Circulation, Vol 87, 162-164, Copyright © 1993 by American Heart Association
G Fornaro, P Rossi, PG Mantica, ME Caccia, D Aralda, M Lavezzari, F Pamparana and G Milanesi
BACKGROUND. The purpose of this randomized, double-blind study was to
evaluate the efficacy of indobufen, a reversible inhibitor of platelet
cyclooxygenase, in the prevention of embolic events of cardiac origin.
METHODS AND RESULTS. One hundred ninety-six patients with heart disease and
at risk for cardiogenic embolism (90 with atrial fibrillation and 106 in
sinus rhythm) were randomly assigned to receive indobufen (100 mg b.i.d.)
or placebo. All patients were reexamined every 3 months for the duration of
the study. The primary study end points were cerebral ischemic attack
(stroke and transient ischemic attack), systemic embolism, pulmonary
embolism, and fatal myocardial infarction. The median duration of treatment
was 854 days in the indobufen group and 865 days in the placebo group. The
frequencies of primary end points (fatal and nonfatal) were 6.1% and 17.3%,
respectively, in the indobufen and placebo groups (p < 0.05) for a
reduction of 65% in the risk of a primary event (indobufen/placebo relative
risk, 0.35; 95% confidence limits, 0.14-0.89). Adverse drug reactions,
mostly gastrointestinal or hemostasis disorders, occurred in 9.2% of
indobufen- treated patients. CONCLUSIONS. The results of the study indicate
that indobufen may reduce the risk of ischemic events in patients with
heart disease associated with an increased risk of embolism.
ARTICLES
Indobufen in the prevention of thromboembolic complications in patients with heart disease. A randomized, placebo-controlled, double-blind study
Division of Cardiology, Novara Hospital, Italy.
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