Interdisciplinary Expert Consensus: the place of original pitavastatin in primary and secondary prevention of cardiovascular diseases

Russian Society of Cardiology, National Atherosclerosis Society, Russian Society of Cardiosomatic Rehabilitation and Secondary Prevention, Russian Association of Endocrinologists

1. Drapkina OM, Imaeva AE, Kutsenko VA, et al. Dyslipidemia in the Russian Federation: population data, associations with risk factors. Cardiovascular Therapy and Prevention. 2023;22(8S):3791. (In Russ.) doi:10.15829/1728-8800-2023-3791. EDN DGYJLA.

2. Borén J, Chapman MJ, Krauss RM, et al. Low-density lipoproteins cause atherosclerotic cardiovascular disease: pathophysiological, genetic, and therapeutic insights: a consensus statement from the European Atherosclerosis Society Consensus Panel. Eur Heart J. 2020;41(24):2313-30. doi:10.1093/eurheartj/ehz962.

3. Erina AM, Usoltsev DA, Boyarinova MA, et al. Appointment of lipid-lowering therapy in the Russian population: comparison of SCORE and SCORE2 (according to the ESSE-RF study). Russian Journal of Cardiology. 2022;27(5):5006. (In Russ.) doi:10.15829/1560-4071-2022-5006. EDN HBBGKQ.

4. Alieva AS, Usova EI, Zvartau NE, Shlyakhto EV. Implementation study to introduce clinical guidelines on lipid metabolism disorders into routine practice: results of the first stage. Russian Journal of Cardiology. 2024;29(1):5724. (In Russ.) doi:10.15829/1560-4071-2024-5724. EDN ADVLHL.

5. Ezhov MV, Kukharchuk VV, Sergienko IV, et al. Disorders of lipid metabolism. Clinical Guidelines 2023. Russian Journal of Cardiology. 2023;28(5):5471. (In Russ.) doi:10.15829/1560-4071-2023-5471. EDN YVZOWJ.

6. Mach F, Baigent C, Catapano AL, et al. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. Eur Heart J. 2020. 41(1):111-88. doi:10.1093/eurheartj/ehz455.

7. Visseren FLJ, Mach F, Smulders YM, et al. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice Eur Heart J. 2021.42(34):3227-337. doi:10.1093/eurheartj/ehab4847-9.

8. Yebyo HG, Aschmann HE, Kaufmann M, Puhan MA. Comparative effectiveness and safety of statins as a class and of specific statins for primary prevention of cardiovascular disease: a systematic review, meta-analysis, and network meta-analysis of randomized trials with 94,283 participants. Am Heart J. 2019;210:18-28. doi:10.1016/j.ahj.2018.12.007.

9. Singh BM, Lamichhane HK, Srivatsa SS, et al. Role of statins in the primary prevention of atherosclerotic cardiovascular disease and mortality in the population with mean cholesterol in the near-optimal to borderline high range: a systematic review and meta-analysis. Adv Prev Med. 2020;2020:6617905. doi:10.1155/2020/6617905.

10. Ma W, Pan Q, Pan D, et al. Efficacy and safety of lipid-lowering drugs of different intensity on clinical outcomes: a systematic review and network meta-analysis. Front Pharmacol. 2021;12:713007. doi:10.3389/fphar.2021.713007.

11. Banach M, Surma S. A look to the past — what has had the biggest impact on lipids in the last four decades? A personal perspective. Arch Med Sci. 2023;19(3):559-64. doi:10.5114/aoms/166256.

12. Banach M, Surma S, Toth PP. 2023: the year in cardiovascular disease—the year of new and prospective lipid lowering therapies. Can we render dyslipidemia a rare disease by 2024? Arch Med Sci. 2023;19(6):1602-15. doi:10.5114/aoms/174743.

13. Zhang Y, Vittinghoff E, Pletcher MJ, et al. Associations of blood pressure and cholesterol levels during young adulthood with later cardiovascular events. J Am Coll Cardiol. 2019;74(3):330-41. doi:10.1016/j.jacc.2019.03.529.

14. Wang N, Woodward M, Huffman MD, Rodgers A. Compounding Benefits of Cholesterol-Lowering Therapy for the Reduction of Major Cardiovascular Events: Systematic Review and Meta-Analysis. Circ Cardiovasc Qual Outcomes. 2022;15(6):e008552. doi:10.1161/CIRCOUTCOMES.121.008552.

15. Bubnova MG, Ezhov MV, Aronov DM. Statins adherence and associated muscle symptoms in older coronary heart disease patients. Aging Pathobiology and Therapeutics. 2023;5(4):140-6. doi:10.31491/APT.2023.12.125.

