Current Treatment of Dyslipidemia: A New Paradigm for Statin Drug Use and the Need for Additional Therapies

Drugs

Volumn 75, Issue 11, 2015, Pages 1187-1199

  Kones, Richard ^a   Rumana, Umme ^a  

^a Cardiometabolic Research Institute   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CHOLESTEROL; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; LOW DENSITY LIPOPROTEIN; LOW DENSITY LIPOPROTEIN CHOLESTEROL;

ARTICLE; CAUSE OF DEATH; DRUG EFFICACY; DRUG USE; DYSLIPIDEMIA; FOOD AND DRUG ADMINISTRATION; HUMAN; ISCHEMIC HEART DISEASE; LIFESTYLE MODIFICATION; MEDICAL SOCIETY; MONOTHERAPY; PRACTICE GUIDELINE; RISK ASSESSMENT; SODIUM RESTRICTION; TREATMENT RESPONSE; COMPLICATION; CORONARY DISEASE; DRUG APPROVAL; DRUG DESIGN; DYSLIPIDEMIAS; RISK; UNITED STATES;

CORONARY DISEASE; DRUG APPROVAL; DRUG DESIGN; DYSLIPIDEMIAS; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; PRACTICE GUIDELINES AS TOPIC; RISK; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84938288236     PISSN: 00126667     EISSN: 11791950     Source Type: Journal    
DOI: 10.1007/s40265-015-0428-4     Document Type: Article

References (86)

1. Keller A, Graefen A, Ball M, Matzas M, Boisguerin V, Maixner F, et al. New insights into the Tyrolean Iceman's origin and phenotype as inferred by whole-genome sequencing. Nat Commun. 2012;3:698.
2. Wilson PW, D'Agostino RB, Levy D, Belanger AM, Silbershatz H, Kannel WB. Prediction of coronary heart disease using risk factor categories. Circulation. 1998;97:1837-47.
3. Wong ND. Epidemiological studies of CHD and the evolution of preventive cardiology. Nat Rev Cardiol. 2014;11:276-89.
4. Kones R. Is prevention a fantasy, or the future of medicine? A panoramic view of recent data, status, and direction in cardiovascular prevention. Ther Adv Cardiovasc Dis. 2011;5:51-61.
5. Grundy SM, Cleeman JI, Merz CNB, Brewer HB Jr, Clark LT, Hunninghake DB, For the Coordinating Committee of the National Cholesterol Education Program, et al. Summary of implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III Guidelines. Arterioscler Thromb Vasc Biol. 2004;24:1329-30.
6. Jaffer FA, O'Donnell CJ, Larson MG, et al. Age and sex distribution of subclinical aortic atherosclerosis: a magnetic resonance imaging examination of the Framingham Heart Study. Arterioscler Thromb Biol. 2002;22:849-54.
7. Lloyd-Jones DM, Larson MG, Beiser A, Levy D. Lifetime risk of developing coronary heart disease. Lancet. 1999;353:89-92.
8. Wilson PW, D'Agostino RB, Sullivan L, Parise H, Kannel WB. Overweight and obesity as determinants of cardiovascular risk: the Framingham experience. Arch Intern Med. 2002;162:1867-72.
9. Wilkins JT, Ning H, Berry J, Zhao L, Dyer AR, Lloyd-Jones DM. Lifetime risk and years lived free of total cardiovascular disease. JAMA. 2012;308:1795-801.
10. Grundy SM, Cleeman JI, Merz CN, Brewer HB Jr, Clark LT, Hunninghake DB, et al. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. Circulation. 2004;110:227-39.
11. Ferrières J. Effects on coronary atherosclerosis by targeting lowdensity lipoprotein cholesterol with statins. Am J Cardiovasc Drugs. 2009;9:109-15.
12. Zhou Q, Liao JK. Statins and cardiovascular diseases: from cholesterol lowering to pleiotropy. Curr Pharm Des. 2009;15:467-78.
