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1.
J Eat Disord ; 11(1): 212, 2023 Nov 29.
Artigo em Inglês | MEDLINE | ID: mdl-38031186

RESUMO

BACKGROUND: Acute gastric dilatation can develop in patients with anorexia nervosa who are being refed to achieve weight restoration. If unrecognized, this condition is associated with significant morbidity and mortality. Patients with acute gastric dilatation usually have abdominal pain, nausea, and vomiting. Abdominal imaging confirms the diagnosis. This study aims to identify risk factors associated with the development of acute gastric dilatation in patients with severe restrictive eating disorders in order to hasten diagnosis and guide treatment. This study also aims to define the clinical outcomes of patients with acute gastric dilatation. METHODS: In this retrospective case series, 15 patients with a restrictive eating disorder were studied. Multiple variables were assessed for significant correlation with stomach size. RESULTS: 15 patients with a restrictive eating disorder were identified as being diagnosed with acute gastric dilatation through chart review during the study period. The average dilated stomach size was 20.5 cm. There was no significant correlation of stomach size with any of the following: % ideal body weight on day of admission, % ideal body weight on day of imaging study, rate of weight gain (kg per week), or duration of illness. Serum levels of sodium, potassium, phosphorus, magnesium, calcium, bicarbonate, blood urea nitrogen, glucose, albumin, and hematocrit on the day of imaging, did not correlate with stomach size. All patients were treated with conservative management. None of the patients required surgical intervention or progressed to gastric necrosis or perforation, and there were no recurrences of the acute gastric dilatation. CONCLUSIONS: There are no specific risk factors significantly associated with the development of acute gastric dilatation in patients with severe restrictive eating disorders. Clinicians should maintain a high index of suspicion for this condition when patients are experiencing abdominal pain, nausea, or vomiting. When promptly diagnosed and treated, outcomes are good. If diagnosis is delayed, the outcome can be dire.


The mainstay of treatment of patients with severe restrictive eating disorders is initiation of nutrition to gain weight. One potential complication when patients are started on nutrition is the development of a massively enlarged stomach, also called acute gastric dilatation. If a patient's care provider does not recognize the development of acute gastric dilatation, it can lead to serious problems, including death. Patients with this condition usually have abdominal pain, nausea, and vomiting. These are common symptoms in patients with anorexia nervosa and are often dismissed. Identifying risk factors associated with developing acute gastric dilatation could help providers recognize this condition and promptly start treatment. This study sought to identify risk factors associated with developing acute gastric dilatation in patients with severe restrictive eating disorders. Several variables, including patient age, duration of illness, body mass index, %ideal body weight, laboratory values, medications, type of nutrition, and rate of weight gain were analyzed. This study found that there are no specific risk factors significantly associated with development of acute gastric dilatation in patients with severe restrictive eating disorders being initiated on nutrition. Therefore, providers need to listen to their patients, evaluate symptoms, and have a high index of suspicion for underlying acute gastric dilatation.

2.
Int J Eat Disord ; 55(12): 1853-1858, 2022 12.
Artigo em Inglês | MEDLINE | ID: mdl-36285773

RESUMO

OBJECTIVES: To better understand gastric dimensions in patients diagnosed with restrictive eating disorders (EDs). METHOD: In this retrospective study, 56 patients, with restrictive EDs, and 60 gender/age/race-matched patients from an outpatient clinic, were studied. Difference in stomach size, between cohorts, was ascertained, and regression analyses were used to examine associations with stomach size in the ED cohort. RESULTS: Patients with EDs were found to have significantly enlarged gastric dimensions when compared to the control group (M:14.8 cm [SD: 3.2] vs. 11.4 cm [SD: 2.9], p < .0001). Among the ED cohort, blood urea nitrogen (BUN), on the day of imaging, positively correlated with gastric dimensions (r = .43, p = .0009), while hypoalbuminemia negatively correlated with gastric dimensions (r = -.37, p = .005). BUN and albumin nadir were also significantly associated with stomach size (r2  = .26, F[2,53] = 9.46, p = .0003). There was no significant correlation between gastric dimensions and ED diagnosis, percent ideal body weight, gender, duration of illness, engagement in vomiting behaviors, diagnosis of superior mesenteric artery syndrome, or use of promotility agents. DISCUSSION: Findings in this study suggest that malnutrition, secondary to EDs, may be associated with an enlarged stomach. The relationship between the gastric dimensions and reported GI symptoms in this population remain to be determined. PUBLIC SIGNIFICANCE: There are many physiologic changes to the gastrointestinal system that develop with malnutrition but the contribution of these physiologic changes toward the reported GI symptoms and refeeding difficulties is unclear. This is the first study to suggest that patients with malnutrition, secondary to EDs, may be associated with an enlarged stomach, and this potential relationship requires further investigation.


