Incidence of Acute Renal Failure in Patients Using Levetiracetam Versus Other Antiseizure Medications: A Voluntary Post-Authorization Safety Study.

INTRODUCTION: Acute kidney injury is an expected adverse drug reaction listed in the European Union (EU) Summary of Product Characteristics (SmPC) for levetiracetam, one of the most widely used modern antiseizure medications (ASMs). OBJECTIVE: We conducted a voluntary post-authorization safety study to characterize the rate of acute renal failure (ARF) in patients exposed to levetiracetam versus other ASMs. METHODS: New users of ASMs without prior renal dysfunction were identified and followed for 30 days in the IBM® MarketScan® database (USA, January 2008-December 2017). ARF was defined as a diagnosis on inpatient or emergency department claims. We estimated adjusted incidence rates, incidence rate ratios (IRRs), and incidence rate differences (IRDs) of ARF in patients initiating levetiracetam versus other ASMs. RESULTS: Overall, 110,336 patients were eligible for the monotherapy cohort and 96,215 were eligible for the polytherapy cohort. The overall crude rate of ARF following a new ASM was 6.0 and 6.5 per 10,000 patients for the 'monotherapy' and 'polytherapy' cohorts, respectively, in the first 30 days after the index date. In the monotherapy cohort, the IRR for ARF was 1.37 (95% confidence interval [CI] 0.80-2.34) and the corresponding IRD was 2.0 (95% CI - 1.12 to 5.12) additional ARFs per 10,000 patient-months. In the polytherapy cohort, the adjusted IRR for ARF was 0.94 (95% CI 0.51-1.74) and the corresponding IRD was - 0.42 cases per 10,000 patient-months (95% CI - 4.01 to 3.17). CONCLUSIONS: The rate of ARFs in ASM new users was very low. In patients without prior ASMs, the estimated difference in risk of ARF associated with initiation of levetiracetam versus initiation of other ASMs was small, with 95% CIs compatible with small protective or harmful effects. In patients receiving polytherapy, the difference was compatible with the null and the 95% CI with small protective or harmful effects.

Changes in screening colonoscopy following Medicare reimbursement and cost-sharing changes.

OBJECTIVES: To compare existing algorithms for classifying screening vs diagnostic colonoscopies and to quantify the increase in screening colonoscopy rates when Medicare began reimbursement in 2001 and when the Affordable Care Act (ACA) eliminated cost-sharing. DATA SOURCES: Twenty percent random sample of fee-for-service (FFS) Medicare claims, 2000-2012. STUDY DESIGN: Using recent administrative codes as tarnished gold standards, we examined the sensitivity and specificity of five published algorithms for classifying colonoscopies and calculated annual screening colonoscopy rates. We estimated the change in rates after Medicare began reimbursement and used difference-in-differences analysis to estimate the effects of eliminating cost-sharing by comparing states with and without a mandate to cover screening colonoscopy prior to the ACA. FINDINGS: Model-based algorithms have higher sensitivity (0.53-0.99) than expert-based algorithms (0.35-0.39), but lower specificity (0.43-0.65 vs 0.79-0.88). All algorithms detected increases in screening from both Medicare's reimbursement change (range: 24-93/10 000) and the 2011 cost-sharing change (range: 1.1-34/10 000). Difference-in-difference estimates of the ACA's effect varied from 51 to 155 tests per 10 000 depending on the algorithm. CONCLUSIONS: Screening colonoscopy rates increased after eliminating cost-sharing in 2011, but the increase's size varied depending on the algorithm used to classify the indication. Improvements are needed in Medicare coding for screening.

[Smoking among a cohort of Spanish university graduates. The SUN Project]. / Consumo de tabaco en titulados universitarios. El Proyecto SUN (Seguimiento Universidad de Navarra).

OBJECTIVE: The objective of this study was to assess the association between employment, educational level, marital status, and smoking in a large cohort of Spanish university graduates (3- and 5-year degrees), with a predominance of health professionals. METHODS: A cross-sectional analysis of the baseline data of the first 7,508 participants in the follow-up study of the University of Navarre (SUN Project) was performed. The subjects were classified according to their smoking status. Independent variables were: employment, marital status, highest educational level attained, number of children, alcohol consumption (g/day), body mass index, and age. In the multivariate analysis, 3 non-conditional logistic regression models were built using the following outcomes: a) smokers vs never-smokers plus ex-smokers; b) smokers vs never-smokers; c) smokers of 15 or more cigarettes a day vs smokers of less than 15 cigarettes a day plus never-smokers and ex-smokers. RESULTS: Among men, no association was found between employment and smoking status in any of the comparisons. In contrast, among women, being a nurse was associated with a higher prevalence of smoking. The prevalence of current smokers among nurses was 48.5%. Female students were also more likely to smoke and had a higher risk of being heavy smokers (OR = 1.81; 95% CI, 1.28-2.57). A lower prevalence of smoking was found among participants of both sexes who had completed a doctorate. CONCLUSIONS: Among a large Spanish collective with higher education, the prevalence of smoking was higher in women with a shorter college degree. The prevalence of smoking among nurses was higher than the average among women graduates, which is a cause for concern.