13. Satoh K, Fukumoto Y, Shimokawa H. Rho-kinase: important new therapeutic target in cardiovascular diseases. Am J Physiol Heart Circ Physiol. 2011;301:H287-96.
14. Vaughan CJ, Gotto AM Jr, Basson CT. The evolving role of statins in the management of atherosclerosis. J Am Coll Cardiol. 2000;35:1-10.
15. Cholesterol Treatment Trialists' (CTT) Collaboration. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010;376:1670-81.
16. Cholesterol Treatment Trialists' (CTT) Collaborators. The effects of lowering LDL cholesterol with ststin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trials. Lancet. 2012;380:581-90.
17. Libby P. The forgotten majority: unfinished business in cardiovascular risk reduction. J Am Coll Cardiol. 2005;46:1225-8.
18. Kones R, Rumana U. Cardiovascular prevention: components, levels, early origins, and metrics. Hosp Pract. 2014;42(3):84-95.
19. Ray KK, Cannon, Cairns R, Morrow DA, Rifai N, Kirtane AJ, PROVE IT-TIMI 22 Investigators, et al. Relationship between uncontrolled risk factors and C-reactive protein levels in patients receiving standard or intensive statin therapy for acute coronary syndromes in the PROVE IT-TIMI 22 Trial. J Am Coll Cardiol. 2005;46:1417-24.
20. Cannon CP, Braunwald E, McCabe CH, Rader DJ, Rouleau JL, Belder R, et al. Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med. 2004;350:1495-504.
21. Chen Z, Peto R, Collins R, MacMahon S, Lu J, Li W. Serum cholesterol concentration and coronary heart disease in population with low cholesterol concentrations. BMJ. 1991;303:276-82.
22. O'Keefe JH Jr, Cordain L, Harris WH, Moe RM, Vogel R. Optimal low-density lipoprotein is 50 to 70 mg/dl: Lower is better and physiologically normal. J Am Coll Cardiol. 2004;43:2142-6.
23. O'Keefe JH Jr, Cordain L. Cardiovascular disease resulting from a diet and life-style at odds with our Paleolithic genome: how to become a 21st-century hunter-gatherer. Mayo Clin Proc. 2004;79:101-8.
24. Forrester JS. Redefining normal low-density lipoprotein cholesterol: a strategy to unseat coronary disease as the nation's leading killer. J Am Coll Cardiol. 2010;56:630-6.
25. Hochholzer W, Giugliano RP. Lipid lowering goals: back to nature? Ther Adv Cardiovasc Dis. 2010;4:185-91.
26. Ramjee V, Jacobson TA. Intensifying statin therapy to maximize cardiovascular risk reduction: is 50 the new 70? Goals are getting old. Clin Lipidology. 2011;6:131-6.
27. Nissen S, Tuzcu EM, Schoenhagen P, Brown BG, Ganz P, Vogel RA, For the REVERSAL Investigators, et al. Effect of intensive compared with moderate lipid-lowering therapy on progression of coronary atherosclerosis: a randomized controlled trial. JAMA. 2004;291:1071-80.
28. Benn M, Nordestgaard BG, Grande P, Schnorr P, Tybjærg-Hansen A. PCSK9 R46L, low-density lipoprotein cholesterol levels, and risk of ischemic heart disease: 3 independent studies and meta-analyses. J Am Coll Cardiol. 2010;55:3833-42.
29. Raal FJ, Stein EA. Targeting LDL: is lower better and is it safe? Best Pract Res Clin Endocrinol Metab. 2014;28:309-24.
30. Ference BA, Yoo W, Alesh I, Mahajan N, Mirowska KK, Mewada A, et al. Effect of long-term exposure to lower lowdensity lipoprotein cholesterol beginning early in life on the risk of coronary heart disease: a mendelian randomization analysis. J Am Coll Cardiol. 2012;60:2631-9.
31. Ridker PM, Danielson E, Fonseca FA, Genest J, Gotto AM Jr, Kastelein JJP, For the JUPITER Study Group, et al. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med. 2008;359:2195-207.
