薬物疫学と医薬品の安全性の進歩

概要

Medical Practice Confirms Clinical Trial Results of the Use of Intralesional Human Recombinant Epidermal Growth Factor in Advanced Diabetic Foot Ulcers

Pedro A López-Saura, Isis B Yera-Alos, Carmen Valenzuela-Silva, Odalys González-Díaz, Amaurys del Río-Martín, Jorge Berlanga-Acosta, José I Fernández-Montequín, Boris Acevedo-Castro, Ernesto López-Mola and Luis Herrera-Martínez

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 development of granulation tissue 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 2000 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 neoplasia promotion by the growth factor has been found. The benefit-risk ratio of the procedure is favorable.