Becaplermin

Abstract

Becaplermin is a recombinant human platelet-derived growth factor B-chain homodimer (rh-PDGF-BB) for topical treatment of full-thickness diabetic neuropathic ulcers and pressure ulcers. rh-PDGF-BB promotes wound healing, probably by increasing granulation tissue formation via increased migration and proliferation of cells, with subsequent extracellular matrix deposition. Accelerated healing has been demonstrated in healthy and healing-impaired animals and in patients with lower extremity diabetic neuropathic ulcers and pressure ulcers. Pharmacokinetic studies in humans have shown that systemic absorption of becaplermin after topical administration to ulcers is minimal. A clinical trial in patients with stage III or IV diabetic neuropathic ulcers of the lower extremities which had adequate perfusion showed that becaplermin 100 microg/g applied once daily in conjunction with a standardised programme of good wound care significantly increased the proportion of patients with complete healing of the ulcer and reduced the time to complete healing compared with placebo or good wound care alone. Becaplermin was also superior to placebo in patients with pressure sores. Becaplermin was well tolerated in clinical trials and the rate of discontinuation because of adverse events was similar to that among placebo recipients. Rash, which occurred in 2% of becaplermin and 2% of placebo recipients, may be attributable to the vehicle used.