Abstract | BACKGROUND: METHODS AND RESULTS: Eighty patients with stenosis or occlusion, symptoms of intermittent claudication, and maximum walking distance of > or = 30 and < or = 300 m on a standard treadmill test were randomized to placebo or one of three dosage regimens of AS-013. Drug was administered by intravenous injection 5 d/wk for 4 weeks. Treadmill tests and other assessments were completed at weeks 0, 4, and 8. A statistically significant increase in maximum walking distance was observed at 4 weeks (for placebo: median, 4.5 m; interquartile range [IQR], 20; for active treatment: median, 28.0 m; IQR, 81; P < .01, Mann-Whitney test). A similar response was seen at 8 weeks (for placebo; median, -11.2 m; IQR, 35; for active treatment: median, 35 m; IQR, 68; P < .01, Mann-Whitney test). Dose-related improvements in pain-free walking distance and quality of life were observed. No serious safety issues were noted. CONCLUSIONS:
|
Authors | J J Belch, P R Bell, D Creissen, J A Dormandy, R C Kester, R D McCollum, Y Mizushima, C V Ruckley, J H Scurr, J H Wolfe |
Journal | Circulation
(Circulation)
Vol. 95
Issue 9
Pg. 2298-302
(May 06 1997)
ISSN: 0009-7322 [Print] United States |
PMID | 9142008
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
|
Chemical References |
- Placebos
- Prodrugs
- Alprostadil
|
Topics |
- Aged
- Alprostadil
(administration & dosage, therapeutic use)
- Dose-Response Relationship, Drug
- Double-Blind Method
- Female
- Humans
- Intermittent Claudication
(drug therapy, physiopathology)
- Male
- Middle Aged
- Pain
- Placebos
- Prodrugs
(therapeutic use)
- Quality of Life
- Walking
|