Masiá Mar, Bernal Enrique, Padilla Sergio, García Natalia, Escribano José C, Martínez Esteban, Gutiérrez Félix
Department of Clinical Medicine, Infectious Diseases Unit, Hospital General Universitario de Elche, University Miguel Hernández, Elche, Alicante, Spain.
J Antimicrob Chemother. 2009 Sep;64(3):589-98. doi: 10.1093/jac/dkp250. Epub 2009 Jul 22.
The influence on the progression of atherosclerosis of an intervention on cardiovascular risk factors in HIV-infected patients remains unknown. We evaluated the efficacy and safety of an intensive versus a standard intervention in HIV-infected patients with moderate-high cardiovascular risk.
A pilot randomized clinical trial. Stable HIV-infected patients with viral suppression on antiretroviral therapy, and two or more cardiovascular risk factors or a Framingham risk score >or=10%. An intensive intervention targeting low-density lipoprotein (LDL)-cholesterol <100 mg/dl, using antiplatelet therapy, and switching protease inhibitor (PI) therapy, was compared with the standard intervention aiming for LDL-cholesterol <130 mg/dL. The primary endpoint was progression of atherosclerosis measured by the carotid intima-media thickness (cIMT). Secondary endpoints were efficacy in achieving the LDL-cholesterol goal, changes in inflammatory biomarkers, and feasibility and safety of the intervention.
Thirty-two (47%) and 36 (53%) patients were assigned to the intensive and the standard interventions, respectively. After 12 months, the median proportion of change in the cIMT was +1.63% (-4.95 to +10.54) in the intensive intervention, and +1.79% (-6.61 to +6.1) in the standard group (P = 0.59). LDL-cholesterol (39% versus 7%, P < 0.001) and Framingham score (10% versus 0%, P = 0.03) showed larger reductions in the intensive group. No significant changes in levels of C-reactive protein, interleukin-6 and tumour necrosis factor-alpha were found. No significant adverse events were reported and no virological failures occurred during the study.
An aggressive intervention targeting LDL-cholesterol in HIV-infected patients was safe and capable of attaining very stringent target levels in adherent patients. However, the intervention did not influence cIMT progression or inflammatory biomarkers after 1 year of follow-up.
针对HIV感染患者心血管危险因素进行干预对动脉粥样硬化进展的影响尚不清楚。我们评估了强化干预与标准干预对中度至高度心血管风险的HIV感染患者的疗效和安全性。
一项试点随机临床试验。接受抗逆转录病毒治疗且病毒得到抑制的稳定HIV感染患者，有两个或更多心血管危险因素或弗雷明汉风险评分≥10%。将针对低密度脂蛋白（LDL）胆固醇<100mg/dl、使用抗血小板治疗以及更换蛋白酶抑制剂（PI）治疗的强化干预与旨在使LDL胆固醇<130mg/dL的标准干预进行比较。主要终点是通过颈动脉内膜中层厚度（cIMT）测量的动脉粥样硬化进展。次要终点是实现LDL胆固醇目标的疗效、炎症生物标志物的变化以及干预的可行性和安全性。
分别有32名（47%）和36名（53%）患者被分配到强化干预组和标准干预组。12个月后，强化干预组cIMT变化的中位数比例为+1.63%（-4.95至+10.54），标准组为+1.79%（-6.61至+6.1）（P=0.59）。强化组的LDL胆固醇（39%对7%，P<0.001）和弗雷明汉评分（10%对0%，P=0.03）下降幅度更大。未发现C反应蛋白、白细胞介素-6和肿瘤坏死因子-α水平有显著变化。研究期间未报告重大不良事件，也未发生病毒学失败。
针对HIV感染患者的LDL胆固醇进行积极干预是安全的，并且能够在依从性好的患者中达到非常严格的目标水平。然而，随访1年后，该干预并未影响cIMT进展或炎症生物标志物。
