Circulation, Vol 80, 1549-1556, Copyright © 1989 by American Heart Association
F Lindgarde, R Jelnes, H Bjorkman, G Adielsson, T Kjellstrom, I Palmquist and L Stavenow
A double-blind, parallel group, multicenter clinical trial of
pentoxifylline compared with placebo enrolled 150 patients with moderately
severe chronic occlusive arterial disease (COAD) at three centers in
Scandinavia. The study consisted of a 4-6 week single-blind,
placebo-controlled run-in phase, during which the stabilization of the
initial claudication distance of all patients was assessed before
randomization to a 6-month double-blind observation period. The diagnosis
of COAD was established by clinical findings, conventional angiography, and
noninvasive peripheral Doppler pressure assessment at rest and after
exercise. The results of the overall intention-to-treat analysis of the
study population show statistically significant superiority of
pentoxifylline over placebo for all absolute claudication distance summary
and end point measures. By using two clinically relevant parameters, which
are a resting ankle/arm pressure ratio 0.8 or less and a duration of COAD
for greater than 1 year, a target population could be defined in whom trial
results became highly significant. For nontarget patients with mild COAD,
we conclude that basic therapeutic measures should include the treatment of
risk factors and the initiation of physical training. For target patients,
however, a multifactorial therapeutic approach, including the use of
pentoxifylline, is justified.
ARTICLES
Conservative drug treatment in patients with moderately severe chronic occlusive peripheral arterial disease. Scandinavian Study Group
Department of Medicine, Malmo General Hospital University of Lund, Sweden.
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