16. Catapano AL. Pitavastatin: a different pharmacological profile. Clinical Lipidology. 2012; 7(3 Suppl.1):3-9. doi:10.2217/clp.12.21.

17. Wiggins BS, Saseen JJ, Page RL, et al. Recommendations for management of clinically significant drug-drug interactions with statins and select agents used in patients with cardiovascular disease. Circulation. 2016;134(21):е468-е495. doi:10.1161/CIR.0000000000000456.

18. Sirtori CR. The pharmacology of statins. Pharmacol Res. 2014;88:3-11. doi:10.1016/j.phrs.2014.03.002.

19. Warrington S, Nagakawa S, Hounslow N. Comparison of the pharmacokinetics of Pitavastatin by formulation and ethnic group. Clin Drug Investig. 2011;31(10):735-43. doi:10.2165/11592480-000000000-00000.

20. Kastelein JJ, Braamskamp M. Pitavastatin: an overview of the LIVES study. Clin Lipidol. 2012;7(supp1):25-31. doi:10.2217/CLP.12.24.

21. Pelliccia F, Rosano G, Marazzi G, et al. Pharmacodynamic comparison of pitavastatin versus atorvastatin on platelet reactivity in patients with coronary artery disease treated with dual antiplatelet therapy. Circ J. 2014;78(3):679-84. doi:10.1253/circj.cj-13-1216.

22. Morgan RE, Campbell SE, Suehira K, et al. Effects of Steady-State Lopinavir/Ritonavir on the Pharmacokinetics of Pitavastatin in Healthy Adult Volunteers. J Acquir Immune Defic Syndr. 2012;60(2):158-64. doi:10.1097/QAI.0b013e318251addb.

23. Duggan ST. Pitavastatin A Review of its Use in the Management of Hypercholesterolaemia or Mixed Dyslipidaemia. Drugs. 2012;72(4):565-84. doi:10.2165/11207180-000000000-00000.

24. Morikawa S, Umetani M, Nakagawa S, et al. Relative induction of mRNA for HMG CoA reductase and LDL receptor by five different HMG-CoA reductase inhibitors in cultured human cells. J Atheroscler.Thromb. 2000;7(3):138-44. doi:10.5551/jat1994.7.138.

25. Gotto AM, Moon J. Pitavastatin for the treatment of primary hyperlipidemia and mixed dyslipidemia Expert Rev. Cardiovasc. Ther. 2010;8(8):1079-90. doi:10.1586/erc.10.82.

26. Ose L, Budinski D, Hounslow N, et al. Comparison of pitavastatin with simvastatin in primary hypercholesterolaemia or combined dyslipidaemia. Curr Med Res Opin. 2009; 25(10):2755-64. doi:10/1185/03007990903290886.

27. Eriksson M, Budinski D, Hounslow N, et al. Comparative efficacy of pitavastatin and simvastatin in high-risk patients: a randomized controlled trial. Adv Ther. 2011;28(9): 811-23. doi:10.1007/s12325-011-0056-7.

28. Budinski D, Arneson V, Hounslow N, et al. Pitavastatin compared with atorvastatin in primary hypercholesterolemia or combined dyslipidemia. Clin Lipidol. 2009;4(3):291-302. doi:10.2217/clp.09.20.

29. Gumprecht J, Gosho M, Budinski D, et al. Comparative long-term efficacy and tolerability of pitavastatin 4 mg and atorvastatin 20-40 mg in patients with type 2 diabetes mellitus and combined (mixed) dyslipidaemia. Diabetes Obes Metab. 2011;13(11):1047-55. doi:10.1111/j.1463-1326.2011.01477.x.

30. Saito Y. Treatment Options for Hypercholesterolemia and Combined Dyslipidemia: Focus on Pitavastatin Clinical Medicine Insights: Therapeutics. 2011;3(3):517-25. doi:10.4137/CMT.S6565.

31. Saku K, Zhang B, Noda K on behalf of the PATROL Trial Investigators. Randomized Head-to-Head Comparison of Pitavastatin, Atorvastatin, and Rosuvastatin for Safety and Efficacy (Quantity and Quality of LDL). The PATROL Trial. Circ J. 2011;75(6):1493-505. doi:10.1253/circj.CJ-10-1281.

32. Yokote K, Bujo H, Hanaoka H, et al. Multicenter collaborative randomized parallel group comparative study of pitavastatin and atorvastatin in Japanese hypercholesterolemic patients: Collaborative study on hypercholesterolemia drug intervention and their benefits for atherosclerosis prevention (CHIBA study). Atherosclerosis. 2008;201(2):345-52. doi:10.1016/j.atherosclerosis.2008.02.008.

