Comparison of saftey and cost effectiveness of atorvastatin 40 mg daily, rosuvastatin 20 mg daily and rosuvastatin 20 mg alternate day in 300 patients with type 2 diabetes mellitus
Keywords:Cost effectiveness, Creatine kinase, Dyslipidemia, Saftey profile
Background: Diabetes is recognized as a “coronary heart disease risk equivalent”. This happens because high rates of dyslipidemia among diabetic patients which is thought to be one of the major factors leading to the high percentage of deaths among diabetics due to cardiovascular disease (CVD).
Methods: The study aims to compare the cost effectiveness and tolerance or safety profile of atorvastatin 40 mg daily and rosuvastatin 20 mg daily and on alternate day. This prospective observational study was conducted in 300, type-2 diabetes mellitus patients between November 2013 and 2014.
Results: The total CK level increased after 6 weeks among patients on atorvastatin 40 mg, rosuvastatin 20 mg, and rosuvastatin 20 mg alternate day was stastically significant although it was within accepted normal range. None of the patients reported to have muscle symptoms i.e. myalgia. SGOT, SGPT, bilirubin levels with atorvastatin 40 mg were statistically insignificant. Same was the case with rosuvastatin 20 mg daily. However the SGOT and bilrubin level increased with rosuvastatin 20 mg alternate day was statistically significant, but was within normal range, we attribute it to chance. The cost obviously has shown to half in rosuvastatin 20 mg on alternate day.
Conclusions: Atorvastatin 40 mg, rosuvastatin 20 mg and rosuvastatin 20 mg alternate day was statically significant (p<.0010). SGOT, SGPT, bilirubin with atorvastatin 40 mg were statistically insignificant. Same was case with rosuvastatin 20 mg daily. SGOT, bilirubin level increased with rosuvastatin 20 mg alternate day was statistically significant. Cost obviously shown to half in rosuvastatin 20 mg alternate day.
National cholesterol education program (NCEP) Expert panel on detection, evaluation, and treatment of high blood cholesterol in adults (adult treatment panel III) 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) final report. Circulation. 2002;106(25):3143.
Bener A, Zirie M, Janahi IM, Al-Hamaq AOAA, Musallam M, Wareham NJ. Prevalence of diagnosed and undiagnosed diabetes mellitus and its risk factors in a population-based study of Qatar. Diabetes Research Clinical Practice. 2009;84(1):99-106.
Bener A, Zirie M, Musallam M, Khader YS, Al-Hamaq AOAA. Prevalence of metabolic syndrome according to adult treatment panel III and international diabetes federation criteria: a population-based study. Metabolic Syndrome Related Disorders. 2009;7(3):221-30.
Bener A, Dafeeah E, Ghuloum S, Al-Hamaq AOAA. Association between psychological distress and gastrointestinal symptoms in type 2 diabetes mellitus. World J Diabetes. 2012;3(6):123-9.
Henry RR. Preventing cardiovascular complications of type 2 diabetes: focus on lipid management. Clinical Diabetes. 2001;19(3):113-20.
Vasudevan AR, Hamirani YS, Jones PH. Safety of statins: effects on muscle and the liver. Cleveland Clinic J Med. 2005;72(11):990-1001.
Alsheikh AAA, Karas RH. The relationship of statins to rhabdomyolysis, malignancy, and hepatic toxicity: evidence from clinical trials. Current Atherosclerosis Reports. 2009;11(2):100-4.
Kashani A, Phillips CO, Foody JM. Risks associated with statin therapy: a systematic overview of randomized clinical trials. Circulation. 2006;114(25):2788-97.
Armitage J. The safety of statins in clinical practice. The Lancet. 2007;370(9601):1781-90.
Evans M, Rees A. Effects of HMG-CoA reductase inhibitors on skeletal muscle: are all statins the same? Drug Safety. 2002;25(9):649-63.
Pearson TA, Laurora I, Chu H, Kafonek S. The lipid treatment assessment project (L-TAP): a multicenter survey to evaluate the percentages of dyslipidemic patients receiving lipid lowering therapy and achieving low-density lipoprotein cholesterol goals. Arch Intern Med. 2000;160:459-67.
EA S, Group HFHS: Comparison of rosuvastatin versus atorvastatin in patients with heterozygous familial hypercholesterolemia. Am J Cardiol. 2003;92:1287-93.
Jr BHB: Benefit-risk assessment of rosuvastatin 10 to 40 milligrams. Am J Cardiol. 2003;92:23-9.
Shepherd J, Hunninghake DB, Stein EA, Kastelein JJ, Harris S, Pears J, et al. Safety of rosuvastatin. Am J Cardiol. 2004;94:882-8.
Goettsch WG, Heintjes EM, Kastelein JJ, Rabelink TJ, Johansson S, Herings RM. Results from a rosuvastatin historical cohort study in more than 45,000 Dutch statin users, a PHARMO study. Drug Saf. 2006;15:435.
Tiwari A, Bansal V, Chugh A, Mookhtiar K. Statins and myotoxicity: a therapeutic limitation. Expert Opinion Drug Safety. 2006;5(5):651-66.
Björnsson E, Jacobsen EI, Kalaitzakis E. Hepatotoxicity associated with statins: reports of idiosyncratic liver injury post-marketing. J Hepatology. 2012;56(2):374-80.
Ohsfeldt RL, Gandhi SK, Smolen LJ. Cost effectiveness of rosuvastatin in patients at risk of cardiovascular disease based on findings from the JUPITER trial. J Med Econ. 2010;13:428-37.
Shih YC, Han S, Cantor SB. Impact of generic drug entry on cost effectiveness analysis. Med Decis Making. 2005;25:71-80.
Hoyle M. Future drug prices and cost-effectiveness analyses. Pharmacoeconomics. 2008;26:589-602.
Pharmaceutical Management Agency. Prescription for pharmacoeconomic analysis: methods for cost-utility analysis. May, 2007. Available from: http://www.pharmac.govt.nz/ 2007/06/19/PFPA.
Eichler HG, Kong SX, Gerth WC, Mavros P, Jonsson B. Use of cost effectiveness analysis in health-care resource allocation decision making: how are cost-effectiveness thresholds expected to emerge? Value Health. 2004;7:518-28.
Cutler DM, Rosen AB, VijanS.The value of medical spending in the United States, 1960-2000. N Engl J Med. 2006;355:920-7.
Blomstrom P, Ekman M, Lundqvist CB. Cost effectiveness of cardiac resynchronization therapy in the Nordic region: an analysis based on the CARE-HF trial. Eur J Heart Fail. 2008;10:869-77.