An update on the safety of nutraceuticals and effects on lipid parameters

ABSTRACT

Introduction: Cardiovascular diseases (CVDs) are the leading cause of mortality and disability in developed countries, whereas a large portion of patients in primary prevention have uncontrolled level of CVD risk factors. Dietary supplementation with bioactive natural compounds with demonstrated lipid-lowering effects is currently supported by the international guidelines for CVD prevention and some international expert panels.

Areas covered: This review provides insights on issues concerning the tolerability and safety of the most commonly used nutraceuticals with demonstrated lipid-lowering effect in humans. They will be then divided into three main categories according to their mechanism of action (cholesterol synthesis inhibitors, intestinal cholesterol absorption inhibitors, and LDL-C excretion stimulants) and their pharmacological profile will be discussed.

Expert opinion: A growing body of preclinical, epidemiological and clinical evidence has defined the tolerability and safety profile of the most commonly used lipid-lowering nutraceuticals. In the most part of cases, the side effects are mild and reversible. However, detailed knowledge of specific health risks and pharmacological interactions for each individual compound is needed for the management of frail patients, such as children, elderly, patients with liver or renal failure, and patients consuming numerous drugs.

KEYWORDS:

• Dietary supplements
• nutraceuticals
• tolerability
• safety
• LDL-cholesterol

Article highlights

• The use of nutraceuticals, especially RYR and BBR, in patients with moderate hypercholesterolemia (primary prevention), low cardiovascular risk or intolerant/insensitive to traditional pharmacological treatments, if associated to a correct lifestyle have been provided evidence of lipid-lowering efficacy and to be usually well-tolerated on the short-term.

• The combination of two or more nutraceuticals with different mechanism of action could be used in clinical practice to reduce ‘standard’ doses of individual supplements as much as possible, thereby reducing the risk of side effects and to obtain an additive or synergistic effect on lipid profile (even in association to conventional treatments).

• Further clinical investigations are needed to evaluate the safety of nutraceuticals, in particular in long-term treatment periods. The possibility of known and unknown pharmacological interaction risk has always to be taken in account.

• Good-quality clinical studies are urgently required to assess lipid-lowering efficacy given that for many of them evidence is fragmentary and based on low-quality studies.

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Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose

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Funding

This paper has not been funded.