Policosanol (trade name Ateromixol) is a new cholesterol-lowering drug
that has been isolated and purified from sugar cane wax. The effects
of policosanol (50-500 mg/kg) administered orally for 18 months to mal
e and female Swiss mice were investigated. No differences in daily cli
nical observations, weight gain, food consumption and mortality (survi
val analysis) between groups were found. Histopathological study showe
d that the frequency of neoplastic (benign and malignant) lesions was
similar in the control and policosanol-treated groups. The lesions obs
erved were similar to the spontaneous lesions in Swiss mice reported i
n previous studies. As no drug-related increase in the occurrence of m
alignant or benign neoplasm was found, nor acceleration in tumour grow
th in any specific group observed, this study shows no evidence of pol
icosanol-induced carcinogenicity in Swiss mice.