Incidence Of Severe Outcomes Research Articles

Impact of a drug safety communication on the severity of benzonatate exposures reported to poison centers.

Identify if publication of the 2010 drug safety communication (DSC) regarding benzonatate was associated with a decrease in the incidence of severe benzonatate poisonings reported to United States poison centers. This retrospective database study utilized the National Poison Data System to compare the incidence of severe benzonatate poisonings before and after the publication of a drug safety communication. We utilized interrupted time series analysis to compare 2000-2010 (pre-DSC) to 2012-2019 (post-DSC). There were 18 619 benzonatate exposures reported to US poison centers during the time period covered and 11 554 exposures were included. There was an increase in exposures throughout the time period. There was no difference in the incidence of severe outcomes in the two time periods. In the pre-DSC era, rates of severe outcomes increased by 0.4% per year followed by an immediate non-significant drop of 2.9% in incidence of severe outcomes (P = .15). Finally, the slope of severe outcomes in the post-DSC era showed an increase of 0.3% per year, which was not significantly different from the pre-DSC era (P = .78). Publication of a Drug Safety Communication regarding the risks of benzonatate did not result in a decrease in the proportion of severe benzonatate poisoning reported to US poison centers. Deaths and other severe outcomes continued to occur at a similar rate after the publication.

One year follow-up Assessment of Patients Included in the Brazilian Registry of Acute Coronary Syndromes (ACCEPT).

ResumoFundamento Existe carência de informações prospectivas sobre a evolução em um ano após uma síndrome coronária aguda (SCA) em uma grande amostra de pacientes brasileiros.Objetivos Avaliar a prescrição de terapias baseadas em evidência, a ocorrência de desfechos graves e os preditores para estes desfechos em um registro brasileiro multicêntrico de pacientes com SCA.Métodos O ACCEPT é um estudo observacional prospectivo que incluiu pacientes internados com diagnóstico de SCA em 47 hospitais brasileiros. Os pacientes foram seguidos por 1 ano e coletou-se dados sobre prescrição médica e ocorrência de eventos cardiovasculares maiores (mortalidade cardiovascular, reinfarto e acidente vascular encefálico - AVE). Valores de p < 0,05 foram considerados estatisticamente significantes.Resultados Um total de 5.047 pacientes foram incluídos neste registro, de agosto de 2010 até abril de 2014. Foi confirmado o diagnóstico de SCA em 4.782 pacientes (94,7%) e, dentre os 3 diagnósticos possíveis, o mais comum foi SCA com elevação do segmento ST (35,8%). A taxa de eventos cardiovasculares maiores foi de 13,6 % em 1 ano. A prescrição completa de terapias baseadas em evidência na admissão hospitalar foi de 62,1%. Idade, atendimento público, infarto agudo do miocárdio, AVE, insuficiência renal, diabetes e qualidade da terapia estiveram associados de forma independente à ocorrência de eventos cardiovasculares maiores.Conclusões No seguimento de 1 ano do registro ACCEPT, mais de 10% dos pacientes apresentaram eventos cardiovasculares maiores e esta taxa variou de acordo com a qualidade da terapia. Há necessidade da elaboração de estratégias para melhorar o uso de terapias baseadas em evidência no sentido de minimizar os eventos cardiovasculares na população brasileira. (Arq Bras Cardiol. 2020; 114(6):995-1003)

Effects of antenatal indomethacin on ductus arteriosus early closure and on adverse outcomes in preterm neonates

