Statin intolerance: diagnosis, treatment and alternative therapies

References

• Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet 344(8934), 1383–1389 (1994).
   Google Scholar
• Schwartz GG, Olsson AG, Ezekowitz MD et al. Effects of atorvastatin on early recurrent ischemic events in acute coronary syndromes: the MIRACL study: a randomized controlled trial. JAMA 285(13), 1711–1718 (2001).
   Google Scholar
• Larosa JC, He J, Vupputuri S. Effect of statins on risk of coronary disease: a meta-analysis of randomized controlled trials. JAMA 282(24), 2340–2346 (1999).
   Google Scholar
• Davidson MH, Robinson JG. Safety of aggressive lipid management. J. Am. Coll. Cardiol. 49(17), 1753–1762 (2007). •• Review Of The Safety Of High-Dose Statins Alone Or In Combination With Other Agents.
   Google Scholar
• Kashani A, Phillips CO, Foody JM et al. Risks associated with statin therapy: a systematic overview of randomized clinical trials. Circulation 114(25), 2788–2797 (2006).
   Google Scholar
• Maron DJ, Fazio S, Linton MF. Current perspectives on statins. Circulation 101(2), 207–213 (2000).
   Google Scholar
• Baker SK. Molecular clues into the pathogenesis of statinmediated muscle toxicity. Muscle Nerve 31(5), 572–580 (2005).
   Google Scholar
• Sathasivam S, Lecky B. Statin induced myopathy. BMJ 337, a2286 (2008).
   Google Scholar
• Marcoff L, Thompson PD. The role of coenzyme Q10 in statin-associated myopathy: a systematic review. J. Am. Coll. Cardiol. 49(23), 2231–2237 (2007).
   Google Scholar
• Laaksonen R, Jokelainen K, Sahi T, Tikkanen MJ, Himberg JJ. Decreases in serum ubiquinone concentrations do not result in reduced levels in muscle tissue during short-term simvastatin treatment in humans. Clin. Phamacol. Ther. 57(1), 62–66 (1995).
   Google Scholar
• Mangravite LM, Engelhardt BE, Medina MW et al. A statin-dependent QTL for GATM expression is associated with statin-induced myopathy. Nature 502(7471), 377–380 (2013).
   Google Scholar
• Thompson PD, Parker B. Statins, exercise, and exercise training. J. Am. Coll. Cardiol. 62(8), 715–716 (2013).
   Google Scholar
• Group SC, Link E, Parish S et al. SLCO1B1 variants and statin-induced myopathy – a genomewide study. N. Engl. J. Med. 359(8), 789–799 (2008).
   Google Scholar
• European Association for Cardiovascular P, Rehabilitation, Reiner Z et al. ESC/EAS Guidelines for the management of dyslipidaemias: the Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS). Eur. Heart J. 32(14), 1769–1818 (2011).
   Google Scholar
• Ballantyne CM, Corsini A, Davidson MH et al. Risk for myopathy with statin therapy in high-risk patients. Arch. Intern. Med. 163(5), 553–564 (2003). •• Comprehensive Review Of The Factors That Predisopose High-Risk Patients To Statin Myopathy.
   Google Scholar
• Naderi S, Cho LS. Cardiovascular disease in women: prevention, symptoms, diagnosis, pathogenesis. Cleve. Clin. J. Med. 80(9), 577–587 (2013).
   Google Scholar
• Naci H, Brugts J, Ades T. Comparative tolerability and harms of individual statins: a study-level network meta-analysis of 246 955 participants from 135 randomized, controlled trials. Circ. Cardiovasc. Qual. Outcomes 6(4), 390–399 (2013).
   Google Scholar
• Sinzinger H, O’Grady J. Professional athletes suffering from familial hypercholesterolaemia rarely tolerate statin treatment because of muscular problems. Br. J. Clin. Pharmacol. 57(4), 525–528 (2004).
   Google Scholar
• Parker BA, Augeri AL, Capizzi JA et al. Effect of statins on creatine kinase levels before and after a marathon run. Am. J. Cardiol. 109(2), 282–287 (2012).
   Google Scholar
• Mikus CR, Boyle LJ, Borengasser SJ et al. Simvastatin impairs exercise training adaptations. J. Am. Coll. Cardiol. 62(8), 709–714 (2013).
