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นสภ.อัจจิมา บัวหลวงงาม Risk of myotoxicity all statins can cause myopathy with a risk of progressing to rhabdomyolysis. The risk appears to increase with higher doses. Lipophilicity>>>hydrophillic lipophilic Atorvastatin, Fluvastatin, Lovastatin, Simvastatin hydrophilic Pravastatin, Rosuvastatin Mechanism HMG-CoA HMG-CoA reductase Statins Atrogin-1 mevalonate ubiquinone (coenzyme Q10) mitochondrial adenosine triphosphate (ATP) antioxidant and membrane stabilizer that is utilized by mitochondria for electron transport Classification of Muscular Adverse Events Br J Cardiol,2005 Classification of Muscular Adverse Events Br J Cardiol,2005 The American College of Cardiology/American Heart Association/National Heart, Lung, and Blood Institute (ACC/AHA/NHLBI) 1. Statin myopathy: muscle complaints related to statin drug use 2. Myalgia: muscle complaints without serum CK elevations 3. Myositis: muscle symptoms with serum CK elevations 4. Rhabdomyolysis: markedly elevated CK levels, usually > 10 times ULN, with an elevated creatinine level consistent with pigmentinduced nephropathy J Am Coll Cardiol. 2002; 40: 567-72 สารราชวิทยาลัยอายุรแพทย์ ฯ myopathy มีอาการกล้ามเนื้ออักเสบร่วมกับระดับของ creatine kinase (CK) >10 เท่า ของ ULN สารราชวิทยาลัยอายุรแพทย์ฯ ปี ที2่ 3 ฉบับที่ 3 กรกฎาคม–ธันวาคม 2549 The National Lipid Association rhabdomyolysis muscle cell destruction or enzyme leakage, regardless of the CK level when measured, considered to be causally related to a change in renal function (Thompson et al 2006). The National Lipid Association Classify absolute CK elevation Mild: CK increases < 10 times ULN Moderate: CK increases ≥ 10 times ULN, and Severe: CK increases ≥ 50 times the ULN (Thompson et al 2006). Time to onset Mean duration of thereapy 6.3 months (0.25-48 months) Incidence Myalgia without changes in CK levels (Bays 2006). 21 statin-based clinical trials with over 180,000 person years for evidence of muscle toxicity. The incidence of myopathy was 11 per 100,000 person-years. The incidence of rhabdomyolysis in 2 cohort studies was 3.4 (1.6–6.5) per 100,000 person-years 10-fold higher when gemfibrozil was used in combination with statins. For statins metabolized by CYP3A4 such as lovastatin, atorvastatin, and simvastatin), the incidence was 4.2 per 100,000 person-years. In this group, interaction with drugs known to inhibit CYP3A4 (ie, erythromycin and azole antifungals) occurred in 60% The American Journal of Cardiology. Vol 97 (8A) April 17, 2006 The American Journal of Cardiology. Vol 97 (8A) April 17, 2006 Management Monitor transaminase level When start Statin or fibrates After medication 6-12 weeks Follow up every 1-2 time per year High dose or more than 2 medication 3-6 months Guidelines for Management of Dyslipidemia,สารราชวิทยาลัยอายุรแพทย์ฯ 2545