METHODS: We prospectively enrolled all consecutive patients with dyslipidemia at low cardiovascular risk who were unresponsive to diet and physical activity. Clinical assessments and laboratory analyses, encompassing lipid profile, hepatic function, and CPK levels, were performed at baseline prior to initiating treatment and repeated at the 12-week mark following administration of the study nutraceutical.
RESULTS: Sixty (60) consecutive patients (mean age 48.02 ± 10.1 years; 60% male) were included. At the 12-week follow-up, a statistically significant reduction in Total Cholesterol (13.1%) and LDL-c serum level (20.4%) was observed. Hepatic and muscular function remain stable over the time. The adherence to therapy was 99% and the persistence was maximum.
CONCLUSIONS: The nutraceutical formulation including leucoselect® phytosome® red yeast rice, policosanol and folic acid significantly reduced the LDL-c plasma levels, consistent with previous research showing that the bioactive component in red yeast rice-lovastatin-is effective in addressing problems with lipid metabolism. Importantly, it was safe and well-tolerated among patients with dyslipidemia in a real-world setting.
方法:我们前瞻性招募了所有对饮食和体力活动无反应的低心血管风险血脂异常的连续患者。临床评估和实验室分析,包括脂质分布,肝功能,和CPK水平,在开始治疗之前在基线进行,并在研究营养品给药后12周重复。
结果:纳入60例连续患者(平均年龄48.02±10.1岁;60%为男性)。在12周的随访中,观察到总胆固醇(13.1%)和LDL-c血清水平(20.4%)显著降低.肝脏和肌肉功能随时间保持稳定。对治疗的依从性为99%,持久性最大。
结论:包含leucoselect®photosome®红曲米的营养配方,policosanol和叶酸显着降低LDL-c血浆水平,与以前的研究表明,红曲米中的生物活性成分洛伐他汀在解决脂质代谢问题方面是有效的。重要的是,在真实世界的血脂异常患者中,该药物是安全且耐受性良好的.