Abstract | PURPOSE: METHODS: The study was randomized, multicenter, double blind, and placebo controlled. Patients who met clinical and hemodynamic criteria were randomized to receive placebo or lipo- ecraprost (60 microg) administered intravenously on each of 5 days per week, for a total of 8 weeks. The study's primary endpoint was the rate of a composite end point of death or amputation above the level of the ankle at 180 days (6 months). RESULTS: The study was terminated on a recommendation from the Data and Safety Monitoring Board after the completion of a protocol-specified interim analysis for futility. At the time of termination, 383 of the planned 560 patients had been randomized, of which 379 received at least one dose of study medication and thus were included in the intention-to-treat population. Twenty-three patients were lost to follow-up and were not available for 6-month assessments. At 6 months of follow-up, there were 23 amputations in the 177 patients who received placebo, and 29 amputations in the 179 patients randomized to lipo- ecraprost. At 6 months, 10 deaths had occurred in the placebo group and 18 deaths had occurred in the lipo- ecraprost arm. Changes in lower-extremity hemodynamics over the 6-month study period did not differ between the placebo and lipo- ecraprost treatment arms. CONCLUSION: Intensive treatment with lipo- ecraprost failed to modify the 6-month amputation rate in patients with CLI who were not candidates for revascularization.
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Authors | Eric P Brass, Richard Anthony, John Dormandy, William R Hiatt, Jenny Jiao, Atsushi Nakanishi, Thomas McNamara, Mark Nehler, Circulase investigators |
Journal | Journal of vascular surgery
(J Vasc Surg)
Vol. 43
Issue 4
Pg. 752-9
(Apr 2006)
ISSN: 0741-5214 [Print] United States |
PMID | 16616232
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Drug Carriers
- Lipids
- Alprostadil
- Iloprost
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Alprostadil
(analogs & derivatives)
- Dose-Response Relationship, Drug
- Double-Blind Method
- Drug Administration Schedule
- Drug Carriers
- Female
- Follow-Up Studies
- Humans
- Iloprost
(administration & dosage)
- Infusions, Intravenous
- Intermittent Claudication
(diagnostic imaging, drug therapy)
- Ischemia
(diagnostic imaging, drug therapy)
- Leg
(blood supply)
- Limb Salvage
(methods)
- Lipids
- Male
- Middle Aged
- Pain Measurement
- Peripheral Vascular Diseases
(diagnostic imaging, drug therapy)
- Reference Values
- Risk Assessment
- Treatment Outcome
- Ultrasonography
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