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 Research and Clinical Studies

Used in the formulation of Cholestatrim™

 

Policosanol

1. Dalmer Laboratory. (1990): Policosanol: Experimental Pharmacokinetics. Data on file.

2. Menindez R., Sotolongo V., Fraga V., et al. (1996): Niveles plasmaticus y cxcrecion de la radiactividad total en voluntariois sanos tras la administracion ora de octacosanol-3H. Rev. CENIC Cicn. Biol. 27:32-35.

3. Arruzazabala M. L., Carbajal D., Mas R., et al. (1994): Cholesterol-lowering effects of policosanol in rabbits. Biol. Res. 27:205-209.

4. Menindez R., Arruzazabala M.L., Mas R., et al. (1997): Cholesterol-lowering effect of policosanol on rabbits with hypercholesterolemia induced by a wheat starch-casein diet. Br. J. Nutr. 77:323-932.

5. Menindez R., Fernandez L, Del Rio A., et al. (1994): Policosanol inhibits cholesterol biosynthesis and enhances LDL processing in cultured human fibroblasts. Biol. Res. 27:199-203.

6. Menindez R., Amor A.M. Gonzilez R.M. Fraga V. and Mds R. (1996): Effect of policosanol on the hepatic cholesterol biosynthesis of normocholesterolcmic rats. Biol. Res. 29:253-257.

7. Cruz Bustillo D., Mederos C.M. Mas R., et al. (1991): Efecto hipocolesterol mico del Ateromixol (PPG) en el cerdo en ceba. Rev. CENIC Cien. Biol. 22:62-63.

8. Arruzazabala M. L., Valdes S., Mas R., et al. (1995): Effect of policosanol succesive dose increase in platelet aggregation healthy volunteers. Pharmacol. Res. 34:181-185.

9. Valdes S., Arruzazabala M.L., Carbajal D., et al. (1996): Effect of policosanol on platelet aggregation in healthy volunteers. Intern. J. Clin. Pharmacol. Res. 16:67-72.

10. Carbajal D, Arruzazabala M. L., Mas R., et al. (1998): Effect of policosanol on platelet aggregation and serum levels of arachidonic acid metabolites in healthy volunteers. Prostaglandins Leuko. Essent. Fatty Acids 58(1):61-4.

11. Noa M., Herrera M., Magrancr J. and Mas R. (1994): Effect of policosanol on isoprenaline-induccd myocardial necrosis in rats. J. Pharm. Pharmacol. 46:282-285.

12. Carbajal D, Arruzazabala M. L., Mas R., et al. (1994). Effects of policosanol on experimental thrombosis models. Prostaglandins Leuko. Essent. Fatty Acids 50:249-251.

13. Arruzazabala M.L., Carbajal D., Molina V., et al. (1993): Effect of policosanol on cerebral ischcmia in mongolian gerbils: Role of prostacyclin and thromboxane Az. Prostaglandins Leuko. Essent. Fatty Acids 49:695-697.

14. Noa M., Mas R., and Magraner J. (1994): Effect of policosanol on lipofundin-induced lesions in rats. J. Pharm. Pharmacol. 47:289-291.

15. Noa M., Mas R. and Mesa A. del R. (1997): Effect of policosanol in circulating endothelial cell in experimental models in Sprague-Dawley rats and in rabbits. Br. J. Nutr. 49:999-1002.

16. Noa M, Mas R, Mesa R. (1998): Effect of policosanol on intimal thickening in rabbit cuffed carotid artery. Int. J. Cardiol. 67(2):125-32,

17. Batista J., Stusser I. L., Penichet M. and Uguet E. (1995): Doppler-ultrasound pilot studyof thecffects of long-term policosanol therapy on carotid-vertebral atherosclerosis. Curr. Ther. Res. 56:906-914.

18. Fraga V., Menindez R., Anior A.M., et al. (1997): Effect of policosanol on in vivo and in vitro rat liver microsomal lipid pcroxidation. Arch. Medical Res. 28:355-360.

