LAUSR

Objective. Current treatment strategies for painful critical ischemia in patients with end-stage renal disease (ESRD) are suboptimal. A drug that is non-renally excreted has minimal systemic absorption and does not require dose adjustment in renal failure is attractive. The aim of this study was to evaluate the safety and efficacy of Qutenza® (topical capsaicin 8%) for chronic neuropathic pain from critical ischemia in patients with ESRD. Design and Setting. A prospective cohort study was conducted in a single-center, university teaching hospital. Patients. Twenty patients with ESRD were treated with Qutenza® for neuropathic pain from critical limb ischemia. Methods. Patients were followed-up at 1, 6 and 12 weeks post-treatment. The primary end point was the difference in visual analog scale (VAS) between baseline and week 12. Secondary end points were Brief Pain Inventory questionnaire (BPI) scores, quality of life assessment (EQ-5D) and patient global impression of change (PGIC). Safety and tolerability data were also collected. The trial was prospectively registered with clinical trials databases (EudraCT: 2012-001586-32; NCT01704313). Results. There was significant reduction in VAS from baseline to week 12 (-20+/-7%; P = 0.02). There was a significant reduction in all seven domains of the BPI. Quality of life also improved at 12 weeks following treatment in two of the EQ-5D domains (mobility and pain). Qutenza® was well tolerated with no significant side effects in this patient cohort, which included 20% diabetics. Conclusions. In this small, observational study Qutenza® treatment has been shown to be effective and well-tolerated to treat neuropathic pain from critical ischemia in patients with ESRD.