Assmann G, Cullen P, Erbey J, Ramey DR, Kannenberg F, Schulte H Plasma sitosterol elevations are associated with an increased incidence of coronary events in men: results of a nested case-control analysis of the Prospective Cardiovascular Münster (PROCAM) study. Nutr Metab Cardiovasc Dis. 2006 Jan;16(1):13-21. Epub 2005 Jul 28.
Blair SN, Capuzzi DM, Gottlieb SO, Nguyen T, Morgan JM, Cater NB Incremental reduction of serum total cholesterol and low-density lipoprotein cholesterol with the addition of plant stanol ester-containing spread to statin therapy. Am J Cardiol. 2000 Jul 1;86(1):46-52.
Brufau G, Canela MA, Rafecas M Phytosterols: physiologic and metabolic aspects related to cholesterol-lowering properties. Nutr Res. 2008 Apr;28(4):217-25. doi: 10.1016/j.nutres.2008.02.003. Review.
Cater NB Plant stanol ester: review of cholesterol-lowering efficacy and implications for coronary heart disease risk reduction. Prev Cardiol. 2000 Summer;3(3):121-130.
Child P, Kuksis A Differential uptake of cholesterol and plant sterols by rat erythrocytes in vitro. Lipids. 1982 Oct;17(10):748-54.
de Jong A, Plat J, Mensink RP Plant sterol or stanol consumption does not affect erythrocyte osmotic fragility in patients on statin treatment. Eur J Clin Nutr. 2006 Aug;60(8):985-90. Epub 2006 Feb 15.
Gylling H, Miettinen TA Combination therapy with statins. Curr Opin Investig Drugs. 2002 Sep;3(9):1318-23. Review.
Hallikainen MA, Sarkkinen ES, Uusitupa MI Effects of low-fat stanol ester enriched margarines on concentrations of serum carotenoids in subjects with elevated serum cholesterol concentrations. Eur J Clin Nutr. 1999 Dec;53(12):966-9.
Hallikainen MA, Sarkkinen ES, Uusitupa MI Plant stanol esters affect serum cholesterol concentrations of hypercholesterolemic men and women in a dose-dependent manner. J Nutr. 2000 Apr;130(4):767-76.
Keys A Coronary heart disease, serum cholesterol, and the diet. Acta Med Scand. 1980;207(3):153-60.
Law M Plant sterol and stanol margarines and health. BMJ. 2000 Mar 25;320(7238):861-4.
Law MR, Wald NJ, Thompson SG By how much and how quickly does reduction in serum cholesterol concentration lower risk of ischaemic heart disease? BMJ. 1994 Feb 5;308(6925):367-72.
Law MR, Wald NJ Risk factor thresholds: their existence under scrutiny. BMJ. 2002 Jun 29;324(7353):1570-6. Review.
Lichtenstein AH, Deckelbaum RJ AHA Science Advisory. Stanol/sterol ester-containing foods and blood cholesterol levels. A statement for healthcare professionals from the Nutrition Committee of the Council on Nutrition, Physical Activity, and Metabolism of the American Heart Association. Circulation. 2001 Feb 27;103(8):1177-9.
Mattson FH, Grundy SM, Crouse JR Optimizing the effect of plant sterols on cholesterol absorption in man. Am J Clin Nutr. 1982 Apr;35(4):697-700.
Mensink RP, Ebbing S, Lindhout M, Plat J, van Heugten MM Effects of plant stanol esters supplied in low-fat yoghurt on serum lipids and lipoproteins, non-cholesterol sterols and fat soluble antioxidant concentrations. Atherosclerosis. 2002 Jan;160(1):205-13.
Plat J, van Onselen EN, van Heugten MM, Mensink RP Effects on serum lipids, lipoproteins and fat soluble antioxidant concentrations of consumption frequency of margarines and shortenings enriched with plant stanol esters. Eur J Clin Nutr. 2000 Sep;54(9):671-7.
Rajaratnam RA, Gylling H, Miettinen TA Independent association of serum squalene and noncholesterol sterols with coronary artery disease in postmenopausal women. J Am Coll Cardiol. 2000 Apr;35(5):1185-91.
Sudhop T, von Bergmann K Cholesterol absorption inhibitors for the treatment of hypercholesterolaemia. Drugs. 2002;62(16):2333-47. Review.
Van Horn L, Ernst N A summary of the science supporting the new National Cholesterol Education Program dietary recommendations: what dietitians should know. J Am Diet Assoc. 2001 Oct;101(10):1148-54. 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.