title: Treprostinil sodium (Remodulin), a prostacyclin analog, in the treatment of critical limb ischemia: open-label study.
abstract: The purpose of this study was to assess the safety of continuous subcutaneous therapy with treprostinil sodium (Remodulin), a prostacyclin analog, and its effect on ischemic rest pain and ischemic wound healing in subjects with critical limb ischemia (CLI) and no planned revascularization procedure. This was a 12-week, open-label, single-center pilot study enrolling 10 subjects (mean age 82.4 years) with Fontaine stage III to IV (Rutherford class 4-6) peripheral arterial disease and ankle brachial indices less than 0.55. The primary end point was safety, and the secondary end points were the effects of treatment on ischemic rest pain, limb salvage, and wound healing. There was a 62% reduction in mean worst rest pain and a 57% reduction in mean average rest pain at week 12, with most subjects using less pain medication. Three subjects experienced complete healing of their wounds. No subject developed a new wound during the trial. Treprostinil was generally well tolerated. Subcutaneous infusion-site pain was the most frequently reported side effect, with one subject withdrawing from the study as a result. Jaw pain was reported by two subjects. One subject experienced two serious adverse events considered unrelated to treprostinil (cholecystitis and congestive heart failure). This study demonstrates that chronic, continuous subcutaneous treprostinil is safe and can be useful in the treatment of ischemic pain and wounds in subjects with CLI. Future controlled studies are needed to evaluate these effects and determine appropriate patient selection.
authors.affiliation: Southern Arizona Vascular Institute, Tucson, AZ, USA. sberman@azvasc.com
authors.forename: Scott
authors.initials: S
authors.lastname: Berman
authors.forename: Rhonda
authors.initials: R
authors.lastname: Quick
authors.forename: Pam
authors.initials: P
authors.lastname: Yoder
authors.forename: Sonia
authors.initials: S
authors.lastname: Voigt
authors.forename: Deborah
authors.initials: D
authors.lastname: Strootman
authors.forename: Michael
authors.initials: M
authors.lastname: Wade
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000959:Antihypertensive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D011464:Epoprostenol / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007263:Infusions, Parenteral; D007511:Ischemia / Q000188:drug therapy*; D007866:Leg / Q000098:blood supply*; D007871:Leg Ulcer / Q000188:drug therapy; D023821:Limb Salvage; D008297:Male; D010147:Pain Measurement / Q000379:methods; D016491:Peripheral Vascular Diseases / Q000188:drug therapy; D010865:Pilot Projects; D016896:Treatment Outcome; D014945:Wound Healing
chemical_list: D000959:Antihypertensive Agents; D011464:Epoprostenol; C427248:treprostinil