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This randomized, double-blind, multicenter placebo-controlled study was conducted to investigate the efficacy and tolerability of policosanol, a cholesterol-lowering drug purified from sugar cane wax, in women who had experienced menopause and showed elevated serum total cholesterol and low density lipoprotein (LDL)-cholesterol levels despite a 6-week standard lipid-lowering diet. Thus, 56 eligible patients were randomized to receive placebo or policosanol 5 mg/day for 8 weeks and the dose was doubled to 10 mg/day during the next 8 weeks. Policosanol (5 and 10 mg/day) significantly decreased LDL-cholesterol (17.3% and 26.7%, respectively), total cholesterol (12.9% and 19.5%) as well as the ratios of LDL-cholesterol to high-density lipoprotein (HDL)-cholesterol (17.2% and 26.5%) and total cholesterol to HDL-cholesterol (16.3% and 21.0%) compared with baseline and placebo. HDL-cholesterol levels were significantly raised by 7.4% at study completion. No significant changes occurred in the lipid profile of the placebo group. The drug was safe and well tolerated. No drug-related adverse effects were observed. None of the patients administered policosanol but three of those administered placebo withdrew from the trial because of adverse effects: one due to a serious hypertensive status, one because of an allergic reaction (pruritus plus skin rash) and one due to gastrointestinal disturbances (nauseas plus vomiting). Eleven placebo patients reported 24 adverse effects compared with six policosanol patients who reported seven adverse effects (p < 0.05). In addition, five placebo (17.9%) and 13 policosanol patients (46.4%) (p < 0.05) reported improvements in habitual symptoms and health perception during the study. In conclusion, policosanol was effective and well tolerated in hypercholesterolemic postmenopausal women, showing additional benefits in the health perception of the study patients.
A Mirkin, and
R Mas, and
M Martinto, and
R Boccanera, and
A Robertis, and
R Poudes, and
A Fuster, and
E Lastreto, and
M Yañez, and
G Irico, and
B McCook, and
A Farré
January 1992,
Clinical therapeutics,
A Mirkin, and
R Mas, and
M Martinto, and
R Boccanera, and
A Robertis, and
R Poudes, and
A Fuster, and
E Lastreto, and
M Yañez, and
G Irico, and
B McCook, and
A Farré
January 1992,
Clinical therapeutics,
A Mirkin, and
R Mas, and
M Martinto, and
R Boccanera, and
A Robertis, and
R Poudes, and
A Fuster, and
E Lastreto, and
M Yañez, and
G Irico, and
B McCook, and
A Farré
September 2005,
The Annals of pharmacotherapy,
A Mirkin, and
R Mas, and
M Martinto, and
R Boccanera, and
A Robertis, and
R Poudes, and
A Fuster, and
E Lastreto, and
M Yañez, and
G Irico, and
B McCook, and
A Farré
March 1999,
International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,
A Mirkin, and
R Mas, and
M Martinto, and
R Boccanera, and
A Robertis, and
R Poudes, and
A Fuster, and
E Lastreto, and
M Yañez, and
G Irico, and
B McCook, and
A Farré
September 2007,
Menopause international,
A Mirkin, and
R Mas, and
M Martinto, and
R Boccanera, and
A Robertis, and
R Poudes, and
A Fuster, and
E Lastreto, and
M Yañez, and
G Irico, and
B McCook, and
A Farré
June 2000,
Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology,
A Mirkin, and
R Mas, and
M Martinto, and
R Boccanera, and
A Robertis, and
R Poudes, and
A Fuster, and
E Lastreto, and
M Yañez, and
G Irico, and
B McCook, and
A Farré
January 2000,
Maturitas,
A Mirkin, and
R Mas, and
M Martinto, and
R Boccanera, and
A Robertis, and
R Poudes, and
A Fuster, and
E Lastreto, and
M Yañez, and
G Irico, and
B McCook, and
A Farré
June 2004,
Metabolism: clinical and experimental,
A Mirkin, and
R Mas, and
M Martinto, and
R Boccanera, and
A Robertis, and
R Poudes, and
A Fuster, and
E Lastreto, and
M Yañez, and
G Irico, and
B McCook, and
A Farré
January 1998,
Journal of medicine,
A Mirkin, and
R Mas, and
M Martinto, and
R Boccanera, and
A Robertis, and
R Poudes, and
A Fuster, and
E Lastreto, and
M Yañez, and
G Irico, and
B McCook, and
A Farré
October 2000,
Calcified tissue international,