Introduction: Premature birth is a leading cause of neonatal morbidity and mortality. Since gestational age at birth is the most important predictive factor of adverse neonatal outcomes, strategies to postpone premature labor are of major importance. Studies on tocolytic drugs show that COX inhibitors such as indomethacin are superior to others in terms of efficiency in delaying birth, but results concerning neonatal outcomes associated with prenatal exposure to these drugs show controversial results. Indomethacin is also used in the postnatal age for pharmacologic treatmentof patent ductus arteriosus (PDA), but no data concerning the effects of antenatal exposure on postnatal ductal patency are available.Methods: In this study, we focused primarily on the association between antenatal indomethacin (AI) and postnatal patency of ductus arteriosus while our secondary aim was to highlight any possible influence of AI exposure on adverse neonatal outcomes. We performed a retrospective analysis of 241 medical records of newborns born before 33 weeks' gestation and exposed to antenatal tocolysis. Obstetrical data and neonatal outcomes of newborns exposed to AI were compared to those of neonates exposed to other tocolytic drugs. Early ductal closure (EDC) was defined when functional echocardiography performed within 24 hours of life showed a closed duct. Occurrence of intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), respiratory distress syndrome (RDS), chronic lung disease (CLD), necrotizing enterocolitis (NEC), sepsis, and PDA were compared between the groups and the diagnosis of at least one of III–IV grade IVH, PVL, CLD, sepsis, surgical NEC, or death was defined as a severe outcome.Results: The univariate analysis showed that infants in the AI group were at a higher risk of IVH, CLD, RDS, sepsis, and PDA. The incidence of severe outcomes also appeared to be higher in this group, while no effect of AI on PDA was observed. Since we noticed that infants exposed to AI had a lower gestational age and worse clinical conditions at birth when compared to the controls, we considered this as a confounding factor. To overcome this bias, we performed a multivariate analysis that evidenced no significant role of AI on the occurrence of severe outcomes. On the other hand, a possible association was confirmed for all degrees of IVH (OR: 3.16, 95% CI : [1.41; 7.05]) and sepsis (OR: 2.81, 95% CI: [1.24; 6,28]).Conclusions: The unexpected result shown by the multivariate analysis was the association between AI exposureand EDC (OR: 2.52, 95% CI: [1.02; 6.21]). This result, which has never been evidenced in previous studies, has great clinical importance. It is well known that PDA is more frequent at lower gestational ages, thus reducing the incidence of PDA could lead to an improvement of overall outcomes in extremely preterm newborns.

Prevalence, variability, and outcomes in portal hypertensive colopathy: a study in patients with cirrhosis and paired controls

Management of portal hypertensive colopathy (PHC) has been challenged by controversial results in its prevalence and clinical relevance. To describe the PHC prevalence and to evaluate the variability in diagnosis, the relation to severity of liver disease, and the incidence of severe outcomes. Cross-sectional study. Endoscopic unit of a tertiary-care academic center in Rio de Janeiro, Brazil. Patients with cirrhosis with portal hypertension and controls paired for age and sex. All patients were submitted to standard and image-enhanced colonoscopies, which were recorded in a coded video file and analyzed twice by a blinded endoscopist. The prevalence of PHC. A total of 51 patients with cirrhosis (55% male, mean age 59 years) and 51 healthy controls (43% male, mean age 61 years) were included. The top ranking colonoscopic findings were angiodysplasia-like lesions, nonspecific vascular pattern, red spots, and colorectal varices, all significantly more frequent in patients with cirrhosis compared with controls. PHC prevalence was 71% in patients with cirrhosis. For PHC, interobserver and intraobserver agreement (k values [standard error]) were 0.68 (0.09) and 0.63 (0.10), respectively. Intraobserver agreement for colonoscopic findings was satisfactory. PHC was not related to more severe liver disease or liver stiffness. Only 5 patients developed severe outcomes during follow-up. The exclusion of patients with cirrhosis without esophageal varices and the absence of an interobserver agreement analysis by double-blinded endoscopists. PHC was highly prevalent in patients with cirrhosis, and its diagnostic agreement was satisfactory. PHC is not associated with relevant severe outcomes in a 12-month follow-up.

Daytime versus Night Time Intentional Drug Overdose: The Outcome is Different

Introduction In drug overdose, it is generally perceived that the dosage can predict the clinical outcome. Are the dosages of intentional drug overdosing the same between day and night? If so, are these overdoses followed by similar clinical outcomes? Answers to these two questions might affect resource allocation and clinical judgment. The present study was performed to establish whether daytime patients and night time patients report similar drug doses, and see which group of patients would have a higher incidence of severe outcomes. Method A retrospective observational study on intentional drug overdose was performed. The reported numbers of total tablets ingested and the incidences of major outcomes, in terms of death and intensive care unit admissions, were compared between daytime and night time. Results A total of 400 patients were included. The reported number of ingested tablets in daytime had no statistical difference with that at night time. The numbers of severe outcomes had no differences between the patients presenting to the emergency department at daytime or night time. Yet overdosing at night time was more likely associated with severe outcomes. Conclusions We advise a higher index of suspicion at the emergency department on the reliability of the dosages reported by patients who overdose during night time. The larger number of severe outcomes may also be related to more toxic drug exposures in the night time. More resources in the community could be allocated to self-harm prevention at night time.