Assuntos
Transtornos da Alimentação e da Ingestão de Alimentos , Dilatação Gástrica , Humanos , Estudos Retrospectivos , Transtornos da Alimentação e da Ingestão de Alimentos/complicações
3.
J Public Health Manag Pract ; 28(5): 562-569, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35867506

RESUMO

BACKGROUND: As research into the health of different segments of the American population continues to advance, data show inequalities in health outcomes depending on a variety of characteristics, including income and education levels, gender identity, race and ethnicity, and disability status. The Healthy People initiative explores how specific population groups perform for 10-year objectives, including the Leading Health Indicators, which are a broad set of metrics that track issues from health behaviors to determinants of one's health. FINDINGS: The data show that, when it comes to health, the playing field for all Americans is not even. At the close of Healthy People 2020, an assessment of the Healthy People 2020 Leading Health Indicators showed that threats to the health of every American vary dependent on who they are, where and how they live, and the community they were born into. DISCUSSION: Healthy People 2030 places an emphasis on continued research into these health indicators to uncover how different these realities are for different population groups and to inform and guide effective health policies and interventions in the years ahead.


Assuntos
Equidade em Saúde , Etnicidade , Feminino , Identidade de Gênero , Nível de Saúde , Disparidades nos Níveis de Saúde , Humanos , Renda , Masculino , Estados Unidos
4.
J Public Health Manag Pract ; 28(5): 570-577, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35867507

RESUMO

INTRODUCTION: Healthy People establishes national goals and specific measurable objectives to improve the health and well-being of the nation. An overarching goal of Healthy People 2030 is to "eliminate health disparities, achieve health equity, and attain health literacy to improve the health and well-being of all." To inform Healthy People 2030 health equity and health disparities content and products, the US Department of Health and Human Services (HHS) Office of Disease Prevention and Health Promotion (ODPHP), in collaboration with NORC at the University of Chicago, conducted a review of peer-reviewed and gray literature to examine how health equity is defined, conceptualized, and measured by public health professionals. METHODS: We reviewed (1) peer-reviewed literature, (2) HHS and other public health organization Web sites, and (3) state and territorial health department plans. We also conducted targeted searches of the gray literature to identify tools and recommendations for measuring health equity. RESULTS: While definitions of health equity identified in the scan varied, they often addressed similar concepts, including "highest level of health for all people," "opportunity for all," and "absence of disparities." Measuring health equity is challenging; however, strategies to measure and track progress toward health equity have emerged. There are a range of tools and resources that have the potential to help decision makers address health equity, such as health impact assessments, community health improvement plans, and adapting a Health in All Policies approach. Tools that visualize health equity data also support data-driven decision making. DISCUSSION: Using similar language when discussing health equity will help align and advance efforts to improve health and well-being for all. Healthy People objectives, measures, and targets can help public health professionals advance health equity in their work. HHS ODPHP continues to develop Healthy People tools and resources to support public health professionals as they work with cross-sector partners to achieve health equity.


Assuntos
Equidade em Saúde , Letramento em Saúde , Atenção à Saúde , Avaliação do Impacto na Saúde , Humanos , Saúde Pública
6.
JNCI Cancer Spectr ; 5(2)2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-33733052

RESUMO

Background: European studies reported an increased risk of nonmelanoma skin cancer associated with hydrochlorothiazide (HCTZ)-containing products. We examined the risks of basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) associated with HCTZ compared with angiotensin-converting enzyme inhibitors (ACEIs) in a US population. Methods: We conducted a retrospective cohort study in the US Food and Drug Administration's Sentinel System. From the date of HCTZ or ACEI dispensing, patients were followed until a SCC or BCC diagnosis requiring excision or topical chemotherapy treatment on or within 30 days after the diagnosis date or a censoring event. Using Cox proportional hazards regression models, we estimated the hazard ratios (HRs), overall and separately by age, sex, and race. We also examined site- and age-adjusted incidence rate ratios (IRRs) by cumulative HCTZ dose within the matched cohort. Results: Among 5.2 million propensity-score matched HCTZ and ACEI users, the incidence rate (per 1000 person-years) of BCC was 2.78 and 2.82, respectively, and 1.66 and 1.60 for SCC. Overall, there was no difference in risk between HCTZ and ACEIs for BCC (HR = 0.99, 95% confidence interval [CI] = 0.97 to 1.00), but there was an increased risk for SCC (HR = 1.04, 95% CI = 1.02 to 1.06). HCTZ use was associated with higher risks of BCC (HR = 1.09, 95% CI = 1.07 to 1.11) and SCC (HR = 1.15, 95% CI = 1.12 to 1.17) among Caucasians. Cumulative HCTZ dose of 50 000 mg or more was associated with an increased risk of SCC in the overall population (IRR = 1.19, 95% CI = 1.05 to 1.35) and among Caucasians (IRR = 1.27, 95% CI = 1.10 to 1.47). Conclusions: Among Caucasians, we identified small increased risks of BCC and SCC with HCTZ compared with ACEI. Appropriate risk mitigation strategies should be taken while using HCTZ.


