Trial reportEuropean heart journal. Cardiovascular pharmacotherapy2016
A single infusion of MDCO-216 (ApoA-1 Milano/POPC) increases ABCA1-mediated cholesterol efflux and pre-beta 1 HDL in healthy volunteers and patients with stable coronary artery disease.
Trial report in European heart journal. Cardiovascular pharmacotherapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
30 citing papers in PubMed, 1 synthesis or guideline pooled it, 76 citations in OpenAlex.
- Efficacy and Safety of High-Density Lipoprotein/Apolipoprotein A1 Replacement Therapy in Humans and Mice With Atherosclerosis: A Systematic Review and Meta-Analysis.Frontiers in cardiovascular medicine · 2021Pooled it
- Trial
- MDCO-216 Does Not Induce Adverse Immunostimulation, in Contrast to Its Predecessor ETC-216.Cardiovascular drugs and therapy · 2017Trial
- HDL-replacement therapy: From traditional to emerging clinical applications.Atherosclerosis plus · 2025Review
- Fc-binding nanodisc restores antiviral efficacy of antibodies with reduced neutralizing effects against evolving SARS-CoV-2 variants.Journal of nanobiotechnology · 2025Article
- Recent advances of self-assembled nanoparticles in the diagnosis and treatment of atherosclerosis.Theranostics · 2024Review
- Nanomedicine for Diagnosis and Treatment of Atherosclerosis.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2023Review
- A Study on Multiple Facets of Apolipoprotein A1 Milano.Applied biochemistry and biotechnology · 2023Review
- A Current Update on the Role of HDL-Based Nanomedicine in Targeting Macrophages in Cardiovascular Disease.Pharmaceutics · 2023Review
- HDL-Based Therapy: Vascular Protection at All Stages.Biomedicines · 2023Review
- HDL Composition, Heart Failure, and Its Comorbidities.Frontiers in cardiovascular medicine · 2022Review
- Predictive nomogram for coronary heart disease in patients with type 2 diabetes mellitus.Frontiers in cardiovascular medicine · 2022Article
- Current Understanding of the Immunomodulatory Activities of High-Density Lipoproteins.Biomedicines · 2021Review
- Recent advances in nanomaterials for therapy and diagnosis for atherosclerosis.Advanced drug delivery reviews · 2021Review
- High-Density Lipoprotein-Targeted Therapies for Heart Failure.Biomedicines · 2020Review
- Tackling cardiometabolic risk in the Asia Pacific region.American journal of preventive cardiology · 2020Review
- Administration of apo A-I (Milano) nanoparticles reverses pathological remodelling, cardiac dysfunction, and heart failure in a murine model of HFpEF associated with hypertension.Scientific reports · 2020Article
- Roles of Reconstituted High-Density Lipoprotein Nanoparticles in Cardiovascular Disease: A New Paradigm for Drug Discovery.International journal of molecular sciences · 2020Review
- Advances in HDL: Much More than Lipid Transporters.International journal of molecular sciences · 2020Review
- Discontinued Drugs for the Treatment of Cardiovascular Disease from 2016 to 2018.International journal of molecular sciences · 2019Review
Corrections and comments
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Authors and funding
8 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsApolipoprotein A-1 (ApoA-1), based on epidemiology, is inversely associated with cardiovascular (CV) events. Human carriers of the ApoA-1 Milano variant have a reduced incidence of CV disease. Regression of atherosclerotic plaque burden was previously observed on intravascular ultrasound (IVUS) with ETC-216, a predecessor of MDCO-216. MDCO-216, a complex of dimeric ApoA-1 Milano and 1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine, is being developed to reduce atherosclerotic plaque burden and CV events. We investigated the efficacy and safety of a single infusion of MDCO-216 in healthy volunteers and in patients with coronary artery disease (CAD). METHODS AND
resultsTwenty-four healthy volunteers and 24 patients with documented CAD received a 2-h infusion of MDCO-216 in a randomized, placebo controlled, single ascending dose study. Five cohorts of healthy volunteers and four cohorts of CAD patients received ApoA-1 Milano doses ranging from 5 to 40 mg/kg. Subjects were followed for 30 days. Dose-dependent increases in ApoA-1, phospholipid, and pre-beta 1 HDL and decreases in ApoE were observed. Prominent and sustained increases in triglyceride, and decreases in HDL-C, endogenous ApoA-1 and ApoA-II occurred at doses >20 mg/kg and profound increases in ABCA1-mediated cholesterol efflux were observed. Other lipid and lipoprotein parameters were generally unchanged. MDCO-216 was well tolerated.
conclusionsMDCO-216-modulated lipid parameters profoundly increased ABCA1-mediated cholesterol efflux and was well tolerated. These single-dose data support further development of this agent for reducing atherosclerotic disease and subsequent CV events.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.