The Clinical Study Of Policosanol On Cardiovascular Diseases In The Very Old Patients

Background Cardiovascular diseases are the most important diseases affecting humanhealth. Atherosclerosis is the major cause resulting of cardiovascular diseases. Statin isthe most effective agents preventing and treating atherosclerosis. However, some of thepatients could not stand its severe adverse reactions such as liver damage andrhabdomyolysis. Policosanol is a novel lipid-lowering drug extracted from natural plantwaxes. Athough some literatures showed that it could lower LDL cholesterol and helpprevent atherosclerosis without significant adverse reactions, some literatures evenshowed it also could inhibit platelet aggregation and improve endothelial functions, itwas not enough to confirm its effects by current studies especially in the very oldpatients suffered from cardiovascular diseases.Objective The aim of the study was to comparatively observe Policosanol’slipid-lowering efficacy, safety and its multi effects beyond lipid lowering in the very oldpatients with cardiovascular diseases.Materials and Methods294elderly patients with dyslipidemia from September2010to September2012treated in PLA General Hospital were included. Patients’ age rangedfrom75to98years old (84.62±5.66) with258males and31females. All patients wererandomly divided into four groups: group A (n=64): Policosanol20mg group; group B(n=72): Policosanol10mg group; group C (n=91): atorvastatin20mg group; group D(n=62): policosanol10mg+atorvastatin20mg group. Medications were taken orallybefore going to bed at night once daily in each group. Lipid lowering efficacy, safetyand multi effects were observed at0d,12thweek,24thweek and52thweek. The efficacyof lipid-lower study included changes of TC, TG, LDL-C, HDL-C, Lp(a), ApoA1, andApoB. The safety analysis included changes of ALT, AST, CK and platelet counts. Themulti-effects observations included AA (0.5mg/L) and ADP (10umol/L) inducedchanges of platelet aggregation rates, CECs, and carotid artery intima-media thickness. Results1.The changes in lipid levels: From12thweek, LDL-C and TC levels started todecrease in each group, LDL-C and TC levels decreased more significant with time. At52thweek, the changes of LDL-C and TC levels were most significant in group Damong four groups. LDL-C and TC levels in group A were lower than in group B at52thweek. There was no significant change of HDL-C level in each goup after treatment.There was no significant change of TG level in group A and B after treatment. However,TG level in group C and D at52thweek was statistically lower than baseline but therewas no significant difference of TG level betweent group C and D.2. Changes of apolipoprotein and lipoprotein (a): Lp (a), apo B and apo B/AI weresignificantly lower than baseline in each group after treatment. Lp (a) level decreasingwas most significant in group C and D. Apo B level lowering was most significant ingroup D. Decasing of Apo B/AI in group C and D was more significant than in group Aand B but there was no statistical change of apo B/AI in group A and B at52thweek.3.Safety evaluation：No severe liver damage and rhabdomyolysis occurred inpolicosanol group A and B during the whole study. Four patients suffered from liverdamage in group C and three patients suffered from liver damage in group D but theliver function gradually resume to baseline after discontined the medication. One patientpresented significant gastrointestinal symptoms in group C and the symptoms alsoalleviated with atorvastatin discontinued.4.Multi effects evaluation:ADP induced platelet aggregation rate was decreasedsignificantly in group A than baseline（48.79±20.29%vs40.37±23.56%）but AAinduced platelet aggregation rate was not. Both AA and ADP induced Plateletaggregation rates had no significant changes in other groups.CECs, hs-CRP and Hcy levels were all decreased significantly at52thweek aftertreatment in each group. There was no statistical change of IMT in each group aftertreatment.Conclusions Policosanol could effectively modulate blood lipid levels mainly bydecrease TC and LDL-C levels but it had little effect on HDL-C and TG levels. The effects were increased with increasing of dosage of policosanol and the combinationwith routine dose of atorvastatin could enhance the lipid-lowering effects.10mg,20mgpolicosanol and the combination of little dose of Policosanol with routine dose ofatorvastatin were all safe and well tolerated in the elderly patients. Besides lipidmodulating effects, policosanol also had other effects such as improving endothelialfunctions and preventing progression of atherosclerosis.