Tenore Gian Carlo, Caruso Domenico, Buonomo Giuseppe, D'Avino Maria, Campiglia Pietro, Marinelli Luciana, Novellino Ettore
1 Department of Pharmacy, University of Naples Federico II , Naples, Italy .
2 Department of Internal Medicine, Hospital Cardarelli , Naples, Italy .
J Med Food. 2017 Mar;20(3):288-300. doi: 10.1089/jmf.2016.0152. Epub 2017 Feb 17.
Cardiovascular diseases are nowadays preferential targets of preventive medicine through a straightforward therapy on lipid profile. However, statins, the first-line lipid-lowering drug therapy, specifically act on low-density lipoprotein cholesterol (LDL-C), having a modest effect on plasma high-density lipoprotein cholesterol (HDL-C) concentrations. Today, a number of novel HDL-targeted therapies are emerging, along with unexpected side effects. Thus, novel and possibly safe substances, able to correct impaired lipid profile in humans, are still in great demand. Herein, based on encouraging clinical data, we formulated a nutraceutical product (AppleMetS, AMS), based on a polyphenolic extract from Annurca apple, and demonstrated that two capsules a day of AMS, after one month, have a LDL-C lowering outcome equivalent to 40 mg of simvastatin or 10 mg of atorvastatin. Nevertheless, different from statin-based therapy, AMS exerted a notable effect on HDL (+49.2%). Based on the trial results, we can assert that AMS formulation could effectively integrate the current therapeutic arsenal to correct impaired lipid profile in humans. Specifically, AMS may be considered a complementary and/or alternative safe substance suitable for the treatment of mildly hypercholesterolemic subjects who do not present occurrence of atheromatous plaques yet.
如今，心血管疾病通过对血脂水平进行直接治疗，已成为预防医学的优先目标。然而，他汀类药物作为一线降脂药物治疗，主要作用于低密度脂蛋白胆固醇（LDL-C），对血浆高密度脂蛋白胆固醇（HDL-C）浓度的影响较小。如今，一些针对HDL的新型疗法不断涌现，但也伴随着意想不到的副作用。因此，人们仍然迫切需要能够纠正人体血脂异常的新型且可能安全的物质。在此，基于令人鼓舞的临床数据，我们研发了一种营养补充剂产品（苹果代谢综合征产品，AMS），其基于阿努卡苹果的多酚提取物，并证明每天服用两粒AMS胶囊，一个月后降低LDL-C的效果等同于40毫克辛伐他汀或10毫克阿托伐他汀。然而，与基于他汀类药物的治疗不同，AMS对HDL有显著影响（提高49.2%）。基于试验结果，我们可以断言，AMS配方可以有效地补充当前的治疗手段，以纠正人体血脂异常。具体而言，AMS可被视为一种适合治疗尚未出现动脉粥样硬化斑块的轻度高胆固醇血症患者的补充和/或替代安全物质。
