DOI: http://dx.doi.org/10.18203/2320-6012.ijrms20183249

Comparison of the efficacy and safety of rosuvastatin versus atorvastatin in reduction of low density lipoprotein cholesterol in patients of type 2 diabetes mellitus with dyslipidemia

Hrishikesh Kashyapa, Rupali Bajrang Jadhav, Anuradha Deshkar

Abstract


Background: Approximately 80% of deaths in diabetic patients are attributable to cardiovascular disease (CVD), which in turn is highly correlated with diabetic dyslipidemia. Statins are drug of choice for raised LDL-C in treating dyslipidemia. The present study compares the efficacy and safety of rosuvastatin against commonly used atorvastatin in patients of type 2 diabetes mellitus with dyslipidemia, so as to guide the present treatment strategies in the management of the same in Indian population.

Methods: The study was a single blinded study conducted in a district level tertiary care hospital attached to a medical teaching institute. Patients fulfilling the inclusion criteria were randomized in two groups. Group I received atorvastatin (10mg) and group II received rosuvastatin (5mg) at bedtime orally daily. Serum TC, serum LDL-C, serum HDL-C and serum TG were assessed on week 0, week 6 and week 12.

Results: At the end of 12 weeks, the percentage reduction of LDL-C levels in atorvastatin group was 33.58% whereas in rosuvastatin group, it was 43.12%. The percentage reduction in total cholesterol (TC) in atorvastatin group was 24.85% while in rosuvastatin group, it was 30.8%. Rise in HDL-C levels in atorvastatin group was 7.1% whereas in rosuvastatin group, it was 11.16%. All these differences were statistically significant. There was no significant difference in reduction of TG levels between the two groups.

Conclusions: Rosuvastatin 5mg causes greater reduction in LDL-C and TC, comparable reduction of TG and greater rise in HDL-C when compared with atorvastatin 10mg therapy.


Keywords


Atorvastatin, Cholesterol, Cardiovascular disease, Diabetes, Dyslipidemia, Rosuvastatin

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References


Abou-Seif MA, Youssef AA. Evaluation of some biochemical changes in diabetic patients. Clin Chim Acta. 2004 Aug 16;346(2):161-70.

Mohan V, Sandeep S, Deepa R, Shah B, Varghese C. Epidemiology of type 2 diabetes: Indian scenario. Indian J Med Res. 2007 Mar 1;125(3):217.

International Diabetes Federation. IDF Diabetes Atlas, 7ed. Brussels, Belgium: International Diabetes Federation, 2015. Available from: http://www.diabetesatlas.org/component/attachments/?task= downloadandid=116. Accessed 11 Nov. 2016.

O'Brien RC, Luo M, Balazs N, Mercuri J. In vitro and in vivo antioxidant properties of gliclazide. J Diabetes Complicat. 2000 Aug 31;14(4):201-6.

O'Keefe JH, Miles JM, Harris WH, Moe RM, McCallister BD. Improving the adverse cardiovascular prognosis of type 2 diabetes. Mayo Clin Proc. 1999 Feb;74(2):171-80.

Ginsberg HN. Diabetic dyslipidemia: basic mechanisms underlying the common hypertriglyceridemia and low HDL cholesterol levels. Diabetes. 1996 Jul 1;45(Supplement 3):S27-30.

Grundy SM. Hypertriglyceridemia, atherogenic dyslipidemia, and the metabolic syndrome. Am J Cardiol. 1998 Feb 26;81(4):18B-25B.

Beckman JA, Creager MA, Libby P. Diabetes and Atherosclerosis: Epidemiology, Pathophysiology, and Management. JAMA. 2002;287(19):2570-81.

Lloyd-Jones DM, O'Donnell CJ, D'Agostino RB, Massaro J, Silbershatz H, Wilson PW. Applicability of cholesterol-lowering primary prevention trials to a general population: the Framingham heart study. Arch Intern Med. 2001 Apr 9;161(7):949-54.

Cilla DD, Whitfield LR, Gibson DM, Sedman AJ, Posvar EL. Multiple‐dose pharmacokinetics, pharmacodynamics, and safety of atorvastatin, an inhibitor of HMG‐CoA reductase, in healthy subjects. Clin Pharmacol Ther. 1996;60(6):687-95.

Corsini A, Bellosta S, Baetta R, Fumagalli R, Paoletti R, Bernini F. New insights into the pharmacodynamic and pharmacokinetic properties of statins. Pharmacol Therapeut. 1999;84(3):413-28.

Tsiara S, Elisaf M, Mikhailidis DP. Early vascular benefits of statin therapy. Curr Med Res Opin. 2003 Jan 1;19(6):540-56.

