Plasma LDL-C Goal Achievement With Atorvastatin Monotherapy Versus Atorvastatin And Probucol Combination Therapy In Patients With Coronary Atherosclerosis

Objectives: Major objective is to evaluate the extent to reach LDL-C goal byintensive statin therapy and standard statin therapy with or without probucol incoronary atherosclerotic patients and compare between groups in the extent ofachieving LDL-C goal. LDL-goal was based on European Atherosclerosis Society i.e.<1.8mmol/L. secondary objective is to study the effect of therapies on bloodtriglycerides, total cholesterol, high density lipoprotein blood glucose and liverenzymes, and to assess any adverse effects of intensive lipid lowering therapy.Method: a total of200patients who visited OPD and IPD of CardiologyDepartment, Second Hospital of Jilin University between September2011andAugust2013were assessed for eligibility. Mean age was56.35±8.798years, with56%(112) males, and44%(88) females. Inclusion criteria were, age ranged from35to75yrs, stenosis of one of branches of coronary artery (left anterior descendingartery or left circumflex artery or right coronary artery) between10%to50%, andLDL-C level>2.5mmol/L. Exclusion criteria were acute coronary syndrome,diabetes mellitus, abnormal liver and kidney function, heart failure. Patients wererandomly divided into4groups; standard treatment group: first group aspirin/A,statin/S (AS group), and second group probucol/P, aspirin/A, statin/S (PAS group).Standard dose was aspirin100mg/d, atorvastatin20mg/d, and probucol0.5g/d.Intensive statin group: third group aspirin/A, statin/S (AS group), and fourth groupprobucol/P, aspirin/A, statin/S (PAS group). Intensive dose was aspirin100mg/d,atorvastatin40mg/d, and probucol0.5g/d. Some patients were also prescribed withother medications such as beta blockers, and/or nitrates and/or ACEI drugs and/orCCB drugs for secondary prevention. All data were analysed using SPSS21.0software. A p value <0.05was considered statistically significant, p value>0.05wasconsidered statistically insignificant. Out of200patients,175patients completed thestudy,48patients in20mg AS group,39patients in20mg PAS group,36patients in 40mg AS group,52patients in40mg PAS group.15patients discontinuedintervention and/or lost follow-up.Results: In20mg AS group,14out of48patients i.e.33%patients achievedLDL-C goal of <1.8mmol/L, while in20mg PAS group,24out of39patients i.e.61.5%patients; in40mg AS group,23out of36patients i.e.63.88%patients, and in40mg PAS group,41out of52patients i.e.78.8%patients achieved the goal ofLDL-C <1.8mmol/L. Comparing intensive statin AS group with standard statin ASgroup, there is statistical significance in achieving LDL-C goal (p=0.000). But,comparing intensive statin PAS with standard statin AS, there is no statisticalsignificance in achieving LDL-C goal (p=0.279). there is no statistical significancebetween intensive statin PAS group and intensive statin AS group (p=0.148).However, there is statistical significance between standard statin PAS group andstandard statin AS group (p=0.03).Regarding effect on HDL-C, in intensive statin PAS group, HDL-C decreased by18.10%, with statistical significance (p=0.000), but there was no statisticalsignificance after therapy in standard statin AS group, standard statin PAS group andintensive statin AS group. Intensive statin with probucol therapy decreasestriglycerides (26.28%) and total cholesterol45.27%, which is statistically significant.Among200patients, one patient was found to have liver enzymes increased to3times the higher limit of reference range in40mg PAS group. In the intensivetherapy group,11patients in AS group had blood glucose increased, but meandecrease by3.33%, post therapy blood glucose was5.51±0.72mmol/L, with nostatistical significance (p=0.133),20patients in PAS group had blood glucoseincreased, with mean increase by6.79%, post therapy blood glucose:5.66±0.62mmol/L, with no statistical significance (p=0.679).Conclusion: From the statin dose point of view, we think atorvastatin40mg hashigher rate of achieving LDL-C goal of <1.8mmol/L than standard statin dose by30.88%. Comparing intensive PAS group with intensive AS group, rate of DL-Cgoal of <1.8mmol/L is higher by15%, that means antioxidant probucol has synergic effect. Probucol significantly decreases high density lipoprotein, hence cautiouslyprescribed to the patients with low HDL-C level. Intensive statin therapy is moreeffective than standard statin therapy in decreasing cholesterol. Simultaneously,intensive statin therapy is also effective in decreasing triglycerides when comparedwith standard statin therapy. Besides one case who had liver enzymes elevated3times upper normal limit, there were no cases of other adverse effects, no case ofcardiovascular events, hence intensive lipid lowering therapy is quite safe.Intensive statin group has31patients increased blood glucose, but blood glucosewas in normal range.