| Clinical trial strategies and future challenges in the investigation of human congestive heart failure. | |
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MedLine Citation:
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PMID: 8233998 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Clinical research in the therapeutics of chronic congestive heart failure (CHF) has evolved from simple case reports and general-response studies in the 1960s to large, randomized, controlled trials conducted in the late 1980s and 1990s. Cumulatively, the investigations show that angiotensin-converting enzyme (ACE) inhibitors improve clinical status, exercise capacity, and survival; digoxin augments exercise capacity and, probably, clinical status, with unknown effects on survival; the vasodilator combination hydralazine-nitrate improves survival, and perhaps clinical status and exercise capacity; and the new vasodilator flosequinan has a favorable effect on clinical status and exercise capacity, but is associated with an increased risk of mortality at 100 mg/day (this agent has subsequently been withdrawn voluntarily by the manufacturer from clinical use). Advances in study design and methodology, combined with the outcomes of major clinical trials, have resulted in new challenges in the investigation of CHF in humans. To date, only the ACE inhibitors have been shown to affect all of the major CHF therapeutic end points in a positive manner. Is it reasonable to expect similar results from all future drug interventions? If not, which end points should be targeted? Must the survival end point be investigated for all CHF drugs under development? Can studies be performed ethically without background ACE inhibitor therapy? Have the optimum duration and methods for therapeutic trials in humans been determined? Should controlled trials of nonhemodynamic and nonneurohormonal interventions (e.g., anticoagulation, magnesium, exercise regimens) be performed? How can the results of clinical trials best be applied in treating the broad range of patients encountered in practice?(ABSTRACT TRUNCATED AT 250 WORDS) |
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Authors:
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C V Leier |
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Publication Detail:
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Type: Journal Article; Review |
Journal Detail:
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Title: Pharmacotherapy Volume: 13 ISSN: 0277-0008 ISO Abbreviation: Pharmacotherapy Publication Date: 1993 Sep-Oct |
Date Detail:
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Created Date: 1993-12-22 Completed Date: 1993-12-22 Revised Date: 2007-11-15 |
Medline Journal Info:
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Nlm Unique ID: 8111305 Medline TA: Pharmacotherapy Country: UNITED STATES |
Other Details:
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Languages: eng Pagination: 94S-99S Citation Subset: IM |
Affiliation:
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Department of Medicine, Ohio State University College of Medicine, Columbus. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Angiotensin-Converting Enzyme Inhibitors
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therapeutic use Clinical Trials as Topic* / methods Heart Failure* / drug therapy, mortality Humans Randomized Controlled Trials as Topic / methods Research Design |
| Chemical | |
Reg. No./Substance:
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0/Angiotensin-Converting Enzyme Inhibitors |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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