33. Teramoto T. Pitavastatin: clinical effects from the LIVES Study. Atheroscler Suppl. 2011;12(3):285-8. doi:10.1016/S1567-5688(11)70888-1.

34. Saito Y, Yamada N, Teramoto T, et al. Clinical efficacy of pitavastatin, a new 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor, in patients with hyperlipidemia. Arzneimittelforschung. 2002;52(4):251-5. doi:10.1055/s-0031-1299888.

35. Maejima T, Yamazaki H, Aoki T, et al. Effect of pitavastatin on apolipoprotein A-I production in HepG2 cell. Biochem & Biophys Res Comm. 2004;324(2):835-9. doi:10.1016/j.bbrc.2004.09.122.

36. Fukutomi T, Takeda Y, Suzuki S, et al. High-density lipoprotein cholesterol andapolipoprotein A-I are persistently elevated during long-term treatment with pitavastatin, a new HMG-CoA reductase inhibitor. Int J Cardiol. 2010;141(3):320-2. doi:10.1016/j.ijcard.2008.11.130.

37. Teramoto T, Shimano H, Yokote K, et al. Effects of pitavastatin (LIVALO Tablet) on high density lipoprotein cholesterol (HDL-C) in hypercholesterolemia. J Atheroscler Thromb. 2009;16(5):654-61. doi:10.5551/jat.1719.

38. Kurogi K, Sugiyama S, Sakamoto K, et al. Comparison of pitavastatin with atorvastatin in increasing HDL-cholesterol andadiponectin in patients with dyslipidemia and coronary artery disease: The COMPACT-CAD study. J Cardiol. 2013;62(2):87-94. doi:10.1016/j.jjcc.2013.03.008.

39. Yamashita S, Tsubakio-Yamamoto K, Ohama T, et al. Molecular mechanisms of HDL-cholesterol elevation by statins and its effects on HDL functions. J. Atheroscler. Thromb. 2010;17(5):436-51. doi:10.5551/jat.5405.

40. Kobayashi M, Gouda K, Chisaki I, et al. Regulation mechanism of ABCA1 expression by statins in hepatocytes. Eur J Pharmacol. 2011;662(1-3):9-14. doi:10.1016/j.ejphar.2011.04.043.

41. Miyamoto-Sasaki M, Yasuda T, Monguchi T, et al. Pitavastatin increases HDL particles functionally preserved with cholesterol efflux capacity and antioxidative actions in dyslipidemic patients. J Atheroscler Thromb. 2013;20(9):708-16. doi:10.5551/jat.17210.

42. Nicholls SJ, Tuzcu EM, Sipahi I, et al. Statins, high-density lipoprotein cholesterol, and regression of coronary atherosclerosis. JAMA. 2007;297(5):499-508. doi:10.1001/jama.297.5.499.

43. Kishida K, Funahashi T, Shimomura I. Importance of Assessing the Effect of Statins on the Function of High-Density Lipoproteins on Coronary Plaque. Cardiovascular & Haematological Disorders-Drug Targets. 2012;12(1):28-34. doi:10.2174/1871529128023156.

44. Khera AV, Cuchel M, de la Llera-Moya M, et al. Cholesterol efflux capacity, high-density lipoprotein function, and atherosclerosis. New England Journal of Medicine. 2011;364(2):127-35. doi:10.1056/NEJMoa1001689.

45. Teramoto T, Urashima M, Sfornano H, et al., LIVES Study Extension Group. A Large-Scale Survey on Cardio-Cerebrovascular Events During Pitavastatin (LIVALO Tablet) Therapy in Japanese Patients with Hypercholesterolernia — LiVALO Effectìveness and Safety Study Extension (LIVES Study Extension). Jpn Pharmacol Ther. 2011;39(9):789-803.

46. Miayauchi K, Daida H, Morimoto D, Hiro H, and Japan-ACS Investigators. Reverse vessel remodeling but not coronary plague regression could predict future cardiovascular events in ACS patients with intensive statin therapy — the extended JAPAN-ACS study. Circ J. 2012;76(4):825-32. doi:10.1253/circj.CJ-12-0135.

47. Chan P, Shao L, Tomlinson B, et al. An evaluation of pitavastatin for the treatment of hypercholesterolemia. Expert Opin Pharmacother. 2019;20(1):103-13. doi:10.1080/14656566.2018.1544243.

48. Kronenberg F, Mora S. Stroes ESG, et al. Lipoprotein(a) in atherosclerotic cardiovascular disease and aortic stenosis: a European Atherosclerosis Society consensus statement. Eur Heart J. 2022;43(39):3925-46. doi:10.1093/eurheartj/ehac361.