Pella D, Rybar R, Mechirova V. Pleiotropic effects of statins. Acta Cardiol Sin. 2005 Dec 1;21(4):190-8.

Knopp RH, d’Emden M, Smilde JG, Pocock SJ. Efficacy and safety of atorvastatin in the prevention of cardiovascular end points in subjects with type 2 diabetes the atorvastatin study for prevention of coronary heart disease endpoints in non-insulin-dependent diabetes mellitus (ASPEN). Diabetes care. 2006 Jul 1;29(7):1478-85.

Bersot TP. Drug therapy for hypercholesterolemia and dyslipidemia. Goodman and Gilman’s, The Pharmacological Basis of Therapeutics. 12th edition McGraw-Hill. 2011:877-908.

Kurabayashi M, Yamazaki T. Superior benefit of aggressive lipid lowering therapy for high-risk patients using statins: the SUBARU study-more hypercholesterolemic patients achieve Japan atherosclerosis society LDL-C goals with rosuvastatin therapy than with atorvastatin therapy. J Atheroscler Thromb. 2008;15(6):314-23.

Liao JK. Safety and efficacy of statins in Asians. Am J Cardiol. 2007 Feb 1;99(3):410-4.

Lwanga SK, Lemeshow S. Sample size determination in health studies: a practical manual. World Health Organization; 1991.

Berne C, Siewert-Delle A. URANUS study investigators. Comparison of rosuvastatin and atorvastatin for lipid lowering in patients with type 2 diabetes mellitus: results from the URANUS study. Cardiovasc Diabetol. 2005 Jun 3;4:7.

Betteridge DJ, Gibson JM, Sager PT. Comparison of effectiveness of rosuvastatin versus atorvastatin on the achievement of combined C reactive protein (<2mg/L) and low-density lipoprotein cholesterol (<70mg/dl) targets in patients with type 2 diabetes mellitus. Am J Cardiol. 2007 Oct 15;100(8):1245-8.

Adsule S, Baig M, Gade P, Khandelwal P. A comparative evaluation of safety and efficacy of rosuvastatin, simvastatin, and atorvastatin in patients of type 2 diabetes mellitus with dyslipidemia. Int J Diabetes Dev Ctries. 2009 Apr 1;29(2):74.

Barakat L, Jayyousi A, Bener A, Zuby B, Zirie M. Comparison of efficacy and safety of rosuvastatin, atorvastatin and pravastatin among dyslipidemic diabetic patients. ISRN Pharmacol. 2013;2013.

Ogawa H, Matsui K, Saito Y, Sugiyama S, Jinnouchi H, Sugawara M, et al. Differences between rosuvastatin and atorvastatin in lipidlowering action and effect on glucose metabolism in Japanese hypercholesterolemic patients with concurrent diabetes. Circulation. 2014;78(10):2512-5.

Arshad AR. Comparison of low-dose rosuvastatin with atorvastatin in lipid-lowering efficacy and safety in a high-risk pakistani cohort: an open-label randomized trial. J Lipids. 2014 Mar 30;2014.

FDA. Information for Healthcare Professionals: Crestor (Rosuvastatin Calcium). 2016. Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm124906.htm. [Accessed 16 Nov. 2016].

FDA. Lipitor (atorvastatin calcium) Tablets Prescribing Information. 2015. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020702s065lbl.pdf. Accessed 16 Nov. 2016.

Simsek S, Schalkwijk CG, Wolffenbuttel BH. Effects of rosuvastatin and atorvastatin on glycaemic control in type 2 diabetes-the CORALL study. Diabetic Med. 2012 May 1;29(5):628-31.

Jones PH, Davidson MH, Stein EA, Bays HE, McKenney JM, Miller E, et al. Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR Trial). Am J Cardiol. 2003 Jul 15;92(2):152-60.

Yamazaki T, Kurabayashi M. A randomized controlled study to compare the effects of rosuvastatin 5mg and atorvastatin 10mg on the plasma lipid profile in Japanese patients with hypercholesterolemia (ASTRO-2). Ann Vasc Dis. 2009;2(3):159-73.

Lee E, Ryan S, Birmingham B, Zalikowski J, March R, Ambrose H, et al. Rosuvastatin pharmacokinetics and pharmacogenetics in white and Asian subjects residing in the same environment. Clin Pharmacol Ther. 2005 Oct 1;78(4):330-41.

Kim KT, Birmingham BK, Azumaya CT, Chen Y, Schneck D, Zalikowski J. Increased systemic exposure to rosuvastatin in Asian subjects residing in the United States compared to Caucasian subjects. Clin Pharmacol Ther. 2008 Apr 2;83(Suppl 1):S14.