Assuntos
Anti-Hipertensivos/efeitos adversos , Carcinoma Basocelular/induzido quimicamente , Carcinoma de Células Escamosas/induzido quimicamente , Hidroclorotiazida/efeitos adversos , Fármacos Fotossensibilizantes/efeitos adversos , Neoplasias Cutâneas/induzido quimicamente , Adulto , Fatores Etários , Idoso , Inibidores da Enzima Conversora de Angiotensina/administração & dosagem , Inibidores da Enzima Conversora de Angiotensina/efeitos adversos , Anti-Hipertensivos/administração & dosagem , Carcinoma Basocelular/epidemiologia , Carcinoma Basocelular/etnologia , Carcinoma de Células Escamosas/epidemiologia , Carcinoma de Células Escamosas/etnologia , Relação Dose-Resposta a Droga , Feminino , Humanos , Hidroclorotiazida/administração & dosagem , Incidência , Masculino , Pessoa de Meia-Idade , Fármacos Fotossensibilizantes/administração & dosagem , Pontuação de Propensão , Modelos de Riscos Proporcionais , Grupos Raciais/estatística & dados numéricos , Estudos Retrospectivos , Fatores de Risco , Fatores Sexuais , Neoplasias Cutâneas/epidemiologia , Neoplasias Cutâneas/etnologia , Raios Ultravioleta , Estados Unidos/epidemiologia , Estados Unidos/etnologia , População Branca
7.
J Allergy Clin Immunol Pract ; 9(1): 385-393.e12, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-32795564

RESUMO

BACKGROUND: There have been conflicting results from observational studies regarding the risk of psychiatric adverse events (PAEs) with montelukast use. OBJECTIVE: To determine whether there are associations of depressive disorders, self-harm, and suicide with use of montelukast compared with inhaled corticosteroid (ICS) use. METHODS: Using data from the Sentinel Distributed Database from January 1, 2000, to September 30, 2015, patients (n = 457,377) exposed to montelukast or ICS, aged 6 years and older with a diagnosis of asthma, were matched 1:1 on propensity scores. Hazard ratios (HRs) and 95% CIs were estimated for each study outcome overall and by age, sex, psychiatric history, and pre-/post-2008 labeling updates using Cox proportional hazards regression models. RESULTS: Exposure to montelukast was associated with a lower risk of treated outpatient depressive disorder (HR, 0.91; 95% CI, 0.89-0.93). No increased risks of inpatient depressive disorder (HR, 1.06; 95% CI, 0.90-1.24), self-harm (HR, 0.92; 95% CI, 0.69-1.21), or self-harm using a modified algorithm (HR, 0.81; 95% CI, 0.63-1.05) were observed with montelukast use compared with ICS use. Most PAEs occurred in the roughly one-third of patients having a past psychiatric history. CONCLUSIONS: When compared with use of ICS, we did not find associations between montelukast use and hospitalizations for depression or self-harm events. Our findings should be interpreted considering the study's limitations. Psychiatric comorbidity was common, and most PAEs occurred in patients with a past psychiatric history.


Assuntos
Antiasmáticos , Asma , Quinolinas , Acetatos/efeitos adversos , Antiasmáticos/efeitos adversos , Asma/tratamento farmacológico , Asma/epidemiologia , Criança , Ciclopropanos , Quimioterapia Combinada , Humanos , Quinolinas/efeitos adversos , Sulfetos
8.
Pharmacotherapy ; 40(11): 1099-1107, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-33090530

