May thirteen weeks of octacosanol supplementation affect prooxidant-antioxidant balance in patients on atorvastatin therapy

Abstract

Statins reduce the risk of cardiovascular disease mainly due to cholesterol reduction, but also pleiotropic effects are present. Co-administration of statins with bioactive molecules may obtain a synergistic benefit. The aim of this randomized, placebo-controlled, double-blind study was to investigate whether 13-week long supplementation of policosanol affected antioxidant status and markers of oxidative stress in patients on atorvastatin therapy. Eighty- seven patients aged 40–80 years on chronic (>4 months) atorvastatin therapy (20 mg) were randomly allocated to policosanol (n=42) or placebo (n=45). At baseline, after 8 and 13 weeks, markers of oxidative stress and antioxidant defence include total antioxidant status (TAS), total oxidant status (TOS), advanced oxidation protein products (AOPP) and activity of superoxide dismutase (SOD) were measured. Creatinine phosphokinase and hepatic enzymes were the main safety endpoints. The mean age of the patients was 62.6 ± 0.8 years. Patients in supplemented group had higher TAS and TOS levels 1640 (963–1752) vs 927 (481–1305), [μmol/L], p < 0.001 and 18 (13––20) vs 6 (5–11), [μmol/L], p < 0.001], respectively, compared to baseline. In placebo group, subjects had also higher TAS and TOS levels after 13-week compared to baseline. SOD and AOPP were not influenced by the intervention. The investigated supplement possessed a good safety profile. Combination of policosanol with atorvastatin may be useful in an attempt to avoid potential adverse effects associated with statins. 13-week supplementation was not sufficient to induce remarkably changes in SOD and AOPP. TAS and TOS were increased in both groups.