19. Mas R., Menindez R., Fraga V., etal. (1997): Modification of rat lipoprotein peroxidation by oral administration of policosanol. Abstract from the 4th International Conference on Preventive Cardiology, June 29-July3. Can. J. Cardiol. 13:Suppl. B. 310B.

20. Hernendez F., Illnait J., Mas R., et al. (1992): Effects of policosanol on serum lipids and lipoproteins in healthy volunteers. Curr. Ther. Res. 51:568-575.

21. Pons P., Mas R., Illnait J., et al. (1992): Efficacy and safety of policosanol in patients with primary hypercholesterolemia. Curr. Ther. Res. S2:507-513.

22. Pons P., Rodriguez M., Robaina C., et al. (1994): Effects of succesive dose increases of policosanol on lipid profile of patients with type-II hypercholesterolemia and tolerability to treatment. J. Clin. Pharmacol. Res. 14:27-33.

23. Soltero I., Fuenmayor I., Colmenares J. (1993): Ensayo doble ciego para la evalaucion del policosanol en el tratamiento de la hiperlipoproteinemia tipo II. Arch. Venezol. Farmacol. Terap. 12:65-70.

24. Aneiros E. Calderon B., Mas R., et al. (1993): Effects of successive dose increases of policosanol on the lipid profile and tolerability of treatment. Curr. Ther. Res. 54:304-312.

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

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

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

28. Canetti M., Morera M., Illnait J., et al. (1995): One year study on the effect of policosanol (5 mg-twice-a-day) on lipid profile in patients with type II hypercholesterolemia. Adv. Ther. 12:245-254.

29. Canetti M., Morera M., Illnait J., et al. (1995): A two year study on the efficacy and tolerability of policosanol in patients with type II hypercholesterolemia. Intern. J. Clin. Pharmacol. Res. 15:159-165.

30. Canetti M., Morera M., Mas R., et al. (1997): Effects of policosanol on primary hypercholesterolemia: A 3-year open follow-up. Curr. Ther Res. 58:868-75.

31. Castano G., Nodarse M., Mas R., et al. (1996): Comparaciones de los efectos del policosanol y la lovastatina en pacicntes con hipercolesterolemia primiaria tipo II. Rev. CENIC Cicn. Biol. 27:57-63.

32. Dalmer Laboratory. Policosanol vs lovastatin: Comparative study on efficacy, safety and tolerability in the treatment of type-II hypercholesterolemia. Data on file.

33. Benitez M., Romero C., Mas R., et al. (1997): A comparative study of policosanol vs pravastatin in patients with type-II hypercholesterolemia. Curr. Ther. Res. 58:859-67.

34. Ortensi G., Gladstein J., Vail H. and Tesone P.A. (1997): A comparativc study of policosanol vs. simvastatin in elderly patients with hypercholesterolemia. Curr. Ther. Res. 58:390-401.

35.  One-Year Study of the Effect of Policosanol on Lipid Profile in Patients With Type II Hypercholesterolemia; Int. Journal Clin. Pharmacol. Volume 12 No. 4, July/August 1995
Pgs. 245-254

Resveratrol

1. Gronback, M. et al. Type of alcohol consumed and mortality from all causes, coronary heart diseaes, and cancer. Ann. Intern. Med. 2000;133:411-19.

2. Tadolini, B. et al. Resveratrol inhibition of lipid peroxidation. Free Radic. Res. 2000;33:105-14.

 3 Simonini, G. et al. Emerging potentials for an antioxidant therapy as a new approach to the treatment of systemic sclerosis. Toxicology 2000;155:1-15.

4 Zou JG, et al. Effect of red wine and wine polyphenol resveratrol on endothelial function in hypercholesterolemic rabbits. Int. J. Mol. Med. 2003;11:317-20.

5 Haider, U.G. et al. Resveratrol increases serine 15-phosphorylated but transcriptionally impaired p53 and induces a reversible DNA replication block in serum-activated vascular smooth muscle cells. Mol. Pharmacol. 200;363:925-32.