32. Sattar N, Preiss D, Murray HM, Welsh P, Buckley BM, de Craen AJ, et al. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet. 2010;375: 735-42.
33. Macedo AF, Taylor FC, Casas JP, Adler A, Prieto-Merino D, Ebrahim S. Unintended effects of statins from observational studies in the general population: systematic review and metaanalysis. BMC Med. 2014;12:51.
34. Golomb BA, Evans MA. Statin adverse effects: a review of the literature and evidence for a mitochondrial mechanism. Am J Cardiovasc Drugs. 2008;8:373-418.
35. Jacobson TA, The NLA. Task force on statin safety - 2014 update. J Clin Lipidol. 2014;8(Suppl):S1-4.
36. Zhang H, Plutzky J, Skentzos S, Morrison F, Mar P, Shubina M, et al. Discontinuation of statins in routine care settings: a cohort study. Ann Intern Med. 2013;158:526-34.
37. Chen YH, Feng B, Chen ZW. Statins for primary prevention in cardiovascular and cerebrovascular events in diabetic patients without established cardiovascular disease: a meta-analysis. Exp Clin Endocrinol Diabetes. 2012;120:116-20.
38. Navarese EP, Buffon A, Andreotti F, Kozinski M, Welton N, Fabiszak T, et al. Meta-analysis of impact of different types and doses of statins on new-onset diabetes mellitus. Am J Cardiol. 2013;111:1123-30.
39. Hu M, Cheung BMY, Tomlinson B. Safety of statins. Ther Adv Drug Saf. 2012;3:133-44.
40. Rosenson RS, Baker SK, Jacobson TA, Kopecky SL, Parker BA. An assessment by the statin muscle safety task force: 2014 update. J Clin Lipidol. 2014;8:S58-71.
41. Hoffman KB, Kraus C, Dimbil M, Golomb BA. A survey of the FDA's AERS database regarding muscle and tendon adverse events linked to the statin drug class. PLoS One. 2012;7:e42866.
42. Liao JK. Isoprenoids as mediators of the biological effects of statins. J Clin Invest. 2002;110:285-8.
43. Sakamoto K, Wada I, Kimura J. Inhibition of Rab1 GTPase and endoplasmic reticulum-to-Golgi trafficking underlies statin's toxicity in rat skeletal myofibers. J Pharmacol Exp Ther. 2011;338:62-9.
44. Barylski M, Nikolic D, Banach M, Toth PP, Montalto G, Rizzo M. Statins and new-onset diabetes. Curr Pharm Des. 2014;20:3657-64.
45. Mallinson JE, Marimuthu K, Murton A, Selby A, Smith K, Constantin-Teodosiu D, et al. Statin myalgia is not associated with reduced muscle strength, mass or protein turnover in older male volunteers, but is allied with a slowing of time to peak power output, insulin resistance and differential muscle mRNA expression. J Physiol. 2015;593:1239-57.
46. Vaklavas C, Chatzizisis YS, Ziakas A, Zamboulis C, Giannoglou GD. Molecular basis of statin-associated myopathy. Atherosclerosis. 2009;202:18-28.
47. Sirvent P, Mercier J, Vassort G, Lacampagne A. Simvastatin triggers mitochondria-induced Ca2? signaling alteration in skeletal muscle. Biochem Biophys Res Commun. 2005;329: 1067-75.
48. Sirvent P, Mercier J, Lacampagne A. New insights into mechanisms of statin-associated myotoxicity. Curr Opin Pharmacol. 2008;8:333-8.
49. Chapman MJ, Carrie A. Mechanisms of statin-induced myopathy: a role for the ubiquitin-proteasome pathway? Arterioscler Thromb Vasc Biol. 2005;25:2441-4.
50. Dirks AJ, Jones KM. Statin-induced apoptosis and skeletal myopathy. Am J Physiol Cell Physiol. 2006;291:C1208-12.
51. Zorgiebel T, Weigl L, Genth H, Hohenegger M. Activation of RhoB in simvastatin-induced apoptosis of differentiated human skeletal muscle cells. BMC Pharmacol. 2007;7(Suppl 2):A16.
