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This editorial discusses the reasons behind conflicting results in clinical trials evaluating treatments for congestive heart failure.
Editorials1 July 1988Clinical Trials in Congestive Heart Failure: Why Do Studies Report Conflicting Results?Milton Packer, MDMilton Packer, MDAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-109-1-3 SectionsAboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail ExcerptAs subscribers to peer-reviewed medical journals, we commonly read reports about advances in the treatment of acute and chronic diseases. Some reports describe highly favorable results and are enthusiastic about the future role of the new treatment; others discern no therapeutic benefit and raise questions about the usefulness of the new drug. Frequently, such divergent opinions concern the same therapeutic agent. Why should studies using the same drug administered to patients with the same disease differ so markedly in their conclusions about the drug's efficacy?In their review of controlled clinical trials in chronic heart failure in this issue, Marantz...References1. Marantz P, Alderman M, and Tobin J. Diagnostic heterogeneity in clinical trials of treatment for congestive heart failure. Ann Intern Med. 1988;109:55-61. LinkGoogle Scholar2. Packer M, Meller J, Medina N, Gorlin R, and Herman M. Importance of left ventricular chamber size in determining the response to hydralazine in severe chronic heart failure. N Engl J Med. 1980; 303:250-5. CrossrefMedlineGoogle Scholar3. Packer M, Lee W, Medina N, Yushak M, and Kessler P. Identification of patients with severe heart failure most likely to fail long-term therapy with converting-enzyme inhibitors [Abstract]. J Am Coll Cardiol. 1986;7:181A. Google Scholar4. Likoff M, Weber K, and Andrews V. Amrinone in the treatment of chronic heart failure. 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Double-blind trial of chronic oral beta blockade in congestive cardiomyopathy. Lancet. 1981;2:490-3. CrossrefMedlineGoogle Scholar10. Engelmeier R, O'Connell J, Walsh R, Rad N, Scanlon P, and Gunnar R. Improvement in symptoms and exercise tolerance by metoprolol in patients with dilated cardiomyopathy: a double-blind, randomized, placebo-controlled trial. Circulation. 1985;72:536-46. CrossrefMedlineGoogle Scholar11. Gilbert E, Anderson J, and Deitchman D. Chronic β blockade with bucindolol improves resting cardiac function in dilated cardiomyopathy [Abstract]. Circulation. 1987;76(suppl IV): IV-358. Google Scholar12. Creager M, Massie B, and Faxon D. Acute and long-term effects of enalapril on the cardiovascular response to exercise and exercise tolerance in patients with congestive heart failure. J Am Coll Cardiol. 1985;6:163-70. CrossrefMedlineGoogle Scholar13. Franciosa J, Jordan R, Wilen M, and Leddy C. Minoxidil in patients with left heart failure: contrasting hemodynamic and clinical effects in a controlled trial. Circulation. 1984;70:63-9. CrossrefMedlineGoogle Scholar14. Franciosa J, Weber K, and Levine B. Hydralazine in the long-term treatment of chronic heart failure: lack of difference from placebo. Am Heart J. 1982;104:587-94. CrossrefMedlineGoogle Scholar15. Leier C, Huss P, Magorien R, and Unverferth D. Improved exercise capacity and differing arterial and venous tolerance during chronic isosorbide dinitrate therapy for congestive heart failure. Circulation. 1983;67:817-22. CrossrefMedlineGoogle Scholar16. Packer M. How should we judge the efficacy of drug therapy in patients with chronic congestive heart failure? The insights of six blind men. J Am Coll Cardiol. 1987;9:433-8. CrossrefMedlineGoogle Scholar17. Kramer B, Massie B, and Topic N. Controlled trial of captopril in chronic heart failure: a rest and exercise hemodynamic study. Circulation. 1983;67:807-16. CrossrefMedlineGoogle Scholar18. Franciosa J, Wilen M, and Jordan R. Effect of enalapril, a new angiotensin converting enzyme inhibitor, in a controlled trial in heart failure. J Am Coll Cardiol. 1985;5:101-7. CrossrefMedlineGoogle Scholar19. Shapiro M and Charrow P. Scientific misconduct in investigational drug trials. N Engl J Med. 1985;312:731-6. CrossrefMedlineGoogle Scholar This content is PDF only. To continue reading please click on the PDF icon. Author, Article, and Disclosure InformationAuthors: Milton Packer, MDAffiliations: Mount Sinai School of Medicine New York, NY 10029 PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetails Metrics Cited byReporting and Interpreting of ResultsReporting and Interpreting of ResultsAssessment of Heart FailureAssessment of Heart FailureReporting and Interpreting of ResultsThe management of heart failure: A matter of definition?Cardiac failure: Symptoms and functional statusTissue and plasma angiotensin converting enzyme and the response to ACE inhibitor drugs.Drugs for Heart FailureMeta-Analysis: Whither Narrative Review?Treatment of Congestive Heart Failure with Angiotensin-Converting Enzyme Inhibitors 1 July 1988Volume 109, Issue 1Page: 3-5KeywordsClinical trial reportingClinical trialsDrugsForecastingHeart failureLongitudinal studies ePublished: 1 December 2008 Issue Published: 1 July 1988 PDF downloadLoading ...
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