Adverse effects of statin therapy: perception vs. the evidence - focus on glucose homeostasis, cognitive, renal and hepatic function, haemorrhagic stroke and cataract

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Citações na Scopus
Tipo de produção
article
Data de publicação
2018
Editora
OXFORD UNIV PRESS
Indexadores
Título da Revista
ISSN da Revista
Título do Volume
Autores
MACH, Francois
RAY, Kausik K.
WIKLUND, Olov
CORSINI, Alberto
CATAPANO, Alberico L.
BRUCKERT, Eric
BACKER, Guy De
HEGELE, Robert A.
HOVINGH, G. Kees
JACOBSON, Terry A.
Autor de Grupo de pesquisa
European Atherosclerosis So
Editores
Coordenadores
Organizadores
Citação
EUROPEAN HEART JOURNAL, v.39, n.27, p.2526-+, 2018
Projetos de Pesquisa
Unidades Organizacionais
Fascículo
Resumo
Aims To objectively appraise evidence for possible adverse effects of long-term statin therapy on glucose homeostasis, cognitive, renal and hepatic function, and risk for haemorrhagic stroke or cataract. Methods and results A literature search covering 2000-2017 was performed. The Panel critically appraised the data and agreed by consensus on the categorization of reported adverse effects. Randomized controlled trials (RCTs) and genetic studies show that statin therapy is associated with a modest increase in the risk of new-onset diabetes mellitus (about one per thousand patient-years), generally defined by laboratory findings (glycated haemoglobin >= 6.5); this risk is significantly higher in the metabolic syndrome or prediabetes. Statin treatment does not adversely affect cognitive function, even at very low levels of low-density lipoprotein cholesterol and is not associated with clinically significant deterioration of renal function, or development of cataract. Transient increases in liver enzymes occur in 0.5-2% of patients taking statins but are not clinically relevant; idiosyncratic liver injury due to statins is very rare and causality difficult to prove. The evidence base does not support an increased risk of haemorrhagic stroke in individuals without cerebrovascular disease; a small increase in risk was suggested by the Stroke Prevention by Aggressive Reduction of Cholesterol Levels study in subjects with prior stroke but has not been confirmed in the substantive evidence base of RCTs, cohort studies and case-control studies. Conclusion Long-term statin treatment is remarkably safe with a low risk of clinically relevant adverse effects as defined above; statin-associated muscle symptoms were discussed in a previous Consensus Statement. Importantly, the established cardiovascular benefits of statin therapy far outweigh the risk of adverse effects.
Palavras-chave
