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The effect of digoxin on the quality of life in patients with heart failure.
J Card Fail. 2003 Feb; 9(1):4-12.JC

Abstract

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.

Authors+Show Affiliations

New York University School of Medicine, New York, New York, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

12612867

Citation

Lader, Ellis, et al. "The Effect of Digoxin On the Quality of Life in Patients With Heart Failure." Journal of Cardiac Failure, vol. 9, no. 1, 2003, pp. 4-12.
Lader E, Egan D, Hunsberger S, et al. The effect of digoxin on the quality of life in patients with heart failure. J Card Fail. 2003;9(1):4-12.
Lader, E., Egan, D., Hunsberger, S., Garg, R., Czajkowski, S., & McSherry, F. (2003). The effect of digoxin on the quality of life in patients with heart failure. Journal of Cardiac Failure, 9(1), 4-12.
Lader E, et al. The Effect of Digoxin On the Quality of Life in Patients With Heart Failure. J Card Fail. 2003;9(1):4-12. PubMed PMID: 12612867.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The effect of digoxin on the quality of life in patients with heart failure. AU - Lader,Ellis, AU - Egan,Debra, AU - Hunsberger,Sally, AU - Garg,Rekha, AU - Czajkowski,Susan, AU - McSherry,Frances, PY - 2003/3/4/pubmed PY - 2003/6/28/medline PY - 2003/3/4/entrez SP - 4 EP - 12 JF - Journal of cardiac failure JO - J. Card. Fail. VL - 9 IS - 1 N2 - 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. SN - 1071-9164 UR - https://www.unboundmedicine.com/medline/citation/12612867/The_effect_of_digoxin_on_the_quality_of_life_in_patients_with_heart_failure_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S107191640225407X DB - PRIME DP - Unbound Medicine ER -