The "New" Cholestin™

By Steve Bratman, MD

A recently marketed product called "new" Cholestin™ purportedly contains policosanol, but actually contains a related product manufactured from beeswax. (The original Cholestin contained red yeast rice as its active ingredient, a natural product that contains lovastatin and related statins [see Alternative Therapies in Women’s Health, July 2001, pp. 53-55]. When court action forced Pharmanex, the manufacturers of Cholestin, to desist marketing the original product, the company substituted a beeswax extract.)

Although the label on "new" Cholestin states that it contains "policosanol," the accuracy of this statement has been challenged by Rosa Mas.1 Although beeswax does contain higher aliphatic alcohols, the proportions of these ingredients vary substantially from those in sugar cane. In beeswax, triacontanol rather than octacosanol is the primary constituent, and the proportions of other constituents differ as well.

Cuban researchers have investigated certain beeswax extracts extensively and report that while they possess cytoprotective and anti-inflammatory properties, they lack hypolipidemic action.2-19 Conversely, they state that sugar cane policosanol lacks cytoprotective and anti-inflammatory properties.

In response to this criticism, Pharmanex stated that their beeswax product is manufactured differently from the extract studied in Cuba, and is delivered in a different galenic formulation. Furthermore, they cite unpublished animal trials and two small open-label human trials in suggesting that their product does have hypolipidemic effects in moderately hyperlipidemic individuals. Pharmanex states that it has begun a double-blind, placebo-controlled trial on the product and expects to report results in March 2002.

References

1. Mas R. Beeswax alcohols. Drugs Future 2001;26: 731-744.

2. Aleman C, et al. One-year dog toxicity study of D-002, a mixture of aliphatic alcohols. J Appl Toxicol 2001; 21:179-184.

3. Carbajal D, et al. Efecto del D-002 en modelos experimentales de anafilaxia [English abstract]. Rev CENIC Cienc Biol 2001;32:1-4.

4. Rodeiro I, et al. Toxicologia aguda oral del D-002 en ratas Sprague Dawley [English abstract]. Rev CENIC Cienc Biol 1995;26:34-36.

5. Carbajal D, et al. Effect of D-002 on gastric mucus composition in ethanol-induced ulcer. Pharmacol Res 2000;42:329-334.

6. Carbajal D, et al. Anti-ulcer activity of higher primary alcohols of beeswax. J Pharm Pharmacol 1995;47: 731-733.

7. Carbajal D, et al. Anti-ulcer activity of higher primary alcohols of beeswax. J Pharm Pharmacol 1995;47: 731-733.

8. Gamez Menendez R, et al. Evaluacion mutagenica del D-002 en el ensayo de micronucleos en medula osea en ratas Sprague Dawley de ambos sexos [English abstract]. Rev CENIC Cienc Biol 1999;30:70-72.

9. Rodeiro Guerra I, et al. Estudio de la induccion de letales dominantes del D-002 en ratones NMRI de los dos sexos. Rev Cubana Invest Biomed 1999;18:43-44.

10. Noa M, et al. Comparative study of D-002 versus sulfasalazine on acetic acid-induced colitis in rats. Drugs Exp Clin Res 2000;26:13-17.

11. Noa M, Mas R. Effect of D-002 on the pre-ulcerative phase of carrageenan-induced colonic ulceration in the guinea-pig. J Pharm Pharmacol 1998;50:549-553.

12. Rodeiro I, et al. Oral toxicological studies of D-002 in mice. Rev CENIC Cienc Biol 1999;30:73-76.

13. Noa M, et al. Effect of D-002 on acetic acid-induced colitis in rats at single and repeated doses. Pharmacol Res 2000;41:391-395.

14. Rodeiro I, et al. Preclinical oral toxicology in rats of D-002, a natural drug with antiulcer effects. Drug Chem Toxicol 1998;21:151-162.

15. Rodeiro I, et al. Estudio genotoxico del D-002, un producto con actividad antiulcerosa [English abstract]. Rev Toxicol 1998;15:117-121.

16. Rodriguez MD, et al. Developmental toxicity of D-002 (a mixture of aliphatic primary alcohols) in rats and rabbits. J Appl Toxicol 1998;18:313-316.

17. Rodeiro I, et al. D-002: effects on hepatic drug metabolizing enzyme activities in rats. Biotecnol Aplicada 2001;18:88-90.

18. Valdes S, et al. Estudio comparativo de los efectos antiulcerosos del D-002 con sucralfato y omeprazol [English abstract]. Rev CENIC Cienc Biol 2000;31: 117-120.

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