Statin, Adverse effects, Glucose homeostasis, Metabolic syndrome, Cognitive function, Renal function, Liver function, Haemorrhagic stroke, Cataract
Referências
  1. Acharya T, 2016, AM J CARDIOL, V117, P647, DOI 10.1016/j.amjcard.2015.11.031
  2. Amarenco P, 2006, NEW ENGL J MED, V355, P549
  3. Andrade RJ, 2009, PHARMACOGENOMICS, V10, P1467, DOI [10.2217/pgs.09.111, 10.2217/PGS.09.111]
  4. Athyros VG, 2010, LANCET, V376, P1916, DOI 10.1016/S0140-6736(10)61272-X
  5. Athyros VG, 2004, J CLIN PATHOL, V57, P728, DOI 10.1136/jcp.2003.012989
  6. Baigent C, 2010, LANCET, V376, P1670, DOI 10.1016/S0140-6736(10)61350-5
  7. Baigent C, 2011, LANCET, V377, P2181, DOI 10.1016/S0140-6736(11)60739-3
  8. Bang CN, 2015, AM J CARDIOL, V116, P1840, DOI 10.1016/j.amjcard.2015.09.026
  9. Bangalore S, 2014, AM J CARDIOL, V113, P2018, DOI 10.1016/j.amjcard.2014.03.046
  10. Bays H, 2014, J CLIN LIPIDOL, V8, pS47, DOI 10.1016/j.jacl.2014.02.011
  11. BENN M, 2017, BMJ BRIT MED J, V357
  12. Besseling J, 2015, JAMA-J AM MED ASSOC, V313, P1029, DOI 10.1001/jama.2015.1206
  13. Betteridge DJ, 2016, NAT REV ENDOCRINOL, V12, P99, DOI 10.1038/nrendo.2015.194
  14. Bjornsson E, 2012, J HEPATOL, V56, P374, DOI [10.1016/j.jhep.2011.08.016, 10.1016/j.jhep.2011.07.023]
  15. Boekholdt SM, 2014, J AM COLL CARDIOL, V64, P485, DOI 10.1016/j.jacc.2014.02.615
  16. Brunner EJ, 2017, J GERONTOL A-BIOL, V72, P237, DOI 10.1093/gerona/glw092
  17. Casula M, 2016, ATHEROSCLEROSIS, V251, P153, DOI 10.1016/j.atherosclerosis.2016.06.020
  18. Catapano AL, 2016, EUR HEART J, V37, P2999, DOI 10.1093/eurheartj/ehw272
  19. Cederberg H, 2015, DIABETOLOGIA, V58, P1109, DOI 10.1007/s00125-015-3528-5
  20. Chalasani N, 2008, GASTROENTEROLOGY, V135, P1924, DOI 10.1053/j.gastro.2008.09.011
  21. Clarke AT, 2016, PLOS ONE, V11, DOI 10.1371/journal.pone.0151587
  22. Colhoun HM, 2016, EUR HEART J, V37, P2981, DOI 10.1093/eurheartj/ehw292
  23. Colhoun HM, 2004, LANCET, V364, P685, DOI 10.1016/S0140-6736(04)16895-5
  24. Collins R, 2002, LANCET, V360, P7
  25. Collins R, 2003, LANCET, V361, P2005
  26. Collins R, 2016, LANCET, V388, P2532, DOI 10.1016/S0140-6736(16)31357-5
  27. Corsini A, 2013, J CLIN PHARMACOL, V53, P463, DOI 10.1002/jcph.23
  28. Corsini A, 2012, DRUG SAFETY, V35, P1099, DOI 10.2165/11632970-000000000-00000
  29. Davidson Michael H, 2004, Expert Opin Drug Saf, V3, P547, DOI 10.1517/14740338.3.6.547
  30. de Zeeuw D, 2015, LANCET DIABETES ENDO, V3, P181, DOI 10.1016/S2213-8587(14)70246-3
  31. DeGorter MK, 2013, CIRC-CARDIOVASC GENE, V6, P400, DOI 10.1161/CIRCGENETICS.113.000099
  32. Desai CS, 2014, BMJ-BRIT MED J, V349, DOI 10.1136/bmj.g3743
  33. Dormuth CR, 2013, BMJ-BRIT MED J, V346, DOI 10.1136/bmj.f880
