The effect of digoxin on the quality of life in patients with heart failure.
BACKGROUND
The Digitalis Investigation Group (DIG) trial was a randomized double-blind placebo-controlled study that examined the effect of digoxin on mortality in 7,788 patients with heart failure and sinus rhythm. A prespecified substudy evaluated the effect of digoxin therapy on health-related quality of life (HQOL) in a subset of these patients.


METHODS
Patients in the DIG trial had clinical heart failure and were randomized to either digoxin or placebo in addition to their baseline diuretic and angiotensin-converting enzyme therapy (n = 7,788). The patients in this substudy had HQOL measured using a self-administered questionnaire employing scales that measured general health, physical functioning, depression, anger, anxiety, life satisfaction, and disease specific measures. A subjective assessment by the investigator and a 6-minute walk test evaluated functional status. HQOL was measured at baseline and at the 4- and 12-month follow-up visits.


RESULTS
The baseline characteristics of the patients in the quality of life substudy (n = 589) were comparable to the remaining patients in the study (n = 7,199) by age and other clinical measures, including history of prior myocardial infarction or etiology of heart failure; heart failure was of shorter duration and the ejection fraction was slightly better than in the main trial. Within the substudy, patients receiving digoxin (n = 298) or placebo (n = 291) were also similar in baseline characteristics. There was no statistically significant difference in any HQOL measure between the digoxin and the placebo groups at baseline. At the 4-month visit, only perceived health was improved in the digoxin group. At 12 months, there was no statistically significant difference in perceived health, physical functioning, Minnesota Living with Heart Failure, depression, anxiety, anger, Ladder of Life, or the 6-minute walk between the digoxin and placebo groups.


CONCLUSIONS
In this subset of the DIG population, digoxin therapy had no effect on the HQOL in patients with heart failure in sinus rhythm.
Lader
Ellis
E
New York University School of Medicine, New York, New York, USA.
Egan
Debra
D
Hunsberger
Sally
S
Garg
Rekha
R
Czajkowski
Susan
S
McSherry
Frances
F
D000368:Aged; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000627:therapeutic use; D000889:Anti-Arrhythmia Agents / Q000627:therapeutic use*; D004077:Digoxin / Q000627:therapeutic use*; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009656:North America; D011237:Predictive Value of Tests; D011788:Quality of Life / Q000523:psychology*; D012044:Regression Analysis; D015203:Reproducibility of Results; D012720:Severity of Illness Index; D013318:Stroke Volume / Q000502:physiology; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
D000806:Angiotensin-Converting Enzyme Inhibitors; D000889:Anti-Arrhythmia Agents; D004077:Digoxin