The effectiveness of statins in the primary and secondary prevention of cardiovascular (CV) diseases has been widely proven. However, the onset of adverse events associated with their use prevents to achieve the therapeutic targets recommended by the guidelines (GL) for the management of dyslipidemia. In the event of statin intolerance, the GL recommend to use bile acid sequestrants, fibrates, and ezetimibe in monotherapy, but their benefits in improving lipid pattern are quite modest. This study aims at evaluating the effectiveness and safety of a nutraceutical compound (NC) associated with ezetimibe (EZE) on the lipid profile in statin-intolerant patients with moderate-to-high CV risk. Ninety-six statin-intolerant hypertensive and hypercholesterolemic subjects treated pharmacologically with EZE 10 mg daily were randomized in open label (n = 48) to take for 3 months a NC containing Monacolin-K (MK), Berberine Hydrochloride (BC), t-Resveratrol (RES), Quercetin (QUER), and Chromium (CH) in the form of a gastro-resistant tablet that improves enteric bioaccessibility and bioavailability of these substances. The control group (n = 48) took only EZE in monotherapy at the same dosage; both groups followed a standardized lipid-lowering diet. The total serum cholesterol (TC), low density lipoprotein cholesterol (LDLC), high density lipoprotein cholesterol (HDLC), triglycerides (TG), aspartate aminotransferase (AST), alanine aminotransferase (ALT), and creatinine phosphokinase (CPK) levels were compared at the follow-up in both groups using Student's t-test. TC and LDL levels reduced in both groups, but were lower in the group treated with EZE + NC (−25.9% vs. −15%, P < .05 and −38.7% vs. −21.0%, P < .05, respectively). No changes were observed in either group regarding a decrease in TG (−9.4% vs. −11.7%, NS) and an increase in HDLC (+4.2% vs. +1.1%, NS). The AST, ALT, and CPK levels increased in the group treated with the EZE + NC compared to the control group, but were still within the acceptable range. There was no difference concerning the lipid-lowering treatment between gender, and no patient withdrew from the study. In the short term, the EZE + NC combination therapy is well tolerated and effective in improving TC and LDLC levels in statin-intolerant patients with moderate-to-high CV risk.

中文翻译：

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在依他汀耐受性高至心血管高风险的耐不耐受他汀类药物的人群中，添加依泽替米贝的新型营养配方的有效性和安全性。

他汀类药物在心血管疾病的一级和二级预防中的有效性已得到广泛证明。然而，与使用不良事件有关的不良事件的发作阻碍了达到血脂异常指南（GL）推荐的治疗目标。如果他汀类药物不耐受，GL建议在单一疗法中使用胆汁酸螯合剂，贝特类药物和依折麦布，但它们在改善血脂模式方面的益处相当有限。这项研究旨在评估与依泽替米贝（EZE）相关的营养药物（NC）对中度至高CV风险他汀类药物耐受患者的脂质谱的有效性和安全性。每天接受10毫克EZE的药理治疗的96例他汀类药物不耐受的高血压和高胆固醇血症受试者被随机分为开放标签（n  = 48）进行3个月的NC检验，其中含有莫纳可林K（MK），盐酸小ber碱（BC），叔白藜芦醇（RES），槲皮素（QUER）和铬（CH）呈胃抗性改善这些物质的肠道生物利用度和生物利用度的片剂。对照组（n  = 48）在单一治疗中以相同剂量仅服用了EZE；两组均遵循标准的降脂饮食。比较了总血清胆固醇（TC），低密度脂蛋白胆固醇（LDLC），高密度脂蛋白胆固醇（HDLC），甘油三酸酯（TG），天冬氨酸转氨酶（AST），丙氨酸转氨酶（ALT）和肌酸酐磷酸激酶（CPK）的水平在两组的随访中，使用学生的t-测试。两组的TC和LDL水平均降低，但用EZE + NC治疗的组更低（分别为-25.9％vs. -15％，P  <.05和-38.7％vs. -21.0％，P  <.05 ）。两组均未观察到TG降低（-9.4％vs.-11.7％，NS）和HDLC升高（+ 4.2％vs. + 1.1％，NS）的变化。与对照组相比，EZE + NC治疗组的AST，ALT和CPK水平升高，但仍在可接受的范围内。性别之间的降脂治疗没有差异，也没有患者退出研究。在短期内，EZE + NC联合疗法对中度至高心血管风险的他汀类药物耐受不良患者的TC和LDLC水平具有良好的耐受性和有效性。