RESUMO

BACKGROUND: Cutaneous small vessel vasculitis (CSVV) has been reported after exposure to direct oral anticoagulants (DOACs), such as dabigatran, rivaroxaban, apixaban, and edoxaban. OBJECTIVE: We used the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) to describe clinical characteristics associated with CSVV among DOAC-exposed patients. Furthermore, we characterized this signal in the Sentinel System to relate the clinical data from the individual FAERS cases to population-based electronic healthcare data. METHODS: We queried FAERS for all cases of CSVV associated with DOACs from U.S. approval date of each DOAC through March 16, 2018. Within the Sentinel System, we identified incident CSVV cases using ICD-9 and ICD-10 diagnosis codes among adults aged ≥ 30 years who received a DOAC in the prior 90 days between January 1, 2010, and June 30, 2018. We excluded patients with evidence of select autoimmune diagnoses in the 183 days prior to their CSVV diagnoses and reported patient characteristics in the 183-day period prior to CSVV diagnoses. RESULTS: In FAERS, we identified 50 cases of CSVV reported with rivaroxaban (n=26), apixaban (n=14), dabigatran (n=9), and edoxaban (n=1). Approximately 50% of the cases reported time to onset within 10 days after DOAC exposure. When specified, the predominant type of CSVV reported was leukocytoclastic vasculitis (n=31), followed by Henoch-Schonlein purpura (n=4). Hospitalization occurred in most of the cases (n=37). Switching of the offending agent after the development of CSVV was reported (n=26). Three rivaroxaban (n=3) cases and one dabigatran case (n=1) reported positive rechallenge. In the Sentinel system, we identified 3659 CSVV cases with prior DOAC exposure, with 85% of events occurring within 10 days. CONCLUSIONS: The assessment of FAERS cases, combined with the temporal clustering of the Sentinel System cases suggest a possible causal relationship of DOACs and CSVV. Future efforts should characterize the risk of CSVV among the various DOAC users.


Assuntos
Anticoagulantes/efeitos adversos , Vasculite/epidemiologia , Administração Oral , Adolescente , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/administração & dosagem , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estados Unidos/epidemiologia , United States Food and Drug Administration , Vasculite/etiologia , Adulto Jovem
9.
JAMA Netw Open ; 3(8): e2012252, 2020 08 03.
Artigo em Inglês | MEDLINE | ID: mdl-32761160

RESUMO

Importance: Observational studies have suggested that angiotensin receptor blockers are associated with a unique cognitive protection. It is unclear if this is due to reduced blood pressure (BP) or angiotensin receptors type 1 blockade. Objective: To determine neurocognitive effects of candesartan vs lisinopril in older adults with mild cognitive impairment (MCI). Design, Setting, and Participants: This randomized clinical trial included participants aged 55 years or older with MCI and hypertension. Individuals were withdrawn from prior antihypertensive therapy and randomized in a 1 to 1 ratio to candesartan or lisinopril from June 2014 to December 2018. Participants underwent cognitive assessments at baseline and at 6 and 12 months. Brain magnetic resonance images were obtained at baseline and 12 months. This intent-to-treat study was double-blind and powered for a sample size accounting for 20% dropout. Data were analyzed from May to October 2019. Interventions: Escalating doses of oral candesartan (up to 32 mg) or lisinopril (up to 40 mg) once daily. Open-label antihypertensive drug treatments were added as needed to achieve BP less than 140/90 mm Hg. Main Outcomes and Measures: The primary outcome was executive function (measured using the Trail Making Test, Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research tool) and secondary outcomes were episodic memory (measured using the Hopkins Verbal Learning Test-Revised) and microvascular brain injury reflected by magnetic resonance images of white matter lesions. Results: Among 176 randomized participants (mean [SD] age, 66.0 [7.8] years; 101 [57.4%] women; 113 [64.2%] African American), 87 were assigned to candesartan and 89 were assigned to lisinopril. Among these, 141 participants completed the trial, including 77 in the candesartan group and 64 in the lisinopril group. Although the lisinopril vs candesartan groups achieved similar BP (12-month mean [SD] systolic BP: 130 [17] mm Hg vs 134 [20] mm Hg; P = .20; 12-month mean [SD] diastolic BP: 77 [10] mm Hg vs 78 [11] mm Hg; P = .52), candesartan was superior to lisinopril on the primary outcome of executive function measured by Trail Making Test Part B (effect size [ES] = -12.8 [95% CI, -22.5 to -3.1]) but not Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research score (ES = -0.03 [95% CI, -0.08 to 0.03]). Candesartan was also superior to lisinopril on the secondary outcome of Hopkins Verbal Learning Test-Revised delayed recall (ES = 0.4 [95% CI, 0.02 to 0.8]) and retention (ES = 5.1 [95% CI, 0.7 to 9.5]). Conclusions and Relevance: These findings suggest that in older adults with MCI, 1-year treatment with candesartan had superior neurocognitive outcomes compared with lisinopril. These effects are likely independent of the BP-lowering effect of candesartan. Trial Registration: ClinicalTrials.gov Identifier: NCT01984164.


Assuntos
Anti-Hipertensivos/uso terapêutico , Benzimidazóis/uso terapêutico , Disfunção Cognitiva/tratamento farmacológico , Lisinopril/uso terapêutico , Tetrazóis/uso terapêutico , Administração Oral , Idoso , Anti-Hipertensivos/administração & dosagem , Anti-Hipertensivos/farmacologia , Benzimidazóis/administração & dosagem , Benzimidazóis/farmacologia , Compostos de Bifenilo , Pressão Sanguínea/efeitos dos fármacos , Encéfalo/diagnóstico por imagem , Disfunção Cognitiva/diagnóstico por imagem , Feminino , Humanos , Hipertensão/tratamento farmacológico , Lisinopril/administração & dosagem , Lisinopril/farmacologia , Imageamento por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Tetrazóis/administração & dosagem , Tetrazóis/farmacologia
11.
Clin Case Rep ; 8(1): 185-189, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31998513

RESUMO

Superior mesenteric artery syndrome presents with nonspecific GI complaints, hindering weight restoration in those with anorexia nervosa. Diagnosis is made with radiologic testing, and treatment requires only weight restoration, negating the need for surgical intervention.