49. De Boer LM, Oorthuys AOJ, Wiegman A, et al. Statin therapy and lipoprotein(a) levels: a systematic review and meta-analysis. Eur J Prev Cardiol. 2022;29(5):779-92. doi:10.1093/eurjpc/zwab171.

50. Tsimikas S, Gordts PLSM, Nora C, et al. Statin therapy increases lipoprotein (a) levels. Eur Heart J. 2020;41(24):2275-84. doi:10.1093/eurheartj/ehz310.

51. Wang X, Li J, Ju J, et al. Effect of different types and dosages of statins on plasma lipoprotein(a) levels: A network meta-analysis. Pharmacological Research. 2021; 163:105275. doi:10.1016/j.phrs.2020.105275.

52. Ezhov MV, Sergienko IV, Alekseeva IA. Pitavastatin (Livazo) in the treatment of dyslipidemia in routine clinical practice in russia. Russian programme "LEADER". The Journal of Atherosclerosis and Dyslipidemias. 2020;3(40):5-14. (In Russ.) doi:10.34687/2219-8202.JAD.2020.03.0001.

53. Tsujita K, Yokote K, Ako J, et al. on behalf of the K-924 Clinical Study Group. Efficacy and Safety of Pitavastatin/Ezetimibe Fixed-Dose Combination vs. Pitavastatin: Phase III, Double-Blind, Randomized Controlled Trial. J Atheroscler Thromb. 2023;30(11):1580-600. doi:10.5551/jat.64006.

54. Fici F, Faikoglu G, Tarim BA, et al. Pitavastatin: Coronary Atherosclerotic Plaques Changes and Cardiovascular Prevention. High Blood Pressure Cardiovascular Prevention. 2022;29(2):137-44. doi:10.1007/s40292-021-00496-0.

55. Moroi M, Nagayama D, Hara F, et al. Outcome of pitavastatin versus atorvastatin therapy in patients with hypercholesterolemia at high risk for atherosclerotic cardiovascular disease. International J Cardiol. 2020;305:139-46. doi:10.1016/j.ijcard.2020.01.006.

56. Ikeda K, Takahashi T, Yamada H, et al. (for the PEACE Investigators). Effect of intensive statin therapy on regression of carotid intima-media thickness in patients with subclinical carotid atherosclerosis (a prospective, randomized trial: PEACE (Pitavastatin Evaluation of Atherosclerosis Regression by Intensive Cholesterol-lowering Therapy) study. Eur J Prevent Cardiol. 2012;20(6):1069-79. doi:10.1177/2047487312451539.

57. Nakagomi A, Shibui T, Kohashi K, et al. Differential effects of atorvastatin and pitavastatin on inflammation, insulin resistance, and carotid intima-media thickness in patients with dyslipidemia. J Atheroscler Thromb. 2015;22(11):1158-71. doi:10.5551/jat.29520.

58. Takayama K, Taki W, Toma N, et al. Effect of Pitavastatin on Preventing Ischemic Complications with Carotid Artery Stenting: A Multicenter Prospective Study — EPOCH-CAS Study. Cardiovasc Intervent Radiol. 2014;37(6):1436-43. doi:10.1007/s00270-013-0813-x.

59. Nakamura T, Obata JE, Kitta Y, et al. Rapid stabilization of vulnerable carotid plaque within 1 month of pitavastatin treatment in patients with acute coronary syndrome. J Cardiovasc Pharmacol. 2008;51(4):365-71. doi:10.1097/FJC.0b013e318165dcad.

60. Kodama K, Komatsu S, Ueda Y, et al. Stabilization and regression of coronary plaques treated with pitavastatin proven by angioscopy and intravascular ultrasound — the TOGETHAR trial. Circ J. 2010;74(9):1922-8. doi:10.1253/circj.cj-10-0038.

61. Nozue T, Yamamoto S, Tohyama S, et al. Comparison of the effects of pitavastatin versus pravastatin on coronary artery plaque phenotype assessed by tissue characterization using serial virtual histology intravascular ultrasound. Heart Vessels. 2015;30(1):36-44. doi:10.1007/s00380-013-0453-8.

62. Hattori K, Ozaki Y, Ismail TF, et al. Impact of Statin Therapy on Plaque Characteristics as Assessed by Serial OCT, Grayscale and Integrated Backscatter—IVUS. J Am Coll Cardiol Img. 2012;5(2):169-77. doi:10.1016/j.jcmg.2011.11.012.

