Impact of rosuvastatin on atherosclerosis in people with HIV at moderate cardiovascular risk: a randomised, controlled trial.

Autor:	Trevillyan JM; Department of Infectious Diseases, Alfred Health and Monash University., Dart A; Department of Cardiology, Alfred Health., Paul E; Biostatistics Consulting Platform, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia., Cavassini M; Division of Infectious Diseases, University Hospital Lausanne, University of Lausanne, Lausanne, Switzerland., Fehr J; Department of Public & Global Health, Epidemiology, Biostatistics and Prevention Institute, University of Zurich.; Division of Infectious Diseases & Hospital Epidemiology, University Hospital Zurich, Zurich., Staehelin C; Inselspital, Bern., Dewar EM; Department of Cardiology, Alfred Health., Hoy JF; Department of Infectious Diseases, Alfred Health and Monash University., Calmy A; Division of Infectious Diseases, HIV/AIDS Unit, Geneva University Hospitals, Geneva, Switzerland.
Jazyk:	angličtina
Zdroj:	AIDS (London, England) [AIDS] 2021 Mar 15; Vol. 35 (4), pp. 619-624.
DOI:	10.1097/QAD.0000000000002764
Abstrakt:	Background: People living with HIV-1 (PLHIV) are at increased risk for cardiovascular disease. Objective: This study aimed to determine if PLHIV would benefit from starting statins at a lower threshold than currently recommended in the general population. Design: A double-blind multicentre, randomised, placebo-controlled trial was performed. Methods: Participants (n = 88) with well controlled HIV, at moderate cardiovascular risk (Framingham score of 10-15%), and not recommended for statins were recruited from Australia and Switzerland. They were randomized 1 : 1 to rosuvastatin (n = 44) 20 mg daily, 10 mg if co-administered with ritonavir/cobicistat-boosted antiretroviral therapy, or placebo (n = 40) for 96 weeks. Assessments including fasting blood collection and carotid--intima media thickness (CIMT) were performed at baseline, and weeks 48 and 96. The primary outcome was the change from baseline to week 96 in CIMT (clinicaltrials.gov: NCT01813357). Results: Participants were predominantly men [82 (97.6%); mean age 54 years (SD 6.0)]. At 96 weeks, there was no difference in the progression of CIMT between the rosuvastatin (mean 0.004 mm, SE 0.0036) and placebo (0.0062 mm, SE 0.0039) arms (P = 0.684), leading to no difference in CIMT levels between groups at week 96 [rosuvastatin arm, 0.7232 mm (SE 0.030); placebo arm 0.7785 mm (SE 0.032), P = 0.075].Adverse events were common (n = 146) and predominantly in the rosuvastatin arm [108 (73.9%)]. Participants on rosuvastatin were more likely to cease study medication because of an adverse event [7 (15.9%) vs. 2 (5.0%), P = 0.011]. Conclusion: In PLHIV, statins prescribed at a lower threshold than guidelines did not lead to improvements in CIMT but was associated with significant adverse events. (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)
Databáze:	MEDLINE
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