   Google Scholar
• Armitage J. The safety of statins in clinical practice. Lancet 370(9601), 1781–1790 (2007).
   Google Scholar
• Heart Protection Study Collaborative G. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet 360(9326), 7–22 (2002).
   Google Scholar
• Bays H. Statin safety: an overview and assessment of the data – 2005. Am. J. Cardiol. 97(8A), 6C–26C (2006).
   Google Scholar
• Fernandez G, Spatz ES, Jablecki C, Phillips PS. Statin myopathy: a common dilemma not reflected in clinical trials. Cleve. Clin. J. Med. 78(6), 393–403 (2011). •• Thorough Review Of The Factors That Contribute To A Disconnect Between Clinical Trial And Observational Data Regarding The Incidence Of Statin Myopathy.
   Google Scholar
• Bruckert E, Hayem G, Dejager S, Yau C, Begaud B. Mild to moderate muscular symptoms with high-dosage statin therapy in hyperlipidemic patients – the PRIMO study. Cardiovasc. Drugs Ther. 19(6), 403–414 (2005).
   Google Scholar
• MRC/BHF Heart Protection Study of cholesterol-lowering therapy and of antioxidant vitamin supplementation in a wide range of patients at increased risk of coronary heart disease death: early safety and efficacy experience. Eur. Heart J. 20(10), 725–741 (1999).
   Google Scholar
• Hansen KE, Hildebrand JP, Ferguson EE, Stein JH. Outcomes in 45 patients with statin-associated myopathy. Arch. Intern. Med. 165(22), 2671–2676 (2005).
   Google Scholar
• Law M, Rudnicka AR. Statin safety: a systematic review. Am. J. Cardiol. 97(8A), C52–C60 (2006).
   Google Scholar
• Phillips PS, Haas RH, Bannykh S et al. Statin-associated myopathy with normal creatine kinase levels. Ann. Intern. Med. 137(7), 581–585 (2002).
   Google Scholar
• Ahmed W, Khan N, Glueck CJ et al. Low serum 25 (OH) vitamin D levels (<32 ng/mL) are associated with reversible myositis-myalgia in statin-treated patients. Trans. Res. 153(1), 11–16 (2009).
   Google Scholar
• Bar SL, Holmes DT, Frohlich J. Asymptomatic hypothyroidism and statin-induced myopathy. Can. Fam. Physician 53(3), 428–431 (2007).
   Google Scholar
• Young JM, Florkowski CM, Molyneux SL et al. Effect of coenzyme Q(10) supplementation on simvastatin-induced myalgia. Am. J. Cardiol. 100(9), 1400–1403 (2007).
   Google Scholar
• Caso G, Kelly P, Mcnurlan MA, Lawson WE. Effect of coenzyme q10 on myopathic symptoms in patients treated with statins. Am. J. Cardiol. 99(10), 1409–1412 (2007).
   Google Scholar
• Gazzerro P, Proto MC, Gangemi G et al. Pharmacological actions of statins: a critical appraisal in the management of cancer. Pharmacol. Rev. 64(1), 102–146 (2012).
   Google Scholar
• Hamelin BA, Turgeon J. Hydrophilicity/lipophilicity: relevance for the pharmacology and clinical effects of HMG-CoA reductase inhibitors. Trends. Pharmacol. Sci. 19(1), 26–37 (1998).
   Google Scholar
• Corsini A, Bellosta S, Baetta R, Fumagalli R, Paoletti R, Bernini F. New insights into the pharmacodynamic and pharmacokinetic properties of statins. Pharmacol. Ther. 84(3), 413–428 (1999).
   Google Scholar
• Kobayashi M, Chisaki I, Narumi K et al. Association between risk of myopathy and cholesterol-lowering effect: a comparison of all statins. Life Sci. 82(17–18), 969–975 (2008).
   Google Scholar
• Backes JM, Venero CV, Gibson CA et al. Effectiveness and tolerability of every-other-day rosuvastatin dosing in patients with prior statin intolerance. Ann. Pharmacother. 42(3), 341–346 (2008).
   Google Scholar
• Ruisinger JF, Backes JM, Gibson CA, Moriarty PM. Once-a-week rosuvastatin (2.5 to 20 mg) in patients with a previous statin intolerance. Am. J. Cardiol. 103(3), 393–394 (2009).
