title: Rosuvastatin vs. protease inhibitor switching for hypercholesterolaemia: a randomized trial.
abstract: The aim of the study was to compare the efficacy and safety of rosuvastatin initiation with those of switching of ritonavir-boosted protease inhibitors (PI/rs) in HIV-1-infected adults with hypercholesterolaemia and increased cardiovascular risk scores.
  
  
  
  In this open-label, multicentre study, HIV-1-infected adults on PI/r-based therapy with viral load < 50 HIV-1 RNA copies/mL, fasting total cholesterol ≥ 5.5 mmol/L (both for ≥ 6 months) and elevated cardiovascular risk (Framingham score ≥ 8% or diabetes or family history), and not on lipid-lowering therapy, were randomized to open-label rosuvastatin 10 mg/day or to PI/r switching, both with standardized diet/exercise advice. The primary endpoint was change in total cholesterol at week 12 (intention to treat).
  
  
  
  There were 43 participants (23 on rosuvastatin). Baseline characteristics were: mean [± standard deviation (SD)] age 55 (8.5) years, 42 (98%) male, 41 (95%) white race, and mean (± SD) total cholesterol 6.2 (1.2) mmol/L. At enrolment, PI/rs were lopinavir/ritonavir (n = 22; 51%), atazanavir/ritonavir (n = 12; 28%) and darunavir/ritonavir (n = 9; 21%). The commonest PI/r substitutes were raltegravir (n = 9; 45%) and rilpivirine (n = 4; 20%). All participants were adherent through to week 12. Rosuvastatin yielded greater declines than PI/r switching in total (- 21.4% vs. - 8.7%, respectively; P = 0.003) and low-density lipoprotein (- 29.9% vs. - 1.0%, respectively; P < 0.001) cholesterol, but smaller declines in very low-density lipoprotein cholesterol and triglycerides (P < 0.01). Cholesterol lowering was greater in participants on atazanavir/ritonavir or once-daily darunavir/ritonavir (vs. lopinavir/ritonavir). More study drug-related adverse events (mostly grade 1 nausea/diarrhoea; 10 vs. one, respectively; P = 0.001) occurred with PI/r switching than with rosuvastatin.
  
  
  
  In adults receiving a PI/r, rosuvastatin 10 mg/day for 12 weeks yielded larger decreases in total and low-density lipoprotein cholesterol than PI/r switching, and was better tolerated.
authors.affiliation: Clinical Research Program, Centre for Applied Medical Research, St Vincent's Hospital, Sydney, NSW, Australia.|Sydney Medical School, University of Sydney, Sydney, NSW, Australia.
authors.forename: F J
authors.initials: FJ
authors.lastname: Lee
authors.affiliation: Infectious Diseases Unit, Hospital Cliníc, University of Barcelona, Barcelona, Spain.
authors.forename: P
authors.initials: P
authors.lastname: Monteiro
authors.affiliation: East Sydney Doctors, Sydney, NSW, Australia.
authors.forename: D
authors.initials: D
authors.lastname: Baker
authors.affiliation: Holdsworth House Medical Practice, Sydney, NSW, Australia.
authors.forename: M
authors.initials: M
authors.lastname: Bloch
authors.affiliation: Prahran Market Clinic, Melbourne, Vic., Australia.
authors.forename: N
authors.initials: N
authors.lastname: Roth
authors.affiliation: Taylor Square Private Clinic, Sydney, NSW, Australia.
authors.forename: R
authors.initials: R
authors.lastname: Finlayson
authors.affiliation: Northside Clinic, Melbourne, Vic., Australia.
authors.forename: R
authors.initials: R
authors.lastname: Moore
authors.affiliation: Department of Infectious Diseases, The Alfred Hospital & Monash University, Melbourne, Vic., Australia.
authors.forename: J
authors.initials: J
authors.lastname: Hoy
authors.affiliation: Infectious Diseases Unit, Hospital Cliníc, University of Barcelona, Barcelona, Spain.
authors.forename: E
authors.initials: E
authors.lastname: Martinez
authors.affiliation: Clinical Research Program, Centre for Applied Medical Research, St Vincent's Hospital, Sydney, NSW, Australia.
authors.forename: A
authors.initials: A
authors.lastname: Carr
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D044966:Anti-Retroviral Agents / Q000008:administration & dosage*; D000924:Anticholesteremic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002784:Cholesterol / Q000097:blood; D005260:Female; D015658:HIV Infections / Q000150:complications* / Q000188:drug therapy*; D017320:HIV Protease Inhibitors / Q000008:administration & dosage*; D006801:Humans; D006937:Hypercholesterolemia / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D000068718:Rosuvastatin Calcium / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D044966:Anti-Retroviral Agents; D000924:Anticholesteremic Agents; D017320:HIV Protease Inhibitors; D000068718:Rosuvastatin Calcium; D002784:Cholesterol
keywords: HIV; cardiovascular risk; hypercholesterolaemia; protease inhibitors; statins