Racecadotril versus loperamide - Antidiarrheal research revisited

Racecadotril is an enkephalinase inhibitor, presented as a purely antisecretory agent with advantages over the opiate-receptor agonist loperamide in the treatment of diarrhea. A critical review of the literature and the models used was performed. Although pretreatment with high doses of racecadotril reduced cholera toxin-induced secretion and although clinical efficacy was demonstrated in young infants-a population characterized by 10-fold higher plasma enkephalin concentrations compared with adults, the analysis calls into question the peripheral antisecretory selectivity and relative clinical efficacy. Conversely, loperamide can be proposed as an antisecretory agent at therapeutic concentrations. Its efficacy is well established in acute and chronic diarrhea. Current experimental and clinical comparative studies of both drugs have problems with regard to the selection of the doses, the validity of models, and/or the trial design. The conclusion is that more research is needed before reliable conclusions can be drawn on the place of racecadotril in diarrhea treatmen

Automated T Wave End Detection Methods: Comparison of Four Different Methods for T Wave End Detection

Copyright © 2017 by SCITEPRESS – Science and Technology Publications, Lda. All rights reserved T wave end detection is essential for electrocardiogram (ECG) processing and analysis. Several methods have been proposed and tested, but an objective comparison is lacking. In this paper, four different (semi-) automated methods are compared with the manually annotated T wave ends of the PhysioNet QT database. The first method is a semi-automatic method, based on a template matching algorithm. The second method uses the tangent of the steepest point of the descending limb of the T wave. The third and fourth method perform a maximum area search of, respectively, a trapezium and the area under the curve. In order to evaluate the accuracy and repeatability of the proposed algorithms, the mean and standard deviation (sd) of the detection errors were computed. This was performed for leads I and II separately, after selection of the best annotated T wave end per beat and after selection of the best lead. We demonstrated that the trapezium method is the least repeatable of all methods tested (sd=29.7ms), whilst the integral method scores best in terms of accuracy (mean=2.2ms). These findings were strengthened by the analysis of the generated Bland-Altman plots, where the smallest bias was observed for the integral method (-1.89ms).status: publishe

Influence of food intake on the QT and QT/RR relation

BACKGROUND: There are conflicting data on the influence of meal intake on the QT interval. METHODS: Ten healthy subjects were studied before and after a standardized breakfast and lunch with a sequence of supine resting, standing and exercise. Data collection was performed using a 12-lead Holter with semi-automated analysis. QT correction was performed using Fridericia (QTcF) correction formula and a subject-specific method based on individual QT/RR-regression (QTcI). RESULTS: Meal intake induced significant changes in HR (p<0.001), but not in QTcF (p=0.512) or QTcI (p=0.739). Postural analysis showed only significant differences in supine position for HR (p=0.010), not when standing or during exercise. CONCLUSION: Food intake induced an increase in heart rate limited to supine position. Using QTcF and QTcI no QTc changes were found.publisher: Elsevier articletitle: Influence of food intake on the QT and QT/RR relation journaltitle: Journal of Electrocardiology articlelink: http://dx.doi.org/10.1016/j.jelectrocard.2016.06.009 content_type: article copyright: © 2016 Elsevier Inc. All rights reserved.status: publishe

Medical devices that look like medicines: Safety and regulatory concerns for children in Europe

INTRODUCTION: Medical devices (MedDevs) and medicines are assessed (and monitored) differently before and after launch. There are products for repeated oral ingestion that are marketed in the European Union as MedDevs. OBJECTIVES AND METHODS: To illustrate the consequences of these differences in assessment, we compared the leaflet information of three MedDevs with the standards for medicines and with published evidence at launch. As examples, gelatin tannate (GT), its combination with tyndalised probiotics (TP) (GTTP) for diarrhoea and a gel containing hyaluronic acid (HA)/chondroitin sulfate (CS)/poloxamer (Pol407) (HACSPol) for gastro-oesophageal reflux disease were examined. RESULTS: Applying standards for medicines, product composition is insufficiently defined in the MedDev leaflet (eg, plant origin, polymerisation grade, dose and ratio of the relevant constituents). As no age limit is mentioned in the leaflets, all 3 products allow use in children from birth onwards, although published clinical documentation in children was poor (GT) or lacking (GTTP and HACSPol). MedDev leaflets do not mention adverse events (AEs), while literature search suggests safety concerns such as tannic acid (TA) cytotoxicity, potentially more diarrhoea/AEs with TP, use of doses higher than established safe (TA and HA) and lack of chronic toxicity studies for oral Pol407. None refers to interactions with medicines, although some ingredients may affect medicine absorption. CONCLUSION: Although these MedDevs require repeated oral intake as do medicines, their assessment and monitoring differ significantly from the standards for medicines. Compared with medicines, MedDevs for repeated oral use are poorly labelled and rely on very limited clinical information at market release.status: publishe