Patients with ARFID were demographically and clinically distinct from those with AN or BN. They were significantly underweight with a longer duration of illness and had a greater likelihood of comorbid medical and/or psychiatric symptoms.
BACKGROUND
Adverse event reports from North America have raised concerns that medications for attention deficit-hyperactivity disorder (ADHD) increase risk of serious cardiovascular events.
METHODS
We conducted a retrospective cohort study with automated data from four health plans (Tennessee Medicaid, Kaiser Permanente California, OptumInsight Epidemiology, Washington State Medicaid), with 1,200,438 children and youth aged 2–24 years and 2,579,104 person-years of follow-up, including 373,667 person-years of current ADHD medication use. We identified serious cardiovascular events (sudden cardiac death, acute myocardial infarction, and stroke) from health plan data and vital records, with endpoints validated by medical record review. We estimated the relative risk for endpoints in current users compared to nonusers with hazard ratios from Cox regression models.
RESULTS
Cohort members had 81 serious cardiovascular events (3.1/100,000 person-years). Current ADHD medication users had no 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 endpoints, or for current users compared to former users (adjusted hazard ratio 0.70; 95% CI 0.29 to 1.72). Alternative analyses addressing several study assumptions also found no significant association between ADHD medication use and the risk of study endpoints.
CONCLUSIONS
Although there was no evidence of increased risk of serious cardiovascular events for current users of ADHD medications, the upper bound of the 95% confidence interval indicates that up to a two-fold increased risk cannot be ruled out. However, the absolute magnitude of such an increased risk would be low.
Background
Cytomegalovirus (CMV) is a leading cause of congenital infection and an important target for vaccine development.
Methods
CMV seronegative girls between 12 and 17 years of age received CMV glycoprotein B (gB) vaccine with MF59 or saline placebo at 0, 1 and 6 months. Blood and urine were collected throughout the study for evidence of CMV infection based on PCR and/or seroconversion to non-vaccine CMV antigens.
Results
402 CMV seronegative subjects were vaccinated (195 vaccine, 207 placebo). The vaccine was generally well tolerated, although local and systemic adverse events were significantly more common in the vaccine group. The vaccine induced gB antibody in all vaccine recipients with a gB geometric mean titer of 13,400 EU; 95%CI 11,436, 15,700, after 3 doses. Overall, 48 CMV infections were detected (21 vaccine, 27 placebo). In the per protocol population (124 vaccine, 125 placebo) vaccine efficacy was 43%; 95% CI: −36; 76, P=0.20. The most significant difference was after 2 doses, administered as per protocol; vaccine efficacy 45%, 95% CI: −9; 72, P=0.08.
Conclusion
The vaccine was safe and immunogenic. Although the efficacy did not reach conventional levels of significance, the results are consistent with a previous study in adult women (Pass et al NEJM 360:1191, 2009) using the same formulation.
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