Long-term effects of evolocumab in participants with HIV and dyslipidemia: results from the open-label extension period.
Antibodies, Monoclonal, Humanized
/ adverse effects
Atherosclerosis
/ chemically induced
Cholesterol
Cholesterol, LDL
Double-Blind Method
Dyslipidemias
/ complications
Female
HIV Infections
/ complications
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors
/ therapeutic use
Male
Middle Aged
Treatment Outcome
Triglycerides
/ therapeutic use
Journal
AIDS (London, England)
ISSN: 1473-5571
Titre abrégé: AIDS
Pays: England
ID NLM: 8710219
Informations de publication
Date de publication:
01 Apr 2022
01 Apr 2022
Historique:
pubmed:
14
1
2022
medline:
22
4
2022
entrez:
13
1
2022
Statut:
ppublish
Résumé
People with HIV (PWH) are at an increased risk of atherosclerotic cardiovascular disease. Suboptimal responses to statin therapy in PWH may result from antiretroviral therapies (ARTs). This open-label extension study aimed to evaluate the long-term safety and efficacy of evolocumab up to 52 weeks in PWH. This final analysis of a multinational, placebo-controlled, double-blind, randomized phase 3 trial evaluated the effect of monthly subcutaneous evolocumab 420 mg on low-density lipoprotein cholesterol (LDL-C) during the open-label period (OLP) following 24 weeks of double-blind period in PWH with hypercholesterolemia/mixed dyslipidemia. All participants enrolled had elevated LDL-C or nonhigh-density lipoprotein cholesterol (non-HDL-C) and were on stable maximally tolerated statin and stable ART. Efficacy was assessed by percentage change from baseline in LDL-C, triglycerides, and atherogenic lipoproteins. Treatment-emergent adverse events (TEAEs) were examined. Of the 467 participants randomized in the double-blind period, 451 (96.6%) received at least one dose of evolocumab during the OLP (mean age of 56.4 years, 82.5% male, mean duration with HIV of 17.4 years). By the end of the 52-week OLP, the overall mean (SD) percentage change in LDL-C from baseline was -57.8% (22.8%). Evolocumab also reduced triglycerides, atherogenic lipid parameters (non-HDL-C, apolipoprotein B, total cholesterol, very-low-density lipoprotein cholesterol, and lipoprotein[a]), and increased HDL-C. TEAEs were similar between placebo and evolocumab during the OLP. Long-term administration of evolocumab lowered LDL-C and non-HDL-C, allowing more PWH to achieve recommended lipid goals with no serious adverse events. NCT02833844. http://links.lww.com/QAD/C441.
Identifiants
pubmed: 35025817
doi: 10.1097/QAD.0000000000003175
pii: 00002030-202204010-00008
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
Cholesterol, LDL
0
Hydroxymethylglutaryl-CoA Reductase Inhibitors
0
Triglycerides
0
Cholesterol
97C5T2UQ7J
evolocumab
LKC0U3A8NJ
Banques de données
ClinicalTrials.gov
['NCT02833844']
Types de publication
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Video-Audio Media
Langues
eng
Sous-ensembles de citation
IM
Pagination
675-682Commentaires et corrections
Type : CommentIn
Informations de copyright
Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.
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