The Side Effects of Policosanol are
extremely rare and always mild.
In clinical
trials the side effects of policosanol were comparable to a placebo.
In all controlled studies,
policosanol has exerted no negative effect of any clinical or laboratory
parameter. Following is a list of the side effects
of policosanol, that although rare, have been reported:
Policosanol Side Effects in Elderly Persons
Policosanol administered for short or long-term in patients over the
age of 60 years with hypercholesterolemia has been effective, safe and
nearly free of side effects.
In older
adults policosanol has a similar efficacy
profile to that observed in patients below 60 years old. Table 3 summarizes
the main results obtained at months 6 and 12 in a long-term study performed
in elderly patients.
The withdrawal
rate for policosanol in short and long-term clinical studies was comparable
or even lesser than that of placebo; only 0.2 % policosanol-patients withdrew
before conclusion of the study as a result of policosanol side effects, compared
with 0.6 % of placebo patients.
Comparative studies have shown a dropout
rate due to side effects of policosanol of 0.9% compared
with a 4.4% rate for those treated with other lipid-lowering drugs (e.g.,
statins, fibrates, probucol, and acipimox).
In a large post marketing
surveillance study, the side effects of policosanol were assessed in 27,879
patients (17,225 patients for two years and 10,654 patients for four years).
All of the patients were treated for at least one month.
During the study only
86 patients ( 0.31%) reported adverse effects, the most frequent of which
was weight loss.
A single dose (1,000 mg/day) as much as 50 times
the maximum recommended dose (20 mg/day) administered to healthy volunteers
produced no adverse reaction, hence no over dosage symptoms have been
detected.
Animal studies demonstrate the policosanol is virtually
side effect free and non-toxic
as the oral LD50 in rats, mice, rabbits and dogs was > 5 000 mg/kg. Body
weight gain, behavioral assays, as well as biochemical and hematological
determinations in surviving animals at the end of the test (14 days) did
not reveal differences between treated and control groups. Moreover, weight
organ analysis and histopathological study did not reveal differences
between groups.
The effects of successive dosage increases of policosanol
administered orally to Macaca arctoides monkeys demonstrated that even
the highest dose administered (500 mg/kg) Policosanol was tolerated.
Similar
results have been shown toxicity models in
rats, dogs, and monkeys. Policosanol did not produce any adverse
side effects on fertility and reproduction in animal studies, nor has it exerted
any mutagenic or carcinogenic effects.
Specifically, policosanol
administered orally up to 500 and 1000 mg/kg did not produce embryotoxic nor teratogenic effects in rats or
rabbits and a multigenerational study did not show any toxicity. In
other words there were no side effects of policosanol.
Pregnancy
Although policosanol neither induced teratogenic effects in rats or rabbits
nor affected rat fertility and reproduction, the treatment is not allowed
to use in pregnant women. The reason for this restriction is that cholesterol
and associated metabolic products are required for an adequate fetal development.
Since hypercholesterolemia and atherosclerosis are chronic diseases, the
suspension of lipid-lowering therapy for 9 months cannot be considered
as an additional coronary risk factor.
Lactation
It is not known whether the product or some active metabolite is excreted
via the human milk during nursing, therefore policosanol therapy should be discontinued
during lactation.
Pediatric use
Efficacy, safety of policosanol side effects in children has not been well established.
Thus, treatment of children with policosanol is not recommended at the
present.
|
A survivor unlocks the
mystery of
lowering cholesterol
without the side effects of policosanol