63. Matsushita K, Hibi K, Komura N, et al. Effects of 4 statins on regression of coronary plaque in acute coronary syndrome. Circ J. 2016;8(7):1634-43. doi:10.1253/circj.CJ-15-1379.

64. Nishiguchi T, Kubo T, Tanimoto T, et al. Effect of early pitavastatin therapy on coronary fibrous-cap thickness assessed by optical coherence tomography in patients with acute coronary syndrome. The ESCORT study. JACC Cardiovasc Imaging. 2018;11(6):829-38. doi:10.1016/j.jcmg.2017.07.011.

65. Hiro T, Kimura T, Morimoto T, et al. for the JAPAN-ACS Investigators. Effect of Intensive Statin Therapy on Regression of Coronary Atherosclerosis in Patients With Acute Coronary Syndrome A Multicenter Randomized Trial Evaluated by Volumetric Intravascular Ultrasound Using Pitavastatin Versus Atorvastatin (JAPAN-ACS [Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome] Study). J Am Coll Cardiol. 2009;54(4):293-302. doi:10.1016/j.jacc.2009.04.033.

66. Takashima H, Ozaki Y, Yasukawa T, et al. Impact of lipid-lowering therapy with pitavastatin, a new HMG-CoA reductase inhibitor, on regression of coronary atherosclerotic plaque. Circ J. 2007;71(11):1678-84. doi:10.1253/circj.71.1678.

67. Toi T, Taguchi I, Yoneda S, et al. Early effect of lipid-lowering therapy with pitavastatin on regression of coronary atherosclerotic plaque — comparison with atorvastatin. Circ J. 2009;73(8):1466-72. doi:10.1253/circj.CJ-08-1051.

68. Taguchi I, Iimuro S, Iwata H, et al. High dose versus low-dose pitavastatin in Japanese patients with stable coronary artery disease (REAL-CAD): a randomized superiority trial. Circulation. 2018;137(19):1997-2009. doi:10.1161/circulationaha.117.032615.

69. Maruyama T, Takada M, Nishibori Y, et al. Comparison of preventive effect on cardiovascular events with different statins. The CIRCLE study. Circ J. 2011;75(8):1951-9. doi:10.1253/circj.CJ-10-1163.

70. Suh SY, Rha S-W, Ahn TH, et al. Long-term safety and efficacy of Pitavastatin in patients with acute myocardial infarction (from the Livalo Acute Myocardial Infarction Study [LAMIS]). Am J Cardiol. 2011;108(11):1530-5. doi:10.1016/j.amjcard.2011.07.009.

71. Hagiwara N, Kawala-Wayanabe E, Koyanagi R, et al. Low-density lipoprotein cholesterol targeting with pitavastatin + ezetimibe for patients with acute coronary syndrome and dyslipidemia: the HIJ-PROPER study, a prospective, open-label, randomized trial. Eur Heart J. 2017;38(29):2264-76. doi:10.1093/eurheartj/ehx162.

72. Takano H, Mizuma H, Kuwabara Y, et al. оn behalf of the PEARL Study Investigators. Effects of Pitavastatin in Japanese Patients With Chronic Heart Failure. The Pitavastatin Heart Failure Study (PEARL Study). Circ J. 2013;77(4):917-25. doi:10.1253/circj.CJ-12-1062.

73. Im J, Kawada-Watanabe E, Yamaguchi J, et al. Baseline low-density lipoprotein cholesterol predicts the benefit of adding ezetimibe on statin in statin-naïve acute coronary syndrome. Scientific Reports. 2021;11(1):7480. doi:10.1038/s41598-021-87098-x.

74. Kurihara Y, Douzono T, Kawakita K, Nagasaka Y. A large-scale, long-term, prospective post-marketing surveillance of pitavastatin (LIVALO tablet) — LIVALO effectiveness and safety (LIVES) study. Jpn Pharmacol Ther. 2008;36:709-31.

75. Harada-Shiba M, Arisaka O, Ohtake A, Okada T and Suganami H: Efficacy and Safety of Pitavastatin in Japanese Male Children with Familial Hypercholesterolemia. J Atheroscler Thromb. 2016;23(1):48-55. doi:10.5551/jat.28753.

76. Harada-Shiba M, Kastelein JJP, Hovingh GK, et al. Efficacy and Safety of Pitavastatin in Children and Adolescents with Familial Hypercholesterolemia in Japan and Europe. J Atheroscler Thromb. 2018;25(5):422-9. doi:10.5551/jat.42242.

77. Stroes ES, Thompson PD, Corsini A, et al. Statin-associated muscle symptoms: impact on statin therapy — European Atherosclerosis Society Consensus Panel Statement on Assessment, Aetiology and Management. Eur Heart J. 2015;36(17):1012-22. doi:10.1093/eurheartj/ehv043.

