Calza Leonardo, Manfredi Roberto, Colangeli Vincenzo, Tampellini Livia, Sebastiani Teresa, Pocaterra Daria, Chiodo Francesco
Department of Clinical and Experimental Medicine, Division of Infectious Diseases, "Alma Mater Studiorum" University of Bologna, S. Orsola Hospital, Bologna, Italy.
AIDS. 2005 Jul 1;19(10):1051-8. doi: 10.1097/01.aids.0000174451.78497.8f.
To evaluate simplified protease inhibitor (PI)-sparing antiretroviral treatment versus lipid-lowering therapy for the management of highly active antiretroviral therapy (HAART)-induced hyperlipidaemia.
Randomized, open-label clinical trial assessing the efficacy on hyperlipidaemia of a switching therapy from PI to non-nucleoside reverse transcriptase inhibitor (NNRTI) nevirapine or efavirenz versus a hypolipidaemic treatment (with pravastatin or bezafibrate) added to current, unchanged antiretroviral combination.
All HIV-infected patients on their first HAART regimen, with stable immuno-virological features, naive to all NNRTIs, and with mixed hyperlipidaemia, were randomized to replace PI with nevirapine (arm A) or efavirenz (arm B), or to receive pravastatin (arm C) or bezafibrate (arm D) with unchanged HAART regimen, and were followed-up for 12 months.
One hundred and thirty patients were evaluated: 29 patients were randomized to arm A, 34 to arm B, 36 to arm C, and 31 to arm D. At the end of the 12-month follow-up, a reduction of 25.2, 9.4, 41.2 and 46.6% in mean triglyceridaemia versus respective baseline values was reported in groups A, B, C and D, respectively, with statistically significant difference between arms A-B and C-D (P < 0.01). Similar results were reported for total and low-density lipoprotein cholesterol levels. Viro-immunological efficacy and tolerability profile were comparable in all considered arms.
Pravastatin and bezafibrate proved significantly more effective in the management of HAART-related hyperlipidaemia than the switching therapy from PI to nevirapine or efavirenz.
评估简化蛋白酶抑制剂（PI）方案的抗逆转录病毒治疗与降脂治疗对高效抗逆转录病毒治疗（HAART）引起的高脂血症的管理效果。
随机、开放标签临床试验，评估从PI转换为非核苷类逆转录酶抑制剂（NNRTI）奈韦拉平或依非韦伦的转换疗法与添加到当前不变的抗逆转录病毒联合用药中的降脂治疗（使用普伐他汀或苯扎贝特）对高脂血症的疗效。
所有接受首个HAART方案、免疫病毒学特征稳定、对所有NNRTIs均未用过且患有混合性高脂血症的HIV感染患者，被随机分为用奈韦拉平替代PI组（A组）或依非韦伦组（B组），或在HAART方案不变的情况下接受普伐他汀治疗（C组）或苯扎贝特治疗（D组），并随访12个月。
评估了130例患者：29例随机分入A组，34例分入B组，36例分入C组，31例分入D组。在12个月随访结束时，A、B、C和D组的平均甘油三酯血症相对于各自基线值分别降低了25.2%、9.4%、41.2%和46.6%，A - B组和C - D组之间有统计学显著差异（P < 0.01）。总胆固醇和低密度脂蛋白胆固醇水平也有类似结果。所有研究组的病毒免疫疗效和耐受性相当。
在管理HAART相关高脂血症方面，普伐他汀和苯扎贝特被证明比从PI转换为奈韦拉平或依非韦伦的转换疗法显著更有效。
