Erlandson Kristine M, Jiang Ying, Debanne Sara M, McComsey Grace A
aDepartment of Medicine, Divisions of Infectious Diseases and Geriatric Medicine, University of Colorado, Aurora, Colorado bDepartment of Biostatistics cDepartment of Medicine and Pediatrics, Division of Pediatric Infectious Diseases and Rheumatology, Case Western Reserve University, Cleveland, Ohio, USA.
AIDS. 2015 Jan 14;29(2):175-82. doi: 10.1097/QAD.0000000000000526.
Statins have a beneficial effect on bone mineral density (BMD) and lean mass in some studies of HIV-uninfected adults; however, this has never been investigated in the setting of HIV infection.
HIV-infected individuals on stable antiretroviral therapy with a low-density lipoprotein cholesterol level of 130 mg/dl or less and evidence of heightened immune activation or inflammation were randomized to rosuvastatin 10 mg daily or placebo for 96 weeks.
This was a prespecified interim analysis at 48 weeks. Between-group and within-group differences were compared; multivariable regression models were constructed.
Seventy-two individuals were randomized to statin therapy and 75 to placebo. Modest 48-week relative increases in trochanter BMD [0.9%; 95% confidence interval (95% CI) -0.9 to 0.6] and total hip BMD (0.6%; 95% CI 0.0-1.1) in the statin arm were significantly greater than placebo (P < 0.05). The relationship between statin use and total hip BMD change was robust to adjustment of age, sex, race and smoking status (P = 0.02) and strengthened by inclusion of baseline (P = 0.01) and week 48 change in soluble tumour necrosis factor-α receptor (sTNFR)-1 (P = 0.009). Relative increases in total body, trunk and limb fat were similar between statin and placebo arms (P ≥ 0.58). Although a significant gain in leg lean mass was seen in the statin arm, this was not significantly different compared with placebo (P = 0.36).
The improvements seen in total hip BMD after 48 weeks of rosuvastatin therapy support further potential benefits of statin therapy in HIV, beyond a reduction of cardiovascular risk.
在一些针对未感染HIV的成年人的研究中，他汀类药物对骨密度（BMD）和瘦体重有有益影响；然而，在HIV感染的情况下从未对此进行过研究。
接受稳定抗逆转录病毒治疗、低密度脂蛋白胆固醇水平为130 mg/dl或更低且有免疫激活或炎症增强证据的HIV感染者被随机分为每日服用10 mg瑞舒伐他汀或安慰剂，为期96周。
这是一项在48周时进行的预先设定的中期分析。比较组间和组内差异；构建多变量回归模型。
72人被随机分配接受他汀类药物治疗，75人接受安慰剂治疗。他汀类药物组在48周时转子骨密度[0.9%；95%置信区间（95%CI）-0.9至0.6]和全髋骨密度（0.6%；95%CI 0.0 - 1.1）的适度相对增加显著大于安慰剂组（P<0.05）。他汀类药物使用与全髋骨密度变化之间的关系在调整年龄、性别、种族和吸烟状况后仍然显著（P = 0.02），并且通过纳入基线（P = 0.01）和第48周可溶性肿瘤坏死因子-α受体（sTNFR）-1的变化（P = 0.009）而得到加强。他汀类药物组和安慰剂组全身、躯干和四肢脂肪的相对增加相似（P≥0.58）。虽然他汀类药物组腿部瘦体重有显著增加，但与安慰剂组相比无显著差异（P = 0.36）。
瑞舒伐他汀治疗48周后全髋骨密度的改善支持了他汀类药物治疗在HIV患者中除降低心血管风险之外的进一步潜在益处。