78. Rosenson RS, Baker SK, Jacobson TA, et al. The National Lipid Association's Muscle Safety Expert P. An assessment by the Statin Muscle Safety Task Force: 2014 update. J Clin Lipidol. 2014;8(3Suppl.):S58-S71. doi:10.1016/j.jacl.2014.03.004.

79. Banach M, Rizzo M, Toth PP, et al. Statin intolerance — an attempt at a unified definition. Position paper from an International Lipid Expert Panel. Arch Med Sci. 2015;11(1):1-23. doi:10.5114/aoms.2015.49807.

80. Ito MK, Maki KC, Brinton EA, et al. Muscle symptoms in statin users, associations with cytochrome P450, and membrane transporter inhibitor use: A subanalysis of the USAGE study. J Clin Lipidol. 2014;8(1):69-76. doi:10.1016/j.jacl.2013.10.006.

81. Yee LL, Wright EA. Pitavastatin calcium: clinical review of a new antihyperlipidemic medication. Clin Ther. 2011;33(8):1023-42. doi:10.1016/j.clinthera.2011.07.011.

82. Corsini A, Ceska R. Drug-drug interactions with statins: will pitavastatin overcome the statins' Achilles' heel? Current Medical Research & Opinion. 2011;27(8):1551-62. doi:10.1185/03007995.2011.589433.

83. Cziraky MJ, Willey VJ, McKenney JM, et al. Statin safety: an assessment using an administrative claims database. Am J Cardiol. 2006;97(8А):61C-68C. doi:10.1016/j.amjcard.2005.12.011.

84. Silva MA, Swanson AC, Gandhi PJ, Tataronis GR. Statin-related adverse events: a meta-analysis. Clin Ther. 2006;28(1):26-35. doi:10.1016/j.clinthera.2006.01.005.

85. Hyogo H, Ikegami T, Tokushige K, et al. Efficacy of pitavastatin for the treatment of non-alcoholic steatohepatitis with dyslipidemia: An open-label, pilot study. Hepatol Res. 2011;41:1057-65. doi:10.1111/j.1872-034X.2011.00849.x.

86. Han KH, Rha SW, Kang HJ, et al. Evaluation of short-term safety and efficacy of HMG-CoA reductase inhibitors in hypercholesterolemic patients with elevated serum alanine transaminase concentrations: PITCH study (PITavastatin versus atorvastatin to evaluate the effect on patients with hypercholesterolemia and mild to moderate hepatic damage). J Clin Lipidol. 2012;6(4):340-51. doi:10.1016/j.jacl.2012.01.009.

87. Davidson MH, Clark JA, Glass LM, Kanumalla A. Statin safety: an appraisal from the Adverse Event Reporting System. Am. J. Cardiol. 2006;97(8A):32C-43C. doi:10.1016/j.amjcard.2005.12.008.

88. Kimura K, Shimano H, Yokote K, et al. Effects of pitavastatin (LIVALO tablet) on the estimated glomerular filtration rate (eGFR) in hypercholesterolemic patients with chronic kidney disease-subanalysis of the LIVALO effectiveness and safety (LIVES) study. J Atheroscler Thromb. 2010;17(6):601-9. doi:10.551/jat.3764.

89. Kang WC, Kim M, Park SM, et al. Preventive Effect of Pretreatment with Pitavastatin on Contrast-Induced Nephropathy in Patients with Renal Dysfunction Undergoing Coronary Procedure: PRINCIPLE-II Randomized Clinical Trial. J. Clin. Med. 2020;9(11):3689. doi:10.3390/jcm9113689.

90. Abe M, Maruyama N, Maruyama T, et al. A trial of pitavastatin versus rosuvastatin for dyslipidemia in chronic kidney disease. J Atheroscler Thromb. 2015;22(12):1235-47. doi:10.5551/jat.29264.

91. Seo WW, Seo SI, Kim Y, et al. Impact of pitavastatin on new-onset diabetes mellitus compared to atorvastatin and rosuvastatin: a distributed network analysis of 10 real-world databases. Cardiovasc Diabetol. 2022;21(1):82. doi:10.1186/s12933-022-01524-6.

92. Trias F, Pinto X, Corbella E, et al. Differences in the diabetogenic effect of statins in patients with prediabetes. The PRELIPID study. Med Clin (Barc). 2022;158(11):531-9. doi:10.1016/j.medcli.2021.06.018.

93. Yoon D, Sheen SS, Lee S, et al. Statins and risk for new-onset diabetes mellitus. A real-world cohort study using a clinical research database. Medicine. 2016;95(46):e5429. doi:10.1097/MD.0000000000005429.

