R. Antonicelli et al., Randomized trial of the effects of low-dose calcium-heparin in patients with peripheral arterial disease and claudication, AM J MED, 107(3), 1999, pp. 234-239
Citations number
25
Categorie Soggetti
General & Internal Medicine","Medical Research General Topics
PURPOSE: We performed a long-term, multicenter, randomized, double-blind tr
ial to evaluate the efficacy and tolerability of low-dose, subcutaneous cal
cium-heparin (12,500 IU/day) in comparison with placebo in patients with st
able peripheral arterial disease of the lower extremities.
PATIENTS AND METHODS: At the end of a 2-week wash- out period, during which
aspirin placebo was given, 201 patients were randomly assigned to receive
either subcutaneous calcium-heparin or placebo for two S-month treatment pe
riods, each of which was followed by a 6-month period of observation. All o
f the patients were given low-dose aspirin (50 mg/ day) throughout the 18-m
onth study. The main efficacy variables were pain-free and maximum walking
time (by standard treadmill test). Patients answered a questionnaire about
pain and the limitation of daily activities. Results were analyzed by inten
tion-to-treat.
RESULTS: At the end of the study, the estimated increase in pain-free walki
ng time was 39% in the heparin group and 23% in the placebo group (P = 0.09
). The estimated increase in maximum walking time was 40% in the heparin gr
oup and 16% in the placebo group (P = 0.05). Patients treated with heparin
also reported that they had to stop walking because of leg pain, or had dai
ly activities limited by leg pain, less frequently than the placebo group (
P < 0.01).
CONCLUSIONS: Treatment with low-dose subcutaneous calcium-heparin is safe a
nd effective in improving walking performance and reducing physical disabil
ity in patients with stable peripheral arterial disease and claudication. (
C) 1999 by Excerpta Medica, Inc.