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. 2020 Apr 1;27(4):375-396.
doi: 10.5551/jat.50948. Epub 2019 Oct 4.

Statin Intolerance Clinical Guide 2018

Kouji Kajinami  1 , Kazuhisa Tsukamoto  2 , Shinji Koba  3 , Ikuo Inoue  4 , Masashi Yamakawa  5 , Shigeaki Suzuki  6 , Tadanori Hamano  7 , Hidetsugu Saito  8 , Yoshiro Saito  9 , Satohiro Masuda  10 , Takeo Nakayama  11 , Tomonori Okamura  12 , Shizuya Yamashita  13   14 , Tatehiro Kagawa  15 , Junji Kaneyama  16 , Akira Kuriyama  17 , Rumi Tanaka  10 , Aya Hirata  12 ; Statin Intolerance Clinical Guide Working Group; The Japan Society of Hepatology, Japanese Society of Neurology, Japan Atherosclerosis Society, The Japanese Society for the Study of Xenobiotics
Affiliations

Statin Intolerance Clinical Guide 2018

Kouji Kajinami et al. J Atheroscler Thromb. .
No abstract available

Keywords: Liver injury; Myopathy; Renal dysfunction; Rhabdomyolysis; Statin intolerance.

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Conflict of interest statement

In accordance with the “COI Management Guidelines for Clinical Research” established by the Japan Association of Medical Sciences' COI committee, a conflict of interest (COI) statement has been obtained form each member of the committee involved in drafting the Statin Intolerance Clinical Guide 2018. The names of the enterprises disclosed in the COI statement are provided below. The applicable period is January 01, 2015, to December 31, 2017.

Abbvie, Astellas Amgen BioPharma, Astellas Pharma, Bayer, Boehringer Ingelheim Japan, Bristol- Myers Squibb, Central Medical, Daiichi Sankyo, Dai- Nihon Insatsu Kenko Hoken Kumiai, East Japan Institute of Technology, Eisai, Fujifilm, Gilead Sciences, Japan Data Center, Kowa, Kusatsu City Hall, Kyowa Medics, Medical Review, Mitsubishi Tanabe Pharma, Mochida Pharmaceutical, MSD, Municipal Kaizuka Hospital, Novartis Pharma, Nakamura Hospital, Novo Nordisk, Ono Pharmaceutical, Otsuka Pharmaceutical, Pfizer Japan, Rinku General Medical Center, Rohto Pharmaceutical, Sanofi, Sanwa Kagaku Kenkyusho, Skylight Biotech, St. Jude Medical, Sumitomo Dainippon Pharma, Takeda Pharmaceuctical, the City of Izumisano,.

Figures

Fig. 1-1.
Fig. 1-1.
Recommended approaches to adverse events (myopathy, liver dysfunction) at initial statin Step 1: When statin treatment was introduced according to clinical indications, subjective symptoms and laboratory test results (e.g., lipids, liver function, CK) are assessed around week 4 after its start. Step 2: If muscle symptoms and/or elevated CK levels are observed, follow the “muscle flowchart.” If liver dysfunction is observed, follow the “liver flowchart.” For indications of statin administration and its administered dose, see the “Atherosclerotic Disease Prevention Guidelines, 2017 Edition” and the “Dyslipidemia Examination Guide for the Purpose of Preventing Artherosclerotic Diseases, 2018 Edition” (both: Japan Atherosclerosis Society eds.), as well as the package inserts of the specific drugs utilized.
Fig. 1-2.
Fig. 1-2.
Recommended approaches to adverse events (myopathy) during statin administration • Myopathy is categorized in the A, B, C, or D groups as shown in the chart according to SAMS and CK level. CK levels may be increased as a result of vigorous exercise and intramuscular injections, which can persist for several days. Thus, when serum CK level is found to be elevated, there is a need to confirm whether the patient experienced either of the above prior to the blood test. In such cases, it is advisable to have the patient remain in a rested state as much as possible for several days and repeat the blood test. Other risk factors associated with myopathy onset include: Being an elderly female, short stature, Asian descent, renal dysfunction, hypothyroidism, excessive alcohol consumption, and surgery. Concomitant drugs that require particular attention include: azure-based anti-fungaldrugs that are antagonists to the drug metabolism system, macrolide antibiotics, protease inhibitors (anti-viral agents), verapamil, diltiazem, amiodarone, warfarin, and cyclosporine (ref 33). • Proceed according to the relevant flowchart. See the text of the current Guide for details regarding the specific ways of handling each category. As a general rule, the follow-up period for categories B and C are 2–4 weeks and 4–6 weeks, respectively, but following-up on patient progress more frequently may be appropriate.
Fig. 1-3.
Fig. 1-3.
Recommended approaches for adverse events (liver dysfunction) during statin administration • Liver dysfunction is categorized into A, B, and C groups as shown in the chart according to ALT level and T-bil level • See the flowchart for each for approaches. • Simultaneously check for complications with acute diseases that may cause liver dysfunction such as acute viral infection and hepatobiliary diseases as well as concomitant drugs that may cause liver dysfunction.
Fig. 2.
Fig. 2.
Risk ratio obtained from prospective studies of the relation between statins and Alzheimer's disease/mild cognitive impairment (ref 59)
Fig. 3.
Fig. 3.
Statin and Depression (Meta-analysis) (ref 65)
See this image and copyright information in PMC

References

    1. Endo A. The discovery and development of HMG-CoA reductase inhibitors. J Lipid Res, 1992; 33: 1569-1582 - PubMed
    1. Teramoto T, Sasaki J, Ishibashi S, Birou S, Daida H, Dohi S, Egusa G, Hiro T, Hirobe K, Iida M, Kihara S, Kinoshita M, Maruyama C, Ohta T, Okamura T, Yamashita S, Yokode M, Yokote K. Executive summary of the Japan Atherosclerosis Society (JAS) guidelines for the diagnosis and prevention of atherosclerotic cardiovascular diseases in Japan — 2012 version. J Atheroscler Thromb, 2013; 20: 517-523 - PubMed
    1. Fitchett DH, Hegele RA, Verma S. Cardiology patient page. Statin intolerance. Circulation, 2015; 31: 131 - PubMed
    1. Stroes ES, Thompson PD, Corsini A, Vladutiu GD, Raal FJ, Ray KK, Roden M, Stein E, Tokgözoğlu L, Nordestgaard BG, Bruckert E, De Backer G, Krauss RM, Laufs U, Santos RD, Hegele RA, Hovingh GK, Leiter LA, Mach F, Marz W, Newman CB, Wiklund O, Jacobson TA, Catapano AL, Chapman MJ, Ginsberg HN: European Atherosclerosis Society Consensus Panel. Statin-associated muscle symptoms: impact on statin therapy-European Atherosclerosis Society Consensus Panel Statement on Assessment, Aetiology and Management. Eur Heart J, 2015; 36: 1012-1022 - PMC - PubMed
    1. Cannon CP, Blazing MA, Giugliano RP, McCagg A, White JA, Theroux P, Darius H, Lewis BS, Ophuis TO, Jukema JW, De Ferrari GM, Ruzyllo W, De Lucca P, Im K, Bohula EA, Reist C, Wiviott SD, Tershakovec AM, Musliner TA, Braunwald E, Califf RM, IMPROVE-IT Investigators Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes. N Engl J Med, 2015; 372: 2387-2397 - PubMed

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