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© 2006 National Lipid Association Statin Safety: Key Conclusions and Recommendations of the NLA
© 2006 National Lipid Association Conclusions of the NLA Safety Task Force for Muscle Safety Myopathy and rhabdomyolysis are associated with statin therapy, as a class effect Elevated creatine kinase (CK) levels may indicate statin- induced muscle damage Muscle weakness or pain without CK elevation may indicate statin-induced muscle damage Myopathy and rhabdomyolysis risk increases with increased statin dose and serum levels Myopathy and rhabdomyolysis risk increases with drug- drug interactions that retard statin metabolism Drugs that can interact to amplify statin related myopathy include gemfibrozil and CYP-3A4 inhibitors Thompson PD et al. Am J Cardiol. 2006;97:69C-76C
© 2006 National Lipid Association Conclusions of the NLA Safety Task Force on Liver Function Statin use is associated with elevated serum aminotransferase levels, but it is unclear whether this is a causual link Statin-associated serum aminotransferase elevation is not predictive of liver damage Very rare case reports of liver failure have occurred in patients receiving statin therapy Patients on statin therapy do not require routine liver function testing Statin therapy is not contraindicated in any hepatic conditions, with the exception of decompensated cirrhosis and acute liver failure Cohen DE et al. Am J Cardiol. 2006;97:77C-81C
© 2006 National Lipid Association Conclusions of the NLA Safety Task Force on Renal Issues Marketed doses of statins do not produce clinically meaningful proteinuria There is no association between statin use and renal tubular damage There is no evidence that statin use leads to renal glomerular damage There is no convincing link between statin use and hematouria Some evidence indicates statins may provide some kidney protection Kasiske BL et al. Am J Cardiol. 2006;97:82C-85C
© 2006 National Lipid Association Conclusions of the NLA Safety Task Force on Neurology There is no association between statin use and clinically meaningful peripheral neuropathy There is no convincing evidence that statins cause impaired memory or cognitive dysfunction Clinical trial data indicate that lowering lipids with statins does not increase risk of cerebral hemorrhage Brass LM et al. Am J Cardiol. 2006;97:86C-88C
© 2006 National Lipid Association Recommendations Regarding Patient Monitoring Monitoring CK levels is recommended only for symptomatic patients Patients on statin therapy do not require routine monitoring of liver function*, renal function, or cognitive function *Note: Liver function monitoring is currently recommended by the regulatory authorities and manufacturers
© 2006 National Lipid Association Messages for Patients Statins can produce muscle pain and weakness, which can very rarely become an important medical problem Serious liver damage due to statins is extremely rare Marketed doses of statins do not have any direct adverse effects on the kidney Statins do not cause peripheral neuropathy and do not impair memory or cognition
Statin Induce Myotoxicity
Endocrinologic & Metabolic Drugs Advisory Committee Meeting
Slide Source: Lipids Online Slide Library Initiating and Monitoring Statin Therapy Kimberly K. Birtcher, MS, PharmD, BCPS (AQ Cardiology),
Safety update Anthony Ormerod. Why is safety important? Clinical trial / European directive MHRA / governance Severe disease Patients have large burden.
Rhabdomyolysis W. Rose. Rhabdomyolysis W. Rose 2015 Condition in which muscle cells die and release intracellular contents into the systemic circulation.
Statins in Renal Failure Andrea Fox Sunnybrook Health Science Center May 2010.
Clinical question: When do you get statin induced myopathy?
Treatment of Dyslipidemia. The most serious side effects are liver failure and rhabdomyolysis. Serious liver damage caused by statins is rare. More often,
AA-7-1 René Belder, MD Executive Director Clinical Development and Life Cycle Management Cardiovascular / Metabolics 7asdf.
Rapivab™ - peramivir injection
VOYAGER An indiVidual patient data meta- analysis Of statin therapY in At risk Groups: Effects of Rosuvastatin, atorvastatin and simvastatin Please see.
1 The Role of Exposure-Response Evaluation in Drug Development and Regulatory Decisions Case Study: Rosuvastatin Hae-Young Ahn, Ph.D. Office of Clinical.
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Demographic Characteristics of Individuals With AERS of Rhabdomyolysis, Proteinuria/Nephropathy, or Renal Failure (COMPOSITE AERS) Alsheikh-Ali AA et al.
