Evaluationg the role of Nutraceuticals in Primary Prevention

Abstract

Prevention has become a main factor in the management of cardiovascular diseases. There are many options to control the LDL-Cholesterol levels, which reduction has been widely proved to diminish cardiovascular events rate. Despite the many pharmacological options, an important percentage of the patients do not reach the control target. Among other factors, the available drugs present tolerance problems that limit their use, emerging the necessity to develop new options of treatment that combine efficacy and security. In this field arise the nutraceuticals, which may become an alternative, in selected patients, especially in primary prevention, where the necessity of LDL-cholesterol reduction is not so ambitious, and tolerance and security are essential to achieve the patient adherence to the treatment.  The objective of the study is to demonstrate that the new formulation of Lipok®(a nutraceutical based in red yeast rice and berberine) adapting the concentration of monacolines  to the new European regulation, is effective in the lipidic profile control. 97 patients in primary prevention that present LDL-Cholesterol levels over the guidelines objective (116mg/dL) where included. Security and effectiveness of adding Lipok® 6 months to the treatment was evaluated. We observed a statistically significant reduction in the TCH values (-34.3mg/dL), LDL-C (-33,8mg/dL) and triglycerides (-29,3mg/dL) at 6 months’ treatment. No variation in the levels of HDL-C was observed. No relevant side effects were reported (constipation <2%, no myalgias). There were mild reductions (that even reached statistical significance) in creatinine, GPT and glycosylated hemoglobin. No patient discontinued treatment in the 6 months. NO patient discontinued the treatment during the study.  New formulation of Lipok® has proved to be effective in the control of the LDL-Cholesterol levels without relevant side effects. Considering the significant reduction shown in this study, it may become an alternative to other pharmacological treatments in the management of dyslipidaemia in primary prevention where adherence to the treatment is fundamental.