We conducted a prospective, double-blind, placebo-controlled multicent
er trial in order to evaluate the long-term effects of captopril (50 m
g/day), digoxin (0.25 mg/day) and placebo on quality of life, cardiova
scular events, clinical symptoms and exercise tolerance in patients wi
th documented myocardial infarction, resulting in regional wall motion
abnormalities, and with mild heart failure (NYHA class II to III with
out treatment) and exercise not limited by angina. 222 patients were s
tudied, 63 were randomized to captopril, 66 to digoxin, 67 to placebo.
Follow-up was conducted for two years. Base line characteristics in t
he three treatment groups were similar. After one year of therapy, dig
oxin had significantly improved general well-being (p < 0.01 vs captop
ril), symptom score (p < 0.05 vs captopril and placebo), and vitality
(p < 0.05 vs captopril). Digoxin improved NYHA class in 45% as compare
d to placebo (28%, p < 0.05). Worsening of angina was more frequent wi
th captopril as compared to digoxin (p < 0.05). However, cardiovascula
r events during follow-up were lower in the captopril group as compare
d to placebo and digoxin (p < 0.01 captopril vs placebo). No differenc
es between groups were observed in baseline and follow-up exercise tol
erance between the three groups. Dizziness during upright tilt and cou
gh were more frequent with captopril as compared to digoxin or placebo
. After two years of follow-up (captopril n = 32, digoxin n = 29, plac
ebo n = 27) general well-being was improved with both digoxin and capt
opril (p < 0.004 and p < 0.03 vs placebo). In addition, digoxin improv
ed vitality, symptom scores, and Minnesota score (p < 0.04, p < 0.01 a
nd p < 0.05 vs placebo). We conclude that in patients with coronary ar
tery disease, after myocardial infarction and with mild heart failure,
digoxin exerted a beneficial effect on several measures of quality of
life and improved clinical symptoms. A divergent pattern was observed
with captopril, that is, a worsening of angina symptoms early on, par
ticularly in patients with multivessel disease, but a remarkable effec
t on quality of life, as well as a reduction in cardiovascular events
in the longer follow-up of two years.