12.
Pharmacoepidemiol Drug Saf ; 29(7): 786-795, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-31828887

RESUMO

PURPOSE: To describe utilization of filgrastim and infliximab, the first two products with biosimilars approved in the United States. METHODS: We identified use of filgrastim (reference, tbo-filgrastim, and filgrastim-sndz) and infliximab (reference, infliximab-dyyb, and infliximab-abda) in the Sentinel Distributed Database using Healthcare Common Procedure Coding System (HCPCS) codes and National Drug Codes (NDCs) from January 2015 to August 2018. We calculated the proportion of use by code type and assessed uptake over time. We compared baseline patient characteristics and treatment indications. Among patients with >1 exposure episode, we characterized gaps between episodes. RESULTS: Use was identified primarily via HCPCS codes (filgrastim: 86.4%-97.7%; infliximab: 87.8%-100%) although some was identified via NDCs (filgrastim: 2.2%-13.5%; infliximab: <0.1%-6.5%). Filgrastim reference product use declined from 89.4% in January 2015 to 30.3% in June 2018, with corresponding increases in filgrastim-sndz (0% to 49.3%) and tbo-filgrastim (10.6% to 20.4%). Infliximab biosimilar uptake was low (9.7% in June 2018). We identified 94 846 filgrastim reference product, 27 143 tbo-filgrastim, and 38 264 filgrastim-sndz users. For infliximab, we identified 125 412 reference product, 1034 infliximab-dyyb, 49 infliximab-abda, and 4855 undetermined biosimilar users. Patients receiving filgrastim products were largely similar, but differences in age, sex, and indication were observed across infliximab product users. The median exposure episode gap ranged from 1 to 3 days for filgrastim and 48 to 50 days for infliximab. CONCLUSION: Use of biosimilar filgrastim has increased in the United States, but infliximab biosimilar use remains low. Data on identification of biosimilars in claims data and observed gaps between exposure episodes can be used to support drug safety studies of biosimilars.


Assuntos
Medicamentos Biossimilares , Vigilância de Produtos Comercializados , Antirreumáticos/administração & dosagem , Antirreumáticos/uso terapêutico , Filgrastim/administração & dosagem , Filgrastim/uso terapêutico , Fármacos Hematológicos/administração & dosagem , Fármacos Hematológicos/uso terapêutico , Humanos , Infliximab/administração & dosagem , Infliximab/uso terapêutico , Farmacoepidemiologia , Estados Unidos
13.
Diabetes Care ; 43(1): 90-97, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31601640

RESUMO

OBJECTIVE: To estimate real-world off-label use of sodium-glucose cotransporter 2 (SGLT2) inhibitors in patients with type 1 diabetes, estimate rates of diabetic ketoacidosis (DKA), and compare them with DKA rates observed in sotagliflozin clinical trials. RESEARCH DESIGN AND METHODS: We identified initiators of SGLT2 inhibitors in the Sentinel System from March 2013 to June 2018, determined the prevalence of type 1 diabetes using a narrow and a broad definition, and measured rates of DKA using administrative claims data. Standardized incidence ratios (SIRs) were calculated using age- and sex-specific follow-up time in Sentinel and age- and sex-specific DKA rates from sotagliflozin trials 309, 310, and 312. RESULTS: Among 475,527 initiators of SGLT2 inhibitors, 0.50% and 0.92% met narrow and broad criteria for type 1 diabetes, respectively. Rates of DKA in the narrow and broad groups were 7.3/100 person-years and 4.5/100 person-years, respectively. Among patients who met narrow criteria for type 1 diabetes, rates of DKA were highest for patients aged 25-44 years, especially females aged 25-44 years (19.7/100 person-years). More DKA events were observed during off-label use of SGLT2 inhibitors in Sentinel than would be expected based on sotagliflozin clinical trials (SIR = 1.83; 95% CI 1.45-2.28). CONCLUSIONS: Real-world off-label use of SGLT2 inhibitors among patients with type 1 diabetes accounted for a small proportion of overall SGLT2 inhibitor use. However, the risk for DKA during off-label use was notable, especially among young, female patients. Although real-word rates of DKA exceeded the expectation based on clinical trials, results should be interpreted with caution due to differences in study methods, patient samples, and study drugs.


