Adverse-event reports from North America have raised concern that the use of drugs for attention deficit-hyperactivity disorder (ADHD) increases the risk of serious cardiovascular events.
We ...conducted a retrospective cohort study with automated data from four health plans (Tennessee Medicaid, Washington State Medicaid, Kaiser Permanente California, and OptumInsight Epidemiology), with 1,200,438 children and young adults between the ages of 2 and 24 years and 2,579,104 person-years of follow-up, including 373,667 person-years of current use of ADHD drugs. We identified serious cardiovascular events (sudden cardiac death, acute myocardial infarction, and stroke) from health-plan data and vital records, with end points validated by medical-record review. We estimated the relative risk of end points among current users, as compared with nonusers, with hazard ratios from Cox regression models.
Cohort members had 81 serious cardiovascular events (3.1 per 100,000 person-years). Current users of ADHD drugs were not at increased risk for serious cardiovascular events (adjusted hazard ratio, 0.75; 95% confidence interval CI, 0.31 to 1.85). Risk was not increased for any of the individual end points, or for current users as compared with former users (adjusted hazard ratio, 0.70; 95% CI, 0.29 to 1.72). Alternative analyses addressing several study assumptions also showed no significant association between the use of an ADHD drug and the risk of a study end point.
This large study showed no evidence that current use of an ADHD drug was associated with an increased risk of serious cardiovascular events, although the upper limit of the 95% confidence interval indicated that a doubling of the risk could not be ruled out. However, the absolute magnitude of such an increased risk would be low. (Funded by the Agency for Healthcare Research and Quality and the Food and Drug Administration.).
Passive surveillance systems are susceptible to the under-reporting of adverse events (AE) and a lack of information pertaining to vaccinated populations. Conventional active surveillance focuses on ...predefined AEs. Advanced data mining tools could be used to identify unusual clusters of potential AEs after vaccination.
To assess the feasibility of a novel tree-based statistical approach to the identification of AE clustering following the implementation of a varicella vaccination program among one-year-olds.
This nationwide safety surveillance was based on data from the Taiwan National Health Insurance database and National Immunization Information System for the period 2004 through 2014. The study population was children aged 12–35 months who received the varicella vaccine.
First-dose varicella vaccine.
All incident ICD-9-CM diagnoses (emergency or inpatient departments) occurring 1–56 days after the varicella vaccination were classified within a hierarchical system of diagnosis categories using Multi-Level Clinical Classifications Software. A self-controlled tree-temporal data mining tool was then used to explore the incidence of AE clustering with a variety of potential risk intervals. The comparison interval consisted of days in the 56-day follow-up period that fell outside the risk interval.
Among 1,194,189 varicella vaccinees with no other same-day vaccinations, nine diagnoses with clustering features were categorized into four safety signals: fever on days 1–6 (attributable risk AR 38.5 per 100,000, p < 0.001), gastritis and duodenitis on days 1–2 (AR 5.9 per 100,000, p < 0.001), acute upper respiratory infection on days 1–5 (AR 11.0 per 100,000, p = 0.006), and varicella infection on days 1–9 (AR 2.7 per 100,000, p < 0.001). These safety profiles and their corresponding risk intervals have been identified in previous safety surveillance studies.
Unexpected clusters of AEs were not detected after the mass administration of childhood varicella vaccines in Taiwan. The tree-temporal statistical method is a feasible approach to the safety surveillance of vaccines in populations of young children.
ABSTRACT
Objective: To estimate risk and relative risk (RR) of acute pancreatitis among patients using incretin-based diabetes therapies (exenatide or sitagliptin) compared to patients treated with ...agents with established safety profiles (metformin or glyburide).
Research design and methods: The study population was derived from a large US commercial health insurance transaction database using an active drug safety surveillance system (i3 Aperio*). This analysis is based on data from June 2005 through June 2008. Cohorts of exenatide and sitagliptin initiators were each matched to an equal number of metformin or glyburide (met/gly) initiators using propensity scores to reduce confounding in the comparison of outcomes during follow-up. Patients with claims suggesting pancreatic disease in the 6 months prior to cohort entry were excluded.
*i3 Drug Safety, Waltham, MA 02451, USA, www.i3aperio.com
Main outcome measure: Claims for hospitalizations associated with a primary diagnosis of acute pancreatitis (ICD-9 577.0).
Results: There were 27 996 exenatide initiators and 16 276 sitagliptin initiators and approximately equal numbers of matched comparators. During follow-up of up to 1 year, acute pancreatitis occurred among 0.13% of patients treated with exenatide and 0.12% of patients treated with sitagliptin. The risk of acute pancreatitis was comparable for initiators of exenatide (RR 1.0; 95% confidence interval (CI) 0.6-1.7) and sitagliptin (RR 1.0; 95% CI 0.5-2.0) relative to the comparison cohorts.