   Google Scholar
• Kennedy SP, Barnas GP, Schmidt MJ, Glisczinski MS, Paniagua AC. Efficacy and tolerability of once-weekly rosuvastatin in patients with previous statin intolerance. J. Clin. Lipidol. 5(4), 308–315 (2011). •• Demonstrates The Safety And Efficacy Of Weekly Rosuvastatin Dosing.
   Google Scholar
• Mampuya WM, Frid D, Rocco M et al. Treatment strategies in patients with statin intolerance: the Cleveland Clinic experience. Am. Heart J. 166(3), 597–603 (2013). •• Overview Of Alternative Treatment Options For Those With Statin Intolerance And Outcomes Of Those On These Alternative Therapies.
   Google Scholar
• Mckenney JM, Davidson MH, Jacobson TA, Guyton JR. National Lipid Association Statin Safety Assessment Task F. Final conclusions and recommendations of the National Lipid Association Statin Safety Assessment Task Force. Am. J. Cardiol. 97(8A), C89–C94 (2006).
   Google Scholar
• Pasternak RC, Smith SC Jr, Bairey-Merz CN et al. ACC/AHA/NHLBI clinical advisory on the use and safety of statins. Circulation 106(8), 1024–1028 (2002).
   Google Scholar
• Farmer JA, Torre-Amione G. Comparative tolerability of the HMG-CoA reductase inhibitors. Drug Saf. 23(3), 197–213 (2000).
   Google Scholar
• Parra JL, Reddy KR. Hepatotoxicity of hypolipidemic drugs. Clin. Liver Dis. 7(2), 415–433 (2003).
   Google Scholar
• Cohen DE, Anania FA, Chalasani N. National Lipid Association Statin Safety Task Force Liver Expert P. An assessment of statin safety by hepatologists. Am. J. Cardiol. 97(8A), C77–C81 (2006). •• Consensus Statement Regarding The Use Of Statins In Patients With Liver Disease.
   Google Scholar
• Silva M, Matthews ML, Jarvis C et al. Meta-analysis of druginduced adverse events associated with intensive-dose statin therapy. Clin. Ther. 29(2), 253–260 (2007).
   Google Scholar
• Calderon RM, Cubeddu LX, Goldberg RB, Schiff ER. Statins in the treatment of dyslipidemia in the presence of elevated liver aminotransferase levels: a therapeutic dilemma. Mayo Clin. Proc. 85(4), 349–356 (2010).
   Google Scholar
• Kiyici M, Gulten M, Gurel S et al. Ursodeoxycholic acid and atorvastatin in the treatment of nonalcoholic steatohepatitis. Can. J. Gastroenterol. 17(12), 713–718 (2003).
   Google Scholar
• Savarese G, Musella F, Volpe M, Paneni F, Perrone-Filardi P. Effects of atorvastatin and rosuvastatin on renal function: a meta-analysis. Int. J. Cardiol. 167(6), 2482–2489 (2013).
   Google Scholar
• Agarwal R. Effects of statins on renal function. Am. J. Cardiol. 97(5), 748–755 (2006).
   Google Scholar
• Ridker PM, Danielson E, Fonseca FA et al. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N. Engl. J. Med. 359(21), 2195–2207 (2008).
   Google Scholar
• Ridker PM, Pradhan A, Macfadyen JG, Libby P, Glynn RJ. Cardiovascular benefits and diabetes risks of statin therapy in primary prevention: an analysis from the JUPITER trial. Lancet 380(9841), 565–571 (2012).
   Google Scholar
• Baker WL, Talati R, White CM, Coleman CI. Differing effect of statins on insulin sensitivity in non-diabetics: a systematic review and meta-analysis. Diabetes Res. Clin. Prac. 87(1), 98–107 (2010).
   Google Scholar
• Mcguinness B, Craig D, Bullock R, Passmore P. Statins for the prevention of dementia. Cochrane Database Syst. Rev. (2), CD003160 (2009).
   Google Scholar
• Shepherd J, Blauw GJ, Murphy MB et al. Pravastatin in elderly individuals at risk of vascular disease (PROSPER): a randomised controlled trial. Lancet 360(9346), 1623–1630 (2002).