Manufacturer: AstraZeneca FDA Approval Date: December 22, 2015
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The presence of cardiovascular disease is an important predictor of mortality in patients with end-stage renal disease, as it accounts for almost 50 percent.
An unpleasant sensory or emotional experience associated with actual or potential tissue damage The World Health Organization (WHO) has stated that pain.
EMT 296 Medical Presentations Blaze Amodei. Rhabdomyolysis is the rapid breakdown of skeletal muscle tissue due to injury to muscle tissue. skeletal muscle.
Manufacturer: Amgen Inc FDA Approval Date: August 27, 2015
C-1 Safety Results S. aureus Bacteremia and Endocarditis Study Gloria Vigliani, M.D. Vice President, Medical Strategy Cubist Pharmaceuticals.
Slide 1 EZT 2002-W-6022-SS Ezetimibe Co-administered with Statins: Efficacy and Tolerability Copyright © 2003 MSP Singapore Company, LLC. All rights reserved.
Factors That Increase the Risk of Myopathy in People Taking Statins Philip J. Barter, and Kerry-Anne Rye Circulation 2006;114: ) Jones PH, Davidson.
신장내과 R4 강혜란 Cardiorenal syndrome (CRS). Patients with heart failure (HF) who have a reduced GFR -> Mortality ↑ Patients with chronic kidney disease.
Treating to New Targets Study TNT Trial Presented at The American College of Cardiology Scientific Sessions 2005 Presented by Dr. John C. LaRosa.
Primary Prevention Nice Guidelines. Who to offer therapy to? Offer lipid-modification therapyto people aged 84 years and younger if their estimated 10-year.
PHM142 Fall 2015 Instructor: Dr. Jeffrey Henderson.
New Agents Heather Kertland, PharmD.
BHIVA Clinical Audit Management of patients who switch therapy; re-audit of patients starting therapy from naïve.
Bacon will kill you, But damn is it delicious! Here’s to more Statins!
Farxiga™ - Dapagliflozin
Gout Familial metabolic disease characterized by : Acute arthritis Uric acid stones in the kidneys Hyperuricemia.
Ponatinib as Initial Therapy for Patients with Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Cortes JE et al. Proc ASH 2013;Abstract 1483.
Susan Alexander, DNP, CNS, CRNP, BC- ADM College of Nursing University of Alabama in Huntsville Clinical Affiliation: Outpatient Diabetes Self-Management.
7. Anti-TB regimen in special situations of liver disease, renal impairment, and pregnancy.
Liver transplantation for HCV infection R3 양 인 호 /Prof 김 병 호.
Module 4 Basic Principles of Treatment. “ubo! ubo! ubo!” (cough for 2 weeks or more) Did not take medication medication In Loving Memory of In Loving.
The ARBs include the following drugs: azilsartan (Edarbi),candesartan (Atacand), eprosartan (Teveten), irbesartan(Avapro), losartan (Cozaar), olmesartan.
CCB in Management of Hypertension in Older Persons Presented by Mona Ahmed sherif Marwa Shaaban Shimaa Adel Ahmed Salma Sadek Alia khalid.
Pathophysiology. Maximum therapeutic dose: - 4g in adults - 90mg/kg in children Toxicity is with single ingestion of 150 mg/kg or ~7-10 g (adult)
2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults Scott W. Rypkema, M.D.
OVERALL SURVIVAL Adapted from Scandinavian Simvastatin Survival Study Group Lancet 1994;344: % of patients alive Simvastatin (n=2221)
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1. 2 The primary Objective of IDEAL LDL-C Simvastatin mg/d Atorvastatin 80 mg/d risk CHD In stable CHD patients IDEAL: The Incremental Decrease.
© 2006 National Lipid Association NLA Safety Task Force Report: The Nonstatins March 19, 2007.
Sprout Pharmaceuticals Inc. FDA Approval Date: August 18, 2015
This lecture was conducted during the Nephrology Unit Grand Ground by Nephrology Registrar under Nephrology Division, Department of Medicine in King Saud.
Copyleft Clinical Trial Results. You Must Redistribute Slides The American College of Cardiology Foundation / American Heart Association Clopidogrel Recommendations.
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