94. Na E, Cho S, Kim DJ, et al. Time-varying and dose-dependent effect of long-term statin use on risk of type 2 diabetes: a retrospective cohort study. Cardiovasc Diabetol. 2020;19(1):1-11. doi:10.1186/s12933-020-01037-0.

95. Yamazaki T, Kishimoto J, Ito C, et al. Japan Prevention Trial of Diabetes by Pitavastatin in Patients with Impaired Glucose Tolerance (the J-PREDICT study): rationale, study design, and clinical characteristics of 1269 patients. Diabetol Int. 2011;2:134-40. doi:10.1007/s13340-011-0032-0.

96. Chapman MJ, Orsoni A, Robillard P, et al. Effect of high-dose pitavastatin on glucose homeostasis in patients at elevated risk of new-onset diabetes: insights from the CAPITAIN and PREVAIL-US studies. Curr Med Res Opin. 2014;30(5):775-84. doi:10.1185/03007995.2013.874989.

97. Liu P-Y, Lin L-Y, Lin H-J, et al. Pitavastatin and Atorvastatin Double-Blind Randomized ComPArative Study among HiGh-Risk Patients, Including ThOse with Type 2 Diabetes Mellitus, in Taiwan (PAPAGO-T Study). PLOS ONE. 2013;8(10):e76298. doi:10.1371/journal.pone.0076298.

98. Matsubara T, Naruse K, Arakawa T, et al. Impact of pitavastatin on high-sensitivity C-reactive protein and adiponectin in hypercholesterolemic patients with the metabolic syndrome: The PREMIUM Study. J Cardiol. 2012;60(5):389-94. doi:10.1016/j.jjcc.2012.07.012.

99. Hong YJ, Jeong MH, Bae JH, et al. Efficacy and safety of pitavastatins in patients with acute myocardial infarction: Livalo in Acute Myocardial Infarction Study (LAMIS) II. Korean J Intern Med. 2017;32(4):656-67. doi:10.3904/kjim.2016.016.

100. Vallejo-Vaz AJ, Seshasai SRK, Kurogi K, et al. Effect of pitavastatin on glucose, HbA1c and incident diabetes: a meta-analysis of randomized controlled clinical trials in individuals without diabetes. Atherosclerosis. 2015;241(12):409-18. doi:10.1016/j.atherosclerosis.2015.06.001.

101. Thakker D, Nair S, Pagada A, et al. Statin use and the risk of developing diabetes: a network meta-analysis. Pharmacoepidemiology and drug safety. 2016;25(10):1131-49. doi:10.1002/pds.4020.

102. Choi JY, Choi CU, Hwang S-Y, et al. Effect of pitavastatin compared with atorvastatin and rosuvastatin on new-onset diabetes mellitus in patients with acute myocardial infarction. Am J Cardiol. 2018;122(6):922-8. doi:10.1016/j.amjcard.2018/06.017.

103. Liu W-T, Lin C, Tsai M-C, et al. Effects of Pitavastatin, Atorvastatin, and Rosuvastatin on the Risk of New-Onset Diabetes Mellitus: A Single-Center Cohort Study. Biomedicines 2020;8(11):499. doi:10.3390/biomedicines8110499.

104. Wang Y, Fu X, Gu X, et al. Effects of intensive pitavastatin therapy on glucose control in patients with non-ST elevation acute coronary syndrome. Am J Cardiovasc Dis. 2017;7(4):89-96.

105. Lee H-Y, Han K-H, Chung W-B, et al. Safety and Efficacy of Pitavastatin in Patients with Impaired Glucose Tolerance and hyperlipidemia: randomized, open-labeled, multicentered, Phase IV Study. Clinical Therapeutics. 2020;42(10):2036-48. doi:10/1016/j.clinthera.2020.07.013.

106. Zhao W, Zhao SP. Different effects of statins on induction of diabetes mellitus:an experimental study. Drug Des Devel Ther. 2015;9:6211-23. doi:10.2147/DDDT.S87979.

107. Chrusciel P, Sahebkar A, Rembek-Wieliczko M, et al. Impact of statin therapy on plasma adiponectin concentrations: a systematic review and meta-analysis of 43 randomized controlled trial arms. Atherosclerosis. 2016;253:194-208. doi:10.1016/j.atherosclerosis.2016.07.897.

108. Betteridge DJ, Carmena R. The diabetogenic action of statins: mechanisms and clinical implications. Nat Rev Endocrinol. 2016;12(2):99-110. doi:10.1038/nrendo.2015.194.

