Hyperlipidemia Clinical Trial
Official title:
Additive Effects of Nutraceuticals to Non-pharmacologic Intervention to Improve Lipid Profile in the Real World Clinical Practice in European Countries - The PIN (Portugul Italy Nutraceutical) Study
Cardiovascular prevention include a class I indication to statins in addition to
non-pharmacologic intervention and prevention strategies in patients deemed to be 'high
risk' according to current scientific guidelines. In the real world, however, statin
treatment is often discontinued due to side effects.
In addition, statins are not indicated in those subjects deemed to be 'low risk', in whom
only non-pharmacologic intervention and prevention strategies are currently prescribed.
Along with non-pharmacologic intervention and prevention strategies, newer approaches to
reduce cholesterol blood levels currently include nutraceuticals, which are compounds
derived from foods with cholesterol lowering actions.
The primary objective of this study is twofold:
First, to prospectively compare in the real world clinical practice the efficacy and
tolerability of non-pharmacologic intervention vs. the combination of non-pharmacologic
intervention with a nutraceutical-based protocol in patients in whom statin treatment is not
tolerated or is not indicated.
Second, to evaluate gender and race/ethnic differences in the hypolipidemic effects of a
nutraceutical-based protocol among European countries.
Cardiovascular prevention include a class I indication to statins in addition to
non-pharmacologic intervention and prevention strategies in patients deemed to be 'high
risk' according to current scientific guidelines. In the real world, however, statin
treatment is often discontinued due to side effects.
In addition, statins are not indicated in those subjects deemed to be 'low risk', in whom
only non-pharmacologic intervention and prevention strategies are currently prescribed.
Along with non-pharmacologic intervention and prevention strategies, newer approaches to
reduce cholesterol blood levels currently include nutraceuticals, which are compounds
derived from foods with cholesterol lowering actions.
In the real world clinical practice, however, it remains unclear if nutraceuticals yield
additive therapeutic effects to non-pharmacologic intervention and prevention strategies in
patients in whom statin treatment is not tolerated or is not indicated.
The primary objective of this study is twofold:
First, to prospectively compare in the real world clinical practice the efficacy and
tolerability of non-pharmacologic intervention vs. the combination of non-pharmacologic
intervention with a nutraceutical-based protocol in patients in whom statin treatment is not
tolerated or is not indicated.
Second, to evaluate gender and race/ethnic differences in the hypolipidemic effects of a
nutraceutical-based protocol among European countries.
Patients will be assigned at the discretion of their own general practitioner to receive for
1 year either non-pharmacologic intervention and prevention strategies or non-pharmacologic
intervention and prevention strategies associated with a commercially available
nutraceutical combined pill (1 capsule/day containing red yeast rice 200 mg, policosanol 10
mg, and berberine 500 mg).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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