Dataset Information

ADHD drugs and serious cardiovascular events in children and young adults.

ABSTRACT: 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.).

SUBMITTER: Cooper WO

PROVIDER: S-EPMC4943074 | biostudies-literature | 2011 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

ADHD drugs and serious cardiovascular events in children and young adults.

Cooper William O WO Habel Laurel A LA Sox Colin M CM Chan K Arnold KA Arbogast Patrick G PG Cheetham T Craig TC Murray Katherine T KT Quinn Virginia P VP Stein C Michael CM Callahan S Todd ST Fireman Bruce H BH Fish Frank A FA Kirshner Howard S HS O'Duffy Anne A Connell Frederick A FA Ray Wayne A WA

The New England journal of medicine 20111101 20

<h4>Background</h4>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.<h4>Methods</h4>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 2,5 ...[more]

PMID: 22043968

Similar Datasets

Project description:More than 1.5 million US adults use stimulants and other medications labeled for treatment of attention-deficit/hyperactivity disorder (ADHD). These agents can increase heart rate and blood pressure, raising concerns about their cardiovascular safety.To examine whether current use of medications prescribed primarily to treat ADHD is associated with increased risk of serious cardiovascular events in young and middle-aged adults.Retrospective, population-based cohort study using electronic health care records from 4 study sites (OptumInsight Epidemiology, Tennessee Medicaid, Kaiser Permanente California, and the HMO Research Network), starting in 1986 at 1 site and ending in 2005 at all sites, with additional covariate assessment using 2007 survey data. Participants were adults aged 25 through 64 years with dispensed prescriptions for methylphenidate, amphetamine, or atomoxetine at baseline. Each medication user (n = 150,359) was matched to 2 nonusers on study site, birth year, sex, and calendar year (443,198 total users and nonusers).Serious cardiovascular events, including myocardial infarction (MI), sudden cardiac death (SCD), or stroke, with comparison between current or new users and remote users to account for potential healthy-user bias.During 806,182 person-years of follow-up (median, 1.3 years per person), 1357 cases of MI, 296 cases of SCD, and 575 cases of stroke occurred. There were 107,322 person-years of current use (median, 0.33 years), with a crude incidence per 1000 person-years of 1.34 (95% CI, 1.14-1.57) for MI, 0.30 (95% CI, 0.20-0.42) for SCD, and 0.56 (95% CI, 0.43-0.72) for stroke. The multivariable-adjusted rate ratio (RR) of serious cardiovascular events for current use vs nonuse of ADHD medications was 0.83 (95% CI, 0.72-0.96). Among new users of ADHD medications, the adjusted RR was 0.77 (95% CI, 0.63-0.94). The adjusted RR for current use vs remote use was 1.03 (95% CI, 0.86-1.24); for new use vs remote use, the adjusted RR was 1.02 (95% CI, 0.82-1.28); the upper limit of 1.28 corresponds to an additional 0.19 events per 1000 person-years at ages 25-44 years and 0.77 events per 1000 person-years at ages 45-64 years.Among young and middle-aged adults, current or new use of ADHD medications, compared with nonuse or remote use, was not associated with an increased risk of serious cardiovascular events. Apparent protective associations likely represent healthy-user bias.

Project description:INTRODUCTION:Children with attention-deficit/hyperactivity disorder (ADHD) are at increased risk for smoking cigarettes, but there is little longitudinal research on the array of smoking characteristics known to be prognostic of long-term smoking outcomes into adulthood. These variables were studied into early adulthood in a multisite sample diagnosed with ADHD combined type at ages 7-9.9 and followed prospectively alongside an age- and sex-matched local normative comparison group (LNCG). METHODS:Cigarette smoking quantity, quit attempts, dependence, and other characteristics were assessed in the longitudinal Multimodal Treatment Study of Children with ADHD (MTA) eight times to a mean age of 24.9 years: ADHD n = 469; LNCG n = 240. RESULTS:In adulthood, the ADHD group had higher rates of daily cigarette smoking, one or more quit attempts, shorter time to first cigarette of the day, and more severe withdrawal than the LNCG. The ADHD group did not appear to have better smoking cessation rates despite a higher proportion quitting at least once. Smoking quantity and nicotine dependence did not differ between groups. The ADHD group reported younger daily smoking onset and faster progression from smoking initiation to daily smoking across assessments. Finally, ADHD symptom severity in later adolescence and adulthood was associated with higher risk for daily smoking across assessments in the ADHD sample. CONCLUSIONS:This study shows that ADHD-related smoking risk begins at a young age, progresses rapidly, and becomes resistant to cessation attempts by adulthood. Prevention efforts should acknowledge the speed of uptake; treatments should target the higher relapse risk in this vulnerable population. IMPLICATIONS:Although childhood ADHD predicts later smoking, longitudinal studies of this population have yet to fully characterize smoking behaviors into adulthood that are known to be prognostic of long-term smoking outcome. The current study demonstrates earlier and faster progression to daily smoking among those with a childhood ADHD diagnosis, as well as greater risk for failed quit attempts. Prevention efforts should address speed of smoking uptake, while treatments are needed that address smoking relapse risk. The current study also demonstrates ADHD symptom severity over development increases daily smoking risk, implicating the need for continuous ADHD symptom management.

