Lipid lowering effect of policosanol and omega-3 fatty acids combined therapy in hypercholestero- lemic patients

Although low-density lipoprotein cholesterol (LDL-C) remains the primary treatment target, the management of dyslipidemia for the coronary prevention includes the modification of secondary lipid targets, like the decrease of non-high-density lipoprotein cholesterol (HDL-C) and serum triglycerides (TG), and the increase of serum HDL-C. It has been acknowledged that fish oils rich in omega-3 fatty acids (ω-3-FA), which reduce serum TG and non-HDL-C levels, may decrease the risk of cardiovascular events through these lipid and through non-lipid (reduction of pulse rate, antiarrythmic effects, modest decreases of blood pressure and of platelet aggregation) mechanisms. While their effects on serum HDL-C and total cholesterol (TC) have been variable, treatment with ω-3-FA, however, may sometimes increase serum LDL-C levels. Policosanol has been shown to reduce serum LDL-C, TC and to increase HDL-C in normocholesterolemic and hyperlipidemic individuals, without marginal and inconsistent effects on TG. Policosanol administered concomitantly with ω-3-FA for short-term has been shown to reduce serum LDL-C, TC and to raise HDL-C more than ω-3-FA + placebo, unaffecting the TG-lowering effect of ω-3-FA. No information of the persistence of such effects, however, has been reported. This study investigated whether the benefits of administering ω-3-FA + policosanol (ω-3-FA-poli) persisted after longer (24 weeks) therapy. After a diet-only period, 60 patients were randomized, under double-blind conditions, to ω-3-FA (1 g/d) + placebo (ω-3-FA-pla) or ω-3-FA (1 g/d) + policosanol 10 mg/d . Laboratory variables were assessed at baseline and every 12 weeks, while physical indicators, drug compliance and adverse experiences (AE) were controlled every six José Illnait, Gladys Castaño, Julio Fernández, Ernesto López,* Rosa Más, Lilia Fernández, Sarahí Mendoza, Melbis Mesa and Rafael Gámez. Centro de Productos Naturales, Centro Nacional de Investigaciones Científicas, Calle 198 entre avenidas 19 y 21, Reparto Atabey, Playa, Apartado Postal 6414, Ciudad de La Habana. Correo electrónico: [email protected]. *Centro de Investigaciones Médico Quirúrgicas, Ciudad de La Habana, Cuba. Revista CENIC Ciencias Biológicas, Vol. 41, No. 2, pp 103-109, mayo-agosto, 2010. 104 weeks. After 12 weeks on therapy, treatment with ω-3-FA-pla reduced significantly (p < 0.000 1) TG (15.8 %) compared with baseline, while at week 24 significant (p < 0.000 1) decreases of TG (22.8 %) and increases (p < 0.05) of HDL-C (1.4 %) were seen, without changes on other lipid variables. At weeks 12 and 24, ω-3-FA-poli reduced (p < 0.000 1) LDL-C (23.4 and 26.0 %, respectively), TC (15.4 and 16.6 %) and raised HDL-C (9.0 and 14.5 %) compared with baseline and -3-FA + placebo, while lowered (p < 0.0001) serum TG (16.7 and 23.3 %, respectively) versus baseline, but not versus ω-3-FA + placebo. There were not study withdrawals. Seven patients reported mild AE, without differences between both groups. In conclusion, combined therapy with ω-3-FA-poli given for 24 weeks showed complementary and persistent benefits on lipid profile targets compared ω-3-FA + placebo, and was well tolerated in hypercholesterolemic patients.