6 Zbikowska, H.M. et al. Antioxidants with carcinostatic activity (resveratrol, vitamin E and selenium) in modulation of blood platelet adhesion. J. Physiol. Pharmacol. 2000;51:513-20.

 7 Pace-Asciak, C.R. et al. The red wine phenolics trans-resveratrol and quercetin block human platelet aggregation and eicosanoid synthesis: implications for protection against coronary heart disease. Clin. Chim. Acta. 1995;235:207-19.

8 Burkitt, M.J. et al. Effects of trans-resveratrol on copper-dependent hydroxyl-radical formation and DNA damage: evidence for hydroxyl-radical scavenging and a novel, glutathione-sparing mechnism of action. Arch. Biochem. Biophys. 2000;381:253-63.

9 Draczyska-Lusiak, B. et al. Oxidized lipoproteins may play a role in neuronal cell death in Alzheimer disease. Mol. Chem. Neuropathol. 1998; 33:139-48. 

10. Jang, J.H. et al. Protective effect of resveratrol on beta-amyloid-induced oxidative PC12 cell death. Free Radic. Biol. Med. 2003;34:1100-10.

 11. Chanvitayapongs, S. et al. Amelioration of oxidative stress by antioxidants and resveratrol in PC12 cells. Neuroreport 1997;8:1499-502.

 12. Yang, Y.B. et al. Effects of resveratrol on secondary damages after acute spinal cord injury in rats. Acta. Pharmacol. Sin. 2003; 24:703-10.

13. Sinha, K. et al. Protective effect of resveratrol against oxidative stress in middle cerebral artery occlusion model of stroke in rats. Life Sci. 2002;71:655-65.

14. Cal, C. et al. Resveratrol and cancer: chemoprevention, apoptosis, and chemoimmunosensitizing activities. Curr. Med. Chem-Anti-Cancer Agents 2003;3:77-93.

15. Pervaiz, S. Resveratrol–from the bottle to the bedside? Leuk. Lymphoma 2001;40:491-8.

16. Ding, X.Z. et al. Resveratrol inhibits proliferation and induces apoptosis in human pancreatic cancer cells. Pancreas 2002;25:e71-e76.

17. Gusman, J. et al. A reappraisal of the potential chemopreventive and chemotherapeutic properties of resveratrol. Carcinogenesis 2001;22:1111-17.

 18. Lu, R. et al. Resveratrol, a natural product derived from grape, exhibits antiestrogenic activity and inhibits the growth of human breast cancer cells. J. Cell. Physiol. 1999;179:297-304.

19. Serrero, G. et al. Effect of resveratrol on the expression of autocrine growth modulators in human breast cancer cells. Antioxid. Redox. Signal 2001;3:969-79.

20. Mitchell, S.H. et al. Resveratrol inhibits the expression and function of the androgen receptor in LNCaP prostate cancer cells. Cancer Res. 1999;59:5892-5.

21. Narayanan, B.A. et al. Interactive gene expression pattern in prostate cancer cells exposed to phenolic antioxidants. Life Sci. 2002;70:1821-39.

22. Pozo-Guisado, E. et al. The antiproliferative activity of resveratrol results in apoptosis in MCF-7 but not in MDA-MB-231 human breast cancer cells: cell-specific alteration of the cell cycle. Biochem. Pharmacol. 2002;64:1375-86.

23. Wietzke, J.A. et al. Phytoestrogen regulation of a vitamin D3 receptor promoter and 1.25-dihydroxyvitamin D3 actions in human breast cancer cells. J. Steroid Biochem. Mol. Biol. 2003; 84:149-57.

24. Ulsperger, E. et al. Resveratrol pretreatment desensitizes AHTO-7 human osteoblasts to growth stimulation in response to carcinoma cell supernatants. Int. J. Oncol. 1999;15:955-59.

25. Lipkin, M. et al. Dietary factors in human colorectal cancer. Annu. Rev. Nutr. 1999;19:545-86.

26. Nakagawa, H. et al. Resveratrol inhibits human breast cancer cell growth and may mitigate the effect of linoleic acid, a potent breast cancer cell stimulator. J. Cancer Res. Clin. Oncol. 2001;127:258-64.

