Citations: 1-5
<1>
Title
[Comparative effects of policosanol and two HMG-CoA
reductase inhibitors on type II hypercholesterolemia]. [Spanish]
Source
Revista Medica de Chile. 127(3):286-94, 1999 Mar.
Abstract
BACKGROUND: Policosanol is a new cholesterol lowering agent
derived from sugar cane. AIM: To compare the cholesterol lowering efficacy of
policosanol with HMG CoA inhibitors. PATIENTS AND METHODS:
Patients with a LDL cholesterol over 160 mg/dl were studied. If, after 6
weeks of diet, cholesterol persisted elevated, they were doubly blind
randomized to receive policosanol 10 mg/day (55 patients),
lovastatin 20 mg/day (26 patients) or simvastatin 10 mg/day (25 patients).
Serum cholesterol was measured again after 8 weeks of therapy. RESULTS:
Initial demographic and laboratory data were similar among treatment groups.
A 24% LDL cholesterol reduction was obtained with
policosanol, compared with a 22% reduction with lovastatin
and a 15% reduction with simvastatin. HDL cholesterol significantly increased
in patients on policosanol and did not change in the other
treatment groups. Adverse effects of policosanol were mild
and unspecific. No changes in hepatic enzymes were observed. CONCLUSIONS:
Policosanol is a safe and effective cholesterol reducing
agent.
<2>
Title
Effects of policosanol in patients with type II
hypercholesterolemia and additional coronary risk factors.
Source
Clinical Pharmacology & Therapeutics. 65(4):439-47, 1999 Apr.
Abstract
INTRODUCTION: This study was undertaken to evaluate the efficacy, safety, and
tolerability of policosanol, a new cholesterol-lowering
drug, in patients with type II hypercholesterolemia and additional coronary
risk factors. PATIENTS AND METHODS: After 5 weeks of a standard step-1
lipid-lowering diet, 437 patients were randomized to receive, under
double-blind conditions, 5 mg policosanol or placebo once a
day with the evening meal for 12 weeks and 10 mg policosanol
or placebo for the next 12 weeks. RESULTS: Both groups were similar at
randomization. Policosanol (5 and 10 mg/day) significantly
reduced (P < .001) serum low-density lipoprotein cholesterol (18.2% and
25.6%, respectively) and cholesterol (13.0% and 17.4%), and it significantly
raised (P < .01) high-density lipoprotein cholesterol (15.5% and 28.4%).
Triglycerides remained unchanged after the first 12 weeks and lowered
significantly (5.2%; P < .01) at study completion.
Policosanol was safe and well tolerated, and no drug-related
disturbances were observed. Two male patients who received placebo died
during the study--one because of a myocardial infarction and the other
because of a cardiac arrest that occurred during a surgical intervention.
There were 11 serious adverse events (5.1%) in 10 patients who received
placebo (4.6%), 7 of which were vascular, compared with no serious adverse
events reported in patients receiving policosanol (P < .01).
CONCLUSIONS: Subjects in the group treated with policosanol
did not have serious adverse events during the 24-week study. This study
shows that policosanol is effective, safe, and well
tolerated in patients with hypercholesterolemia and concomitant coronary risk
factors.
<3>
Title
A double-blind, placebo-controlled study of the effects of
policosanol in patients with intermittent claudication.
Source
Angiology. 50(2):123-30, 1999 Feb.
Abstract
This study was undertaken to evaluate the efficacy and tolerability of
policosanol, a new cholesterol-lowering drug with
concomitant antiplatelet effects, in patients with intermittent claudication.
After a baseline period of 6 weeks, 62 patients were randomized to receive,
under double-blind conditions, either placebo (31 patients) or
policosanol (31), 10 mg twice daily. Walking distances in a
treadmill (constant speed 3.2 km/hr, slope 10 degrees) were assessed before
and after 6 months of treatment. Both groups were similar at randomization.
