A randomized, placebo-controlled trial of rosiglitazone for HIV-related lipoatrophy
A randomized, placebo-controlled trial of rosiglitazone for HIV-related lipoatrophy
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DOI：
10.1086/518005
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发表时间：
2007-06-15
影响因子：
6.4
通讯作者：
Walmsley, Sharon
中科院分区：
文献类型：
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作者：
Cavalcanti, Rodrigo B.;Raboud, Janet;Walmsley, Sharon
背景罗格列酮等噻唑烷二酮可能有助于改善人类免疫缺陷病毒（HIV）脂肪萎缩。方法。接受稳定的、含蛋白酶抑制剂的高效抗逆转录病毒治疗的HIV阳性伴HIV脂肪营养不良患者前瞻性随机分配至罗格列酮组（4 mg/天）或安慰剂组。主要终点是通过双能X射线吸收测定法（DEXA）测量的24周手臂脂肪百分比变化。在基线和第24周进行临床和人体测量评估、空腹血脂参数、口服葡萄糖耐量试验、CD 36表达、生活质量测量和DEXA扫描。对96例入组患者中的78例进行了评价。中位年龄为46.8岁，97.4%为男性，54%接受胸苷类似物治疗。罗格列酮组和对照组的基线肢体脂肪中位数分别为3.76和2.99公斤。24周时，两组间手臂、腿部、躯干和全身脂肪的中位变化无显著差异（7.1% vs. 5.0% [P = .94]; 0.1% vs. -2.4% [P = .90]; 1.2% vs. -1.4% [P = .81]; 1.7% vs. 0.4% [P = .76]）。次要终点无显著变化。体脂或治疗臂的变化与CD 36表达之间无相关性。这项随机、安慰剂对照试验未显示4 mg/天罗格列酮对HIV脂肪营养不良患者的脂肪萎缩或代谢参数的益处。
Background. Thiazolidinediones such as rosiglitazone may have benefit in ameliorating human immunodeficiency virus (HIV) lipoatrophy.Methods. HIV-positive patients receiving stable, protease inhibitor - containing highly active antiretroviral therapy with HIV lipodystrophy were prospectively randomized to rosiglitazone (4 mg/day) or placebo. The primary end point was the 24-week percentage change in arm fat by dual-energy x-ray absorptiometry (DEXA). Clinical and anthropometric evaluations, fasting lipid parameters, oral glucose tolerance testing, CD36 expression, quality of life measures, and DEXA scanning were performed at baseline and week 24.Results. Seventy-eight of the 96 enrolled patients were evaluated. Median age was 46.8 years, 97.4% were male, and 54% were treated with thymidine analogues. Median baseline limb fat was 3.76 and 2.99 kg in the rosiglitazone and control groups, respectively. Median changes in arm, leg, trunk, and total body fat at 24 weeks were not significantly different between groups (7.1% vs. 5.0% [P = .94]; 0.1% vs. -2.4% [P = .90]; 1.2% vs. -1.4% [P = .81]; and 1.7% vs. 0.4% [P = .76]). There were no significant changes in secondary end points. There was no correlation between changes in body fat or treatment- arm and CD36 expression.Conclusions. This randomized, placebo- controlled trial did not show benefit of 4 mg/day of rosiglitazone on lipoatrophy or metabolic parameters in patients with HIV lipodystrophy.