Author/Authors :
Harold L. Kennedy، نويسنده , , Robert S. Rosenson، نويسنده ,
Abstract :
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.
Keywords :
FDA , Food and Drug Administration , heart failure , ACE , HMO , AMI , MERIT-HF , BEST , MIRACL , Bucindolol Evaluation Survival Trial , Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering study , CIBIS , NYHA , Cardiac Insufficiency BIsoprolol Study , New York Heart Association , Consensus , Cooperative New Scandinavian Enalapril Survival Study , COPERNICUS , Carvedilol Prospective Randomized Cumulative Survival trial , angiotensin-converting enzyme , Health maintenance organization , Acute myocardial infarction , Metoprolol CR/XL Randomized Intervention Trial in Congestive Heart Failure , Hf