CLINICAL SAFETY OF BECAPLERMIN (RHPDGF-BB) GEL

This overview of the safety of becaplermin gel is based on six well-co ntrolled clinical studies that included patients with lower extremity diabetic neuropathic ulcers. Patients receiving becaplermin gel (n = 5 38), placebo gel (n = 278), or good ulcer care alone (n = 190) had a s imilar incidence of ulcer-related adverse events, such as infection, c ellulitis, or osteomyelitis. Erythematous rash occurred in 2% of patie nts with suspected wound infections treated with becaplermin gel and 1 % of patients treated with placebo gel. No rashes were observed in pat ients treated with good ulcer care alone. The incidence of cardiovascu lar, respiratory, musculoskeletal, and central and peripheral nervous system disorders were similar across all treatment groups. Mortality r ates were also similar across all treatment groups. Patients treated w ith becaplermin gel did not develop neutralizing antibodies against be caplermin. Therefore, becaplermin gel appears to be a safe therapy for the treatment of lower extremity diabetic ulcers. Am J Surg. 1998;176 (Suppl 2A):68S-73S. (C) 1998 by Excerpta Medica, Inc.