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Stanols are substances that occur naturally in various plants. Their cholesterol-lowering effects were first observed in animals in the 1950s. Since then, a substantial amount of research suggests that plant stanols (modified into stanol esters) can help to lower cholesterol in individuals with normal or mildly to moderately elevated cholesterol levels. Stanols are available in margarine spreads, salad dressings, and dietary supplement tablets. Related substances called sterols and sterol esters appear to function similarly.

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Requirements/Sources

Stanols occur naturally in wood pulp, tall oil, and soybean oil, and can also be manufactured from sterols (substances found in many foods). For incorporation into foods, stanols are processed with fatty acids from vegetable oils to form chemicals called stanol esters.3 (A similar process converts sterols to sterol esters). Stanols and sterols and their esters are added to margarine spreads and salad dressings, and are also available as dietary supplement tablets.

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Therapeutic Dosages

Typical dosages of stanol esters to lower cholesterol levels range from 3.4 to 5.1 g per day.4 One manufacturer of a commercially prepared margarine spread recommends taking 3 teaspoons (1.5 g of sitostanol ester per teaspoon) per day. The suggested use varies depending on the product and the quantity of sitostanol ester per serving. One study suggests that using stanol products once a day may be as effective as dividing up your intake throughout the day.5 It may take up to 3 months to show a substantial decrease in total cholesterol values.6

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Therapeutic Uses

Strong evidence tells us that stanol esters and related substances can significantly improve cholesterol levels.7–20,54-56

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What Is the Scientific Evidence for Stanols?

Plant stanol esters reduce serum cholesterol levels by inhibiting cholesterol absorption.21 Because they are structurally similar to cholesterol, stanols (and sterols) can displace cholesterol from the "packages" that deliver cholesterol for absorption from the intestines to the bloodstream.22 The displaced cholesterol is not absorbed and is excreted from the body; the stanols themselves are ultimately not absorbed either. Numerous double-blind, placebo-controlled studies, ranging in length from 30 days to 12 months and involving a total of more than 1,000 people, have found stanol esters and their chemical relatives effective for improving cholesterol levels.23–36,54-56 The combined results suggest that these substances can reduce total cholesterol and LDL ("bad") cholesterol by about 10 to 15%. Stanol esters did not have any significant effect on HDL ("good") cholesterol or triglycerides in most of these studies.37 However, when combined with a standard cholesterol-lowering diet, use of a spread enhanced with plant sterols improved total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides as compared to a normal reduced-fat spread.38 In one of the best of the double-blind, placebo-controlled studies, 153 people with mildly elevated cholesterol were given sitostanol esters in margarine (at 1.8 or 2.6 g of sitostanol per day), or margarine without sitostanol ester, for a total of 1 year.39 The results in the treated group receiving 2.6 g per day showed improvements in total cholesterol by 10.2% and LDL cholesterol by 14.1%—significantly better than the results in the control group. Neither triglycerides nor HDL cholesterol levels were affected. Other studies have found evidence that people taking statin drugs may benefit from using stanols/sterols as well.42,43,57 According to one study, if you are on statins and start taking sterol ester margarine as well, your cholesterol will improve to the same effect as if you doubled the statin dose.57 Two studies found stanols to be helpful for lowering cholesterol levels in people with type 2 (adult-onset) diabetes.40,41

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Safety Issues

Stanols are considered safe because they are not absorbed.44,45 No adverse effects have been reported in any of the studies on lowering cholesterol, with the exception of one study that reported mild gastrointestinal complaints in a few preschool children.46 In addition, no toxic signs were observed in rats given stanol esters for 13 weeks at levels comparable to or exceeding those recommended for lowering cholesterol.47 Although concerns have been expressed that stanols might impair absorption of the fat-soluble vitamins A, D, and E, this does not seem to occur at the dosages of stanols required to lower cholesterol.48 Stanols might, however, interfere with absorption of alpha- and beta-carotene,49,50 although some studies have found no such effect.51,52 Until more is learned, it may be reasonable for people using stanol products to make sure to consume carotenoid-rich vegetables (yellow/orange and dark green vegetables).53

1. Saint-John M, McNaughton L. Octacosanol ingestion and its effects on metabolic responses to submaximal cycle ergometry, reaction time and chest and grip strength Int Clin Nutr Rev. 1986;6:81–87.

2. Snider SR. Octacosanol in parkinsonism [letter]. Ann Neurol. 1984;16:723.

3. Mas R. D-002. Drugs Future. 2001, 26(8):731–744 [in press].

4. Crespo N, Illnait J, Mas R, et al. Comparative study of the efficacy and tolerability of policosanol and lovastatin in patients with hypercholesterolemia and noninsulin dependent diabetes mellitus. Int J Clin Pharmacol Res. 1999;19:117–127

5. Crespo N, Alvarez R, Mas R, et al. Effect of policosanol on patients with non-insulin-dependent diabetes mellitus and hypercholesterolemia: a pilot study. Curr Ther Res. 1997;58:44–51.