27. Zhuang, H. et al. Potential mechanism by which resveratrol, a red wine constituent, protects neurons. Ann. N.Y. Acad. Sci. 2003;993:276-86.

28. Floreani, M. et al. Oral administration of trans-resveratrol to guinea pigs increases cardiac DT-diaphorase and catalase activities, and protects isolated atria from menadione toxicity. Life Sci. 2003;72:2741-50.

29. Ferguson, L.R. Role of plant polyphenols in genomic stability. Mut. Res. 2001;475:89-111.

30. Casper, R.F. et al. Resveratrol has antagonist activityon the aryl hydrocarbon receptor: implications for prevention of dioxin toxicity. Mol. Pharmacol. 1999;56:784-90.

31. Hsieh, T.C. et al. Cell cycle effects and control of gene expression by resveratrol in human breast carcinoma cell lines with different metastatic potentials. Int. J. Oncol. 1999;15:245-52.

32. Bagnardi V. et al. A meta-analysis of alcohol drinking and cancer risk. BR. J. Cancer. 2001;85:1700-1705.

33. Agelink, M.W. et al. Alcoholism, Peripheral neuropathy (PNP) and cardiovascular autonomic neuropathy (CAN). J. neurol. Sci. 1998 Dec 11;161(2):135-42.

34. Torres-Lopez, J.E. et al. Comparison of the antinociceptive effect of celecoxib, diclofenac and resveratrol in the formalin test. Life Sci. 2002;70:1669-76.

 35. Mahady, G.B. et al. Resveratrol and red wine extracts inhibit the growth of CagA+ strains of Helicobacter pylori in vitro. Am. J. Gastroenterol. 2003;98:1440-1.

36. Yen, G.C. et al. Effects of resveratrol and 4-hexylresorcinol on hydrogen peroxide-induced oxidative DNA damage in human lymphocytes. Free Radic. Res. 2003;37:509-14.

37. Revel, A. et al. Resveratrol, a natural aryl hydrocarbon receptor antagonist, protects lung from DNA damage and apoptosis caused by benzo[a]pyrene. J. Appl. Toxicol. 2003;23:255-61.

38. Adhami, V.M. et al. Suppression of ultraviolet B exposure-mediated activation of NF-kappaB in normal human keratinocytes by resveratrol. Neoplasia 2003;5:74-82.

39.  Brito, P. et al.  The Interaction of Resveratrol with Ferrylmyoglobin and Peroxynitrite, protection against LDL Oxidation.  Pub. Med.  2002

40.  Franken EN, et al.  Inhibition of Human LDL Oxidation by Resveratrol.  Lancet 1993

Vitamins A, C, E

1.  Knekt, P.  Antioxidant Vitamin Intake and Coronary Mortality in a Longitudinal Population Study.  American Journal of Epidemiology, 1994. 

2.  Block, G. et al.  Plasma C-Reactive Protein Concentrations in Active and Passive Smokers: Influence of Antioxidant Supplementation.  Journal of the American College of Nutrition, 2004. 23:141-147.

3. MacWilliam, Lyle. Comparative Guide To Nutritional Supplements.  Northern Dimensions Publishing 2003.  pgs. 7-59

4.  Strand R., Bionutrition: Winning the War Within. Comprehensive Wellness Publishing, 1998.  pg.s 18-26

5.  Ross R. and Glomser JA.  The Pathogenesis of Atherosclerosis.  New England Journal of Medicine 1976.  295:369-377.

6.  Diaz MN, Frei, B, Vita JA, et al.  Antioxidants and Atherosclerotic Heart Disease.   New England Journal of Medicine 1997.  337:408-416.

7.  Bottiglieri T.  Folate, Vitamin B12, and Neuropsychiatric Disorders.  Nutrition Review 1996.  54:382-390.

  1. Esterbauer H, Dieber-Rothender M, Striegl G, et al.  Role of Vitamin E In Preventing The Oxidation of Low-Density Lipoprotein.  American Journal of Clinical Nutrition 1991.  314s-321s.

