Clinical-demographic and adverse-event characterization during treatment with Heberprot-P

Abstract

Introduction: Heberprot-P is a novel drug that has come for the reduction of amputation risks; like any drug it is not devoid of adverse events. Objectives: to characterize patients during Heberprot-P treatment according to demographic and clinical variables, as well as to describe adverse events reported during therapy. Methods: a longitudinal study was conducted at the Comprehensive Care Clinic for patients with diabetic foot ulcers at "Policlínico Manuel Piti Fajardo" in Santo Domingo, Villa Clara, between January 2017 and September 2019. The sample was 104 patients who were applied the Heberprot-P. Variables used were: age, sex, Wagner's classification, etiopathogenic classification of the diabetic foot, treatment effectiveness and reported adverse events (frequency, intensity, severity and causality relationship were addressed). Results: females and patients over 60 years old predominated (67.31%). According to Wagner's classification for diabetic foot ulcer, grade 1 prevailed (73.08%), and according to etiopathogenesis, patients with neuroinfective foot prevailed (58.65%). Total effectiveness of treatment was 90.38%. The most frequent adverse events were burning, pain and headache. Adverse events dependent on the mode of administration and the product itself (burning and pain) predominated, mostly of mild intensity and defined causality. Conclusions: the beneficial effect of Heberprot-P in diabetic foot ulcers to achieve granulation was confirmed. Adverse events associated with treatment present similar characteristics to those reported at national and international level.

Keywords

• heberprot-p
• pie diabético
• reacciones adversas