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Clinical Research
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Treprostinil sodium for management of wounds refractory to standard therapy secondary to critical limb ischemia: Buerger's disease First Author: Dianne Zwicke Authors: Dianne Zwicke, M.D., Brian Buggy, M.D., Don Lobacz, R.N., Wendy Schmidt, M.D., Karen Harris, R.N., Michael Wade, Ph.D., Deb Strootman, R.N. Buerger's disease (thromboangiitis oliterans or TAO) is a clinical syndrome characterized by the development of segmental thrombotic occlusions of the medium and small arteries. The primary treatment for Buerger's disease is cessation of cigarette smoking; therapeutic options are very limited. Prostacyclin (PGI2) and its analogs have been proposed as a pharmacologic therapy.(1, 2) One published case report suggested that therapy with subcutaneous treprostinil sodium (prostacyclin analog currently approved for patients with pulmonary arterial hypertension) (3,4) could be clinically useful in Buerger's disease, particularly in the presence of critical limb ischemia where other therapeutic options have failed.(5) Methods: Twenty-two adults with CLI who failed standard medical wound care (hyperbaric treatment, surgical intervention, and/or endovascular intervention) were invited to participate in a 12-week open-label study to assess the safety and efficacy (wound healing and pain relief) of continuous subcutaneous infusion of treprostinil. Four patients had refractory wounds or ischemic pain related to Buerger's disease. Results: These 4 subjects reported significant decreases in ischemic pain and marked decrease in narcotic usage while receiving treprostinil. Pain returned when treprostinil was discontinued. Three subjects had complete wound healing and another had partial healing before premature study withdrawal. Side effects included subcutaneous infusion site pain (2 patients), and jaw pain, headache, nausea, and diarrhea (1 patient). Conclusions: Patients with Buerger's disease may benefit from a course of continuous subcutaneous treprostinil. A controlled trial of treprostinil in this patient population is warranted. Aurora St. Luke's Medical Center, University of Wisconsin School of Medicine and Public Health-Milwaukee Clinical Campus, Milwaukee, WI. United Therapeutics Inc., Silver Springs, MD. |
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