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Introduction

Published:November 29, 2006DOI:https://doi.org/10.1016/j.amjcard.2006.11.015
      We are fortunate that the currently available lipid-altering drugs have proved remarkably effecting in reducing the risk for future coronary artery disease events and strokes. More than 30 major randomized, placebo-controlled clinical trials conducted over the past 2 decades have clearly established this. We are also fortunate that these drugs are very safe. In fact, for every serious adverse event encountered with 1 of these drugs, thousands of patients benefit from significant reductions in the risk for major cardiovascular (CV) events. To deploy these therapies in a manner that maximizes their benefit, health professionals need to have a thorough understanding of potential adverse effects and know how to minimize their impact. This supplement to The American Journal of Cardiology is provided to help health professionals meet this goal.
      The National Lipid Association (NLA) assembled the Safety Task Force to conduct a rigorous, scholarly, up-to-date, and unbiased assessment of the safety of lipid-altering therapies and to summarize its findings in a leading medical journal. The first phase of its work, addressing the safety of statins, was published by the task force in a supplement to The American Journal of Cardiology on April 17, 2006.
      • McKenney J.M.
      • Guyton J.R.
      • Davidson M.H.
      • Jacobson T.A.
      A symposium: report of the National Lipid Association’s Statin Safety Task Force.
      The second phase of its assessment, focusing on fibrates, nicotinic acid (niacin), bile acid sequestrants, cholesterol absorption inhibitors, and omega-3 fatty acids, is presented in this supplement. The members of the task force are Dr. James M. McKenney (chair, Virginia Commonwealth University, Richmond, VA), Dr. Harold E. Bays (Louisville Metabolic and Atherosclerosis Research Center, Louisville, KY), Dr. Michael H. Davidson (Rush University Medical Center, Chicago, IL), John R. Guyton (Duke University Medical Center, Durham, NC), and Dr. Terry A. Jacobson (Emory University, Atlanta, GA).
      The Safety Task Force carried out phase 2 of its assignment by first shaping questions, answerable with a yes or no, that addressed key potential adverse effects that may be encountered with these therapies. These questions addressed relatively common as well as rare, but important, adverse events. No attempt was made to carry out a comprehensive survey of all potential adverse effects associated with the target drugs. Task force members reviewed and debated the wisdom of including each question in the assessment and ultimately agreed to the questions that are included in this supplement. Each task force member was assigned ≥1 question to answer by carrying out a comprehensive study of the available published research, seeking the guidance and advice of consultants as necessary, summarizing the evidence applicable to each question and the rationale for the answer, and formulating recommendations that emanated from this evidence for health professionals to use in deploying lipid-altering drug therapies for CV risk reduction. Each task force member presented his or her findings to other task force members and to consultants, Dr. Annemarie Armani (Imprint Science, New York, NY) and Dr. Neil J. Stone (Northwestern University Feinberg School of Medicine, Chicago, IL) during a workshop so that the completeness of the identified evidence could be verified, the rationales for answers debated, and a list of recommendations to health professional agreed to.
      Independent critical reviews of selected questions and rationales were provided by the following experts, to whom we are indebted: Dr. Jacques Genest (McGill University Health Center, Montreal, Quebec, Canada), Dr. Douglas M. Heuman (Virginia Commonwealth University), Dr. Bertram L. Kasiske (University of Minnesota, Minneapolis, MN), Dr. Frank M. Sacks (Harvard School of Public Health, Boston, MA), Dr. Paul D. Thompson (University of Connecticut, Farmington, CT). Additionally, all questions pertaining to particular drug categories (eg, fibrates, nicotinic acid, omega-3 fatty acids, and gastrointestinally active drugs) were sent to recognized experts, who were invited to review these reports and craft independent expert commentaries on the subject. We are indebted to these experts—Dr. W. Virgil Brown (Emory University School of Medicine) on fibrates, Dr. B. Greg Brown (University of Washington School of Medicine, Seattle, WA) on niacin, Dr. William S. Harris (Sanford School of Medicine of the University of South Dakota, Sioux Falls, SD) on omega-3 fatty acids, and Dr. Peter P. Toth (Sterling Rock Falls Clinic, Sterling, IL) on gastrointestinally active lipid-altering drugs—and for their fine contributions to this publication.

      References

        • McKenney J.M.
        • Guyton J.R.
        • Davidson M.H.
        • Jacobson T.A.
        A symposium: report of the National Lipid Association’s Statin Safety Task Force.
        Am J Cardiol. 2006; 97: 1C-97C