  34. Elias PK, 2005, PSYCHOSOM MED, V67, P24, DOI 10.1097/01.psy.0000151745.67285.c2
  35. European Medicines Authority, 2017, PRAV SOD 40 MG TABL
  36. Farrer LA, 1997, JAMA-J AM MED ASSOC, V278, P1349, DOI 10.1001/jama.278.16.1349
  37. FDA, 2009, GUID IND DRUG IND LI
  38. Fellstrom BC, 2009, NEW ENGL J MED, V360, P1395, DOI 10.1056/NEJMoa0810177
  39. Ference BA, 2017, EUR HEART J, V38, P2459, DOI 10.1093/eurheartj/ehx144
  40. Ference BA, 2016, NEW ENGL J MED, V375, P2144, DOI 10.1056/NEJMoa1604304
  41. Freeman DJ, 2001, CIRCULATION, V103, P357
  42. Fulcher J, 2015, LANCET, V385, P1397, DOI 10.1016/S0140-6736(14)61368-4
  43. Giugliano RP, 2017, LANCET, V390, P1962, DOI 10.1016/S0140-6736(17)32290-0
  44. Giugliano RP, 2017, NEW ENGL J MED, V377, P633, DOI 10.1056/NEJMoa1701131
  45. Giugliano RP, 2017, JAMA CARDIOL, V2, P547, DOI 10.1001/jamacardio.2017.0083
  46. Goldstein LB, 2008, NEUROLOGY, V70, P2364, DOI 10.1212/01.wnl.0000296277.63350.77
  47. Goodarzi MO, 2013, DIABETES CARE, V36, pE100, DOI 10.2337/dc13-0490
  48. Gupta A, 2017, LANCET, V389, P2473, DOI 10.1016/S0140-6736(17)31075-9
  49. Hackam DG, 2011, CIRCULATION, V124, P2233, DOI 10.1161/CIRCULATIONAHA.111.055269
  50. HARRIS ML, 1995, BRIT J OPHTHALMOL, V79, P996, DOI 10.1136/bjo.79.11.996
  51. Healy D, 2009, BMJ CASE REPORTS, DOI [10.1136/bcr.06.2008.0033, DOI 10.1136/BCR.06.2008.0033]
  52. Herrick C, 2014, BEST PRACT RES CL EN, V28, P339, DOI 10.1016/j.beem.2013.11.006
  53. Herrington WG, 2016, LANCET DIABETES ENDO, V4, P829, DOI 10.1016/S2213-8587(16)30156-5
  54. HIPPISLEYCOX J, 2010, BRIT MED J, V340
  55. Hockwin O, 1990, Lens Eye Toxic Res, V7, P563
  56. Hou WY, 2013, EUR HEART J, V34, P1807, DOI 10.1093/eurheartj/eht065
  57. Kesse-Guyot E, 2015, J NUTR HEALTH AGING, V19, P183, DOI 10.1007/s12603-014-0508-2
  58. Kim RG, 2017, CLIN GASTROENTEROL H, V15, P1521, DOI 10.1016/j.cgh.2017.04.039
  59. Knowler WC, 2002, NEW ENGL J MED, V346, P393
  60. Kohli P, 2015, J AM COLL CARDIOL, V65, P402, DOI 10.1016/j.jacc.2014.10.053
  61. Koren MJ, 2017, JAMA CARDIOL, V2, P598, DOI 10.1001/jamacardio.2017.0747
  62. Kostis JB, 2016, AM J CARDIOL, V117, P1196, DOI 10.1016/j.amjcard.2016.01.001
  63. Kowa Pharmaceutical Europe Co. Ltd, 2018, LIV CONS SMPC SUMM P
  64. Lafeber M, 2016, EUR J PREV CARDIOL, V23, P1289, DOI 10.1177/2047487315624523
  65. Lammert C, 2010, HEPATOLOGY, V51, P615, DOI 10.1002/hep.23317
  66. LATIES AM, 1991, AM J CARDIOL, V67, P447, DOI 10.1016/0002-9149(91)90002-3
  67. Leuschen J, 2013, JAMA OPHTHALMOL, V131, P1427, DOI 10.1001/jamaophthalmol.2013.4575
  68. Lim S, 2014, J ATHEROSCLER THROMB, V21, P997, DOI 10.5551/jat.24398
