A comparative study on the effects of niacin plus atorvastatin with that of fenofibrate plus atorvastatin in dyslipidemia

Abstract

Introduction: Coronary heart disease (CHD) patients usually associated with low HDL-cholesterol, high triglycerides as well as elevated LDL-cholesterol. Low HDL-cholesterol predicts CHD risk independently even when LDL-cholesterol is low. Previous studies suggest that statin combined with either niacin or fibrate significantly modify lipid profile in patients with CHD. The present study was designed to evaluate and compare the effects of co-administration of atorvastatin either with niacin or fenofibrate in dyslipidaemia. Material(s) and Method(s): This prospective consecutive interventional study was conducted on a total number of 108 CHD patients with evidence of dyslipidaemia in the Department of Pharmacology and Therapeutics in active collaboration with Department of Cardiology of Sylhet MAG Osmani Medical College Hospital (SOMCH) during the period of July 2006 to June 2007. Niacin 1000 mg plus atorvastatin 10 mg was administered to 64 patients (Group I) while 44 patients were (Group II) treated with fenofibrate 200 mg plus atorvastatin 10 mg daily for 12 weeks. Of them, a total 67 patients (35 patients in Group I and 32 patients in Group II) completed the study. Their fasting lipid profiles, SGPT, serum creatinine and fasting blood glucose levels were estimated before and 12 weeks after initiation of treatment. Predisposing risk factors such as age, sex, obesity, history of diabetes mellitus (DM), hypertension (HTN), smoking and family history of coronary heart disease (CHD) were also analyzed. Adverse events were also recorded to assess the safety and tolerability. Obtained data were analyzed using by paired't' and 'Z'-test at 95% confidence interval. Result(s): The niacin-atorvastatin combination significantly reduced TC by 25.73%, TG by 14.03%, LDL-C by 38.41% and increased HDL-C by 10.04% (p<0.001 for all). Another combination of fenofibrateatorvastatin significantly reduced TC by 30.22%, TG by 35.03%, LDL-C by 38.58%, whereas it increased HDL-C by 7.22% (p<0.001 for all). In comparison between two groups, there were no significant difference in serum lipid profile except in level of TG reduction where fenofibrate-atorvastatin combination yielded significant (p<0.001) results. In this study, SGPT level significantly raised and fasting blood glucose level decreased in fenofibrate-atorvastatin treated group than niacin-atorvastatin combination. Serum creatinine level decreased in niacin-atorvastatin treated group compared to fenofibrate-atorvastatin, but the changes was within normal limit. Conclusion(s): This study showed that both combinations are equally effective in dyslipidaemia. Although, fenofibrate-atorvastatin combination decreased more TG and niacin-atorvastatin combination appeared safer considering some adverse effects. Further studies including randomized, double blind, multi-center trials with different dose schedule and different combination have been suggested.