clinicaltrials.gov Identifier: NCT00816166.

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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.

Videofluoroscopy was used to examine movement patterns during swallowing and speech production in 6 parkinsonian subjects and 6 age-matched controls. Motility patterns for liquid and semisolid swallows were documented. We performed temporospatial analyses of oropharyngeal structures, particularly the velum, which is prominently involved in both motor speech production and swallowing. Differences were found between groups and conditions. All of the parkinsonian subjects exhibited abnormal oropharyngeal movement patterns and timing during the volitional oral as well as the pharyngeal stage of swallowing; only 50% of these subjects admitted to any swallowing difficulty upon questioning. Two of the subjects with Parkinson's disease aspirated liquids. Duration of velar movement during speech production significantly differentiated the groups (p less than 0.01), reflecting reduced range of velar motion. Our findings suggest that rigidity and bradykinesia underlie the volitional speech abnormality as well as the disordered oral and pharyngeal stages of swallowing. Findings indicate that parkinsonian patients may be "silent aspirators" with decreased cough reflexes and lack of awareness of aspiration. The clinical value of videofluoroscopic monitoring of swallowing is that aspiration may be detected and managed early.

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