Efficacy by Ulcer Type and Safety of Lipo-PGE1 for Japanese Patients with Diabetic Foot Ulcers

Abstract

To examine the efficacy and safety of prostaglandin E(1) incorporated into lipid microspheres (lipo-PGE(1)), Palux Injection, in patients with diabetic foot ulcers classified as ischemic, neuropathic, or neuroischemic at 108 medical institutions throughout Japan. A prospective observational study. The safety and efficacy of the drug were analyzed in 388 and 280 patients, respectively.The overall ulcer size reduction rate at the end of administration was 42.5%: 34.0%, 61.8%, and 33.1% in 71 patients with ischemic ulcer, 70 patients with neuropathic ulcer, and 125 patients with neuroischemic ulcers, respectively. Although lipo-PGE(1) was effective for all the ulcer types examined, the ulcer size reduction rate was significantly higher for neuropathic ulcer than for other types of ulcers. The overall change in the ulcer severity score was -6.1. The change rates in ulcer severity scores were -5.5, -8.4, and -5.2 for ischemic, neuropathic, and neuroischemic ulcers, respectively. The overall efficacy rate was 71.5%. The efficacy rate for neuropathic ulcer was 83.6%, which was significantly higher than for ischemic (68.8%) and neuroischemic (65.3%) ulcers. On the other hand, the incidence of adverse drug reactions was 4.1% (16 cases among 388 patients), indicating that the drug was well tolerated. Lipo-PGE(1) can be administered relatively safely for diabetic foot ulcers and is effective for all the ulcer types examined, especially for neuropathic ulcer.