Department of Medical Sciences, IRCCS San Raffaele, Rome, Italy.
Adv Ther. 2011 Dec;28(12):1105-13. doi: 10.1007/s12325-011-0082-5. Epub 2011 Nov 21.
Statins are at the forefront of strategies to manage dyslipidemia, although they are not always well tolerated. At 6-7 months after the drug was supplied, discontinuation rates averaged 30%. Alternate agents to statins have been studied. Some nutraceuticals demonstrated an efficacy in reducing cholesterol concentrations. However, there are no data regarding the use of nutraceuticals in elderly dyslipidemic patients. The purpose of this study was to examine the efficacy, safety, and tolerability of a nutraceutical-based protocol in elderly hypercholesterolemic patients previously intolerant to statins.
This study was performed as a randomized, prospective, parallel group, single-blind study. Patients were included in the study if they had high total cholesterolemia, high low-density lipoprotein cholesterol (LDL-C), >75 years of age, statin-intolerant, and were refusing other pharmaceutical treatments for hypercholesterolemia. At the baseline visit, eligible patients were randomized to either nutraceutical-combined pill (containing berberine 500 mg, policosanol 10 mg, red yeast rice 200 mg, folic acid 0.2 mg, coenzyme Q10 2.0 mg, and astaxanthin 0.5 mg) or placebo, and the first dose was dispensed. The efficacy, safety, and tolerability of the proposed treatment were fully assessed after 3, 6, and 12 months of treatment.
Out of 106 consecutive patients screened, 80 eligible patients were randomized to receive either nutraceutical-combined pill (40 patients) or placebo (40 patients). No patients were lost and no deaths occurred during the follow-up. There was a statistically significant reduction in total cholesterolemia (-20%), LDL-C (-31%), and insulin resistance (-10%) with nutraceutical treatment. No significant changes were detected for plasma high-density lipoprotein cholesterol (HDL-C). Furthermore, no statistical differences were found between baseline and end-study safety parameters. Medication compliance and tolerability were high.
In this study the authors have demonstrated that combined nutraceuticals significantly reduce cholesterolemia and achieved acceptable plasma LDL-C levels in elderly hypercholesterolemic patients who were previously statin-intolerant. Combined nutraceuticals is also safe and well tolerated in these patients.
他汀类药物是管理血脂异常的最前沿策略，尽管它们并不总是被很好地耐受。在药物供应后 6-7 个月，停药率平均为 30%。已经研究了他汀类药物的替代药物。一些营养保健品在降低胆固醇浓度方面显示出疗效。然而，关于营养保健品在老年血脂异常患者中的使用尚无数据。本研究旨在检查基于营养保健品的方案在以前不能耐受他汀类药物的老年高胆固醇血症患者中的疗效、安全性和耐受性。
本研究是一项随机、前瞻性、平行组、单盲研究。如果患者总胆固醇高、低密度脂蛋白胆固醇（LDL-C）高、年龄>75 岁、不能耐受他汀类药物且拒绝其他治疗高胆固醇血症的药物治疗，则将其纳入研究。在基线就诊时，符合条件的患者被随机分配至营养保健品联合药丸（含黄连素 500mg、多廿烷醇 10mg、红曲米 200mg、叶酸 0.2mg、辅酶 Q10 2.0mg 和虾青素 0.5mg）或安慰剂组，并发放第一剂药物。在治疗 3、6 和 12 个月后，全面评估了拟议治疗的疗效、安全性和耐受性。
在 106 例连续筛选的患者中，80 例符合条件的患者被随机分配至接受营养保健品联合药丸（40 例）或安慰剂（40 例）治疗。在随访期间没有患者失访或死亡。营养保健品治疗后，总胆固醇（-20%）、LDL-C（-31%）和胰岛素抵抗（-10%）均有统计学显著降低。血浆高密度脂蛋白胆固醇（HDL-C）无明显变化。此外，基线和终末研究安全性参数之间未发现统计学差异。药物依从性和耐受性高。
在这项研究中，作者证明了联合营养保健品可显著降低胆固醇，并使以前不能耐受他汀类药物的老年高胆固醇血症患者达到可接受的血浆 LDL-C 水平。联合营养保健品在这些患者中也是安全且耐受良好的。