  69. Lotta LA, 2016, JAMA-J AM MED ASSOC, V316, P1383, DOI 10.1001/jama.2016.14568
  70. Mahley RW, 2016, ARTERIOSCL THROM VAS, V36, P1305, DOI 10.1161/ATVBAHA.116.307023
  71. Mancini GBJ, 2016, CAN J CARDIOL, V32, pS35, DOI 10.1016/j.cjca.2016.01.003
  72. Matthews A, 2016, BMJ-BRIT MED J, V353, DOI 10.1136/bmj.i3283
  73. McGuinness B, 2014, COCHRANE DB SYST REV, DOI 10.1002/14651858.CD007514.pub3
  74. McKinney JS, 2012, STROKE, V43, P2149, DOI 10.1161/STROKEAHA.112.655894
  75. Mora S, 2010, CIRCULATION, V121, P1069, DOI 10.1161/CIRCULATIONAHA.109.906479
  76. Naci H, 2013, CIRC-CARDIOVASC QUAL, V6, P390, DOI 10.1161/CIRCOUTCOMES.111.000071
  77. Newman C, 2006, AM J CARDIOL, V97, P61, DOI 10.1016/j.amjcard.2005.07.108
  78. Nielsen SF, 2014, LANCET DIABETES ENDO, V2, P894, DOI 10.1016/S2213-8587(14)70173-1
  79. Nielsen SF, 2016, EUR HEART J, V37, P908, DOI 10.1093/eurheartj/ehv641
  80. Nikolic D, 2013, INT J CARDIOL, V168, P5437, DOI 10.1016/j.ijcard.2013.08.060
  81. Org E, 2017, GENOME BIOL, V18, DOI 10.1186/s13059-017-1194-2
  82. Ott BR, 2015, J GEN INTERN MED, V30, P348, DOI 10.1007/s11606-014-3115-3
  83. Palmer SC, 2014, COCHRANE DB SYST REV, V1
  84. Palmer SC, 2014, COCHRANE DB SYST REV, DOI 10.1002/14651858.CD007784.pub2
  85. Pastori D, 2015, DIGEST LIVER DIS, V47, P4, DOI 10.1016/j.dld.2014.07.170
  86. Perdices EV, 2014, REV ESP ENFERM DIG, V106, P246
  87. Piepoli MF, 2016, EUR HEART J, V37, P2315, DOI [10.1093/eurheartj/ehw106, 10.1016/j.rec.2016.09.009]
  88. Preiss D, 2011, JAMA-J AM MED ASSOC, V305, P2556, DOI 10.1001/jama.2011.860
  89. Ray KK, 2009, LANCET, V373, P1765, DOI 10.1016/S0140-6736(09)60697-8
  90. Richardson K, 2013, ANN INTERN MED, V159, P688, DOI 10.7326/0003-4819-159-10-201311190-00007
  91. Ridker PM, 2012, LANCET, V380, P565, DOI 10.1016/S0140-6736(12)61190-8
  92. Ridker PM, 2010, J AM COLL CARDIOL, V55, P1266, DOI 10.1016/j.jacc.2010.01.020
  93. Robinson JG, 2017, J AM COLL CARDIOL, V69, P471, DOI 10.1016/j.jacc.2016.11.037
  94. Russo MW, 2014, HEPATOLOGY, V60, P679, DOI 10.1002/hep.27157
  95. Sabatine MS, 2017, LANCET DIABETES ENDO, V5, P941, DOI 10.1016/S2213-8587(17)30313-3
  96. Salat David, 2009, Expert Rev Cardiovasc Ther, V7, P1219, DOI 10.1586/erc.09.52
  97. Sanguankeo A, 2015, PLOS ONE, V10, DOI 10.1371/journal.pone.0132970
  98. Sattar N, 2010, LANCET, V375, P735, DOI 10.1016/S0140-6736(09)61965-6
  99. Saunders NLJ, 2011, NEUROPSYCHOLOGY, V25, P237, DOI 10.1037/a0021134
  100. Schmidt AF, 2017, LANCET DIABETES ENDO, V5, P97, DOI 10.1016/S2213-8587(16)30396-5
  101. Scott RA, 2012, NAT GENET, V44, P991, DOI 10.1038/ng.2385
  102. Serban MC, 2017, J AM COLL CARDIOL, V69, P1386, DOI 10.1016/j.jacc.2016.12.036
