CO 037: MEDICAL PRACTICE CONFIRMS CLINICAL TRIAL RESULTS OF THE USE OF INTRALESIONAL HUMAN RECOMBINANT EPIDERMAL GROWTH FACTOR IN ADVANCED DIABETIC FOOT ULCERS

J Pharm Pharmacogn Res 2(Suppl. 1): S20, 2014

Special supplement with the abstract book of LATINFARMA 2013

Oral Communication

CO 037: MEDICAL PRACTICE CONFIRMS CLINICAL TRIAL RESULTS OF THE USE OF INTRALESIONAL HUMAN RECOMBINANT EPIDERMAL GROWTH FACTOR IN ADVANCED DIABETIC FOOT ULCERS

López-Saura PA1, Yera-Alos IB1, Valenzuela-Silva C1, González-Díaz O1, del Río-Martín A1, Berlanga-Acosta J1, Fernández-Montequín JI2, Acevedo-Castro B1, López-Mola E1, Herrera-Martínez L1.

1Center for Genetic Engineering and Biotechnology, Havana, Cuba. E-mail: lopez.saura@cigb.edu.cu
2National Institute for Angiology and Vascular Surgery, Havana, Cuba.
Abstract

The intralesional injection of recombinant human epidermal growth factor (rhEGF) has been recently approved and introduced in several countries for the treatment of advanced diabetic foot ulcers (DFU), based on the results of five exploratory and one confirmatory, phase III clinical trials in 344 subjects. A significant stimulatory effect of this product on the healing process, given by granulation tissue development and re-epithelization was shown in these trials, as well as a reduction in lesion recurrences during follow-up, and a tendency to a reduction of the risk of amputations, with an acceptable safety profile. However, products not always perform the same way in current medical practice. The present review summarizes the clinical information available from the intralesional use of rhEGF for advanced DFU and shows that in this case the postmarketing experiences in more than 4000 subjects confirm the results of the clinical trials, with 75% probability of complete granulation response, 61% healing, and a 16% absolute and 71% relative reduction of the risk of amputation. The benefit includes ischemic patients. The safety profile in current practice was satisfactory. Serious adverse events are not attributable to the treatment but to the underlying conditions of the patients. No evidence of cancer promotion by the growth factor has been found. The benefitrisk ratio of the procedure is favorable.