52. Smith R, Solberg R, Jacobsen LL, Voreland AL, Rustan AC, et al. Simvastatin inhibits glucose metabolism and legumain activity in human myotubes. PLoS One. 2014;9(1):e85721.
53. Mitchell P, Marette A. Statin-induced insulin resistance through inflammasome activation: sailing between scylla and charybdis. Diabetes. 2014;63(11):3569-71.
54. Tamblyn R, Eguale T, Huang A, Winslade N, Doran P. The incidence and determinants of primary nonadherence with prescribed medication in primary care: a cohort study. Ann Intern Med. 2014;160:441-50.
55. Chi DM, Vansomphone SS, Liu IL, Cheetham TC, Green KR, Scott RD, et al. Adherence to statins and LDL-cholesterol goal attainment. Am J Manag Care. 2014;20:e105-12.
56. Kones R. Primary prevention of coronary heart disease: integration of new data, evolving views, revised goals, and role of rosuvastatin in management. A comprehensive survey. Drug Des Devel Ther. 2011:5;325-80.
57. Thavendiranathan P. Primary prevention of cardiovascular disease with statin therapy. Arch Intern Med. 2006;166:2307-13.
58. Baigent C, Keech A, Kearney PM, Cholesterol Treatment Trialists' (CTT) Collaborators, et al. Efficacy and safety of cholesterol-lowering treatment. Lancet. 2005;366:1267-78.
59. Newman D. Statins given for 5 years for heart disease prevention (with known heart disease). The NNT Group; 2 Nov 2013. Available at: http://www.thennt.com/nnt/statins-for-heart-diseaseprevention-with-known-heart-disease/. Accessed 19 Mar 2015.
60. Newman D. Statins given for 5 years for heart disease prevention (without known heart disease). The NNT Group; 2 Nov 2013. Available at: http://www.thennt.com/nnt/statins-for-heart-diseaseprevention-without-prior-heart-disease/. Accessed 19 Mar 2015.
61. Ray KK, Seshasai SR, Erqou S, Sever P, Jukema JW, Ford I, et al. Statins and all-cause mortality in high-risk primary prevention: a meta-analysis of 11 randomized controlled trials involving 65,229 participants. Arch Intern Med. 2010;170:1024-31.
62. Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, et al. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/ American Heart Association Task Force on Practice Guidelines. Circulation. 2014;129(Suppl 2):S1-45.
63. Goff DC Jr, Lloyd-Jones DM, Bennett G, Coady S, D'Agostino RB, Gibbons R, et al. 2013 ACC/AHA Guideline on the assessment of cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014;129(Suppl 2):S49-73.
64. Robinson JG. Evidence for statins in secondary and primary prevention. National Lipid Association, 2013 clinical lipid update agenda, understanding clinical guidelines and assessing CVD risk. 27 Feb 2013. Available at: www.lipid.org/sites/default/files/1-robinson-02-27-13.pdf. Accessed 19 Mar 2015.
65. Myerson M, Rosenson RS. 2013 ACC/AHA guidelines: a guideline for the population-without evidence from the population. Cardiovas Drug Ther. 2014;28:203-4.
66. D'Agostino RB Sr, Ansell BJ, Mora S, Krumholz HM. The guidelines battle on starting statins. N Engl J Med. 2014;370:1652-8.
67. Schutte JM, Rothaus CS, Adler JN. Clinical decisions. Starting statins: polling results. N Engl J Med. 2014;371:e6.
68. Ioannidis JPA. More than a billion people taking statins? Potential implications of the new cardiovascular guidelines. JAMA. 2014;311:463-4.
69. Martin SS, Abel TT, Jones SR, Michos ED, Blumenthal RS, Blaha MJ. 2013 ACC/AHA cholesterol treatment guideline. What was done well and what could be done better J Am Coll Cardiol. 2014;63:2674-8.
