Efficacy of prostaglandin E1 in the treatment of lower extremity ischemic ulcers secondary to peripheral vascular occlusive disease

Abstract

Most previous reports suggesting beneficial effects ofprostaglandin E1 (PGEI) have been retrospective and uncontrolled. Therefore, this study was undertaken to assess the efficacy of PGE1 in the treatment ofischemic ulcers in patients with peripheral vascular occlusive disease (PVOD). One hundred twenty patients with one to three ischemic ulcers not healing for 3 weeks with standard care were randomized to receive either PGE1 (20 ng/kg/min) or a placebo for 72 hours through a central venous catheter. Ulcers were measured and photographed, and the rest pain was evaluated before and after infusion and at 1-and 2-month follow-up intervals. Fifty-seven patients with 95 ulcers received PGE1. Seventeen ulcers healed (18%); 22 ulcers decreased in size (23%); 37 ulcers remained unchanged or increased in size (39%); five new ulcers developed during the study (5%); and 14 ulcers had inadequate follow-up (15%). Sixty-three patients with 115 ulcers received a placebo. Nineteen ulcers healed (16%); 38 ulcers decreased in size (33%); 45 ulcers remained unchanged or increased in size (39%); three new ulcers developed during the study (3%); and 10 ulcers had inadequate follow-up (9%). None of the above differences between the drug-treated group and the placebo-treated group was statistically significant. This study did not demonstrate efficacy for intravenously administered PGE~ in the healing of ischemic ulcers in patients with PVOD. (J VASC SURG 1984; 1:160-70.) The treatment of ischemic ulcers and rest pain of the lower extremities continues to be one of the most important problems in the management of peripheral vascular occlusive disease. This is especially true for those patients in whom lower extremity revascularization is not indicated or in whom conventional revascularization with bypass techniques is judged unlikely to be of long-term benefit. Treatment with various vasodilators has been shown to be ineffective and may in fact increase the degree of

ACC/AHA 2005 Guidelines for the Management of Patients With Peripheral Arterial Disease (Lower Extremity, Renal, Mesenteric, and Abdominal Aortic): A Collaborative Report from the American Association for Vascular Surgery/Society for Vascular Surgery,⁎Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients

“…There have been at least 8 short-term trials of parenteral administration of PGE-1 or prostacyclin in patients with CLI. The results have been inconsistent and for the most part have not demonstrated efficacy in terms of amelioration of pain or healing of ulcers (1,(521)(522)(523)(524)(525)(526)(527). In addition, there have been at least 11 randomized, placebo-controlled trials of intravenous PGE-1, or iloprost, administered for 7 to 28 days (1).…”

ACC/AHA 2005 Guidelines for the Management of Patients With Peripheral Arterial Disease (Lower Extremity, Renal, Mesenteric, and Abdominal Aortic): Executive Summary A Collaborative Report From the American Association for Vascular Surgery/Society for Vascular Surgery,⁎⁎AAVS/SVS when Guideline initiated, now merged into SVSSociety for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guideline

“…Therefore, the use of autogenous vein is also strongly favored for bypasses to the popliteal artery below the knee. Femoral tibial bypass grafting with autogenous vein should rarely be necessary for the treatment of intermittent claudication because of the increased risk of amputation associated with failure of In the 8 short-term trials of parenteral administration of PGE-1 or prostacyclin in patients with CLI, the results have been inconsistent and for the most part have not demonstrated efficacy, as defined by amelioration of pain or healing of ulcers (16,(121)(122)(123)(124)(125)(126)(127). In addition, there have been at least 11 randomized, placebo-controlled trials of intravenous PGE-1 or iloprost (16).…”

Stem cell therapy and gene transfer for regeneration

“…15 The transplantation of human EPCs has been shown to facilitate successful salvage of limb vasculature and perfusion in athymic nude mice with severe hindlimb ischemia, while differentiated endothelial cells (human microvascular endothelial cells, HUMEC) failed to accomplish limb-saving neovascularization. 19 The committed stem and progenitor cells isolated from the adult species have several advantages as compared with ES cell in terms of their possible therapeutic application for tissue regeneration. First, committed stem and progenitor cells can be transplanted autologously without immunologic consequences.…”