| Autor: |
Boccara, Franck, Caramelli, Bruno, Calmy, Alexandra, Kumar, Princy, López, J Antonio G, Bray, Sarah, Cyrille, Marcoli, Rosenson, Robert, S Australia: David Baker, Mark, Bloch, Robert, Finlayson, Jennifer, Hoy, Kenneth, Koh, Norman, Roth, Belgium: Stephane De Wit, Eric, Florence, Linos, Vandekerckhove, Brazil: Bruno Caramelli, Jose Valdez Ramalho Madruga, Sandra Wagner Cardoso, Canada: Greg Bondy, Michael, Gill, George, Tsoukas, Sylvie, Trottier, Marek, Smieja, France: Franck Boccara, Christine, Katlama, Fabrice, Bonnet, Francois, Raffi, Laurent, Cotte, Jean-Michel, Molina, Jacques, Reynes, Greece: Antonios Papadopoulos, Simeon, Metallidis, Vassilios, Paparizos, Vasileios, Papastamopoulos, Italy: Cristina Mussini, Massimo, Galli, Andrea, Antinori, DI BIAGIO, Antonio, Pierluigi, Viale, Poland: Andrzej Horban, Portugal: Nuno Marques, Daniel, Coutinho, Joaquim, Oliveira, Paula, Freitas, Romania: Liliana-Lucia Preotescu, Iosif, Marincu, Rodica, Silaghi, Sorin, Rugina, South Africa: Noluthando Mwelase, Sheena Kotze, Spain: Jose Ignacio Bernardino de la Serna, Vicente Estrada Perez, Esteban, Martinez, Adrian, Curran, Switzerland: Dominique Laurent Braun, Alexandra, Calmy, Enos, Bernasconi, Matthias, Cavassini, United Kingdom: John Walsh, Julie, Fox, Graeme, Moyle, United States: Robert Rosenson, Jamie, Morano, Jason, Baker, Gerald, Pierone, Carl, Fichtenbaum, Paul, Benson, Deborah, Goldstein, Joseph, Sacco, Princy, Kumar, Robert, Grossberg, Kara, Chew, Christopher, Defilippi, Vilma, Drelichman, Norman, Markowitz, David, Parenti, Katherine, Doktor, Paul, Thompson. |
| Jazyk: |
angličtina |
| Rok vydání: |
2022 |
| Předmět: |
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| Popis: |
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. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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