70. Amin NP, Martin SS, Blaha MJ, Nasir K, Blumenthal RS, Michose ED. Headed in the right direction but at risk for miscalculation. A critical appraisal of the 2013 ACC/AHA risk assessment guidelines. J Am Coll Cardiol. 2014;63:2789-94.
71. Pencina MJ, Navar-Boggan AM, D'Agostino RB, Williams K, Neely B, Sniderman AD, et al. Application of new cholesterol guidelines to a population-based sample. N Engl J Med. 2014;370:1422-31.
72. Brown WV. The art of prevention. J Clin Lipid. 2014;8:359-62.
73. Expert Dyslipidemia Panel of the International Atherosclerosis Society. An International Atherosclerosis Society position paper: global recommendations for the management of dyslipidemia-full report. J Clin Lipid. 2014;8:29-60.
74. Ray KK, Kastelein JJ, Boekholdt SM, Nicholls SJ, Khaw KT, Ballantyne CM, et al. The ACC/AHA 2013 guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular disease risk in adults: the good the bad and the uncertain: a comparison with ESC/EAS guidelines for the management of dyslipidaemias 2011. Eur Heart J. 2014;35:960-8.
75. Kavousi M, Leening MJG, Nanchen D, Greenland P, Graham IM, Steyerberg EW, et al. Comparison of application of the ACC/AHA guidelines, Adult Treatment Panel III guidelines, and European Society of Cardiology guidelines for cardiovascular disease prevention in a European cohort. JAMA. 2014;311:1416-23.
76. Ridker PM, Cook NR. Statins: new American guidelines for prevention of cardiovascular disease. Lancet. 2013;382:1762-5.
77. DeFilippis AP, Young R, Carrubba CJ, McEvoy JW, Budoff MJ, Blumenthal RS, et al. An analysis of calibration and discrimination among multiple cardiovascular risk scores in a modern multiethnic cohort calibration and discrimination among CVD risk scores. Ann Intern Med. 2015;162:266-75.
78. Ridker PM, Cook NR. Comparing cardiovascular risk prediction scores. Ann Intern Med. 2015;162:313-4.
79. Hayward RA. Should family physicians follow the new ACC/ AHA Cholesterol Treatment Guideline? Am Fam Phys. 2014;90:223-4.
80. Kones R, Rumana U. Current therapy of dyslipidemia: evolving roles of non-statin and newer drugs. Drugs. 2015. doi:10.1007/s40265-015-0429-3.
81. Boekholdt SM, Hovingh GK, Mora S, Arsenault BJ, Amarenco P, Pedersen TR, et al. Very low levels of atherogenic lipoproteins and the risk for cardiovascular events. A meta-analysis of statin trials. J Am Coll Cardiol. 2014;64:485-94.
82. Kataoka Y, St John J, Wolski K, Uno K, Puri R, Tuczu EM, et al. Atheroma progression in hyporesponders to statin therapy. Arterioscler Thromb Vasc Biol. 2015;35:990-5.
83. Johnson KM, Dowe DA. Accuracy of statin assignment using the 2013 AHA/ACC cholesterol guideline versus the 2001 NCEP ATP III guideline: correlation with atherosclerotic plaque imaging. J Am Coll Cardiol. 2014;64:910-9.
84. Pursnani A. The 2013 ACC/AHA cardiovascular prevention guidelines improve alignment of statin therapy with coronary atherosclerosis as detected by coronary computed tomography angiography [abstract no. 100]. In: Society of Cardiovascular Computed Tomography 2014 Annual Scientific Meeting; 11 Jul 2014; San Diego.
85. Sugiyama T, Tsugawa Y, Tseng CH, Kobayashi Y, Shapiro MF. Different time trends of caloric and fat intake between statin users and nonusers among US adults: gluttony in the time of statins? JAMA Intern Med. 2014;174:1038-45.
86. Lee DSH, Markwardt S, Goeres L, Lee CG, Eckstrom E, Williams C, et al. Statins and physical activity in older men: the Osteoporotic Fractures in Men Study. JAMA Intern Med. 2014;174:1263-70.