alexa Medical Practice Confirms Clinical Trial Results of the Use of Intralesional Human Recombinant Epidermal Growth Factor in Advanced Diabetic Foot Ulcers | Abstract
ISSN: 2167-1052

Advances in Pharmacoepidemiology and Drug Safety
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Research Article

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

Pedro A López-Saura1*, Isis B Yera-Alos2, Carmen Valenzuela-Silva2, Odalys González-Díaz2, Amaurys del Río-Martín2, Jorge Berlanga- Acosta3, José I Fernández-Montequín4, Boris Acevedo-Castro5, Ernesto López-Mola5 and Luis Herrera-Martínez6
1Clinical Research Direction, Center for Genetic Engineering and Biotechnology, Havana (CIGB), Cuba
2Clinical Research Direction, CIGB, Cuba
3BiomedicalResearch Direction, CIGB, Cuba
4National Institute for Angiology and Vascular Surgery, Havana, Cuba
5Business and Projects Development Direction, CIGB, Cuba
6Luis Herrera-Martínez: General Direction, CIGB, Cuba
*Corresponding Author : Pedro A López-Saura
Clinical Research Direction
Center for Genetic Engineering and Biotechnology
P.O. Box 6162, La Habana 10600, Cuba
Tel: +53-7-208721 ext. 145
Fax: +53-7-2736008
E-mail: [email protected], [email protected]
Received February 06, 2013; Accepted March 18, 2013; Published March 20, 2013
Citation: López-Saura PA, Yera-Alos IB, Valenzuela-Silva C, González-Díaz O, Río-Martín Ad, et al. (2013) Medical Practice Confirms Clinical Trial Results of the Use of Intralesional Human Recombinant Epidermal Growth Factor in Advanced Diabetic Foot Ulcers. Adv Pharmacoepidem Drug Safety 2:128. doi:10.4172/2167-1052.1000128
Copyright: © 2013 López-Saura PA, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

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 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.

 

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