6. Castano G, Mas R, Fernandez L, et al. Effects of policosanol on postmenopausal women with type II hypercholesterolemia. Gynecol Endocrinol. 2000;14:187–195.

7. Castano G, Mas R, Arruzazabala ML, et al. Effects of policosanol and pravastatin on lipid profile, platelet aggregation and endothelemia in older hypercholesterolemic patients. Int J Clin Pharmacol Res. 1999;19:105–116.

8. Benitez M, Romero C, Mas R, et al. A comparative study of policosanol versus pravastatin in patients with type II hypercholesterolemia. Curr Ther Res. 1997;58:859–867.

9. Ortensi G, Gladstein J, Valli H, et al. A comparative study of policosanol versus simvastatin in elderly patients with hypercholesterolemia. Curr Ther Res. 1997;58:390–401.

10. Alcocer L, Fernandez L, Campos E, et al. A comparative study of policosanol versus acipimox in patients with type II hypercholesterolemia. Int J Tissue React. 1999;21:85–92.

11. Torres O, Agramonte AJ, Illnait J, et al. Treatment of hypercholesterolemia in NIDDM with policosanol. Diabetes Care. 1995;19:393–397.

12. Mas R, Castano G, Illnait J, et al. Effects of policosanol in patients with type II hypercholesterolemia and additional coronary risk factors. Clin Pharmacol Ther. 1999;65:439–447.

13. Aneiros E, Mas R, Calderon B, et al. Effect of policosanol in lowering cholesterol levels in patients with type II hypercholesterolemia. Curr Ther Res. 1995;56:176–182.

14. Castano G, Canetti M, Moreira M, et al. Efficacy and tolerability of policosanol in elderly patients with type II hypercholesterolemia: a 12-month study. Curr Ther Res. 1995;56:819–828.

15. Castano G, Tula L, Canetti M, et al. Effects of policosanol in hypertensive patients with type II hypercholesterolemia. Curr Ther Res. 1996;57:691–699.

16. Torres O, Agramonte AJ, Illnait J, et al. Treatment of hypercholesterolemia in NIDDM with policosanol. Diabetes Care. 1995;18:393–397.

17. Aneiros E, Calderon B, Mas R, et al. Effect of successive dose increases of policosanol on the lipid profile and tolerability of treatment. Curr Ther Res. 1993;54:304–312.

18. Castano G, Mas R, Nodarse M, et al. One-year study of the efficacy and safety of policosanol (5 mg twice daily) in the treatment of type II hypercholesterolemia. Curr Ther Res. 1995;56:296–304.

19. Batista J, Stusser R, Penichet M, et al. Doppler-ultrasound pilot study of the effects of long-term policosanol therapy on carotid-vertebral atherosclerosis. Curr Ther Res. 1995;56:906–914.

20. Pons P, Rodriguez M, Mas R, et al. One-year efficacy and safety of policosanol in patients with type II hypercholesterolemia. Curr Ther Res. 1994;55:1084–1092.

21. Pons P, Rodriguez M, Robaina C, et al. Effects of successive dose increases of policosanol on the lipid profile of patients with type II hypercholesterolaemia and tolerability to treatment. Int J Clin Pharm Res. 1994;14:27–33.

22. Pons P, Mas R, Illnait J, et al. Efficacy and safety of policosanol in patients with primary hypercholesterolemia. Curr Ther Res. 1992;52:507–513.

23. Castano G, Mas R, Roca J, et al. A double-blind, placebo-controlled study of the effects of policosanol in patients with intermittent claudication. Angiology. 1999;50:123–130.

24. Saint-John M, McNaughton L. Octacosanol ingestion and its effects on metabolic responses to submaximal cycle ergometry, reaction time and chest and grip strength. Int Clin Nutr Rev. 1986;6:81–87.

25. Snider SR. Octacosanol in parkinsonism. Ann Neurol. 1984;16:723.

26. Norris FH, Denys EH, Fallat RJ. Trial of octacosanol in amyotrophic lateral sclerosis. Neurology. 1986;36:1263–1264.

27. Menendez R, Arruzazabala L, Mas R, et al. Cholesterol-lowering effect of policosanol on rabbits with hypercholesterolaemia induced by a wheat starch-casein diet. Br J Nutr. 1997;77:923–932.

28. Torres O, Agramonte AJ, Illnait J, et al. Treatment of hypercholesterolemia in NIDDM with policosanol. Diabetes Care. 1995;18:393–397.