  103. Sidaway JE, 2004, J AM SOC NEPHROL, V15, P2258, DOI 10.1097/01.ANS.0000138236.82706.EE
  104. Simons M, 2001, NEUROLOGY, V57, P1089, DOI 10.1212/WNL.57.6.1089
  105. Singh-Manoux A, 2008, ARTERIOSCL THROM VAS, V28, P1556, DOI 10.1161/ATVBAHA.108.163998
  106. Sirtori CR, 2014, PHARMACOL RES, V88, P3, DOI 10.1016/j.phrs.2014.03.002
  107. Song Y, 2013, GERIATR GERONTOL INT, V13, P817, DOI 10.1111/ggi.12044
  108. Sorokin A, 2007, ATHEROSCLEROSIS, V194, P293, DOI 10.1016/j.atherosclerosis.2006.11.036
  109. Speliotes EK, 2010, NAT GENET, V42, P937, DOI 10.1038/ng.686
  110. Stroes ES, 2015, EUR HEART J, V36, P1012, DOI 10.1093/eurheartj/ehv043
  111. Sturgeon JD, 2007, STROKE, V38, P2718, DOI 10.1161/STROKEAHA.107.487090
  112. Su XL, 2016, AM J KIDNEY DIS, V67, P881, DOI 10.1053/j.ajkd.2016.01.016
  113. Swerdlow DI, 2015, LANCET, V385, P351, DOI 10.1016/S0140-6736(14)61183-1
  114. Szendroedi J, 2009, DIABETES CARE, V32, P209, DOI 10.2337/dc08-1123
  115. Tobert JA, 2016, J CLIN LIPIDOL, V10, P739, DOI 10.1016/j.jacl.2016.05.002
  116. Tolman KG, 2002, AM J CARDIOL, V89, P1374, DOI 10.1016/S0002-9149(02)02355-X
  117. Tonelli M, 2003, J AM SOC NEPHROL, V14, P1605, DOI 10.1097/01.ASN.0000068461.45784.2F
  118. Trompet S, 2010, J NEUROL, V257, P85, DOI 10.1007/s00415-009-5271-7
  119. US Food and Drug Administration, 2012, FDA DRUG SAF COMM IM
  120. Vallejo-Vaz AJ, 2015, ATHEROSCLEROSIS, V241, P409, DOI 10.1016/j.atherosclerosis.2015.06.001
  121. Vergouwen MDI, 2008, STROKE, V39, P497, DOI 10.1161/STROKEAHA.107.488791
  122. Verhulst A, 2004, J AM SOC NEPHROL, V15, P2249, DOI 10.1097/01.ASN.0000136778.32499.05
  123. Vidt DG, 2004, CARDIOLOGY, V102, P52, DOI 10.1159/000077704
  124. Wanner C, 2005, NEW ENGL J MED, V353, P238, DOI 10.1056/NEJMoa043545
  125. Wanner C, 2014, KIDNEY INT, V85, P1303, DOI 10.1038/ki.2014.31
  126. Waters DD, 2013, J AM COLL CARDIOL, V61, P148, DOI 10.1016/j.jacc.2012.09.042
  127. Wise SJ, 2014, CAN J CARDIOL, V30, P1613, DOI 10.1016/j.cjca.2014.08.020
  128. Wurtz P, 2016, J AM COLL CARDIOL, V67, P1200, DOI 10.1016/j.jacc.2015.12.060
  129. Xu HC, 2017, DIABETES, V66, P2054, DOI 10.2337/db17-0173
  130. Yamazaki T, 2011, DIABETOL INT, V2, P134, DOI 10.1007/s13340-011-0032-0
  131. Yu SD, 2017, J AM HEART ASSOC, V6, DOI 10.1161/JAHA.116.004180
  132. Yusuf S, 2016, NEW ENGL J MED, V374, P2021, DOI 10.1056/NEJMoa1600176
  133. Zhang ZH, 2016, PHARMACOL RES, V105, P74, DOI 10.1016/j.phrs.2016.01.005
  134. Zhong GC, 2015, PLOS ONE, V10, DOI 10.1371/journal.pone.0118333
  135. Zimmerman H. J., 1999, HEPATOTOXICITY ADVER, P428
  136. 2017, N ENGL J MED, V377, P1217