In this pilot, randomized, double-blind study, we compared the effects of
policosanol and
lovastatin on
lipid profile and lipid peroxidation in patients with
dyslipidemia and
type 2 diabetes mellitus. After 4 weeks on a
cholesterol-lowering diet, 36 patients were randomized to
policosanol (10 mg/day) or
lovastatin (20 mg/day)
tablets o.i.d. for 8 weeks.
Policosanol significantly (p < 0.001) lowered serum
low-density lipoprotein-cholesterol (
LDL-C) (29.9%), total
cholesterol (21.1%),
triglycerides (13.6%) and the
LDL-C/
high-density lipoprotein-cholesterol (HDL-C) (36.7%) and total
cholesterol/HDL-C (28.9%) ratios and significantly (p < 0.01) increased HDL-C (12.5%).
Lovastatin significantly (p < 0.001) lowered
LDL-C (25%), total
cholesterol (18%),
triglycerides (10.9%) and the
LDL-C/HDL-C (30.4%) and total
cholesterol/HDL-C ratios (23.9%) and significantly (p < 0.01) raised HDL-C (8.3%).
Policosanol was more effective (p < 0.05) than
lovastatin in reducing both ratios and in increasing (p < 0.05) HDL-C.
Policosanol, but not
lovastatin, significantly raised the lag time (20.9%) of Cu+2-induced
LDL peroxidation and total plasma
antioxidant activity (24.2%) (p < 0.05). Both
policosanol and
lovastatin significantly decreased the propagation rate (41.9% and 41.6% respectively, p < 0.001), maximal diene production (8.3% and 5.7%) and plasma levels of
thiobarbituric acid reactive substances (9.7% and 11.5%, p < 0.001). Both treatments were well tolerated. Only one patient in the
lovastatin group withdrew from the trial due to adverse events. In conclusion,
policosanol and
lovastatin administered short term to patients with
dyslipidemia secondary to
type 2 diabetes were effective in lowering
cholesterol and in inhibiting the extent of lipid peroxidation.
Policosanol (10 mg/day) was slightly more effective than
lovastatin (20 mg/day) in reducing the
LDL-C/HDL-C and total
cholesterol/HDL-C ratios, in increasing HDL-C levels and in preventing
LDL oxidation. Nevertheless, since this was a pilot study, further clinical studies performed in larger sample sizes of diabetic patients are needed for definitive conclusions.