Assuntos
Diabetes Mellitus Tipo 1/tratamento farmacológico , Diabetes Mellitus Tipo 1/epidemiologia , Cetoacidose Diabética/epidemiologia , Hipoglicemiantes/uso terapêutico , Inibidores do Transportador 2 de Sódio-Glicose/uso terapêutico , Adulto , Algoritmos , Diabetes Mellitus Tipo 1/complicações , Cetoacidose Diabética/induzido quimicamente , Feminino , Glicosídeos/uso terapêutico , Humanos , Incidência , Masculino , Prevalência , Estados Unidos/epidemiologia
14.
Pharmacoepidemiol Drug Saf ; 28(10): 1405-1410, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31483085

RESUMO

PURPOSE: In July 2015, the US Food and Drug Administration (FDA) published a drug safety communication regarding errors in prescribing and dispensing of the antidepressant Brintellix (vortioxetine) and the antiplatelet Brilinta (ticagrelor) that arose due to proprietary drug name confusion. Brintellix is indicated for major depressive disorder; Brilinta is indicated to reduce cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome or history of myocardial infarction. Brintellix was renamed to Trintellix in May 2016. Using Brilinta and Brintellix as a proof-of-concept feasibility use case, we assessed whether drug name confusion errors between the pair could be identified in electronic health care data via the combination of a claims-based algorithm and limited manual claims data review. METHODS: Using data from the Sentinel System, we defined potential errors as Brintellix users without an on- or off-label indication for Brintellix, without a dispensing for a drug with the same indications as Brintellix, and with an on- or off-label indication for Brilinta between -365 and +30 days after index Brintellix dispensing; the reverse was done for Brilinta. We manually reviewed claims profiles of potential cases. RESULTS: We identified 27 (0.1%) potential errors among 21 208 Brintellix users; 16 appeared to be likely errors based on claims profile review. Fifty-one (0.3%) of the 16 779 Brilinta users were identified as potential errors, and four appeared to be likely errors. CONCLUSIONS: A claims-based algorithm combined with manual review of claims profiles could identify potential drug name confusion errors, and narrow down likely errors that warrant further investigation.


Assuntos
Antidepressivos/efeitos adversos , Rotulagem de Medicamentos/normas , Erros de Medicação/estatística & dados numéricos , Inibidores da Agregação Plaquetária/efeitos adversos , Vigilância de Produtos Comercializados/métodos , Síndrome Coronariana Aguda/tratamento farmacológico , Demandas Administrativas em Assistência à Saúde/estatística & dados numéricos , Algoritmos , Transtorno Depressivo Maior/tratamento farmacológico , Prescrições de Medicamentos/estatística & dados numéricos , Registros Eletrônicos de Saúde/estatística & dados numéricos , Estudos de Viabilidade , Humanos , Erros de Medicação/prevenção & controle , Uso Off-Label/estatística & dados numéricos , Vigilância de Produtos Comercializados/estatística & dados numéricos , Estudo de Prova de Conceito , Ticagrelor/efeitos adversos , Estados Unidos , United States Food and Drug Administration/normas , Vortioxetina/efeitos adversos
15.
Abdom Radiol (NY) ; 44(9): 3188-3194, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31127323

RESUMO

PURPOSE: To provide a review of the etiology, clinical presentation, and imaging findings of superior mesenteric artery (SMA) syndrome. METHODS: A literature review of 24 relevant articles regarding SMA syndrome was performed. RESULTS: Clinicians and radiologists with a high index of suspicion based on symptomatology may pursue radiologic investigation in the form of upper gastrointestinal (GI) series and contrast-enhanced abdominal computed tomography (CT). Magnetic resonance imaging (MRI) and ultrasound (US) are less commonly utilized modalities in the work-up of SMA syndrome, but provide imaging alternatives without the use of ionizing radiation. Imaging can assist in diagnosis by demonstrating characteristic findings of reduced aortomesenteric angle, reduced aortomesenteric distance, gastroduodenal distention, bowel caliber narrowing at the takeoff of the superior mesenteric artery from the aorta, as well as delayed gastric emptying or positional obstruction observed with real time with fluoroscopy. CONCLUSION: SMA syndrome is a rare disease that can go unrecognized and undiagnosed, exacerbating weight loss in an already significantly malnourished patient population. The diagnosis of SMA syndrome must be based on clinical symptomatology correlated with radiographic information. Once diagnosed, SMA syndrome can be safely treated by conservative measures although occasionally requires invasive intervention in the form of enteral tube placement, percutaneous jejunostomy tube placement, total parenteral nutrition, ligament of Treitz lysis, or duodenojejunostomy.