9.  Jialal I., Norkus EP, Cristol L, et al.  Beta Carotene Inhibits the Oxidative Modification of Low Density Lipoprotein.  Biochim Biophys. Acta.  1991. 1086:134-138.

  1. Passwater RA. All About Antioxidants.  Avery Publishing, New York, NY.  1998.  Pgs. 31-42.
  1. Cooper, Kenneth.  Advanced Nutritional Therapies.  Thomas Nelson Inc., Vancouver, BC.  1996.  Pgs. 37-55

 12.  Block G. Vitamin C and Cancer Prevention:  The Epidemiologic Evidence.  American Journal of Clinical Nutrition 1991.  53:270-282.

  1. Fairfield KM, Fletcher RH.  Vitamins for Chronic Disease Prevention in Adults Scientific Review.  Journal of the American Medical Assoc. 2002.  287:3116-3126.
  1.   Fairfield KM, Fletcher RH.  Vitamins for Chronic Disease Prevention in Adults Clinical Applications.  Journal of the American Medical Assoc. 2002.  287:3117-3129.
  1.   Enstrom JE, Kanim LE, and Klein MA.  Vitamin C Intake and Mortality Among a Sample of the U.S. Population.  Epidemiology 1992.  3:194-202.
  1.   Stampfer MJ, Hennekens CH, Manson JE, et al.  Vitamin E Consumption and the Risk of Coronary Disease in Women.  New England Journal of Medicine 1993.  328:1444-1449.
  1.   Stampfer MJ, Rimm EB, Ascherio A, et al.  Vitamin E Consumption and the Risk of Coronary Disease in Men.  New England Journal of Medicine 1993.  328:1450-1456.
  1.  Meyer F, Bairati I, and Dagenais GR.  Lower Ischemic Heart Disease Incidence and Mortality Among Vitamin Supplement Users.  Canadian Journal of Cardiology 1996.  12:930-940.
  1.  Stephens NG, Parsons A, Schofield PM, et al.  Randomized Controlled Trial of Vitamin E in Patients With Coronary Heart Disease: Cambridge Heart Antioxidant Study.  Lancet 1996.  347:781-78
  1.   Losonczy KG, Harris TB, and Havlik RJ. Vitamin E and Vitamin C Supplement Use and Risk Of All-cause And Coronary Heart Disease Mortality In Older Persons: The Established Populations for Epidemiologic Studies of the Elderly. American Journal of Clinical Nutrition, 1996.  64:190-196.
  1. Traber MG.  The Biological Activity of Vitamin E.  The Linus Pauling Institute, Oregon State University 1998.
  1. National Institutes of Health.  Facts About Dietary Supplements.  www.cc.nih.gov/ccc/supplements/.  2002
  1. National Academies Press.  Dietary Reference Intakes For Vitamin C, Vitamin E, Selenium, and Carotenoids, Food and Nutrition Board, Institute of Medicine, Washington D.C., 2000.
  1.  Steinberg D. et al.  Antioxidants in the Prevention of Human Atherosclerosis.  Circulation, 1992.  85:2337-2344.
  1.   Strand, RD.  What Your Doctor Doesn’t Know About Nutritional Medicine May Be Killing You.  Thomas Nelson Inc.  2002.  pgs. 21-30,41-50,175-198.

 

Inflammation

  1. Strand, Ray.  What Your Doctor Doesn’t Know About Nutritional Medicine May Be Killing You. Thomas Nelson Publishers 2002; pg. 41-50

2.  Ridker, PC.  Reactive Protein and Other markers of inflammation in the prediction of cardiovascular disease in women.  New England Journal of Medicine, 342.

