No significant effect of uridine or pravastatin treatment for HIV lipoatrophy in men who have ceased thymidine analogue nucleoside reverse transcriptase inhibitor therapy: a randomized trial*

被引:19
|
作者
Calmy, A. [1 ,2 ,3 ]
Bloch, M. [4 ]
Wand, H. [5 ]
Delhumeau, C. [1 ]
Finlayson, R. [6 ]
Rafferty, M. [2 ,3 ]
Norris, R. [2 ,3 ]
Hirschel, B. [1 ]
Cooper, D. A. [2 ,3 ,5 ]
Carr, A. [2 ,3 ]
机构
[1] Univ Hosp Geneva, CH-1205 Geneva, Switzerland
[2] St Vincents Hosp, HIV Immunol & Infect Dis Unit, Sydney, NSW 2010, Australia
[3] St Vincents Hosp, Ctr Appl Med Res, Clin Res Program, Sydney, NSW 2010, Australia
[4] Holdsworth House Med Practice, Sydney, NSW, Australia
[5] Univ New S Wales, Natl Ctr HIV Epidemiol & Clin Res, Sydney, NSW, Australia
[6] Taylor Sq Private Clin, Sydney, NSW, Australia
基金
英国医学研究理事会; 瑞士国家科学基金会;
关键词
HIV lipoatrophy; limb fat; pravastatin; uridine; DOUBLE-BLIND; SPARING REGIMENS; BODY-COMPOSITION; ORAL URIDINE; LIPODYSTROPHY; ROSIGLITAZONE; SUPPLEMENTATION; HYPERLIPIDEMIA; TISSUE;
D O I
10.1111/j.1468-1293.2009.00817.x
中图分类号
R51 [传染病];
学科分类号
100401 ;
摘要
Background Lipoatrophy can complicate thymidine analogue nucleoside reverse transcriptase inhibitor (tNRTI)-based antiretroviral therapy (ART). Lipoatrophy may be less likely with ART including ritonavir-boosted lopinavir (LPV/r). Small, placebo-controlled studies found that uridine (in tNRTI recipients) and pravastatin improved HIV lipoatrophy over 12 weeks. Today, most patients with lipoatrophy receive non-tNRTI-based ART; the effect of uridine in such patients is unknown. Methods We performed a prospective, randomized trial in lipoatrophic adults with plasma HIV RNA < 50 HIV-1 RNA copies/mL on tNRTI-sparing ART including LPV/r. Patients received uridine [36 g three times a day (tid) on 10 consecutive days per month; n=10], pravastatin [40 mg every night (nocte); n=12], uridine plus pravastatin (n=11) or neither (n=12) for 24 weeks. The primary endpoint was mean change in limb fat mass as assessed by dual-energy X-ray absorptiometry (DEXA). With 20 patients per intervention, the study had 80% power to detect a mean difference between a treatment and the control of 0.5 kg, assuming a standard deviation of 0.9 and an alpha threshold equal to 5% (two-sided). Results Of 45 participants (all men, with median age 49.5 years and median limb fat 2.6 kg), two discontinued pravastatin and one participant stopped both pravastatin and uridine. The difference between the mean changes in limb fat mass for uridine vs. no uridine was 0.03 kg [95% confidence interval (CI) -0.35, +0.28; P=0.79]. The respective difference for pravastatin was -0.03 kg (95% CI -0.29, +0.34; P=0.84). Pravastatin slightly decreased total cholesterol (0.44 mmol/L; P=0.099). Visceral adipose tissue measured by computed tomography did not change significantly. Conclusion In this population and at the doses used, neither uridine nor pravastatin for 24 weeks significantly increased limb fat mass.
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页码:493 / 501
页数:9
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