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Efficacy and safety of digoxin in patients with heart failure and reduced ejection fraction according to diabetes status: An analysis of the Digitalis Investigation Group (DIG) trial.
Int J Cardiol 2016; 209:310-6IJ

Abstract

BACKGROUND

Digoxin is recommended in symptomatic heart failure patients with reduced ejection fraction (HF-REF) in sinus rhythm and refractory to other evidence-based therapy. Although HF-REF patients with diabetes have worse functional status than those without, the effects of digoxin have not been specifically evaluated according to diabetes status.

METHODS

We examined the efficacy and safety of digoxin in HF-REF patients with and without diabetes in the Digitalis Investigation Group trial. Mortality from all-cause, cardiovascular (CV) causes and heart failure (HF), along with HF hospitalisation and suspected digoxin toxicity were analyzed according to diabetes status and randomised treatment assignment.

RESULTS

Of the 6800 patients, those with diabetes (n=1933) were older, more often women, had worse clinical status and more co-morbidity than those without diabetes. All-cause and CV mortality were higher in patients with diabetes than in those without and digoxin did not reduce mortality in either sub-group. The rate of HF hospitalization (per 100 person-years) in patients with diabetes was higher than in those without and was reduced by digoxin in both patient groups: diabetes - placebo 20.5 and digoxin 16.0 (HR 0.79, 95% CI: 0.68-0.91); no diabetes - placebo 12.7 and digoxin 8.7 (HR 0.69, 0.62-0.77); interaction p=0.14. Suspected digoxin toxicity in patients randomised to digoxin was more common among patients with diabetes than without (6.5% versus 5.8%), as was hospitalisation for digoxin toxicity (1.4% versus 0.8%).

CONCLUSION

Added to an ACE inhibitor, digoxin reduced HF hospitalisation in HF-REF patients with and without diabetes without a substantial risk of toxicity.

Authors+Show Affiliations

Institute of Cardiovascular and Medical Sciences, University of Glasgow, UK.Institute of Cardiovascular and Medical Sciences, University of Glasgow, UK.Institute of Cardiovascular and Medical Sciences, University of Glasgow, UK.Golden Jubilee National Hospital, Glasgow, UK.Institute of Cardiovascular and Medical Sciences, University of Glasgow, UK.Institute of Cardiovascular and Medical Sciences, University of Glasgow, UK. Electronic address: john.mcmurray@glasgow.ac.uk.No affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26913372

Citation

Abdul-Rahim, Azmil H., et al. "Efficacy and Safety of Digoxin in Patients With Heart Failure and Reduced Ejection Fraction According to Diabetes Status: an Analysis of the Digitalis Investigation Group (DIG) Trial." International Journal of Cardiology, vol. 209, 2016, pp. 310-6.
Abdul-Rahim AH, MacIsaac RL, Jhund PS, et al. Efficacy and safety of digoxin in patients with heart failure and reduced ejection fraction according to diabetes status: An analysis of the Digitalis Investigation Group (DIG) trial. Int J Cardiol. 2016;209:310-6.
Abdul-Rahim, A. H., MacIsaac, R. L., Jhund, P. S., Petrie, M. C., Lees, K. R., & McMurray, J. J. (2016). Efficacy and safety of digoxin in patients with heart failure and reduced ejection fraction according to diabetes status: An analysis of the Digitalis Investigation Group (DIG) trial. International Journal of Cardiology, 209, pp. 310-6. doi:10.1016/j.ijcard.2016.02.074.
Abdul-Rahim AH, et al. Efficacy and Safety of Digoxin in Patients With Heart Failure and Reduced Ejection Fraction According to Diabetes Status: an Analysis of the Digitalis Investigation Group (DIG) Trial. Int J Cardiol. 2016 Apr 15;209:310-6. PubMed PMID: 26913372.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of digoxin in patients with heart failure and reduced ejection fraction according to diabetes status: An analysis of the Digitalis Investigation Group (DIG) trial. AU - Abdul-Rahim,Azmil H, AU - MacIsaac,Rachael L, AU - Jhund,Pardeep S, AU - Petrie,Mark C, AU - Lees,Kennedy R, AU - McMurray,John J V, AU - ,, Y1 - 2016/02/08/ PY - 2015/10/22/received PY - 2016/02/02/revised PY - 2016/02/07/accepted PY - 2016/2/26/entrez PY - 2016/2/26/pubmed PY - 2016/12/15/medline KW - Diabetes KW - Digoxin KW - Heart failure KW - Outcome SP - 310 EP - 6 JF - International journal of cardiology JO - Int. J. Cardiol. VL - 209 N2 - BACKGROUND: Digoxin is recommended in symptomatic heart failure patients with reduced ejection fraction (HF-REF) in sinus rhythm and refractory to other evidence-based therapy. Although HF-REF patients with diabetes have worse functional status than those without, the effects of digoxin have not been specifically evaluated according to diabetes status. METHODS: We examined the efficacy and safety of digoxin in HF-REF patients with and without diabetes in the Digitalis Investigation Group trial. Mortality from all-cause, cardiovascular (CV) causes and heart failure (HF), along with HF hospitalisation and suspected digoxin toxicity were analyzed according to diabetes status and randomised treatment assignment. RESULTS: Of the 6800 patients, those with diabetes (n=1933) were older, more often women, had worse clinical status and more co-morbidity than those without diabetes. All-cause and CV mortality were higher in patients with diabetes than in those without and digoxin did not reduce mortality in either sub-group. The rate of HF hospitalization (per 100 person-years) in patients with diabetes was higher than in those without and was reduced by digoxin in both patient groups: diabetes - placebo 20.5 and digoxin 16.0 (HR 0.79, 95% CI: 0.68-0.91); no diabetes - placebo 12.7 and digoxin 8.7 (HR 0.69, 0.62-0.77); interaction p=0.14. Suspected digoxin toxicity in patients randomised to digoxin was more common among patients with diabetes than without (6.5% versus 5.8%), as was hospitalisation for digoxin toxicity (1.4% versus 0.8%). CONCLUSION: Added to an ACE inhibitor, digoxin reduced HF hospitalisation in HF-REF patients with and without diabetes without a substantial risk of toxicity. SN - 1874-1754 UR - https://www.unboundmedicine.com/medline/citation/26913372/Efficacy_and_safety_of_digoxin_in_patients_with_heart_failure_and_reduced_ejection_fraction_according_to_diabetes_status:_An_analysis_of_the_Digitalis_Investigation_Group__DIG__trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0167-5273(16)30298-4 DB - PRIME DP - Unbound Medicine ER -