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Introduction: Growing evidence suggests that thrombophilia is associated with adverse pregnancy outcomes. As a result, thrombophilia screening is increasingly requested for women with obstetrical complications. Methods: We evaluated the utilization of thrombophilia screening at a large academic tertiary centre requested by obstetricians for women with either early or late pregnancy complications. The indications, appropriateness and results of 199 thrombophilia screenings performed between July 2003 and June 2006 for adverse pregnancy outcomes were retrospectively examined. Results: Of the screenings, 89 were ordered for early miscarriages and 122 for late pregnancy complications (intra-uterine foetal death, intra-uterine growth retardation, abruptio placentae, preeclampsia and/or hellp syndrome). Only 77 patients reported at least three successive early foetal losses. In the whole population, 56 (28.1 %) women were pregnant and 27 (13.6 %) on oral contraception at time of referral. In many patients screening was requested before completion of the routine work-up. Despite these limitations, a thrombophilic abnormality was documented in 26 % women referred for early recurrent miscarriages. In this subgroup, factor V Leiden was the most prevalent thrombophilia (n = 8, 10.4 %). For women with late complications, 18.9 % had a thrombophilic trait. The subgroup referred for third trimester foetal loss showed the highest prevalence of positive screening (41.7 %), mostly Factor V Leiden (n = 5, 20.8 %). Conclusions: In spite of the growing awareness of the negative impact of thrombophilia on pregnancy outcomes, screening is frequently ordered sub-optimally. When indicated, screening should preferably be performed in the absence of confounding clinical variables (pregnancy, oral contraception) for women with appropriate indications and after completion of the routine work-up. The two first authors contributed equally. Introduction : Un nombre croissant d’études laisse suspecter un lien entre diverses anomalies thrombophiliques et plusieurs complications obstétricales. De ce fait, un bilan thrombophilique est fréquemment demandé chez les patientes présentant des complications obstétricales. Méthode : Nous avons évalué l’utilisation du bilan thrombophilique sollicité par les obstétriciens pour les patientes adressées pour des complications obstétricales au sein des Cliniques universitaires Saint-Luc. Les indications et les résultats de 280 bilans thrombophiliques réalisés entre juillet 2003 et juin 2006 parmi les patientes référées à l’Unité d’Hémostase-Thrombose pour complications obstétricales ont été analysés rétrospectivement. Résultats : Parmi les 280 bilans, 122 ont été demandés pour complications obstétricales tardives (mort foetale in utero, retard de croissance intra-utérin, décollement prématuré du placenta, pré-éclampsie et/ou HELLP syndrome). Dans cette population, 43 patientes (35.2 %) étaient enceintes et 24 patientes (19.7 %) étaient sous contraceptif oral au moment du bilan. Pour bon nombre de patientes, le bilan thrombophilique a été demandé avant le bilan complet de routine fait lors de telles complications. Malgré ces limites, une anomalie thrombophilique a été documentée chez 18.9 % à 27.0 % des patientes référées pour complications tardives. Le sous-groupe référé pour mort fœtale du troisième trimestre a montré la plus haute prévalence de bilans positifs (41.7 % à 54.2 %), parmi lesquels la mutation Leiden du facteur V (n = 5 : 20.8 %) et le déficit en protéine S (n = 3 à 5 : 12.5 % - 20.8 %) étaient les plus fréquents. Conclusions : Malgré la prise de conscience grandissante de l’impact négatif des thrombophilies sur le déroulement de la grossesse, les bilans thrombophiliques sont fréquemment réalisés de manière suboptimale. Quand il est indiqué, le bilan devrait préférablement se faire en l’absence de variables cliniques confondantes (grossesse, contraception orale) chez les patientes ayant des indications appropriées et après réalisation du bilan complet de routine justifié par de telles complications.

Thrombophilia --- Pregnancy Complications --- Obstetrics --- Hemostasis

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Background: Phase I clinical trials (PICT) are the first stage a new drug is tested in humans. The effects of investigational medicinal products (IMP) in humans are therefore unknown. Hospital pharmacists have been involved in clinical trials for many years. The management of PICT by hospital pharmacists has not been described yet. Objective: The aim of the study was to analyze the management of PICT in a hospital pharmacy and to compare practices between 4 hospitals and 2 clinical research units (CRU) in France and Belgium in order to identify potential difficulties related to the management of PICT by pharmacists and to elaborate some recommendations. Methods: It was a descriptive observational study. First in a Belgian teaching hospital, we identified and characterized the management of PICT at the pharmacy. Data on PICT prescriptions with preparation were collected. Secondly, in 3 other hospital pharmacies and in 2 pharmacy services CRU we analyzed the management of PICT. A pharmacist of each pharmacy was interviewed. Results: In hospitals the majority of PICT is commercial studies conducted in oncology. At the first hospital we received 84 prescriptions for PICT with a preparation during the collect from 11 protocols. In the 2 clinical research units PICT involve healthy volunteers. In hospital pharmacies no major differences between the management of PICT and phases II and III clinical trials was observed except for the transport from pharmacy to patient. Some difficulties related to commercial bags were explained by interviewed pharmacists. Conclusions: This study highlights for the first time the management of PICT in hospital pharmacies. This is comparable to the management of phase II and III trials. Some difficulties were highlighted regarding preparations of PICT IMP: complexity, timing and non-exact volume with commercial bags. A planning with patients in PICT could be organized for pharmacies. The study could be repeated in other hospitals to confirm these results.

