Abstract

YERA, Isis B; ALONSO, Liuba; ALVAREZ, Alina  and  DEBESA, Francisco. Postmarketing effectiveness and safety of Heberprot-P for diabetic foot ulcer treatment in Cuba. Biotecnol Apl [online]. 2010, vol.27, n.2, pp.127-128. ISSN 1027-2852.

Postmarketing effectiveness and safety of Heberprot-P for diabetic foot ulcer treatment in Cuba. Heberprot-P is a novel and unique drug developed in Cuba to treat diabetic foot ulcers. Its efficacy has been demonstrated in clinical trials, those data requiring to be enriched with the evidences coming from the common medical practice. For that purpose, an observational, longitudinal and multicentered phase IV trial was carried out in 1851 adult patients, who were treated in 85 health institutions where this product is being applied since June 2007. At the end of treatment, 75.6% (IC 95%, 73.6-77.6) of patients showed their lesions completely granulated. One or more adverse events were present in 47.2% of cases during treatment, predominantly mild. The most frequent adverse events included malaise and disorder at the administration site. The clinical evolution of patients treated with Heberprot-P in Cuba together with its drug safety elements contributed to establish its pharmacoepidemiological profile within the context of the common medical practice. All these corroborate the therapeutic window of opportunity for using Heberprot-P to treat diabetic foot ulcers and the relevance of the postmarketing surveillance for patients, manufacturers, sanitary systems and all the society.

Keywords : Heberprot-P; pharmacovigillance; postmarketing.

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