ATORVASTATIN VS ROSUVASTATIN; FENOFIBRATE AS AN ADD ON: AN EXPLORATORY STUDY
Keywords:Statins, Cardiovascular events, Fibrates, Open label, Randomized, HMG Co-A reductase
Objective: Statins being the first choice drug for dyslipidaemia, the quest for better one among all has always been and still a question for research in the field of medicine. ObjectiveÂ The objective of our study was to find out the best statin among the two, Atorvastatin and Rosuvastatin, in terms of efficacy and safety; alone or in combination with Fenofibrate for the management of dyslipidaemia.
Methods: This was an open label, randomized, parallel group, prospective comparative study, carried out in patients in two groups treated with Atorvastatin and Rosuvastatin (10mg each) for 6 weeks, after which Fenofibrate (67mg) was added as an add on therapy in either group for the next 4 weeks before and after treatment.
Results: After the treatment, the TC, TG, LDL- C, HDL- C and Non HDL- C were comparable between two groups. The changes in the levels of TC were -15.90Â±5.16 (-8.53%) vs -20.70Â±4.83 (-11.32%) respectively in groups treated with Atorvastatin (group I) and Rosuvastatin (group II). Changes in TGs were -11.60Â±4.16 (-7.46%) vs -15.10Â±5.18 (-9.99%), respectively; change in LDL- C were -16.90Â±3.58 (-15.31%) vs -13.0Â±3.04 (-11.56%) respectively; change in HDL- C were +6.75Â±0.86 (+18.72%) vs +9.0Â±1.22 (+23.72%) respectively in each group; change in Non HDL- C were found to be -6.90Â±4.83 (-4.4%) vs -7.8Â±4.78 (-5.05%) respectively in groups I and II. After the addition of Fenofibrate (67mg) there were no significant changes in the different parameters of serum lipid profile.
Conclusion: The result of our study suggests that Rosuvastatin (10mg) was more efficacious than Atorvastatin (10mg) in lipid lowering effect and HDL- C raising effect but should be used with great caution and care in patients with uncontrolled hyperglycaemia and in those with compromised hepatic status. Further addition of Fenofibrate (67mg) didn't make any significant difference in the result.
Reiner Z, Sonicki Z, Tedeschi-Reiner E. Physiciansâ€™ perception, knowledge and awareness of cardiovascular risk factors and adherence to prevention guidelines:the PERCRO-DOC survey. J Atherosclerosis 2010;213(2):598â€“603.
Gotto AM Jr. Review of primary and secondary prevention trials with lovastatin, pravastatin, and simvastatin. Am J Cardiol 2005;96(5A):34â€“8.
Expert panel on detection, evaluation and treatment of high blood cholesterol in adults. Executive summary of the third report of the National Cholesterol Education Program (NCEP) expert panel on detection, evaluation and treatment of high blood cholesterol in adults (Adult treatment panel III). JAMA 2001;285(19):2486-97.
Scandanavian Simvastatin Survival Study Group. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease:the Scandinavian Simvastatin Survival Study (4S). J Lancet 1994;344(8934):1383â€“9.
The Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) Study Group. Prevention of cardiovascular events and death with prevastatin in patients with coronary heart disease and a broad range of initial cholesterol levels. N Engl J Med 1998;339(19):1349-57.
Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study (HPS) of cholesterol lowering with simvastatin in 20,536 high-risk individuals:a randomised placebo-controlled trial. J Lancet 2002;360(9326):7â€“22.
Almdal T, Scharling H, Jensen JS, 1. Vestergaard H. The independent effect of type 2 diabetes mellitus on ischemic heart disease, stroke, and death:a population-based study of 13,000 men and women with 20 years of follow-up. J Arch Intern Med 2004;164(13):1422â€“6.
Haffner SM, Lehto S, RÃ¶nnemaa T, 3. PyÃ¶rÃ¤lÃ¤ K, Laakso M. Mortality from cor-onary heart disease in subjects with type 2 diabetes and in nondiabetic subjects with and without prior myocardial infarction. N Engl J Med 1998;339(4):229-34.
Miettinen H, Lehto S, Salomaa V, et al. Impact of diabetes on mortality after the first myocardial infarction. J Diabetes Care 1998;21(1):69-75.
Maurya AK, Kant S, Nag VL, Kushwaha R, Dhole TN. Detection of 123 bp fragment of insertion element IS6110 Mycobacterium tuberculosis for diagnosis of extrapulmonary tuberculosis. Indian J Med Microbiol 2012;30(2):182-6.
Chauhan DS, Sharma VD, Parashar D, Chauhan A, Singh D, Singh HB, et al. Molecular typing of Mycobacterium tuberculosis isolates from different parts of India based on IS6110 element polymorphism using RFLP analysis. Indian J Med Res 2007;125(4):577-81.
Ridker PM, Danielson E, Fonseca FA, et al. Rosuvastatin to prevent vas-cular events in men and women with elevated C-reactive protein. N Engl J Med 2008;359(21):2195â€“207.
Dujovne CA. Side effects of statins: hepatitis versus transaminitisâ€â€“ myositis versus CPKitis. Am J Cardiol 2002;89 (12):1411â€“3.
Wu CC, Sy R, Tanphaichitr V, et al. A multicenter, double-blind study to compare the efficacy and safety of once aily ator-vastatin and aimvastatin in asian people with elevated LDL-cholesterol. Result from ASIA study. J Formos Med Assoc 2002;101(7):478-87.