12.1 Treprostinil sodium for management of wounds refractory to standard therapy secondary to critical limb ischemia
Dianne Zwicke, MD; Brian Buggy, MD; Don Lobacz, RN; Wendy Schmidt, MD; Karen Harris, RN; Michael Wade, PhD; Deb Strootman, RN, Aurora St. Luke's Medical Center, University of Wisconsin School of Medicine and Public Health-Milwaukee Clinical Campus, Milwaukee, Wis. United Therapeutics Inc., Silver Springs, Md
Background: Refractory critical limb ischemia (CLI) can lead to amputation regardless of underlying etiology. Prostacyclin (PGI2) and its analogs have been proposed as a pharmacologic therapy, due to their vasodilatory effects. The prostacyclin analog treprostinil sodium has demonstrated blood flow improvement in severe vascular disease.
Methods: Adults with CLI, who have failed previous therapies (medical wound care, hyperbaric treatment, surgical intervention, endovascular intervention), were invited to participate in a 12-week, open-label study assessing the safety and efficacy of continuous subcutaneous infusion of treprostinil sodium in wound healing, relief of ischemic pain, and limb salvage.
Results: Twenty-two patients (9 males/13 females) were evaluated. Vascular disease etiologies included connective tissue disease (9), Buerger's disease (4), PAD (4) and Raynaud's (3). Four subjects demonstrated complete wound closure. Marked improvement by objective and subjective measures occurred in 12 subjects (2 with osteomyelitis). At the completion of week 12, 1 patient with extensive gangrenous ulceration required modified amputation. The average visual pain score decreased from 4.6 (2Ð8) at Baseline to 0.8 (0Ð6) at Week 12. Eleven patients reported pain resolution by Week 4. The mean peak treprostinil dose was 20 ng/kg/min (6Ð60). No serious adverse events were reported. Side effects included infusion site pain, jaw pain, headache, nausea, and diarrhea. Four subjects withdrew: infusion site pain (3), personal reasons (1).
Conclusions: Treprostinil sodium was safe and appears to contribute to wound healing, ischemic pain relief and limb salvage in patients with CLI.
*Remodulin is a registered trademark of United Therapeutics Inc., Silver Springs, Md
