An open-label, prospective, observational study of the incidence of coronary artery disease in patients with HIV infection receiving highly active antiretroviral therapy

An open-label, prospective, observational study of the incidence of coronary artery disease in patients with HIV infection receiving highly active antiretroviral therapy
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DOI:
10.1016/s0149-2918(03)80283-7
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发表时间:
2003-09-01
影响因子:
3.2
通讯作者:
Barbarini, G
Barbarini, G
中科院分区:
医学3区
文献类型:
--
作者:
Barbaro, G;Di Lorenzo, G;Barbarini, G

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背景资料:包括蛋白酶抑制剂(PI)在内的高效抗逆转录病毒治疗(HAART)方案与代谢和躯体疾病的关联引起了人们对HIV感染患者冠状动脉疾病(CAD)风险增加的可能性的担忧。目的:本研究的目的是评估既往未经治疗的HIV感染者CAD的发病率,感染的门诊患者接受逆转录酶抑制剂与或不PI。方法:在这项开放标签、多中心、前瞻性、观察性试验中,对既往未经治疗和无症状的HIV感染意大利患者进行随访,以评估CAD的发病率(主要终点)根据他们接受的HAART方案:2种核苷类似物逆转录酶抑制剂(NRTI)联合PI(PI+组)或I种非核苷类逆转录酶抑制剂联合2种NRTI(PI-组)。患者进行临床检查和实验室检测,每4 months.Results:共1551例HIV感染患者(994 [64%]男性;中位年龄,35岁;范围,22-50岁)进行了随访,中位数为36个月(范围,34-42个月)。冠心病相关事件的年累积发生率PI+组为9.8/1000,PI-组为0.8/1000(P < 0.001)。心肌梗死年发病率PI+组为5.1/1000,PI-组为0.4/1000(P < 0.001)。与患者年龄无关,男性(P < 0.001)和每天吸烟> 20支的患者(P < 0.001)的CAD发病率较高。PI+组中62%的患者出现脂肪代谢紊乱和代谢改变,PI-组中4%的患者出现脂肪代谢紊乱和代谢改变(P < 0.001)。在23例接受PI治疗的患者中,17例发生CAD,(73.9%)有脂肪代谢障碍,23例均有高脂血症和高胆固醇血症。根据我们的研究结果,包括PI在内的HAART可能会加速年轻男性CAD相关事件的发生,重度吸烟者在治疗过程中出现代谢紊乱和脂肪代谢障碍冠心病风险增加的患者如果接受治疗,应接受仔细的心脏监测和PI。版权所有(C)2003 Excerpta Medica,Inc.
Background: The association of highly active antiretroviral therapy (HAART) regimens that include protease inhibitors (PIs) with metabolic and somatic disorders has raised concerns about the possibility of an increased risk of Coronary artery disease (CAD) in patients with HIV infection.Objective: The aim of this study was to assess the incidence of CAD in previously untreated HIV-infected outpatients who received reverse transcriptase inhibitors with or without PIs.Methods: In this open-label, multicenter, prospective, observational trial, previously untreated and asymptomatic HIV-infected Italian patients were followed to assess the incidence of CAD (primary end point) according to the HAART regimen they received: 2 nucleoside analogue reverse transcriptase inhibitors (NRTIs) in combination with PIs (group PI+) or I non-nucleoside reverse transcriptase inhibitor in combination with 2 NRTIs (group PI-). Patients underwent clinical examination and laboratory testing every 4 months.Results: A total of 1551 HIV-infected patients (994 [64%] men; median age, 35 years; range, 22-50 years) were followed for a median 36 months (range, 34-42 months). The cumulative annual incidence of CAD-related events was 9.8/1000 in group PI+ and 0.8/1000 in group PI- (P < 0.001). The annual incidence of myocardial infarction was 5.1/1000 in group PI+ and 0.4/1000 in group PI- (P < 0.001). Independent of patient age, the incidence of CAD was greater among men (P < 0.001) and patients who smoked > 20 cigarettes per day (P < 0.001). Lipodystrophy and metabolic alterations were observed in 62% of patients in group PI+ and in 4% of patients in group PI- (P < 0.001). Of 23 patients receiving PIs who developed CAD, 17 (73.9%) had lipodystrophy and all 23 had hypertriglyceridemia and hypercholesterolemia.Conclusions: According to our findings, HAART that includes PIs may accelerate the onset of CAD-related events in young, male, heavy smokers who develop metabolic disorders and lipodystrophy during therapy Patients with increased coronary risk should receive careful cardiac monitoring if treated with PIs. Copyright (C) 2003 Excerpta Medica, Inc.