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VIEWPOINT

Physicians’ interpretation of "class effects"

A need for thoughtful re-evaluation

Harold L. Kennedy, MD, MPH, FACC^*,* and Robert S. Rosenson, MD, FACC

^* Cardiology Section, Department of Medicine, University of South Florida, Tampa, Florida, USA
Division of Cardiology, Department of Medicine, Northwestern University Medical School, Chicago, Illinois, USA

Manuscript received October 24, 2001; revised manuscript received March 28, 2002, accepted April 8, 2002.

^* Reprint requests and correspondence: Dr. Harold L. Kennedy, Professor, University of South Florida, Chief, Department of Medicine, Bay Pines VA Medical Center, Bay Pines, Florida 33744, USA.
Harold.Kennedy{at}med.va.gov

The concept of pharmacologic "class effects" exists across a broad range of medical products and is particularly pervasive with regard to cardiovascular agents. Evolution of the concept over the past two decades has shown the influence of physicians’ practice patterns, pharmaceutical companies, health maintenance organizations and the Food and Drug Administration (FDA). Understanding the evolution of health care, social and economic policies, acknowledging the correction of medical misconceptions and inaccurate understanding and appreciating the emergence of new medical knowledge over the past decade should modify the clinician’s viewpoint of "class effects." These revelations should signal caution in extrapolating the outcome efficacy or safety of one agent to another within a pharmacologic class. The authors urge clinicians, pharmaceutical companies, health maintenance organizations and the FDA to re-examine their concept of "class effects." An appeal is made for physicians to prescribe those pharmaceutical agents with definitive evidence of mortality and morbidity efficacy and safety established by appropriately scaled randomized clinical trials.

Abbreviations and Acronyms   ACE   angiotensin-converting enzyme   AMI   acute myocardial infarction   BEST   Bucindolol Evaluation Survival Trial   CIBIS   Cardiac Insufficiency Bisoprolol Study   CONSENSUS   Cooperative New Scandinavian Enalapril Survival Study   COPERNICUS   Carvedilol Prospective Randomized Cumulative Survival trial   FDA   Food and Drug Administration   HF   heart failure   HMO   health maintenance organization   MERIT-HF   Metoprolol CR/XL Randomized Intervention Trial in Congestive Heart Failure   MIRACL   Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering study   NYHA   New York Heart Association

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