RESUMO
Heparin-induced thrombocytopenia (HIT) is an adverse drug reaction occurring in up to 5% of patients exposed to unfractionated heparin (UFH). We examined the impact of a hospital-wide strategy for avoiding heparin on the incidence of HIT, HIT with thrombosis (HITT), and HIT-related costs. The Avoid-Heparin Initiative, implemented at a tertiary care hospital in Toronto, Ontario, Canada, since 2006, involved replacing UFH with low-molecular-weight heparin (LMWH) for prophylactic and therapeutic indications. Consecutive cases with suspected HIT from 2003 through 2012 were reviewed. Rates of suspected HIT, adjudicated HIT, and HITT, along with HIT-related expenditures were compared in the pre-intervention (2003-2005) and the avoid-heparin (2007-2012) phases. The annual rate of suspected HIT decreased 42%, from 85.5 per 10 000 admissions in the pre-intervention phase to 49.0 per 10 000 admissions in the avoid-heparin phase ( ITALIC! P< .001). The annual rate of patients with a positive HIT assay decreased 63% from 16.5 to 6.1 per 10 000 admissions ( ITALIC! P< .001), adjudicated HIT decreased 79% from 10.7 to 2.2 per 10 000 admissions ( ITALIC! P< .001), and HITT decreased 91% from 4.6 to 0.4 per 10 000 admissions ( ITALIC! P< .001). Hospital HIT-related expenditures decreased by $266 938 per year in the avoid-heparin phase. To the best of our knowledge, this is the first study demonstrating the success and feasibility of a hospital-wide HIT prevention strategy.
Assuntos
Economia Hospitalar/organização & administração , Custos de Cuidados de Saúde , Heparina/efeitos adversos , Gestão da Segurança , Trombocitopenia/induzido quimicamente , Trombocitopenia/economia , Trombocitopenia/prevenção & controle , Feminino , Custos de Cuidados de Saúde/estatística & dados numéricos , Custos de Cuidados de Saúde/tendências , Heparina de Baixo Peso Molecular/uso terapêutico , Hospitalização/estatística & dados numéricos , Hospitais/estatística & dados numéricos , Humanos , Doença Iatrogênica/economia , Doença Iatrogênica/epidemiologia , Incidência , Masculino , Prevenção Primária/métodos , Prevenção Primária/organização & administração , Gestão da Segurança/métodos , Gestão da Segurança/organização & administração , Trombocitopenia/epidemiologiaAssuntos
Falência Renal Crônica/complicações , Prurido/tratamento farmacológico , Diálise Renal/enfermagem , Administração Tópica , Anticonvulsivantes/efeitos adversos , Anticonvulsivantes/uso terapêutico , Antidepressivos/efeitos adversos , Antidepressivos/uso terapêutico , Fármacos Dermatológicos , Emolientes/efeitos adversos , Emolientes/uso terapêutico , Antagonistas dos Receptores Histamínicos/efeitos adversos , Antagonistas dos Receptores Histamínicos/uso terapêutico , Humanos , Falência Renal Crônica/enfermagem , Falência Renal Crônica/terapia , Prurido/diagnóstico , Prurido/etiologia , Prurido/terapiaRESUMO
BACKGROUND: Domperidone, an effective prokinetic agent, is commonly used to manage symptoms of gastroparesis. Health regulatory agencies have issued warnings about an increased risk of sudden cardiac death associated with use of this drug. OBJECTIVE: To evaluate the evidence for domperidone-associated sudden cardiac death and to determine whether this drug can be safely used for gastroparesis in patients undergoing dialysis. DATA SOURCES: Two databases (MEDLINE [1965 to September 2014] and Embase [1980 to September 2014]) were searched using the Medical Subject Headings "domperidone", "sudden cardiac death", and "cardiac arrhythmia". The search was limited to studies conducted in humans and published in English. Advisories from health regulatory agencies (Health Canada, the European Medicines Agency, and the US Food and Drug Administration) were identified and reviewed. STUDY SELECTION: Studies eligible for inclusion in this narrative review were randomized controlled trials and cohort, case-control, cross-sectional, and other epidemiological studies comparing use and non-use of domperidone for the outcome of sudden cardiac death in adults. Abstracts of eligible case reports and case series were also included. DATA SYNTHESIS: Despite inconsistencies in their decisions, the various drug regulatory authorities have acknowledged the potential safety concern of increased risk of sudden cardiac death associated with domperidone. To date, no randomized controlled studies have shown an increased risk of this outcome secondary to domperidone use. Current regulatory recommendations and approval decisions are based on 2 large observational epidemiological studies that generated a signal of increased risk. The strengths and limitations of these studies were evaluated in detail. No direct evidence applicable to patients with end-stage renal disease was found. In vitro evidence suggests that the risk of sudden cardiac death is dose-related. CONCLUSIONS: Given gaps in the literature, use of domperidone for patients undergoing dialysis should be assessed on a case-by-case basis. Extreme caution should be used for patients taking more than 30 mg/day of this drug.