   Google Scholar
• Evans MA, Golomb BA. Statin-associated adverse cognitive effects: survey results from 171 patients. Pharmacotherapy 29(7), 800–811 (2009).
   Google Scholar
• Becker DJ, Gordon RY, Halbert SC, French B, Morris PB, Rader DJ. Red yeast rice for dyslipidemia in statin-intolerant patients: a randomized trial. Ann. Intern. Med. 150(12), 830–839, W147–839 (2009).
   Google Scholar
• Gordon RY, Cooperman T, Obermeyer W, Becker DJ. Marked variability of monacolin levels in commercial red yeast rice products: buyer beware! Arch. Intern. Med. 170(19), 1722–1727 (2010).
   Google Scholar
• Mckenney J. New perspectives on the use of niacin in the treatment of lipid disorders. Arch. Intern. Med. 164(7), 697–705 (2004).
   Google Scholar
• Masana L, Cabre A, Plana N. HPS2-THRIVE results: bad for niacin/laropiprant, good for ezetimibe? Atherosclerosis 229(2), 449–450 (2013).
   Google Scholar
• Group HTC. HPS2-THRIVE randomized placebo-controlled trial in 25 673 high-risk patients of ER niacin/ laropiprant: trial design, pre-specified muscle and liver outcomes, and reasons for stopping study treatment. Eur. Heart J. 34(17), 1279–1291 (2013).
   Google Scholar
• Staels B, Fonseca VA. Bile acids and metabolic regulation: mechanisms and clinical responses to bile acid sequestration. Diabetes Care 32(Suppl. 2), S237–S245 (2009).
   Google Scholar
• Staels B, Dallongeville J, Auwerx J, Schoonjans K, Leitersdorf E, Fruchart JC. Mechanism of action of fibrates on lipid and lipoprotein metabolism. Circulation 98(19), 2088–2093 (1998).
   Google Scholar
• Van Heek M, Farley C, Compton DS, Hoos LM, Smith-Torhan A, Davis HR. Ezetimibe potently inhibits cholesterol absorption but does not affect acute hepatic or intestinal cholesterol synthesis in rats. Br. J. Pharmacol. 138(8), 1459–1464 (2003).
   Google Scholar
• Dujovne CA, Ettinger MP, Mcneer JF et al. Efficacy and safety of a potent new selective cholesterol absorption inhibitor, ezetimibe, in patients with primary hypercholesterolemia. Am. J. Cardiol. 90(10), 1092–1097 (2002).
   Google Scholar
• Pearson T, Ballantyne C, Sisk C, Shah A, Veltri E, Maccubbin D. Comparison of effects of ezetimibe/ simvastatin versus simvastatin versus atorvastatin in reducing C-reactive protein and low-density lipoprotein cholesterol levels. Am. J. Cardiol. 99(12), 1706–1713 (2007).
   Google Scholar
• Cannon CP, Giugliano RP, Blazing MA et al. Rationale and design of IMPROVE-IT (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial): comparison of ezetimbe/simvastatin versus simvastatin monotherapy on cardiovascular outcomes in patients with acute coronary syndromes. Am. Heart J. 156(5), 826–832 (2008).
   Google Scholar
• Kastelein JJ, Wedel MK, Baker BF et al. Potent reduction of apolipoprotein B and low-density lipoprotein cholesterol by short-term administration of an antisense inhibitor of apolipoprotein B. Circulation 114(16), 1729–1735 (2006).
   Google Scholar
• Smith RJ, Hiatt WR. Two new drugs for homozygous familial hypercholesterolemia: managing benefits and risks in a rare disorder. JAMA 173(16), 1491–1492 (2013).
   Google Scholar
• Stein EA, Gipe D, Bergeron J et al. Effect of a monoclonal antibody to PCSK9, REGN727/SAR236553, to reduce low-density lipoprotein cholesterol in patients with heterozygous familial hypercholesterolaemia on stable statin dose with or without ezetimibe therapy: a Phase 2 randomised controlled trial. Lancet 380(9836), 29–36 (2012).
   Google Scholar
• Sheridan C. Phase 3 data for PCSK9 inhibitor wows. Nat. Biotechnol. 31(12), 1057–1058 (2013).
   Google Scholar