The clinical safety, efficacy of a new platelet aggregation inhibitor, cilostazol, with a vasodiating action in patients with peripheral vascular diasease (m-85) accompanied by ischemic symptom such as foot ulcer, resting pain, cold sensation,
numbness
and claudication in multicenter were evaluated by administering the drug orally in daily doses of 200㎎ for consecutive 8 weeks in a open trial manner. The data analysis was done in total cases (n=85) and cases API≤1 (n=45) by Student's paired
t-test
and Wilcoxson signed ranks test.
The results were as follows:
1) The score of resting pain, numbness, cold sensation, claudication granuloma were significantly decreased in total case and cases with API≤1 (p<0.001), and the ulcer size was significantly decreased in total cases after Cilostazol treatment
for
8
weeks (p<0.001).
2) The ankle pressure index was significantly increased from 0.96±0.19 to 0.99±0.19 in total cases (p<0.01), and from 0.85±0.12 to 0.94±0.16 in cases with API≤I (p<0.001) after cilostazol treatment for 8 weeks. The score of arterial
palpation
and
doppler wave were markely improved in both groups after treatment.
3) The headache, the most common side effect, was noted in 18 cases(21.1%) of total 85 cases.
4) The assessment of overall improvement of the diasease made by the attending physician based on the improvement of resting pain, cold sensation, claudication, numbness, ulcer and granuloma indicated that the percent improvement based on the
combined
assessments of "markedly improved", "improved" and "slightly improved " amounted to 87%.
5) The assessment of overall safety of the drug evaluated by the attending physician based on the assessment of "safe" and"almost safe" amounted to 91.7%j.
6) The assessment of overall utility of the drug evaluated by the attending physician based on the assessment of "very useful", "useful" and "slightly useful" amounted to 90.1%.
Based on these results it was concluded that cilostazol ws useful in the treatment of diabetic patients with peripheral vascular disease accompanied by ischemic symptom such as resting pain, cold sensation, claudication, numbness, ulcer and
granuloma in
the extremities at an optimal daily dose of 200㎎.
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