Document Detail

Effects of digoxin on morbidity and mortality in diastolic heart failure: the ancillary digitalis investigation group trial.
MedLine Citation:
PMID:  16864724     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: About half of the 5 million heart failure patients in the United States have diastolic heart failure (clinical heart failure with normal or near-normal ejection fraction). Except for candesartan, no drugs have been tested in randomized clinical trials in these patients. Although digoxin was tested in an appreciable number of diastolic heart failure patients in the Digitalis Investigation Group ancillary trial, detailed findings from this important study have not previously been published.
METHODS AND RESULTS: Ambulatory chronic heart failure patients (n = 988) with normal sinus rhythm and ejection fraction > 45% (median, 53%) from the United States and Canada (1991 to 1993) were randomly assigned to digoxin (n = 492) or placebo (n = 496). During follow-up with a mean length of 37 months, 102 patients (21%) in the digoxin group and 119 patients (24%) in the placebo group (hazard ratio [HR], 0.82; 95% confidence interval [CI], 0.63 to 1.07; P = 0.136) experienced the primary combined outcome of heart failure hospitalization or heart failure mortality. Digoxin had no effect on all-cause or cause-specific mortality or on all-cause or cardiovascular hospitalization. Use of digoxin was associated with a trend toward a reduction in hospitalizations resulting from worsening heart failure (HR, 0.79; 95% CI, 0.59 to 1.04; P = 0.094) but also a trend toward an increase in hospitalizations for unstable angina (HR, 1.37; 95% CI, 0.99 to 1.91; P = 0.061).
CONCLUSIONS: In ambulatory patients with chronic mild to moderate diastolic heart failure and normal sinus rhythm receiving angiotensin-converting enzyme inhibitor and diuretics, digoxin had no effect on natural history end points such as mortality and all-cause or cardiovascular hospitalizations.
Ali Ahmed; Michael W Rich; Jerome L Fleg; Michael R Zile; James B Young; Dalane W Kitzman; Thomas E Love; Wilbert S Aronow; Kirkwood F Adams; Mihai Gheorghiade
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, Non-P.H.S.     Date:  2006-07-24
Journal Detail:
Title:  Circulation     Volume:  114     ISSN:  1524-4539     ISO Abbreviation:  Circulation     Publication Date:  2006 Aug 
Date Detail:
Created Date:  2006-08-01     Completed Date:  2006-08-16     Revised Date:  2014-09-08    
Medline Journal Info:
Nlm Unique ID:  0147763     Medline TA:  Circulation     Country:  United States    
Other Details:
Languages:  eng     Pagination:  397-403     Citation Subset:  AIM; IM    
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MeSH Terms
Angiotensin-Converting Enzyme Inhibitors / therapeutic use
Blood Pressure / drug effects,  physiology
Cardiotonic Agents / adverse effects,  pharmacology*,  therapeutic use
Digoxin / adverse effects,  pharmacology*,  therapeutic use
Diuretics / therapeutic use
Heart Failure / drug therapy*,  mortality*,  physiopathology
Hospitalization / statistics & numerical data
Middle Aged
Sinoatrial Node / physiology
Stroke Volume / physiology
Survival Rate
Treatment Outcome
Grant Support
1-K23-AG19211-04/AG/NIA NIH HHS; K23 AG019211/AG/NIA NIH HHS; K23 AG019211-04/AG/NIA NIH HHS; R37 AG018915/AG/NIA NIH HHS
Reg. No./Substance:
0/Angiotensin-Converting Enzyme Inhibitors; 0/Cardiotonic Agents; 0/Diuretics; 73K4184T59/Digoxin
Comment In:
Nat Clin Pract Cardiovasc Med. 2007 Feb;4(2):70-1   [PMID:  17245399 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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