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Journal of Clinical Pharmacology: Polysterols

Journal Clin. Pharmacol.
Volume 12 No. 4
July/August 1995
Pgs. 245-254
One-Year Study of the Effect of Policosanol on Lipid Profile in Patients With Type II Hypercholesterolemia
M. Canetti, M.D., M. Moreira, M.D., J. Illnait, Ph.D., R. Más, Ph.D., L. Fernández, M.Sc., J. C. Fernández, G. Castaño, Ph.D.
ABSTRACT
A 1-year, double-blind, placebo-controlled study of the efficacy, safety, and tolerability of policosanol 5 mg twice a day was conducted in 97 patients with type II hypercholesterolemia whose total and low-density lipoprotein (LDL) cholesterol was inadequately controlled by diet. After 2 months of policosanol therapy, significant reductions in total and LDL cholesterol were noted that persisted during the 1-year follow-up. Twelve months after therapy, LDL-C and total cholesterol decreased by 27.5% and 16.3%, respectively. Ratios of LDL to high-density lipoprotein (HDL) and total cholesterol to HDL were also signifi-cantly decreased after 2 months; reductions of 37.1% and 28%, respectively, were apparent 1 year after treatment. HDL increased during the study, but the increase (25.9%) reached statistical significance only after 12 months of therapy. Triglycerides changed nonsignificantly compared with baseline and placebo. Six patients (4 from the placebo group and 2 from the policosanol group) withdrew from the trial; no patient withdrew because of adverse experiences. No drug-related clinical or biochemical disturbances were observed. Adverse experiences reported were mild and transient and did not differ significantly from those seen with placebo. Policosanol (10 mg/d) administered for 1 year showed sustained efficacy, as well as very good safety and tolerability.
Selected Research References
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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. Illnait J., Castano G., Mas R. and Fernandez J.C. (1997): A comparative study on the efficacy and tolerability of policosanol and simvastatin for treating type II hypercholesterolemia. Abstract front the 4th International Confereiicc on Preventive Cardiology. June 29-July 3. Can. J. Cardiol. 13:Suppl. B, 342B.
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42. Crespo N., Alvarez R., Mas R., et al. (1997): Effect of policosanol on patients with non-insulin-dependent diabetes mellitus and hypercholesterolemia: A pilot study. Curr. Ther. Res. 58:44-51.
43. Castano G., Tula L., Canetti M., et al. (1996): Effects of policosanol in hypertensive patients with type II hypercholesterolemia. Curr. Ther. Res. 57:691-699.
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46. Zordoya R., Tula L., Castano G., Mas R., et al. (1996): Effects of policosanol on hypercholesterolemic patients with disturbances on serum biochemical indicators of hepatic function. Curr. Ther. Res. 57:568-577.
47. Davalos J.M., Mederos H., Rodriguez J., et al. (1996): Effect of policosanol in hypercholesterolemia due to nephrotic syndrome. X Latinciamerican Congress of Nephrology and Hypertension, 14 September, Santiago de Chile, Chile.
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49. Stusser R., Batista J., Padron R. et al. (1998): Long-term therapy with policosanol improves treadmill exercise-ECG testing performance of coronary heart disease patients. Int J Clin Pharmacol Ther 36(9):469-73.
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51. Aleman C.L., Mas R., Rodeiro L., et al. (1991): Toxicologia aguda del Ateromixol (PPG) en roedores. Rev. CENIC Cien. Biol. 22:102-105.
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53. Rodriguez C., Mesa R., Mas R., et al. (1994): Study of policosanol oral chronic toxicity in male monkeys (Maraca arctoidcs). Food and Chem. Toxicol. 32:565-575.
54. Mesa A. del R., Mas R., Noa M., et al. (1994): Toxicity of policosanol in Beagle dogs: one year study. Toxicol. Letters. 73:131-90.
55. Aleman C.L., Mas R., Hernandez C., et al. (1994): A 12 months study of policosanol oral toxicity in Sprague-Dawley rats. Toxicol. Lett. 70:77-87.
56. Aleman C.L., Noa M., Cerejido E., Mis R., Rodeiro L Hcrnindez C. and Briffis F. (1995): Carcinogenicity of policosanol in mice: A 18 months study. Fd. and Client. Toxicol., 33:573-578.
57. Aleman C.L., Mas R., Noa M., et al. (1994): Carcinogenicity of policosanol in Sprague Dawley rats: A 24 months study. Teratog. Carcinog. and Mutag., 14:239-249.
58. Rodriguez M.D. and Garcia H. (1994): Teratogenic and reproductive studies of policosanol in the rat and rabbit. Teratog., Carcinog. and Mutag., 14:107-113.
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60. Rodriguez M.D., Sanchez M., Garcia H. (1997): Multigeneration reproduction study of policosanol in rats. Toxicol. Lett. 90:97-106. 61. Carbajal D, Arruzazabala M. L., Mas R., et al. (1998): Interaction policosanol-warfarin on bleeding time and thrombosis in rats. Pharmacol Res 38(2):89-91.
61. Batista, J., Stusser, R., Saez, F. et al. (1996): Effect of policosanol on hyperlipidemia and coronary heart disease in middle-aged patient. A 14 month pilot study. International Journal of Clinical Pharmacology Research 34, 134-137.
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