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The effect of digoxin on the quality of life in patients with heart failure
Ellis Lader1, Debra Egan, Sally Hunsberger
1New York University School of Medicine, New York, New York, USA.
Insights
Digoxin did not improve health-related quality of life (HQOL) in patients with heart failure. This study found no significant differences in HQOL measures between digoxin and placebo groups over 12 months.
Area of Science:
- Cardiology
- Clinical Trials
- Health Outcomes Research
Background:
- The Digitalis Investigation Group (DIG) trial assessed digoxin's effect on mortality in 7,788 heart failure patients.
- A substudy specifically investigated digoxin's impact on health-related quality of life (HQOL) in a subset of these patients.
Purpose of the Study:
- To evaluate the effect of digoxin therapy on health-related quality of life (HQOL) in patients with heart failure and sinus rhythm.
- To determine if digoxin improves subjective well-being and functional status in this patient population.
Main Methods:
- A subset of 589 patients from the DIG trial were randomized to receive either digoxin or placebo.
- HQOL was measured using validated questionnaires assessing general health, physical functioning, and psychological well-being.
- Functional status was further assessed via investigator assessment and a 6-minute walk test at baseline and 4- and 12-month follow-ups.
Main Results:
- No statistically significant differences in baseline HQOL measures were observed between the digoxin and placebo groups.
- At 4 months, only perceived health showed a marginal improvement in the digoxin group.
- By 12 months, no significant differences were found in any HQOL measure, including perceived health, physical functioning, or depression, between the two groups.
Conclusions:
- Digoxin therapy demonstrated no significant impact on health-related quality of life in patients with heart failure and sinus rhythm.
- The findings suggest that digoxin does not offer benefits for quality of life in this specific patient group.
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.
Conclusion:
In this subset of the DIG population, digoxin therapy had no effect on the HQOL in patients with heart failure in sinus rhythm.
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