Policosanol increased significantly (p < 0.01) the initial
claudication distance from 132.5+/-13.5 m (baseline) to 205.7+/-36.3 m (after
therapy) and the absolute claudication distance (p<0.0001) from 229.5+/-22.0
m to 365.4+/-46.9 m; meanwhile both variables remained unchanged in the
placebo group (p<0.05). The reduction of lower limb symptoms showed a greater
benefit in the policosanol group. There was no significant
change in either group in the ankle/arm pressure ratio. The treatment was
well tolerated. There were 10 discontinuations (seven placebo, three
policosanol) from the study. Six withdrawals occurred
because of adverse events (AE); all were in placebo patients. There were five
serious vascular AEs in the placebo group but none in the
policosanol group (p<0.05). Overall, 12/31 (38.7%) placebo
patients and 3/31 (9.7%) policosanol patients experienced
AEs after randomization, which showed a lesser incidence of AEs in the
policosanol group (p<0.01). The present study demonstrates a
beneficial effect of policosanol in patients with
intermittent claudication.
<4>
Title
Effect of policosanol on intimal thickening in rabbit cuffed
carotid artery.
Source
International Journal of Cardiology. 67(2):125-32, 1998 Dec 1.
Abstract
We studied the effect of policosanol on smooth muscle cell
proliferation in the cuffed carotid artery of the rabbit.
Policosanol is a mixture of higher aliphatic primary
alcohols isolated from sugar cane wax, with cholesterol lowering effects
proved in experimental models and patients with type II hypercholesterolemia.
It acts by inhibiting cholesterol biosynthesis. The positioning of a
nonocclusive silicone collar around the rabbit carotid artery results in the
formation of a neointima. We wished to determine whether
policosanol orally administered prevented intimal
thickening. Collars were placed around the left carotid for 15 days. The
contralateral artery was sham operated. We included three experimental
groups: a control received vehicle and two others
policosanol at 5 and 25 mg Kg until sacrificed. Samples of
arteries were examined by light and electron microscopy. To evaluate intimal
thickening the cross-sectional area of intima and media were measured.
Neointima was significantly reduced in policosanol-treated
animals compared with controls. The smooth muscle cell proliferation was
studied by the immunohistochemical detection of proliferating cell nuclear
antigen and a significant reduction was observed in
policosanol treated rabbits. It is concluded that
policosanol has a protective effect on the neointima
formation in this experimental model.
<5>
Title
Long-term therapy with policosanol improves treadmill
exercise-ECG testing performance of coronary heart disease patients.
Source
International Journal of Clinical Pharmacology & Therapeutics. 36(9):469-73,
1998 Sep.
Abstract
This study examined the effects of long-term lipid-lowering therapy with
policosanol on the clinical evolution, and exercise-ECG
testing responses of 45 coronary heart disease (CHD) patients with myocardial
ischemia, documented by exercise 201T1-myocardial perfusion scintigraphy, in
an overall randomized, double-blind, placebo-controlled trial, made for
different test endpoints. Fifteen patients were treated with 5 mg of
policosanol twice daily; another 15 patients were
administered the same drug dose plus 125 mg aspirin; and the other 15
patients received placebo plus equal aspirin dose. They were followed for 20
months, previous baseline observations, with treadmill exercise-ECG, besides
serum lipid test. Beneficial changes on proportions among the 2
policosanol groups and the placebo group, showed an
increment on functional capacity class, a decrement on rest and exercise
angina, and a significant decrease in cardiac events, and in ischemic ST
segment response, especially in the policosanol plus aspirin
group (p = 0.05, X2(2df) = 5.8; p = 0.04, p = 0.02; Fisher). After treatment,
sets of mean changes revealed an increase on maximum oxygen uptake, and a
decline on double product simultaneously in both policosanol
groups (p < or = 0.02, p < or = 0.002; Pillais, Hotellings' T2), while the
placebo group was impaired. Aerobic functional capacity percent showed an
increment in policosanol groups (p < or = 0.05, paired T).
Lipid levels improved as other endpoints already reported. A supposed
ergogenic effect of octacosanol, policosanol's main active
compound, was not detected with this design. These results show that
policosanol-treated CHD patients improved clinical
evolution, and exercise-ECG responses, owing to the amelioration of
myocardial ischemia, even more when administered with aspirin.
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