ± 118 mg/dl to 149 ± 37 mg/dl, p<0.001) in the ezetimibe+fenofibrate group, whereas both parameters remained unchanged in the pravastatin group. Mean values of creatine kinase (CK), alanine aminotransferase and aspartate aminotransferase were unchanged in both groups; only one patient in the pravastatin group stopped the treatment after two months, due to increased CK.
  
  
  CONCLUSIONS
  In dyslipidemic HIV+ patients on PI therapy, the association of ezetimibe+fenofibrate is more effective than pravastatin monotherapy in improving lipid profile and is also well tolerated.
authors.affiliation: Department of Clinical and Experimental Medicine, University of Insubria, Varese, Italy.
authors.forename: Anna M
authors.initials: AM
authors.lastname: Grandi
authors.affiliation: Department of Internal Medicine, Ospedale di Circolo, Varese, Italy; elonikolini@libero.it.
authors.forename: Eleonora
authors.initials: E
authors.lastname: Nicolini
authors.affiliation: Department of Surgical and Morphological Sciences, University of Insubria, Varese, Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Rizzi
authors.affiliation: Department of Surgical and Morphological Sciences, University of Insubria, Varese, Italy.
authors.forename: Sara
authors.initials: S
authors.lastname: Caputo
authors.affiliation: Department of Clinical and Experimental Medicine, University of Insubria, Varese, Italy.
authors.forename: Filippo
authors.initials: F
authors.lastname: Annoni
authors.affiliation: Department of Clinical and Experimental Medicine, University of Insubria, Varese, Italy.
authors.forename: Anna M
authors.initials: AM
authors.lastname: Cremona
authors.affiliation: Department of Internal Medicine, Ospedale di Circolo, Varese, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Marchesi
authors.affiliation: Department of Clinical and Experimental Medicine, University of Insubria, Varese, Italy.
authors.forename: Luigina
authors.initials: L
authors.lastname: Guasti
authors.affiliation: Department of Clinical and Experimental Medicine, University of Insubria, Varese, Italy.
authors.forename: Andrea M
authors.initials: AM
authors.lastname: Maresca
authors.affiliation: Department of Surgical and Morphological Sciences, University of Insubria, Varese, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Grossi
mesh_terms: D000328:Adult; D000924:Anticholesteremic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001384:Azetidines / Q000009:adverse effects / Q000627:therapeutic use*; D064420:Drug-Related Side Effects and Adverse Reactions; D050171:Dyslipidemias / Q000139:chemically induced* / Q000188:drug therapy*; D000069438:Ezetimibe; D005260:Female; D011345:Fenofibrate / Q000009:adverse effects / Q000627:therapeutic use*; D015658:HIV Infections / Q000150:complications* / Q000188:drug therapy; D017320:HIV Protease Inhibitors / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D017035:Pravastatin / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D000924:Anticholesteremic Agents; D001384:Azetidines; D017320:HIV Protease Inhibitors; D000069438:Ezetimibe; D017035:Pravastatin; D011345:Fenofibrate
keywords: HIV infection; dyslipidemia; ezetimibe; fenofibrate; pravastatin; protease inhibitors