29. Crespo N, Alvarez R, Mas R, et al. Effect of policosanol on patients with non-insulin-dependent diabetes mellitus and hypercholesterolemia: a pilot study. Curr Ther Res. 1997;58:44–51.

30. Castano G, Mas R, Fernandez L, et al. Effects of policosanol on postmenopausal women with type II hypercholesterolemia. Gynecol Endocrinol. 2000;14:187–195.

31. Torres O, Agramonte AJ, Illnait J, et al. Treatment of hypercholesterolemia in NIDDM with policosanol. Diabetes Care. 1995;19:393–397.

32. Mas R, Castano G, Illnait J, et al. Effects of policosanol in patients with type II hypercholesterolemia and additional coronary risk factors. Clin Pharmacol Ther. 1999;65:439–447.

33. Aneiros E, Mas R, Calderon B, et al. Effect of policosanol in lowering cholesterol levels in patients with type II hypercholesterolemia. Curr Ther Res. 1995;56:176–182.

34. Castano G, Canetti M, Moreira M, et al. Efficacy and tolerability of policosanol in elderly patients with type II hypercholesterolemia: a 12-month study. Curr Ther Res. 1995;56:819–828.

35. Castano G, Tula L, Canetti M, et al. Effects of policosanol in hypertensive patients with type II hypercholesterolemia. Curr Ther Res. 1996;57:691–699.

36. Aneiros E, Calderon B, Mas R, et al. Effect of successive dose increases of policosanol on the lipid profile and tolerability of treatment. Curr Ther Res. 1993;54:304–312.

37. Castano G, Mas R, Nodarse M, et al. One-year study of the efficacy and safety of policosanol (5 mg twice daily) in the treatment of type II hypercholesterolemia. Curr Ther Res. 1995;56:296–304.

38. Batista J, Stusser R, Penichet M, et al. Doppler-ultrasound pilot study of the effects of long-term policosanol therapy on carotid-vertebral atherosclerosis. Curr Ther Res. 1995;56:906–914.

39. Pons P, Rodriguez M, Mas R, et al. One-year efficacy and safety of policosanol in patients with type II hypercholesterolemia. Curr Ther Res. 1994;55:1084–1092.

40. Pons P, Rodriguez M, Robaina C, et al. Effects of successive dose increases of policosanol on the lipid profile of patients with type II hypercholesterolaemia and tolerability to treatment. Int J Clin Pharm Res. 1994;14:27–33.

41. Pons P, Mas R, Illnait J, et al. Efficacy and safety of policosanol in patients with primary hypercholesterolemia. Curr Ther Res. 1992;52:507–513.

42. Zardoya R, Tula L, Castano G, et al. Effects of policosanol on hypercholesterolemic patients with abnormal serum biochemical indicators of hepatic function. Curr Ther Res. 1996;57:568–577.

43. Castano G, Mas R, Fernandez L, et al. Effects of policosanol on postmenopausal women with type II hypercholesterolemia. Gynecol Endocrinol. 2000;14:187–195.

44. Mas R, Castano G, Illnait J, et al. Effects of policosanol in patients with type II hypercholesterolemia and additional coronary risk factors. Clin Pharmacol Ther. 1999;65:439–447.

45. Castano G, Mas R, Arruzazabala ML, et al. Effects of policosanol and pravastatin on lipid profile, platelet aggregation and endothelemia in older hypercholesterolemic patients. Int J Clin Pharmacol Res. 1999;19:105–116.

46. Crespo N, Illnait J, Mas R, et al. Comparative study of the efficacy and tolerability of policosanol and lovastatin in patients with hypercholesterolemia and noninsulin dependent diabetes mellitus. Int J Clin Pharmacol Res. 1999;19:117–127.

47. Benitez M, Romero C, Mas R, et al. A comparative study of policosanol versus pravastatin in patients with type II hypercholesterolemia. Curr Ther Res. 1997;58:859–867.

48. Ortensi G, Gladstein J, Valli H, et al. A comparative study of policosanol versus simvastatin in elderly patients with hypercholesterolemia. Curr Ther Res. 1997;58:390–401.

49. Alcocer L, Fernandez L, Campos E, et al. A comparative study of policosanol Versus acipimox in patients with type II hypercholesterolemia. Int J Tissue React. 1999;21:85–92.

50. Fernandez JC, Mas R, Castano G, et al. Comparison of the efficacy, safety and tolerability of policosanol versus fluvastatin in elderly hypercholesterolaemic women. Clin Drug Invest. 2001;21:103–113.

51. Castano G, Mas R, Fernandez JC, et al. Efficacy and tolerability of policosanol compared with lovastatin in patients with type II hypercholesterolemia and concomitant coronary risk factors. Curr Ther Res. 2000;61:137–146.

