1 DOS CME Course 2011

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1 Statin Myopathy February 23, 2011 Jinny Tavee, MD Associate Professor Neurological Institute Cleveland Clinic Foundation 1 Case 1 50 y/o woman with hyperlipidemia presents with one year history of deep muscle pains and decreased strength Difficulty getting up from kneeling at church and slower with stairs Meds: None currently, but had been on lovostatin 40mg/D over the last year with no recent change in dose until she stopped it 2 months ago Family History: Brother with hyperlipidemia on atorvastatin, also with myalgias 2 1

2 Case 1 Pertinent findings Normal examination with no weakness Anormal Labs CK=253 (220U/L) Triglyceride 153 ( mg/dl) Cholesterol 287 ( mg/dl) HDL Cholesterol 64 (>55 mg/dl) VLDL Cholesterol 31 (6-40 mg/dl) LDL Cholesterol 192 ( mg/dl) 25-OH vitamin D level 11 (30-74mg/mL) Other labs normal TSH, CMP, CBC, B12, ESR, CRPA, ANA, Lactate/pyruvate 3 Statin myopathy Myalgias affect 9-20% of statin users 5-10% will stop statins due to myalgias Definitions of myopathy FDA and NLA: CK 10x upper limit normal ACC/AHA/NHLBI: General term for any muscle disease Myalgias Myositis muscle aches or weakness without CK elevation muscle symptoms with CK elevation 10x ULN Rhabdomyolysis muscle symptoms with CK elevation 10x ULN, elevated creatinine usually with urinary myoglobin De Sauvage etal, A J Card 2002;90: Bruckert etal, CV Drugs Ther 2005;19: Franc etal, CV Drugs Ther 2003;17: Hsu etal, Ann Pharm 1995; 29: Joy etal, Ann Med 2009;150: Mammen etal, Curr Op Rheum 2010;22:

3 Rate of Muscle Symptoms by Statin 1. Fluvastatin 5.1% 2. Pravastatin 10.9% 3. Atorvastatin 14.9% Simvistatin 18.2% Fluvastatin Pravastatin Atorvastatin Simvistatin Bruckert et al, PRIMO study CV Drugs Ther 2005;19: Proposed mechanisms Mitochondrial dysfunction Coenzyme Q10 depletion Decreased cholesterol synthesis Abnormal protein metabolism N-acetylation changes Blocked protein prenylation Mammen et al, Curr Op Rheum 2010;22:

4 Genetic Risk Factors Associated with SNP in SLCO1B1 gene on chromosome 12 Encodes protein involved in regulation of hepatic metabolism of statins More than 60% statin myopathy patients carried this SNP SEARCH Collaborative group. Link et al. NEJM 2008;359; Look For Other Causes and Risk Factors Risk factors Higher doses Diabetes Smaller body frame Liver/kidney disease Older age EtOH and drug abuse Vitamin D deficiency Hypothyroidism Metabolic/inflammatory myopathies Medications: macrolides, HIV protease inhibitors, gemfibrozil, steroids, CCB 8 4

5 Management Intolerable Symptoms Regardless of CK elevation STOP statin until symptoms resolve Rechallenge with same or new med at lower dose 51 statin-intolerant patients started on Rosuvastatin 72% tolerated 5.6mg/D QOD 64.9% achieved LDL cholesterol goals Consider addition of ezetimibe if LDL goal not met Choose non P450 metabolized statins Pravastatin: renal metabolism, more hydrophillic Fluvastatin and Rosuvastatin: CYP2C9 pathway Jacobson, Mayo Clin Proc 2008;83: Backes et al, Ann Pharm 2008;43: Management: Mild symptoms Continue statin at same or reduced dose if CK <10x ULN Use clinical symptoms to guide therapy CoQ mg/D Acetyl-L-carnitine 1000mg TID Pain medications Neurontin titrated up to 3600mg/D Topiramate titrated up to mg/D 10 5

6 Case 2 42 y/o African American man with CAD and hyperlipidemia found to have CK 580 on routine testing Repeat CK level l 600 in one month with no exercise 10 days prior Occasional muscle aches with physical exertion, but otherwise asymptomatic Meds: ASA, propranolol, HCTZ, and atorvastatin t ti 40mg/D No baseline CK prior to statin use Examination normal 11 Asymptomatic HyperCKemia Creatine phosphokinase (CPK or CK) most sensitive blood test for evaluation of neuromuscular disease However, elevated CK not necessarily indicative of NM or cardiac disease Persistent elevation of serum CK in an apparently healthy individual Brewster et al, Acta Neurol Scand1998;77:

7 Differences in Serum CK levels Dependent on race, gender, age, muscle mass, and physical activity Practical reference ranges based on study of 1500 healthy hospital employees Black men: U/L Black women and non-black men: (white/hispanic) Non-black women: (white/asian/hispanic) Wong et al. Am J Clin Path 1983;79: Case 2: Statin Management in Asymptomatic HyperCKemia 20 patients with baseline CK IU/L started on statins with no myalgias or significnat increases on statins in 4 months High baseline CKs in the absence of symptoms or CK rises should NOT preclude statin use Rule out other causes Careful monitoring and check CKs regularly Counsel patients on increased risk of muscle symptoms especially with rigorous exercise Glueck et al, Metabolism 2009;58: Jacobson, Mayo Clin Proc 2008;83:

8 Case 3 60 y/o man with DM II, CAD, HTN, hypothyroidism, and hyperlipidemia presents with one year history of progressive generalized weakness and myalgias On multiple medications including statins, which he stopped 7 months ago Exam shows neck flexor and proximal limb girdle weakness with reduced DTRs Labs: CK=4200, ESR=85, urine myoglobin neg, ANA panel and myositis Ab panel neg 15 Statin-induced Myositis Distinct inflammatory myopathy that persists after statin withdrawal ( 6months) Necrotizing myopathy on biopsy and EMG Inflammation seen in small blood vessels on bx Responds to immunotherapy IV methylprednisolone 500mg to 1gm for 3-5 days IVIg 2gm/kg/D over 5 days Most need maintenance immunotherapy Residual weakness, may relapse with taper of immune modulating medications Antibodies to 200kDA and 100kDA proteins Christopher-Stine, et al Arth Rheu, 2010 Mammen et al, Curr Opin Rheum 2010;22:

9 Rhabdomyolysis Rare in both clinical practice and research trials 0.44 per 10,000 patient-years If CK 10x ULN with creatinine elevation +/- urinary myoglobin, STOP statin ti Treatment with fluid hydration Consider risks/benefits of statin use after CK returns to normal If CPK exceeds >50 times normal, or if renal failure develops, alternative lipid lowering strategies like LDL apheresis or red yeast rice should be considered Mammen et al, Curr Opin Rheum 2010;22: Graham et al, JAMA 2004;292: Jacobson, Mayo Clin Proc 2008;83: Rate of Fatal Rhabdomyolysis by Statin 1. Fluvastatin 10 cases 2. Pravastatin 1/27.1 M 3. Atorvastatin 1/23.4 M 4. Simvistatin 1/8.3 M 5. Lovostatin 1/5.2 M 6. Cerivastatin ti 1/316K Cerivastatin Lovostatin Simvistatin Atorvastatin Pravastatin Staffa et al, NEJM 2002;346:

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