  1. Ross, R.  Atherosclerosis: An Inflammatory Disease.  New England Journal of Medicine, 1999.  340: 115-123
     
  1. Steinberg, D.  Antioxidants in the prevention of human atherosclerosis.  Summary of the National Heart, Lung, and Blood Institute Workshop.  Sept. 1991

 

  1. May, JM.  How Does Ascorbic Acid prevent Endothelial Dysfunction?  Free Radical Biology Med, 2000.  28:1421-1429.

 

  1. Lenhart, S.  Vitamins for management of Cardiovascular Disease, Pharmaco, 1999.  19:1400-1414.

 

  1. Carr, A.  The Role of Natural Antioxidants in preserving the biological activity of endothelium-derived nitric oxide.  Free Radical Biol. Med.  2000.  28:1806-1814.

 

  1. Diaz, MN, et al.  Antioxidants and atherosclerotic heart disease.  New England Journal of Medicine 1997.  337:408-416.

 

  1. Harris, W.  The Prevention of atherosclerosis with antioxidants.  Cardiology 1992.  P 640.

 

  1. Hennekens, CH.  Antioxidants and Heart Disease: Epidemiology and Clinical Evidence.  Clinical Cardiology 1993.  16:10-15.

 

  1. Hodis, MD et al.  Serial Coronary angiographic evidence that antioxidant vitamin intake reduces progression of coronary atherosclerosis.  Journal of the American Medical Association 1995.  273:1849-1854.

 

  1. Koenig, W.  Inflammation and Coronary heart disease: An Overview.  Cardiology Review 2001.  9:31-35.

 

  1. Merchant, N  Oxidative Stress in cardiovascular disease.  Journal of Nuclear Cardiology, 2001.  8:379-389.

 

  1. Stampfer, MD, Meir J., Hennekens, MD et al.  Vitamin E consumption and the risk of coronary disease in women. New England Journal of Medicine, 1993.  328:1444-1449.

 

  1. Zhang, W.  The Role of Lipoic Acid in Inflammation and Atherosclerosis.  Linus Pauling Institute, Oregon State University research report.  2003

 

  1.   Stein, R.  Inflammation May Impair Heart as Much as Cholesterol.  Article in Washington Post, 1-6-2005, front page. 

 

Homocysteine

  1. Stampfer, MJ et al. A perspective study of plasma homocysteine and risk of myocardial infarction; U.S. Phys. J American Medical Assoc., 1992, 268:877-881

 

  1. Glueck, CJ et al. Evidence that Homocysteine is an Independent Risk Factor for Artherosclerosis in Hyperlipidemic patients.  Amer. Journal of Cardiology 1995, 75: 132-136.

 

  1. Landren F et al. Plasma Homocysteine in Acute Myocardial Infarction: Homocysteine-Lowering Effect of Folic Acid.  Journal of Internal Medicine 1995, 89: 208-20

 

  1.   Ellis JM and McKully KS.  Prevention of myocardial infarction by Vitamin B6.  Res Commun Mol Pathol Pharmacol  1995; 89:208-220

 

  1. Van den Berg M et al.  Combined Vitamin B-6 plus Folic Acid Therapy in Young patients with arteriosclerosis and hypohomocysteinemia.  Journal of Vascular Surgery, 1994, 20(6):933-940.

           

  1. Strand, Ray.  What Your Doctor Doesn’t Know About Nutritional Medicine May Be Killing You. Thomas Nelson Publishers 2002; pg. 51-59

 

  1. MacWilliam, Lyle. Comparative Guide To Nutritional Supplements.  Northern Dimensions Publishing 2003.  pgs. 36-37

 

  1. Firshein, R. The Nutraceutical Revolution.  Riverside Books, New York  1998.

 

  1. Boushey, CJ et al.  A Quantitative Assessment of Plasma Homocysteine as a risk factor for Vascular Disease.  Journal of American Medical Association 1995. 

 

  1. Ubbink JB , et al.  Hyperhomocysteinemia and the response to vitamin supplementation.  Clin Invest 1993, 71:993-998.

 

  1. Calvaca, V. Oxidative Stress and Homocysteine in coronary artery disease.  Clinical Chemistry, 2001  47:887-892.

 

 

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