52. Torres O, Agramonte AJ, Illnait J, et al. Treatment of hypercholesterolemia in NIDDM with policosanol. Diabetes Care. 1995;18:393–397.

53. Crespo N, Alvarez R, Mas R, et al. Effect of policosanol on patients with non-insulin-dependent diabetes mellitus and hypercholesterolemia: a pilot study. Curr Ther Res. 1997;58:44–51.

54. Castano G, Mas Ferreiro R, Fernandez L, et al. A long-term study of policosanol in the treatment of intermittent claudication. Angiology. 2001;52:115–125.

55. Castano G, Mas R, Roca J, et al. A double-blind, placebo-controlled study of the effects of policosanol in patients with intermittent claudication. Angiology. 1999;50:123–130.

56. Arruzazabala ML, Valdes S, Mas R, et al . Effect of policosanol successive dose increases on platelet aggregation in healthy volunteers. Pharmacol Res. 1996;34:181–185.

57. Carbajal D, Arruzazabala ML, Valdes S, et al. Effect of policosanol on platelet aggregation and serum levels of arachidonic acid metabolites in healthy volunteers. Prostaglandins Leukot Essent Fatty Acids. 1998;58:61–64.

58. Arruzazabala ML, Valdes S, Mas R, et al. Comparative study of policosanol, aspirin and the combination therapy policosanol-aspirin on platelet aggregation in healthy volunteers. Pharmacol Res. 1997;36:293–297.

59. Fernandez L, Mas R, Illnait J, et al. Policosanol: results of a postmarketing surveillance control on 27,879 patients. Curr Ther Res. 1998;59:717–722.

60. Rodriguez-Echenique C, Mesa R, Mas R, et al. Effects of policosanol chronically administered in male monkeys (Macaca arctoides). Fd Chem Toxic. 1994;32:565–575.

61. Mesa AR, Mas R, Noa M, et al. Toxicity of policosanol in beagle dogs: one-year study. Toxicol Lett. 1994;73:81–90.

62. Aleman CL, Mas R, Hernandez C, et al. A 12-month study of policosanol oral toxicity in Sprague Dawley rats. Toxicol Lett. 1994;70:77–87.

63. Rodriguez MD, Garcia H. Teratogenic and reproductive studies of policosanol in the rat and rabbit. Teratog Carcinog Mutagen. 1994;14:107–113.

64. Zardoya R, Tula L, Castano G, et al. Effects of policosanol on hypercholesterolemic abnormal serum biochemical indicators of hepatic function. Curr Ther Res. 1996;57:568–577.

65. Castano G, Tula L, Canetti M, et al. Effects of policosanol in hypertensive patients with type II hypercholesterolemia. Curr Ther Res. 1996;57:691–699.

66. Castano G, Mas R, Arruzazabala ML, et al. Effects of policosanol and pravastatin on lipid profile, platelet aggregation and endothelemia in older hypercholesterolemic patients. Int J Clin Pharmacol Res. 1999;19:105–116.

67. Arruzazabala ML, Mas R, Molina V, et al. Effect of policosanol on platelet aggregation in type II hypercholesterolemic patients. Int J Tissue React. 1998;20:119–124.

68. Arruzazabala ML, Valdes S, Mas R, et al. Effect of policosanol successive dose increases on platelet aggregation in healthy volunteers. Pharmacol Res. 1996;34:181–185.

69. Arruzazabala ML, Valdes S, Mas R, et al . Comparative study of policosanol, aspirin and the combination therapy policosanol-aspirin on platelet aggregation in healthy volunteers. Pharmacol Res. 1997;36:293–297.

70. Snider SR. Octacosanol in parkinsonism [letter]. Ann Neurol. 1984;16:723.

71. Mirkin A., et al. Efficacy and tolerability of policosanol in hypercholesterolemic postmenopausal women. Int. J Clin Pharm Res 2001;21:31-34.

72. Gamez R, eta l. A 6-month study on the toxicity of high doses of policosanol orally administered to Sprague-Dawley rats. J Med Food. 2001;4:57-65.

73. Gouni-Berthold I, Berthold HK. Policosanol: clinical pharmacology and therapeutic significance of a new lipid-lowering agent. Am Heart J. 2002;143:356–365.

74. Castano G, Mas R, Fernandez JC, et al. Effects of policosanol on older patients with hypertension and type II hypercholesterolemia. Drugs R D. 2002;3:159-172.

75. Arruzazabala ML, Molina V, Mas R, et al. Antiplatelet effects of policosanol (20 and 40 mg/day) in healthy volunteers and dyslipidaemic patients. Clin Exp Pharmacol Physiol. 2002;29:891-897.