On-demand treatment of hereditary angioedema attacks: patient-reported utilization, barriers, and outcomes.

Background: Hereditary angioedema (HAE) is clinically characterized by recurrent attacks of cutaneous and submucosal swelling.

Objective: To investigate real-world timing, potential barriers, and impact of delaying on-demand treatment (OD) of HAE attacks METHODS: Patients with HAE (type I or II) aged ≥12 years with ≥1 treated (Treated Cohort) or untreated (Untreated Cohort) attack in the past 3 months were recruited by the US HAE Association. Respondents completed a 20-minute, self-reported, online survey about their last HAE attack.

Risk of interstitial lung disease in patients treated for atrial fibrillation with dronedarone versus other antiarrhythmics.

Purpose: To compare risks of interstitial lung disease (ILD) between patients treated with dronedarone versus other antiarrhythmics.

Methods: Parallel retrospective cohort studies were conducted in the United States Department of Defense Military Health System database (DoD) and the HealthCore Integrated Research Database (HIRD). Study patients were treated for atrial fibrillation (AF) with dronedarone, amiodarone, sotalol, or flecainide.

Patient Knowledge of Safe Use of ER/LA Opioid Analgesics Following Implementation of the Class-Wide REMS: A Survey Study.

Background/rationale: The US Food and Drug Administration (FDA) approved a Risk Evaluation and Mitigation Strategy (REMS) for extended release/long-acting (ER/LA) opioids in 2012. The purpose of this study was to assess patient knowledge of the safe use of these products following implementation of the REMS and to determine possible effects of the REMS, including impact on medication access.

Objective: To assess patient knowledge of safe use of ER/LA opioids and use of REMS patient education tools such as the Medication Guide (MG) and Patient Counseling Document (PCD).

Incidence of Opioid Overdose Among Patients Using ER/LA Opioid Analgesics Before and After Implementation of the Class-Wide Opioid Risk Evaluation and Mitigation Strategy.

Introduction: The United States (US) Food and Drug Administration (FDA) required a Risk Evaluation and Mitigation Strategy (REMS) for extended-release and long-acting (ER/LA) opioid analgesics on 09 July 2012.

Methods: This study compared the incidence of opioid overdose before (July 2010-June 2012) and after (July 2013-September 2016) the initiation of the Risk Evaluation and Mitigation Strategy (REMS) for extended-release and long-acting (ER/LA) opioid analgesics. We identified patients with ≥1 ER/LA opioid dispensing in either time period in national data from the HealthCore Integrated Research Database (HIRD) and in United States (US) Medicaid claims data from four states.

Development of predictive models to identify advanced-stage cancer patients in a US healthcare claims database.

Background: Although healthcare databases are a valuable source for real-world oncology data, cancer stage is often lacking. We developed predictive models using claims data to identify metastatic/advanced-stage patients with ovarian cancer, urothelial carcinoma, gastric adenocarcinoma, Merkel cell carcinoma (MCC), and non-small cell lung cancer (NSCLC).

Methods: Patients with ≥1 diagnosis of a cancer of interest were identified in the HealthCore Integrated Research Database (HIRD), a United States (US) healthcare database (2010-2016).

Development and Validation of an Algorithm for Identifying Patients with Hemophilia A in an Administrative Claims Database.

Background: The accuracy with which hemophilia A can be identified in claims databases is unknown.

Objective: Develop and validate an algorithm using predictive modeling supported by machine learning to identify patients with hemophilia A in an administrative claims database.

Methods: We first created a screening algorithm using medical and pharmacy claims to identify potential hemophilia A patients in the US HealthCore Integrated Research Database between January 1, 2006 and April 30, 2015.

Risk of severe acute liver injury among patients with brain cancer treated with temozolomide: a nested case-control study using the healthcore integrated research database.

Temozolomide (TMZ) is used to treat adult patients with glioblastoma multiforme (GBM). Cases of hepatotoxicity have been reported among patients using TMZ. The objective of the study was to assess the relation, if any, between exposure to TMZ and serious acute liver injury (SALI).

Comparative Effectiveness of Tacrolimus-Based Steroid Sparing versus Steroid Maintenance Regimens in Kidney Transplantation: Results from Discrete Event Simulation.

