匹伐他汀对血脂异常且接受阿扎那韦/利托那韦治疗的HIV感染患者血脂谱的影响：一项随机、双盲、交叉研究。
Effects of Pitavastatin on Lipid Profiles in HIV-Infected Patients with Dyslipidemia and Receiving Atazanavir/Ritonavir: A Randomized, Double-Blind, Crossover Study.
作者信息
Wongprikorn Asita, Sukasem Chonlaphat, Puangpetch Apichaya, Numthavej Pawin, Thakkinstian Ammarin, Kiertiburanakul Sasisopin
机构信息
Department of Medicine, Division of Infectious Diseases, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.
Department of Pathology, Division of Pharmacogenomics and Personalized Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.
出版信息
PLoS One. 2016 Jun 15;11(6):e0157531. doi: 10.1371/journal.pone.0157531. eCollection 2016.
BACKGROUND
Dyslipidemia as a risk factor of cardiovascular disease is common especially in HIV-infected patients who are using protease inhibitors (PIs) including atazanavir. Pitavastatin has less drug-drug interactions and demonstrable efficacy in decreasing lipid levels in non HIV-infected individuals.
MATERIALS AND METHODS
This study was a randomized, double-blind, crossover study comparing the safety and efficacy of pitavastatin vs placebo in HIV-infected patients with dyslipidemia and receiving atazanavir/ritonavir (ATV/r). Patients were randomized to receive either placebo or pitavastatin for 12 weeks. The follow-up visits were every 4 weeks until the end of the study.
RESULTS
A total of 12 HIV-infected patients were enrolled to each study group. Of all, 14 (58%) patients were men and mean (standard deviation, SD) age was 48.1 (1.8) years. At 12 weeks of treatment with pitavastatin compared to placebo; mean [95% confidence interval (CI)] total cholesterol (TC) was 207 (187.3, 226.8) mg/dL vs 246.3 (226.5, 266) mg/dL (p <0.001); mean (95% CI) triglyceride (TG) was 351.3 (193.2, 509.4) mg/dL vs 279.1 (121, 437.2) mg/dL (p = 0.269); mean (95% CI) high density lipoprotein (HDL) was 45.3 (40.4, 50.2) mg/dL vs 44.2 (39.3, 49.1) mg/dL (p = 0.354); and mean (95% CI) low density lipoprotein (LDL) was 113.2 (100.4, 126) mg/dL vs 145.6 (132.8, 158.4) mg/dL (p <0.001). Mean liver enzyme and median creatine phosphokinase levels were not statistically significant between patients receiving placebo and pitavastatin.
CONCLUSIONS
Pitavastatin decreases TC and LDL level at 12 weeks significantly and shows indifferent in hepatotoxicity and creatine phosphokinase levels compared to those of placebo. Thus, pitavastatin can be a good option of lipid-lowering agent in HIV-infected patients who are receiving ATV/r.
TRIAL REGISTRATION
ClinicalTrials.gov NCT02442700.
背景
血脂异常作为心血管疾病的一个危险因素很常见，尤其在使用蛋白酶抑制剂（PI）包括阿扎那韦的HIV感染患者中。匹伐他汀药物间相互作用较少，并且在降低未感染HIV个体的血脂水平方面有明显疗效。
材料与方法
本研究是一项随机、双盲、交叉研究，比较匹伐他汀与安慰剂在血脂异常且接受阿扎那韦/利托那韦（ATV/r）治疗的HIV感染患者中的安全性和疗效。患者被随机分为接受安慰剂或匹伐他汀治疗12周。随访每4周进行一次，直至研究结束。
结果
每个研究组共纳入12例HIV感染患者。其中，14例（58%）为男性，平均（标准差，SD）年龄为48.1（1.8）岁。与安慰剂相比，匹伐他汀治疗12周时；平均[95%置信区间（CI）]总胆固醇（TC）为207（187.3，226.8）mg/dL，而安慰剂组为246.3（226.5，266）mg/dL（p<0.001）；平均（95%CI）甘油三酯（TG）为351.3（193.2，509.4）mg/dL，而安慰剂组为279.1（121，437.2）mg/dL（p = 0.269）；平均（95%CI）高密度脂蛋白（HDL）为45.3（40.4，50.2）mg/dL，而安慰剂组为44.2（39.3，49.1）mg/dL（p = 0.354）；平均（95%CI）低密度脂蛋白（LDL）为113.2（100.4，126）mg/dL，而安慰剂组为145.6（132.8，158.4）mg/dL（p<0.001）。接受安慰剂和匹伐他汀治疗的患者之间，平均肝酶和肌酸磷酸激酶水平的中位数无统计学意义。
结论
匹伐他汀在12周时显著降低TC和LDL水平，与安慰剂相比，在肝毒性和肌酸磷酸激酶水平方面无差异。因此，匹伐他汀可以成为接受ATV/r治疗的HIV感染患者降脂药物的一个良好选择。
试验注册
ClinicalTrials.gov NCT02442700。
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