109. Drew BG, Rye KA, Duffy SJ, et al. The emerging role of HDL in glucose metabolism. Nat Rev Endocrinol. 2012;8(4):237-45. doi:10.1038/nrendo.2011.235.

110. Li S, Shin HJ, Ding EL, van Dam RM. Adiponectin levels and risk of type 2 diabetes: a systematic review and meta-analysis. JAMA. 2009;302(2):179-88. doi:10.1001/jama.2009.976.

111. Wu X, Yu Z, Su W, et al. Low levels of ApoA1 improve risk prediction of type 2 diabetes mellitus. J Clinic Lipidol. 2017;11(2):362-8. doi:10.1016/j.jacl.2017.01.009.

112. Yamakawa T, Takano T, Tanaka S, et al. Influence of pitavastatin on glucose tolerance in patients with type 2 diabetes mellitus. J Atheroscler Thromb. 2008;15(5):269-75. doi:10.5551/jat.e562.

113. Motomura T, Okamoto M, Kitamura T, et al. Effects of pitavastatin on serum lipids and high sensitivity C-reactive protein in type 2 diabetic patients. J Atheroscler Thromb. 2009; 16(5):546-52. doi:10.5551/jat.992.

114. Sasaki J, Ikeda Y, Kuribayashi T, et al. A 52-week, randomized, open-label, parallel-group comparison of the tolerability and eff ects of pitavastatin and atorvastatin on high-density lipoprotein cholesterol levels and glucose metabolism in Japanese patients with elevated levels of low density lipoprotein cholesterol and glucose intolerance. Clin Ther. 2008;30(6):1089-101. doi:10.1016/j.clinthera.2008.05.017.

115. Nomura S, Shouzu A, Omoto S, et al. Correlation between adiponectin and reduction of cell adhesion molecules after pitavastatin treatment in hyperlipidemic patients with type 2 diabetes mellitus. Thromb Res. 2008;122(1):39-45. doi:10.1016/j.thromres.2007.08.013.

116. Arai H, Hiro T, Kimura T, et al. for the JAPAN-ACS Investigators. More Intensive Effect of Intensive Lipid Lowering is associated with Regression of Coronary Atherosclerosis in diabetec Patients With Acute Coronary Syndrome. Sub-Analysis of JAPAN-ACS Study. J. Atheroscler. Thromb. 2010;17(10):1096-107. doi:10.5551/jat.5660.

117. Zhou X, Wu L, Chen Y, et al. Forty-eight weeks of statin therapy for type 2 diabetes mellitus patients with lower extremity atherosclerotic disease: Comparison of the effects of pitavastatin and atorvastatin on lower femoral total plaque areas. J Diabetes Investig. 2021;12(7):1278-86. doi:10.1111/jdi.13472.

118. Yokote K, Shimano H, Urashima M, Teramoto T. Efficacy and safety of pitavastatin in Japanese patients with hypercholesterolernia: LIVES study and subanalysis. Expect Rev. Cardiovasc. Ther. 2011;9(5):555-62. doi:10.1586/ERS.11.47.

119. Tarim BA, Fici F, Tengiz I, et al. Do Statins Counteract the Effect of Antidiabetic Drugs? Results of the SCEAD Study. Yonsei Med J. 2023;64(3):175-80. doi.10.3349/ymj.2022.0287.

120. Huang C, Huang Y, Hsu B. Pitavastatin improves glycated hemoglobin in patients with poorly controlled type 2 diabetes. Diabetes Investig. 2016;7:769-76. doi:10.1111/jdi.12483.

121. Aberg JA, Sponseller CA, Ward DJ, et al. Pitavastatin versus pravastatin in adults with HIV-1 infection and dyslipidaemia (INTREPID): 12 week and 52 week results of a phase 4, multicentre, randomised,double-blind, superiority trial. Lancet HIV. 2017;4(7):e284-e294. doi:10.1016/S2352-3018(17)30075-9.

122. Grinspoon SK, Fitch KV, Zanni MV, et al. Pitavastatin to prevent cardiovascular disease in HIV infection. N Engl J Med. 2023;389(8):687-99. doi.10.1056/NEJMoa2304146.

123. Vergallo R, Patrono C. Cardiovascular disease prevention in people living with HIV: from REPRIEVE to a statin of grace. Eur Heart J. 2023;44(41):4308-9. doi:10.1093/eurheartj/ehad594.

124. Hoffmann U, Lu MT, Olalere D, et al. Rationale and design of the Mechanistic Substudy of the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE): Effects of pitavastatin on coronary artery disease and inflammatory biomarkers. Am Heart J. 2019;212:1-12. doi:10.1016/j.ahj.2019.02.011.