Tamara Tovar Sanchez, Mireille Mpoudi-Etame, Charles Kouanfack, Eric Delaporte, Alexandra Calmy, Francois Venter, Simiso Sokhela, Bronwyn Bosch, Godspower Akpomiemie, Angela Tembo, Toby Pepperrell, Bryony Simmons, Carmen Perez Casas, Kaitlyn McCann, Manya Mirchandani, Andrew Hill
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This study aims to evaluate the risk of metabolic syndrome in the ADVANCE and NAMSAL trials.</p><p><strong>Methods: </strong>The number of participants with metabolic syndrome was calculated at baseline and week 192 as central obesity and any of the following two factors: raised triglycerides, reduced HDL-cholesterol, raised blood pressure and raised fasting glucose. Differences between the treatment arms were calculated using the <i>χ</i><sup>2</sup> test.</p><p><strong>Results: </strong>Across all visits to week 192, treatment-emergent metabolic syndrome was 15% (TAF/FTC + DTG), 10% (TDF/FTC + DTG) and 7% (TDF/FTC/EFV) in ADVANCE. The results were significantly higher in the TAF/FTC + DTG arm compared to the TDF/FTC/EFV arm (<i>p</i> < 0.001), and the TDF/FTC + DTG vs. the TDF/FTC/EFV arms (<i>p</i> < 0.05) in all patients, and in females. In NAMSAL, the incidence of treatment-emergent metabolic syndrome at any time point was 14% (TDF/3TC + DTG) and 5% (TDF/3TC + EFV) (<i>p</i> < 0.001). This incidence was significantly greater in the TDF/3TC/DTG arm compared to the TDF/3TC/EFV arm in all patients (<i>p</i> < 0.001), and in males (<i>p</i> < 0.001).</p><p><strong>Conclusion: </strong>In this analysis, we highlight treatment-emergent metabolic syndrome associated with dolutegravir, likely driven by obesity. 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引用次数: 0
摘要
引言：ADVANCE和NAMSAL评估抗逆转录病毒药物的试验都报告了参与者的临床肥胖水平相当高。作为代谢综合征的主要危险因素之一，肥胖率的增长可能会导致代谢综合征发展。本研究旨在评估ADVANCE和NAMSAL试验中代谢综合征的风险。方法：在基线和第192周，将代谢综合征的参与者人数计算为中心性肥胖和以下两个因素中的任何一个：甘油三酯升高、高密度脂蛋白胆固醇降低、血压升高和空腹血糖升高。使用χ2检验计算治疗组之间的差异。结果：在192周的所有就诊中，治疗引发的代谢综合征占15%（TAF/FTC + DTG），10%（TDF/FTC + DTG）和7%（TDF/FTC/EFV）的ADVANCE。TAF/FTC的结果明显更高 + DTG臂与TDF/FTC/EFV臂相比（p p p p p 结论：在这项分析中，我们强调了与多卢替韦相关的治疗突发代谢综合征，可能是由肥胖引起的。启动或监测基于INSTI的ART患者的临床医生必须建议优化生活方式，以防止这些影响。
Risks of metabolic syndrome in the ADVANCE and NAMSAL trials.
Introduction: The ADVANCE and NAMSAL trials evaluating antiretroviral drugs have both reported substantial levels of clinical obesity in participants. As one of the main risk factors for metabolic syndrome, growing rates of obesity may drive metabolic syndrome development. This study aims to evaluate the risk of metabolic syndrome in the ADVANCE and NAMSAL trials.
Methods: The number of participants with metabolic syndrome was calculated at baseline and week 192 as central obesity and any of the following two factors: raised triglycerides, reduced HDL-cholesterol, raised blood pressure and raised fasting glucose. Differences between the treatment arms were calculated using the χ2 test.
Results: Across all visits to week 192, treatment-emergent metabolic syndrome was 15% (TAF/FTC + DTG), 10% (TDF/FTC + DTG) and 7% (TDF/FTC/EFV) in ADVANCE. The results were significantly higher in the TAF/FTC + DTG arm compared to the TDF/FTC/EFV arm (p < 0.001), and the TDF/FTC + DTG vs. the TDF/FTC/EFV arms (p < 0.05) in all patients, and in females. In NAMSAL, the incidence of treatment-emergent metabolic syndrome at any time point was 14% (TDF/3TC + DTG) and 5% (TDF/3TC + EFV) (p < 0.001). This incidence was significantly greater in the TDF/3TC/DTG arm compared to the TDF/3TC/EFV arm in all patients (p < 0.001), and in males (p < 0.001).
Conclusion: In this analysis, we highlight treatment-emergent metabolic syndrome associated with dolutegravir, likely driven by obesity. Clinicians initiating or monitoring patients on INSTI-based ART must counsel for lifestyle optimisation to prevent these effects.
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