Berberis aristata/Silybum marianum fixed combination (Berberol®) effects on lipid profile in dyslipidemic patients intolerant to statins at high dosages: A randomized, placebo-controlled, clinical trial
Berberis aristata/Silybum marianum fixed combination (Berberol®) effects on lipid profile in dyslipidemic patients intolerant to statins at high dosages: A randomized, placebo-controlled, clinical trial
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DOI：
10.1016/j.phymed.2014.11.018
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发表时间：
2015-02-15
期刊：
影响因子：
7.9
通讯作者：
Maffioli, Pamela
中科院分区：
文献类型：
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作者：
Derosa, Giuseppe;Romano, Davide;Maffioli, Pamela
目的：在一项随机、双盲、安慰剂对照的临床试验中，评估Berherisaristata/Silybummarionian（Berberol）在对高剂量他汀类药物不耐受的血脂异常患者样本中的功效。在导入期，停用他汀类药物1个月，然后以先前服用剂量的一半重新引入。之后，患者被随机分配服用安慰剂或Berbera（R），午餐服用1片，晚餐服用1片，持续6个月。在随机分组、3个月和6个月时评估人体测量、代谢和炎症参数。结果：Berberor（R）降低了空腹血糖、胰岛素和HOMA指数水平，但安慰剂没有降低;而且，它们低于安慰剂记录的水平。自他汀类药物剂量减少和Berberol（R）引入6个月后，总胆固醇、LDL-C、甘油三酯和髓过氧化物酶没有变化，而安慰剂组的总胆固醇、LDL-C、甘油三酯和髓过氧化物酶增加，并且高于积极治疗组。两组均无严重不良事件发生。结论：我们的研究显示了Berberol（R）和减少剂量的他汀类药物联合治疗对高剂量他汀类药物不耐受的高脂血症患者的基本原理。(C)2015爱思唯尔有限公司All rights reserved.
Aim: to evaluate the efficacy of Berheris aristata/Silybum marionian (Berberol (R)) in a sample of dyslipdemic patients intolerant to statins at high dosages in a randomized, double blind, placebo-controlled clinical trial.Methods: we enrolled 175 euglycemic, dyslipidemic subjects, intolerant to statins at high dosages. During the run-in period, statins were stopped for 1 month, then they were re-introduced at the half of the previously taken dose. After that, patients were randomized to placebo or Berbera (R), 1 tablet during the lunch and 1 tablet during the dinner, for 6 months. Anthropometric, metabolic and inflammatory parameters were assessed at randomization, at 3 and 6 months.Results: fasting plasma glucose, insulin, and HOMA-index levels were reduced by Berberor (R), but not by placebo; moreover they were lower than the ones recorded with placebo. Total cholesterol, LDL-C, triglycerides, and myeloperoxidase did not change after 6 months since the reduction of statin dosage and the introduction of Berberol (R), while they increased in the placebo group, and were higher compared to the ones obtained with active treatment. No patients had serious adverse events in both groups.Conclusions: our study displays the rationale of the combination of Berberol (R) and a reduced dosage of statin for the treatment of hyperlipidemia in patients intolerant to statins at high dosage. (C) 2015 Elsevier GmbH. All rights reserved.