Univ.-Doz. Prof. Dr. W. Renner
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1 Pharmacogenetics of statin-inducedinduced myopathies Wilfried Renner Medical University Graz Clinical Institute of Medical and Chemical Laboratory Diagnostics
2 It started with a fungus 1973: Isolation of Mevastatin (Penicillium) 1978: Isolation of Lovastatin (Aspergillus), Merck 1987: Marketing of Lovastatin 1994: Results from Scandinavian 4S-study (Simvastatin): Statins reduce mortality
3 Statins inhibit cholesterol synthesis Inhibition of HMG-CoA-Reductase (cholesterol synthesis) Lovastatin Simvastatin Cerivastatin (withdrawn) Pravastatin Fluvastatin Rosuvastatin
4 Statins act within the liver cell Liver as target organ Oral administration, uptake into hepatocyte
5 Are statins effective and safe?
6 Statins are safe NNT (number needed to treat) (High risk patients, secondary preventions) (Moderate risk patients, secondary prevention) (Low risk patients, primary prevention) (Fernandez, 2011) NNK (number needed to kill) W. Renner (Thompson, JAMA 2003)
7 Statin-inducedinduced myopathy: Definitions Myopathy: Any disease of muscles Myalgias: Myositis: pain in a muscle or group of muscles ~10% muscle symptoms with CK (-itis?) ~2.5% Rhabdomyolysis: > 50 fold in CK + renal impairment <0.1%
8 Statin & myopathy: Clinical trials versus real life Statin induce muscle pain: A common dilemma not reflected in clinical trials Clinical trials: Clinical routine: Myalgia: 1% - 5% 5% - 10% Pre-exclusion of risk patients in clinical trials (35% of eligible patients!) Patients with pain lost to follow-up
9 Consequences of myalgia? Lipid-lowering: Usually life-long therapy BUT: Discontinuation of statins: 25% within 6 months 60% within 24 months Muscle pain affects patient s compliance When the body aches, the mind will follow... (Rossi, J Am Coll Cardiol, 2009)
10 The search for cause
11 The breakthrough: SLCO1B1 2008: Genome-wide search identifies transporter variant (SLCO1B1): Transporter in hepatocyte membrane SLCO1B1 V174A (T>C): Reduced statin uptake into hepatocyte, higher statin plasma levels, less effect & more side effect Heterozygous (28%): 4-fold myopathy risk Homozygous (2%): 16-fold myopathy risk Link E. et al., N. Engl. J. Med. 2008
12 SLCO1B1 and statin types Effect of SLCO1B1 genotype: dependent on statin type and dose Niemi M, Clin Pharmacol Ther. 2010
13 Complex decisions SLCO1B1 genotype Hyperlipidemia? VV VA AA yes no Standard dose 50% dose No statin! Statin medication No statin medication
14 Statin-inducedinduced myopathy & SLCO1B1 genotyping Patient with statin medication and muscle pain Myopathy related to statins? (Differential diagnosis?) History of muscle pain Physical examination Laboratory tests (CK, inflammation markers, SLCO1B1 genotype...) Evaluation of risk/benefit ratio of current statin medication Primary/secondary prevention? Coronary risk profile? Compliance? Comedication? Re-define lipidlowering goals (NNT?) Decrease statin dose Switch statin Statin holidays
15 Re-defining personal lipid goals (Fernandez, Cleveland Clin J Med 2011) (Österreichischer Lipidkonsensus 2010)
16 Switching statins Niemi M, Clin Pharmacol Ther Fernandez 2011
17 Bioproducts SLCO1B1 Test Entwicklung eines kommerziellen Tests zur SLCO1B1 Typisierung.
18 Summary Statins are effective and major adverse events are very rare. Mild to moderate muscle pain is common statinside-effect and threatens patient s compliance. SLCO1B1 V174A polymorphism is the strongest genetic risk factor for statin-induce myopathy. Decisions about stopping / switching / reducing / continuing statin treatment should include SLCO1B1 genotype. Bioproducts SLCO1B1 test coming soon...
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At a Glance Practical Implications p 330 Author Information p 333 Full text and PDF www.ajpblive.com Lipid Management When Converting Fluvastatin to Pravastatin: Medication Use Evaluation Original Research
Prevention of Heart Disease: The New Guidelines
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rosuvastatin, 5mg, 10mg, 20mg, film-coated tablets (Crestor ) SMC No. (725/11) AstraZeneca UK Ltd.
rosuvastatin, 5mg, 10mg, 20mg, film-coated tablets (Crestor ) SMC No. (725/11) AstraZeneca UK Ltd. 09 September 2011 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product