Assuntos
Meios de Contraste , Imageamento por Ressonância Magnética/métodos , Intensificação de Imagem Radiográfica/métodos , Síndrome da Artéria Mesentérica Superior/diagnóstico por imagem , Tomografia Computadorizada por Raios X/métodos , Ultrassonografia/métodos , Humanos , Artéria Mesentérica Superior/diagnóstico por imagem
16.
Am J Prev Med ; 56(3): 458-463, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30777163

RESUMO

INTRODUCTION: National guidelines recommend test-of-cure for pregnant women and test-of-reinfection for all patients with chlamydia infections in order to interrupt transmission and prevent adverse sequelae for patients, partners, and newborns. Little is known about retesting and positivity rates, and whether they are changing over time, particularly in private sector practices. METHODS: Electronic health record data on patients with chlamydia tests were extracted from three independent clinical practice groups serving ≅20% of the Massachusetts population. Records were extracted using the Electronic medical record Support for Public Health platform (esphealth.org). These data were analyzed for temporal trends in annual repeat testing rates by using generalized estimating equations after index positive chlamydia tests between 2010 and 2015 and for differences in intervals to first repeat tests among pregnant females, non-pregnant females, and males. Data extraction and analysis were performed during calendar years 2017 and 2018. RESULTS: An index positive C. trachomatis result was identified for 972 pregnant female cases, 10,309 non-pregnant female cases, and 4,973 male cases. Test-of-cure 3-5 weeks after an index positive test occurred in 37% of pregnant females. Test-of-reinfection 8-16 weeks after an index positive test occurred in 39% of pregnant females, 18% of non-pregnant females, and 9% of males. There were no significant increases in test-of-cure or test-of-reinfection rates from 2010 to 2015. Among cases with repeat tests, 16% of pregnant females, 15% of non-pregnant females, and 16% of males had positive results. CONCLUSIONS: Chlamydia test-of-cure and test-of-reinfection rates are low, with no evidence of improvement over time. There are substantial opportunities to improve adherence to chlamydia repeat testing recommendations.


Assuntos
Infecções por Chlamydia/diagnóstico , Infecções por Chlamydia/epidemiologia , Programas de Rastreamento/métodos , Programas de Rastreamento/estatística & dados numéricos , Cooperação do Paciente/estatística & dados numéricos , Registros Eletrônicos de Saúde , Feminino , Humanos , Masculino , Massachusetts/epidemiologia , Aceitação pelo Paciente de Cuidados de Saúde , Gravidez , Parceiros Sexuais , Fatores de Tempo
17.
JAMA Pediatr ; 173(2): 134-139, 2019 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-30500056

RESUMO

Importance: Acute flaccid myelitis (AFM) is an emerging poliolike illness of children whose clinical spectrum and associated pathogens are only partially described. The case definition is intentionally encompassing for epidemiologic surveillance to capture all potential AFM cases. Defining a restrictive, homogenous subpopulation may aid our understanding of this emerging disease. Objective: To evaluate the extent to which the US Centers for Disease Control and Prevention (CDC) case definition of AFM incorporates possible alternative diagnoses and to assess the plausibility of a case definition that enriches the biological homogeneity of AFM for inclusion in research studies. Design, Setting, and Participants: Retrospective case analysis of children younger than 18 years diagnosed as having AFM between 2012 and 2016 using the CDC case definition. Group 1 included patients recruited from the United States and Canada based on the CDC case definition of AFM. Group 2 included patients referred to the Johns Hopkins Transverse Myelitis Center for evaluation of suspected AFM. Patients' records and imaging data were critically reviewed by 3 neurologists to identify those cases with definable alternative diagnoses, and the remaining patients were categorized as having restrictively defined AFM (rAFM). Clinical characteristics were compared between patients with rAFM (cases) and those with alternative diagnoses, and a case description distinguishing these AFM groups was identified. Interrater reliability of this description was confirmed for a subset of cases by a fourth neurologist. Data were analyzed between May 2017 and November 2018. Main Outcomes and Measures: Proportion of patients with possible alternative diagnosis. Results: Of the 45 patients who met the CDC AFM case definition and were included, the mean age was 6.1 years; 27 were boys (60%); and 37 were white (82%), 3 were Asian (7%), 1 was Hispanic (2%), and 4 were mixed race/ethnicity (9%). Of the included patients, 34 were classified as having rAFM, and 11 had alternate diagnoses (including transverse myelitis, other demyelinating syndromes, spinal cord stroke, Guillain-Barre syndrome, Chiari I myelopathy, and meningitis). Factors differing between groups were primarily asymmetry of weakness, lower motor neuron signs, preceding viral syndrome, symptoms evolving over hours to days, absence of sensory deficits, and magnetic resonance imaging findings. A case description was able to reliably define the rAFM group. Conclusions and Relevance: We present an approach for defining a homogeneous research population that may more accurately reflect the pathogenesis of the prototypical poliomyelitis-like subgroup of AFM. The definition of rAFM forms a blueprint for inclusion criteria in future research efforts, but more work is required for refinement and external validation.