Clinical Trials, Phase I as Topic --- Pharmacy Service, Hospital --- Hospitals, University

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CLUSTER Headache: which place for the CGRP antagonists among the existing treatments? The Cluster Headache is a disease characterized by extremely important headaches associated with various facial symptoms. The more and more accurate understanding of the disease allowed discovering promising targets like the CGRP (or Calcitonin Gene-Related Peptide) receptor and its ligand. In this paper will be mentioned the physiopathology and the supposed mode of action of the two new drugs, as well as the estimated epidemiology in Belgium. Then, a review of the treatments used routinely will establish a hierarchy among them as well as to glimpse the qualities and defects of these therapies. Afterwards, an analysis of the data of the two antibodies ( Galcanezumab and Fremanezumab) antagonists of the CGRP ligand in migraine will give an insight into the possible benefits of this new therapy in the Cluster Headache. This will make it possible to estimate the place of the new drugs among those available and currently in research stage to establish management algorithms by including them among the existing treatments. Afterwards, a discussion will open the door of the thinking on the future of the therapies of this disease as well as various expectations for the near future of the CGRP antagonists. Finally, we will conclude with the reasoning process that led to this work and the final answer developed to answer the question initially asked: antibodies against the CGRO will certainly occupy an important place as soon as they are marketed, but will also have to wait for a period of current practice to analyze their long-term viability. L'algie vasculaire de la face, ou Cluster Headache, est une maladie caractérisée par des céphalées extrêmement importantes associées à divers symptômes faciaux. La compréhension de plus en plus précise de la maladie a permis de découvrir des cibles prometteuses comme le récepteur au CGRP (ou Calcitonin Gene-Related Peptide). Dans ce travail, seront évoqués la physiopathologie et le mode d’action présumé des 2 nouveaux médicaments, ainsi que l’épidémiologie estimée en Belgique. Ensuite, un bilan des traitements utilisés de manière courante permettra de dresser une hiérarchie parmi ceux-ci ainsi que d’entrevoir les qualités et les défauts, de ces thérapies. Par après, une analyse des données des deux anticorps (Le Galcanezumab et le Fremanezumab) antagonistes du ligand du récepteur au CGRP dans la migraine donnera un aperçu des bénéfices possibles de cette nouvelle thérapie dans le cadre du Cluster Headache. Ceci permettra d’estimer la place de ces nouveaux médicaments parmi ceux disponibles et encore au stade de la recherche afin d’établir des algorithmes de prise en charge en les incluant parmi les traitements existants. Par après, une discussion ouvrira la porte de la réflexion quant à l’avenir des thérapies de cette maladie ainsi que diverses attentes quant au futur proche des antagonistes du CGRP. Pour terminer, seront reprises en conclusion la démarche de réflexion ayant mené ce travail ainsi que la réponse finale développée permettant de répondre à la question initialement posée : les anticorps dirigés contre le CGRP occuperont certainement une place importante dès leur commercialisation, mais devront également attendre une période de pratique courante pour analyser leur viabilité à long terme.

Cluster Headache --- Receptors, Calcitonin Gene-Related Peptide

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Chronical kidney disease (CKD) is considered to be an important problem in public health nowadays. Its prevalence is increasing worldwide. CKD can lead to severe complications that require costly therapy. In the first stages, however, the disease is typically progressing without any specific symptoms. Knowledge of the associations between comorbidities can help detect CKD earlier and is therefore of primary importance. Of particular interest is the relationship between kidney function and blood pressure. On the one hand, hypertension is usually seen as both a cause and a consequence of the CKD. On the other hand, some studies have claimed that the decrease blood pressure leads to decrease in kidney function in older patients. In this study, three methods from statistical analysis and data mining are applied to the longitudinal data set from Intego database in order to examine the evolution of kidney function with blood pressure in patients older than 40 years old. The techniques under consideration are namely linear mixed-effects regression modelling, regression trees and a combination of them, RE-EM tree. The advantages and shortcomings of the methods are discussed. The resulting models are compared. It is demonstrated that linear mixed-effects regression model describes the data better than tree based predictors, which indicates a strong linear relationship between eGFR and covariates under consideration. The biggest amount of change in kidney function is concluded to be due to the aging process.