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• Video of the Statin Safety Task Force Phase I Presentation • Questions and Answers from the Presentation Read More |
National Lipid Association Statin Study: Required Liver Monitoring Unnecessary May Be Causing Patients to Forego Life-Saving Cholesterol Treatment
Boston, MA - In the most comprehensive, rigorous, non-governmental analysis of statins ever undertaken, the National Lipid Association (NLA) confirmed the safety profile and benefits of cholesterol-lowering statin therapy. The NLA concluded that requirements to monitor patients' liver function are no longer necessary and recommends a review of these requirements by the FDA and others.
"The problem is not that too many patients are having too many side effects. The problem is that too many patients are not being treated to reduce their risk of heart disease - the number one killer of both men and women in the United States. Americans do not need to fear statins; they do need to fear the long-term effects of high cholesterol," said James M. McKenney, PharmD, chair of the Statin Safety Task Force. McKenney also is Professor Emeritus at Virginia Commonwealth University and in-coming president of the NLA.
"We can find no evidence to support the continued monitoring of liver function tests in patients receiving statin therapy. Unfortunately, required liver monitoring may cause resistance to medical treatment or withdrawal of statin treatment, thus depriving a considerable number of patients the life-protecting benefits of statin therapy," said Michael H. Davidson, M.D., FACC, FACP, director of Preventative Cardiology and Atherosclerosis Research at Rush University Medical Center. "One in one million people not taking a statin will develop liver failure. One in one million people taking a statin will develop liver failure. There is no difference."
The study's recommendation regarding patient liver-function monitoring does not direct physicians to make any immediate changes, rather, it requests that the appropriate regulatory bodies review the data, and if warranted, remove requirements for liver function monitoring.
"Our data support the conclusion that statins are as safe as taking a daily dose of aspirin," said Terry A. Jacobson, M.D., director of the Office of Health Promotion and Disease Prevention at Emory University. "Each year we could save 40,000 additional lives if all patients with heart disease were treated with a statin."
The NLA's public health mission is to help reduce deaths related to high cholesterol. More than 106 million American adults are affected by borderline or high lipid levels, commonly known to patients as "cholesterol." These adults are considered at higher risk for developing heart disease. When the recommended diet and exercise program, called Therapeutic Lifestyle Changes (TLC), does not sufficiently lower elevated cholesterol levels, national medical guidelines call for physicians to prescribe lipid-lowering drugs. The largest class of these drugs is statins.
The Task Force, created in June of 2005, is a two-year independent NLA initiative to extensively review and evaluate the safety of statins and other lipid-modifying drugs. The Task Force is undertaking its analysis of the effects of cholesterol-lowering medicines in two phases. This first report covers the effects of statins when they are used alone, or in combination with other therapies, to lower cholesterol. The second phase of the study, which is currently underway, examines non-statin lipid altering drugs.
The comprehensive Task Force Report is published as a supplement to the American Journal of Cardiology (AJC). To assure a rigorous, comprehensive assessment of statin safety, the Task Force commissioned reviews of the specialist literature on adverse reaction (conducted by Dr. Harold Bays) and drug interaction literature (conducted by Dr. Michael Bottorff). The Task Force also commissioned new research to be undertaken and reports of this work include up-to-the-minute systematic review of published cohort and clinical trial data; an assessment of the most recently available data from the FDA's Adverse Event Reporting System (AERS); an inspection of the data contained in the New Drug Applications (NDAs) and the FDA's Summary Basis of Approvals for all marketed statins; and, a first-ever analysis of statin use and associated adverse health events taken from a 22 million-person managed care database, which included 490,000 patient-years of continuous statin treatment.
After compilation of the analyses and the commissioned research, these experts presented their conclusions to four Expert Panels comprised of highly credentialed, medical sub-specialists who independently examined the evidence and gave their assessment to the Task Force. Each Expert Panel, comprised of established scholars from major universities, reviewed and considered the evidence relative to their respective fields of expertise: muscle, liver, kidney and neurology. The outcome of each panel's review, as well as the review of the other analyses and commissioned research, were reported to the Task Force for creation of the final conclusions and recommendations for health professionals. The overview of supporting materials used by the presenters will be published in the AJC supplement.
Task Force members include: Chair James M. McKenney, PharmD, president and CEO of National Clinical Research, Inc.; Michael H. Davidson, M.D., FACC, FACP, Rush University Medical Center; John R. Guyton, M.D., Duke University Medical Center and NLA past-president; and Terry A. Jacobson, M.D., Emory University. To see a complete list of all participants and reviewers go to: www.lipid.org.
In addition to funding provided by the NLA, unrestricted grant funding was provided to the NLA by Abbott Laboratories, AstraZeneca, Kos Pharmaceuticals, Inc., Merck/Schering-Plough and Sankyo Pharma Inc.
"The NLA anticipates that the Task Force findings will enhance physician understanding of lipid management and the treatment modalities available to address this area of cardiovascular disease," said Dr. Guyton. "This comprehensive Statin Safety study contributes a larger body of research, based on a long view of statin therapy and its treatment history, that can now be accessed by the medical community as it addresses patients' cardiovascular health."
On-demand Slide Presentation (downloadable)
The findings and recommendations of the NLA Statin Safety Task Force are available here in a downloadable slide presentation. The presentation, which includes lecture notes, can be downloaded into PowerPoint on your computer by clicking the "On-Demand Slide Presentation" link above or by clicking on a title below. We encourage you to incorporate these slides into your slide library for grand rounds lectures, etc
Report of the National Lipid Association's Statin Safety Task Force (PowerPoint)
Introduction
Statins and Liver Safety
Statins and Muscle Safety
Statins and Kidney Safety
Statins and Neurological Safety
Statins and Drug Interactions
Summary
Supporting documents (Password required)
ABOUT THE NATIONAL LIPID ASSOCIATION
The National Lipid Association (NLA) is a non-profit membership association that serves physicians, nurses, pharmacists and dieticians who help manage patients with lipid disorders and cardiovascular disease. The NLA represents more than 2,000 members in the United States and provides continuing medical education for physicians and other healthcare professionals to advance professional development and attain certification in clinical lipidology. The NLA's public health mission is to help reduce deaths related to high cholesterol. For more information, please see the NLA's Web site at: www.lipid.org.
FOR ADDITIONAL INFORMATION, CONTACT:
Kathryn St. John O: 202-530-4503; cell: 703-850-5246
Veronica Brown: O: 202-530-4526; cell: 310-869-8181
The NLA Statin Safety Task Force
James M. McKenney
- Chair; Virginia Commonwealth University, Richmond, VA
Dr. Michael H. Davidson
- Rush University, Chicago, IL
Dr. Terry A. Jacobson
- Emory University, Atlanta, GA
Dr. John R. Guyton
- Duke University, Durham, NC
The NLA Muscle Expert Panel
Paul D. Thompson, MD, Priscilla M. Clarkson, PhD, and Robert S. Rosenson, MD
The NLA Liver Expert Panel
David E. Cohen, MD, PhD, Frank A. Anania, MD, Naga Chalasani, MD
The NLA Kidney Expert Panel
Bertram L. Kasiske, MD, Christoph Wanner, MD, and W. Charles O'Neill, MD
The NLA Neurology Expert Panel
Lawrence M. Brass, MD, Mark J. Alberts, MD, and Larry Sparks, PhD
Additional Expert Comments
John R. Guyton, MD
Antonio M. Gotto, Jr., MD
Task Force Organizational Structure
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