Assuntos
Viroses do Sistema Nervoso Central/diagnóstico , Mielite/diagnóstico , Doenças Neuromusculares/diagnóstico , Doença Aguda , Adolescente , Canadá/epidemiologia , Centers for Disease Control and Prevention, U.S. , Viroses do Sistema Nervoso Central/epidemiologia , Criança , Pré-Escolar , Diagnóstico Diferencial , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Mielite/epidemiologia , Doenças Neuromusculares/epidemiologia , Reprodutibilidade dos Testes , Estudos Retrospectivos , Estados Unidos/epidemiologia
18.
J Opioid Manag ; 13(5): 315-327, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-29199397

RESUMO

OBJECTIVE: A risk evaluation and mitigation strategy for extended-release and long-acting (ER/LA) opioid analgesics was approved by the Food and Drug Administration in 2012. Our objective was to assess frequency of opioid tolerance and urine drug testing for individuals initiating ER/LA opioid analgesics. DESIGN: Retrospective cohort study. SETTING: Sentinel, a distributed database with electronic healthcare data on >190 million predominantly commercially insured members. PATIENTS, PARTICIPANTS: Members under age 65 initiating ER/LA opioid analgesics between January 2009 and December 2013. MAIN OUTCOME MEASURE(S): We examined the proportion of opioid-tolerant-only ER/LA opioid analgesic initiates meeting tolerance criteria: receipt of ≥30 mg oxycodone equivalents per day in 7 days prior to the first opioid-tolerant-only dispensing. We separately examined the proportion of new users of extended-release oxycodone (ERO) and other ER/LA opioid analgesics with a claim for a urine drug test in the 30 days prior to, and separately for the 183 days after, dispensing. RESULTS: We identified 79,824 ERO, 7,343 extended-release hydromorphone, and 91,778 transdermal fentanyl opi-oid-tolerant-only episodes. Tolerance criteria were met in 64 percent of ERO, 64 percent of extended-release hydromorphone and 40 percent of transdermal fentanyl episodes. We identified 210,581 incident ERO and 311,660 other ER/LA opioid analgesic episodes. Use of urine drug testing for ERO compared with other ER/LA opioid analgesics was: 4 percent vs 14 percent respectively in the 30 days prior to initiation and 9 percent vs 23 percent respectively in the 183 days following initiation. CONCLUSIONS: These results suggest potential areas for improving appropriate ER/LA opioid analgesic prescribing practices.


Assuntos
Analgésicos Opioides/urina , Dor Crônica/tratamento farmacológico , Monitoramento de Medicamentos/métodos , Tolerância a Medicamentos , Programas de Monitoramento de Prescrição de Medicamentos , United States Food and Drug Administration , Adolescente , Adulto , Analgésicos Opioides/administração & dosagem , Analgésicos Opioides/efeitos adversos , Criança , Pré-Escolar , Dor Crônica/diagnóstico , Dor Crônica/urina , Bases de Dados Factuais , Preparações de Ação Retardada , Prescrições de Medicamentos , Registros Eletrônicos de Saúde , Feminino , Humanos , Prescrição Inadequada , Lactente , Recém-Nascido , Masculino , Pessoa de Meia-Idade , Padrões de Prática Médica , Valor Preditivo dos Testes , Estudos Retrospectivos , Vigilância de Evento Sentinela , Estados Unidos , Urinálise , Adulto Jovem
20.
Int J Eat Disord ; 48(5): 532-4, 2015 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-25639251

RESUMO

Forty-seven year old female, with a history of anorexia nervosa, was admitted to a medical stabilization unit (ACUTE) complaining of abdominal pain exacerbated by oral intake, associated with nausea, and relieved by emesis. Admission body mass index was 10.6. Labs were notable for hepatitis and hypoglycemia. On her progressive oral refeeding plan, she suddenly developed severe abdominal pain. Computed tomography (CT) revealed gastric dilatation and superior mesenteric artery (SMA) syndrome. SMA syndrome is a rare complication of severe malnutrition resulting from compression of the duodenum between the aorta and the SMA. It is diagnosed by an upper gastrointestinal series or an abdominal CT. Gastric dilatation, in turn, is a rare complication of SMA syndrome to be included in the differential diagnoses of abdominal pain in severely malnourished patients as it is potentially life-threatening. The patient was switched to an oral liquid diet, began weight restoring, and had resolution of symptoms.


Assuntos
Anorexia Nervosa/complicações , Dilatação Gástrica/etiologia , Síndrome da Artéria Mesentérica Superior/complicações , Feminino , Humanos , Pessoa de Meia-Idade
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