Background: Corticosteroids used as immunosuppressants to prevent acute rejection (AR) and graft loss (GL) following kidney transplantation are associated with serious cardiovascular and other adverse events. Evidence from short-term randomized controlled trials suggests that many patients on a tacrolimus-based immunosuppressant regimen can withdraw from steroids without increased AR or GL risk.

Objectives: To measure the long-term tradeoff between GL and adverse events for a heterogeneous-risk population and determine the optimal timing of steroid withdrawal.

Impact of Environmental Factors on Differences in Quality of Medication Use: An Insight for the Medicare Star Rating System.

Background: The Medicare star ratings system incentivizes health plan sponsors based on their performance across a measurement system that contains quality measures related to medication use. As health plan sponsors seek to further engage their network providers, specifically network pharmacies, to improve performance on these measures, it is important to consider the effect of environmental factors on the performance of network pharmacies.

Objective: To determine the effect of environmental factors on pharmacy quality as measured by (a) medication adherence for noninsulin diabetes medications, (b) medication adherence for renin angiotensin receptor antagonists (RASA), (c) medication adherence for cholesterol medications (statins), and (d) use of high-risk medications (HRM) in the elderly.

Sulfonylurea use and the risk of hospital readmission in patients with type 2 diabetes.

Background: Hospital inpatient care for patients with diabetes was estimated to cost $76 billion in 2012. Substantial expense resulted from those patients having multiple hospitalizations. The objective was to compare the risk for diabetes-related hospital readmission in patients with type 2 diabetes treated with sulfonylureas (SUs) compared to those treated with other oral antihyperglycemic agents (AHAs).

Comparative persistence on β-blockers versus calcium channel blockers for ventricular rate control in nonelderly patients with atrial fibrillation.

Background: For patients with atrial fibrillation (AF), early treatment is essential to prevent serious complications such as stroke. Several randomized clinical trials have shown that rate-control may be as effective as rhythm-control medications, whereas the latter have serious side effects. Little evidence exists, however, about which class of rate-control medication-β-blockers (BBs) or calcium channel blockers (CCBs)-may be superior.

Trends in the outpatient treatment of atrial fibrillation in the USA from 2001 to 2010.

Purpose: Several clinical trials have shown that rhythm-control drugs have serious adverse events and no survival advantage over rate-control drugs in patients with atrial fibrillation. The objectives were to determine and explain the recent trends in outpatient prescribing of both drug classes.

Methods: Data were obtained over 10 years from the National Ambulatory Medical Care Survey and the National Hospital Ambulatory Medical Care Survey.

Frequencies, costs, and complications of catheter ablation for tachyarrhythmias in children: 2000-2009.

Background: Over the past two decades, catheter ablation (CA) has revolutionized the treatment of tachyarrhythmias in children by providing a relatively safe and effective alternative to open heart surgery or lifelong pharmacotherapy. This study (1) described national trends in pediatric CAs and their associated costs and complications and (2) predicted the likelihood of major complications based on patient and hospital characteristics.

Methods: Inpatient data were obtained from the Kids' Inpatient Database for the years 2000, 2003, 2006, and 2009.

Trends in the utilization of, spending on, and prices for outpatient antifungal agents in US Medicaid programs: 1991-2009.

Background: The incidence of invasive fungal infections (IFIs) has increased substantially in the recent past. Advances in medical technology, including broad-spectrum antibiotics, may increase the risk for fungal infections. Moreover, immunocompromised patients with cancer, HIV/AIDS, and/or transplants are susceptible to IFIs.

Impact of the Food and Drug Administration's antipsychotic black box warning on psychotropic drug prescribing in elderly patients with dementia in outpatient and office-based settings.

Background: Most patients with dementia also suffer from behavioral and psychological symptoms of dementia, for which there is no Food and Drug Administration-approved treatment.

Objectives: To determine whether the Food and Drug Administration's black box warning in April 2005 has led to a decline in prescriptions of atypical antipsychotics for behavioral and psychological symptoms of dementia, as well as whether prescriptions for other psychotropic drugs, including antidepressants, anxiolytics, and antiepileptics, as substitutes, have increased.

Methods: Data on outpatient visits by elderly dementia patients were obtained from two large national surveys from 2003 to 2008.