Endothelial Dysfunction — Efficacy and Safety Study of Policosanol
Citation(s)
Affuso F, Ruvolo A, Micillo F, Saccà L, Fazio S Effects of a nutraceutical combination (berberine, red yeast rice and policosanols) on lipid levels and endothelial function randomized, double-blind, placebo-controlled study. Nutr Metab Cardiovasc Dis. 20
Faizi AK, Kornmo DW, Agewall S Evaluation of endothelial function using finger plethysmography. Clin Physiol Funct Imaging. 2009 Sep;29(5):372-5. doi: 10.1111/j.1475-097X.2009.00882.x. Epub 2009 Jun 22.
Noa M, Más R, Lariot C Protective effect of policosanol on endothelium and intimal thickness induced by forceps in rabbits. J Med Food. 2007 Sep;10(3):452-9.
Reriani MK, Lerman LO, Lerman A Endothelial function as a functional expression of cardiovascular risk factors. Biomark Med. 2010 Jun;4(3):351-60. doi: 10.2217/bmm.10.61. Review.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