Conclusions: These data do not provide evidence for an association of acute pancreatitis among initiators of exenatide or sitagliptin compared to met/gly initiators. These results are limited by the data available in an administrative, healthcare database.
Crimean-Congo haemorrhagic fever (CCHF) is a potentially fatal tick-borne infection. The virus is widely distributed around the world and reports of sporadic cases and outbreaks have recently ...increased significantly. Some authors have proposed that ribavirin improves survival in CCHF and this view appears to be widely accepted.
We evaluated the efficacy of ribavirin in reducing mortality by conducting a systematic review and meta-analysis. We included randomized controlled trials and observational studies that compared the outcomes of CCHF patients who were treated with ribavirin with those of patients that were not treated. The main endpoint we assessed was survival. We also evaluated secondary endpoints, i.e. adverse events, length of stay in the hospital, time taken for laboratory values to return to normal and requirement for blood products. A pooled estimate of the relative risks for survival from each study was obtained by using random effects models.
One randomized controlled trial and seven observational studies met our inclusion criteria. Most observational studies suffered from different types of bias due to inappropriate selection of controls. Compilation of data from all included studies showed that ribavirin did not improve survival in CCHF (relative risk 1.06, 95% confidence interval 0.97-1.16). Analysis of secondary endpoints did not suggest a clinically significant beneficial effect either.
Our systematic review and meta-analysis revealed that the available data in the literature are inadequate to support a claim of efficacy of ribavirin in CCHF. We believe a real uncertainty exists over the benefit of ribavirin in the treatment of CCHF, which necessitates the urgent conduct of a randomized placebo-controlled trial.
Study Objective. To compare drug adherence rates among patients with gout, hypercholesterolemia, hypertension, hypothyroidism, osteoporosis, seizure disorders, and type 2 diabetes mellitus by using a ...standardized approach.
Design. Longitudinal study
Data Source. Health care claims data from 2001–2004.
Patients. A total of 706,032 adults aged 18 years or older with at least one of the seven medical conditions and with incident use of drug therapy for that condition.
Measurements and Main Results. Drug adherence was measured as the sum of the days' supply of drug therapy over the first year observed. Covariates were age, sex, geographic residence, type of health plan, and a comorbidity score calculated by using the Hierarchical Condition Categories risk adjuster. Bivariate statistics and stratification analyses were used to assess unadjusted means and frequency distributions. Sample sizes ranged from 4984 subjects for seizure disorders to 457,395 for hypertension. During the first year of drug therapy, 72.3% of individuals with hypertension achieved adherence rates of 80% or better compared with 68.4%, 65.4%, 60.8%, 54.6%, 51.2%, or 36.8% for those with hypothyroidism, type 2 diabetes, seizure disorders, hypercholesterolemia, osteoporosis, or gout, respectively. Age younger than 60 years was associated with lower adherence across all diseases except seizure disorders. Comorbidity burden and adherence varied by disease. As comorbidity increased, adherence among subjects with osteoporosis decreased, whereas adherence among those with hypertension, hypercholesterolemia, or gout increased. Add‐on drug therapies and previous experience with taking drugs for the condition increased adherence among subjects with hypertension, type 2 diabetes, hypothyroidism, or seizure disorders but not the other conditions.
Conclusion. This uniform comparison of drug adherence revealed modest variation across six of seven diseases, with the outlier condition being gout.
Purpose
The first paper to specify the core content of pharmacoepidemiology as a profession was published by an ISPE (International Society for Pharmacoepidemiology) workgroup in 2012 (Jones JK et ...al. PDS 2012; 217:677–689). Due to the broader and evolving scope of pharmacoepidemiology, ISPE considers it important to proactively identify, update and expand the list of core competencies to inform curricula of education programs; thus, better positioning pharmacoepidemiologists across academic, government (including regulatory), and industry positions. The aim of this project was to update the list of core competencies in pharmacoepidemiology.
Methods
To ensure applicability of findings to multiple areas, a working group was established consisting of ISPE members with positions in academia, industry, government, and other settings. All competencies outlined by Jones et al. were extracted from the initial manuscript and presented to the working group for review. Expert‐based judgments were collated and used to identify consensus. It was noted that some competencies could contribute to multiple groups and could be directly or indirectly related to a group.
Results
Five core domains were proposed: (1) Epidemiology, (2) Clinical Pharmacology, (3) Regulatory Science, (4) Statistics and data science, and (5) Communication and other professional skills. In total, 55 individual competencies were proposed, of which 25 were new competencies. No competencies from the original work were dropped but aggregation or amendments were made where considered necessary.
Conclusions
While many core competencies in pharmacoepidemiology have remained the same over the past 10 years, there have also been several updates to reflect new and emerging concepts in the field.
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