CONTEXTE: La dompéridone, un agent procinétique efficace, est couramment utilisée pour traiter les symptômes de la gastroparésie. Les organismes de réglementation en santé ont émis des mises en garde à propos du risque accru de mort subite d'origine cardiaque associée à l'utilisation de ce médicament. OBJECTIF: Évaluer les données probantes portant sur la mort subite cardiaque associée à la dompéridone et déterminer si ce médicament peut être utilisé en toute sécurité pour traiter les patients sous dialyse atteints de gastroparésie. SOURCES DES DONNÉES: Deux bases de données (MEDLINE [1965 à septembre 2014] et Embase [1980 à septembre 2014]) ont été interrogées en utilisant les mots clés des Medical Subject Headings suivants : « domperidone ¼ (dompéridone), « sudden cardiac death ¼ (mort subite cardiaque) et « cardiac arrhythmia ¼ (arythmie cardiaque). La recherche se limitait aux études effectuées chez l'humain et publiées en anglais. Les avis émis par les organismes de réglementation en santé (Santé Canada, l'Agence européenne des médicaments et la Food and Drug Administration des États-Unis) ont été relevés et examinés. SÉLECTION DES ÉTUDES: Les études admissibles à cette analyse narrative étaient les essais cliniques à répartition aléatoire, les études de cohorte et cas-témoins, les études transversales et autres études épidémiologiques dans lesquelles étaient comparées l'utilisation et la non-utilisation de la dompéridone quant à la mort subite cardiaque chez les adultes. Les résumés des études de cas et des séries de cas admissibles ont aussi été inclus. SYNTHÈSE DES DONNÉES: Malgré des divergences dans leurs décisions, les différents organismes de réglementation des médicaments reconnaissent qu'un risque accru de mort subite cardiaque soit un éventuel problème de sécurité associé à l'utilisation de la dompéridone. À ce jour, aucun essai clinique à répartition aléatoire n'a montré qu'une augmentation du risque de cet effet est secondaire à l'administration de la dompéridone. Les recommandations réglementaires actuelles et les décisions en matière d'approbation sont fondées sur deux importantes études épidémiologiques d'observation qui ont sonné l'alarme à propos d'une augmentation du risque. Les forces et les faiblesses de ces études ont été examinées en détail. Il n'y a pas de preuve directe applicable à la population atteinte d'insuffisance rénale terminale. D'après les données in vitro, le risque de mort subite cardiaque est lié à la dose administrée. CONCLUSIONS: Étant donné les lacunes dans la littérature, il est recommandé que l'utilisation de dompéridone chez les patients sous dialyse soit évaluée au cas par cas. Il faut faire preuve d'énormément de prudence chez les patients qui prennent quotidiennement plus de 30 mg de ce médicament. [Treduction par l'éditeur].