THE SAFETY OF STATINS: WHAT A PHYSICIAN NEEDS TO KNOW
https://doi.org/10.20996/1819-6446-2014-10-3-334-338
Abstract
Various aspects of the safety of statins in clinical practice are discussed: hepatotoxicity, myopathy and rhabdomyolysis, the impact on the diabetes and cognitive dysfunction onset, renal function impairment.
About the Author
D. A. Napalkov
I.M. Sechenov First Moscow State Medical University
Russian Federation
Trubetskaya ul. 8-2, Moscow, 119991 Russia
Russian Federation
Trubetskaya ul. 8-2, Moscow, 119991 Russia
References
1. US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER). Guidance for Industry, Drug-Induced Liver Injury: Premarketing Clinical Evaluation 2009. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM174090.pdf. Accessed March 14, 2014.
2. Bays H, Cohen DE, Chalasani N, Harrison SA. An Assessment by the Statin Liver Safety Task Force: 2014 Update. J Clin Lipidology 2014; 8: S47-S57.
3. Newman C, Tsai J, Szarek M, Luo D, Gibson E. Comparative safety of atorvastatin 80 mg versus 10 mg derived from analysis of 49 completed trials in 14,236 patients. Am J Cardiol 2006; 97 (1): 61-7.
4. Rosenson RS, Baker SK, Jacobson TA, et al. An Assessment by the Statin Muscle Safety Task Force: 2014 Update. J Clin Lipidology 2014; 8: S58-S71.
5. Phillips PS, Haas RH, Bannykh S, et al, Scripps Mercy Clinical Research Center. Statin-associated myopathy with normal creatine kinase levels. Ann Intern Med 2002; 137: 581-5.
6. Phillips PS, Haas RH. Observations from a statin myopathy clinic. Arch Intern Med 2006; 166: 1232-1233.
7. Bruckert E, Hayem G, Dejager S, et al. Mild to moderate muscular symptoms with high-dosage statin therapy in hyperlipidemic patients—the PRIMO study. Cardiovasc Drugs Ther 2005; 19: 403-14.
8. Buettner C, Davis RB, Leveille SG, et al. Prevalence of musculoskeletal pain and statin use. J Gen Intern Med 2008; 23: 1182-6.
9. El-Salem K, Ababneh B, Rudnicki S, et al. Prevalence and risk factors of muscle complications secondary to statins. Muscle Nerve 2011; 44: 877-81.
10. Cohen JD, Brinton EA, Ito MK, Jacobson TA. Understanding Statin Use in America and Gaps in Patient Education (USAGE): an internet-based survey of 10,138 current and former statin users. J Clin Lipidol 2012; 6: 208-15.
11. Parker BA, Capizzi JA, Grimaldi AS, et al. Effect of statins on skeletal muscle function. Circulation 2013;127:96-103.
12. Rajpathak SN, Kumbhani DJ, Crandall J, et al. Statin therapy and risk of developing type 2 diabetes: a meta-analysis. Diabetes Care 2009; 32: 1924-9.
13. Sattar N, Preiss D, Murray HM, et al. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet 2010; 375: 735-42.
14. Waters DD, Ho JE, Boekholdt SM, et al. Cardiovascular event reduction versus new-onset diabetes during atorvastatin therapy: effect of baseline risk factors for diabetes. J Am Coll Cardiol 2013; 61: 148-52.
15. Ridker PM, Pradhan A, MacFadyen JG, et al. Cardiovascular benefits and diabetes risks of statin therapy in primary prevention: an analysis from the JUPITER trial. Lancet 2012; 380: 565-71.
16. Maki KC, Ridker PM, Brown WV, et al. An Assessment by the Statin Diabetes Safety Task Force: 2014 Update. J Clin Lipidology 2014; 8: S17-S29.
17. Colhoun HM, Betteridge DJ, Durrington PN, et al, CARDS investigators. Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo-controlled trial. Lancet 2004; 364: 685-96.
18. Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet 2002; 360: 7-22.
19. Collins R, Armitage J, Parish S, et al, Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol-lowering with simvastatin in 5963 people with diabetes: a randomized placebo-controlled trial. Lancet 2003; 361: 2005-16.
20. Pyorala K, Pedersen TR, Kjekshus J, et al. Cholesterol lowering with simvastatin improves prognosis of diabetic patients with coronary heart disease. A subgroup analysis of the Scandinavian Simvastatin Survival Study (4S). Diabetes Care 1997; 20: 614-20.
21. Rojas-Fernandez CH, Goldstein LB, Levey AI, et al. An Assessment by the Statin Cognitive Safety Task Force: 2014 Update. J Clin Lipidology 2014; 8: S5-S16.
22. Ray KK, Cannon CP, McCabe CH, et al. Early and late benefits of high-dose atorvastatin in patients with acute coronary syndromes: results from the PROVE IT-TIMI 22 trial. J Am Coll Cardiol 2005;46(8):1405-10.
23. Neil HA, DeMicco DA, Luo D, et al. Analysis of efficacy and safety in patients aged 65-75 years at randomization: Collaborative Atorvastatin Diabetes Study (CARDS). Diabetes Care 2006;29(11):2378-84.
24. Sever PS, Dahlöf B, Poulter NR, et al. Prevention of coronary and stroke events with atorvastatin in hypertensive patients who have average or lower-than-average cholesterol concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial--Lipid Lowering Arm (ASCOT-LLA): a multicentre randomized controlled trial. Lancet 2003;361(9364):1149-58.
25. LaRosa JC, Grundy SM, Kastelein JJ, et al. Safety and efficacy of Atorvastatin-induced very low-density lipoprotein cholesterol levels in Patients with coronary heart disease (a post hoc analysis of the treating to new targets [TNT] study). Am J Cardiol 2007;100(5):747-52.
26. Nissen SE. Halting the progression of atherosclerosis with intensive lipid lowering: results from the Reversal of Atherosclerosis with Aggressive Lipid Lowering (REVERSAL) trial. Am J Med 2005;118 Suppl 12A:22-7.
Review
For citations:
Napalkov D.A. THE SAFETY OF STATINS: WHAT A PHYSICIAN NEEDS TO KNOW. Rational Pharmacotherapy in Cardiology. 2014;10(3):334-338. (In Russ.) https://doi.org/10.20996/1819-6446-2014-10-3-334-338
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