http://www.theheart.org/web_slides/1425503.do A randomized, double-blind, simple, multicenter study to determine if digoxin had a beneficial, harmful, or no effect on total mortality in patients with clinical heart failure and sinus rhythm

1. DIG (Digitalis Investigation Group)

2. DIG (Digitalis Investigation Group)
M Gheorghiade (Northwestern University Feinberg School of Medicine, Chicago, IL)
Heart Failure Congress 2012
• A randomized, double-blind, simple, multicenter study to determine if digoxin had
a beneficial, harmful, or no effect on total mortality in patients with clinical heart
failure and sinus rhythm
• Population and treatment:
In the main trial, patients with LVEF of 0.45 or less were randomly assigned to
digoxin (3397 patients) or placebo (3403 patients) in addition to diuretics and
ACE inhibitors
In an ancillary trial of patients with ejection fractions greater than 0.45, 492
patients were randomly assigned to digoxin and 496 to placebo
• Primary outcome:
All-cause mortality
LVEF=left ventricular ejection fractions

3. DIG: Results
• >1/2 of patients with systolic HF randomized fell into three high-risk subgroups,
and in all three, HF-related mortality or hospitalization fell significantly over two
years with digoxin
• Composite of all-cause mortality or hospitalization also declined significantly but
less sharply—mortality didn't figure much in either of the two benefits, driven
primarily by fewer hospitalizations with digoxin
DIG prespecified high-risk-subgroup analysis: Hazard ratios
(95% CI), p, for composite end points that include
hospitalization
End point NYHA 3-4, n=2223 LVEF<25%, n=2256 CTR >55%, n=2345 Any of the 3 high-risk
features, n=4367
All-cause mortality or hospitalization 0.88 (0.80–0.97); 0.84 (0.76–0.93); 0.85 (0.77–0.94); 0.87 (0.81–0.94);
p=0.012 p=0.001 p=0.002 p<0.001
Heart-failure-related mortality or 0.65 (0.57–0.75); 0.61 (0.53–0.71); 0.65 (0.57–0.75); 0.66 (0.59–0.73);
hospitalization p<0.001 p<0.001 p<0.001 p<0.001
HF=heart failure
CTR=cardiothoracic ratio

4. DIG: Commentary*
"Based on this data, and this is consistent with the guidelines, I think digoxin
therapy should be considered in patients who continue to have signs and symptoms
in spite of available therapies. But this is not happening. There are many patients
who continue to have signs and symptoms at my own institution, and digoxin is not
even considered."
- Dr Mihai Gheorghiade
"Maybe we should also have it in our minds for those intolerant of beta blockade."
- Prof Theresa A McDonagh
"I strongly believe we may need to revisit the data again in the contemporary
population."
- Dr Piotr Ponikowski
*All comments from DIG revisited: Digoxin scrutinized anew for chronic heart failure
(http://www.theheart.org/article/1404951.do)

5. Become a member of http://www.theheart.org
Become a fan on Facebook: http://www.facebook.com/theheartorg
Follow us on Twitter: http://www.twitter.com/theheartorg
theheart.org is the leading online source of independent cardiology news.
We are the top provider of news and opinions for over 100 000 physicians.