Project description:ImportanceRituximab is among the most frequently used immunotherapies in pediatrics. Few studies have reported long-term adverse events associated with its use for children.ObjectiveTo describe the use of rituximab and to assess whether its use is associated with short- or long-term adverse events, infections, or time to immune reconstitution in a diverse group of young people.Design, setting, and participantsThis retrospective cohort study included 468 patients aged younger than 21 years who received rituximab for diverse indications between October 1, 2010, and December 31, 2017, at Texas Children's Hospital, a large pediatric referral hospital. Patterns of adverse events, infections, and immune recovery are described. Data analyses were conducted from December 2019 to June 2020.ExposureOne or more doses of rituximab.Main outcomes and measuresAdverse drug events (eg, anaphylaxis), incidence of mild and severe infections, and time to recovery of B lymphocyte subset counts and immunoglobulin levels. Survival models and logistic regression analyses and were used to identify associated risk factors of infectious and noninfectious adverse drug events.ResultsWe identified 468 patients receiving at least 1 dose of rituximab. The total follow-up time was 11 713 person-months. Of the 468 patients, 293 (62.6%) were female, the median (interquartile range) age at receipt of dose was 14.3 (9.9-16.8) years, and 209 (44.7%) were self-reported White Hispanic. Adverse events associated with rituximab infusion occurred in 72 patients (15.4%), and anaphylaxis occurred in 17 patients (3.6%). Long-term adverse events, such as prolonged neutropenia and leukoencephalopathy, were absent. Infections occurred in 224 patients (47.9%); 84 patients (17.9%) had severe infections, and 3 patients (0.6%) had lethal infections. Concurrent use of intravenous chemotherapy, treatment of systemic lupus erythematosus, neutropenia, and use of intravenous immunoglobulin were associated with increased risk of infection. Among 135 patients (28.8%) followed up to B cell count recovery, CD19+ or CD20+ cell numbers normalized in a median of 9.0 months (interquartile range, 5.9-14.4 months) following rituximab use; 48 of 95 patients (51%) evaluated beyond a year had low-for-age B cell counts. Recovery of CD27+ memory B cell number occurred in a median of 15.7 months (interquartile range, 6.0-22.7 months). Among patients with normal baseline values, low immunoglobulin G (IgG) levels developed in 67 of 289 patients (23.2%) and low IgM levels in 118 of 255 patients (40.8%); of these patients evaluated beyond 12 months from rituximab, 16 of 117 (13.7%) had persistently low IgG and 37 (33.9%) of 109 had persistently low IgM.Conclusions and relevanceRituximab is well tolerated among young people and is associated with few serious adverse events, but infections are common, corresponding to a prolonged period of B cell count recovery often lasting for longer than a year. Further examination of strategies to prevent infections following rituximab should be pursued.

Project description:Background Diminished peak lung function in young adulthood is a risk factor for future chronic obstructive pulmonary disease. The association between lung disease and cardiovascular disease later in life is well documented. Whether peak lung function measured in young adulthood is associated with risk of future cardiovascular events is unknown. Methods and Results CARDIA (The Coronary Artery Risk Development in Young Adults) study is a prospective, multicenter, community-based, longitudinal cohort study including 4761 participants aged 18 to 30 years with lung function testing we investigated the association between lung health in young adulthood and risk of subsequent cardiovascular events. We performed Cox proportional hazards regression to test the association between baseline and years 10 and 20 pulmonary function with incident cardiovascular events. Linear and logistic regression was performed to explore the associations of lung function with development of risk factors for cardiovascular disease as well as carotid intima-media thickness and coronary artery calcified plaque. At baseline, mean age (± SD ) was 24.9±3.6 years. Baseline forced expiratory volume in 1 second (hazard ratio) per -10-unit decrement in percent predicted forced expiratory volume in 1 second (hazard ratio, 1.18; 95% CI, 1.06-1.31 [ P=0.002]) and FVC per -10-unit decrement in percent predicted FVC (hazard ratio, 1.19; 95% CI, 1.06-1.33 [ P=0.003]) were associated with future cardiovascular events independent of traditional cardiovascular risk factors. Baseline lung function was associated with heart failure and cerebrovascular events but not coronary artery disease events. Conclusions Lung function in young adulthood is independently associated with cardiovascular events into middle age. This association appears to be driven by heart failure and cerebrovascular events rather than coronary heart disease. Clinical Trial Registration URL : https://www.clinicaltrials.gov . Unique identifier: NCT 00005130.

Project description:Importance:Few tools exist for assessing the risk for early atherosclerotic cardiovascular disease (ASCVD) events in young adults. Objective:To assess the performance of the Healthy Heart Score (HHS), a lifestyle-based tool that estimates ASCVD events in older adults, for ASCVD events occurring before 55 years of age. Design, Setting, and Participants:This prospective cohort study included 4893 US adults aged 18 to 30 years from the Coronary Artery Risk Development in Young Adults (CARDIA) study. Participants underwent measurement of lifestyle factors from March 25, 1985, through June 7, 1986, and were followed up for a median of 27.1 years (interquartile range, 26.9-27.2 years). Data for this study were analyzed from February 24 through December 12, 2016. Exposures:The HHS includes age, smoking status, body mass index, alcohol intake, exercise, and a diet score composed of self-reported daily intake of cereal fiber, fruits and/or vegetables, nuts, sugar-sweetened beverages, and red and/or processed meats. The HHS in the CARDIA study was calculated using sex-specific equations produced by its derivation cohorts. Main Outcomes and Measures:The ability of the HHS to assess the 25-year risk for ASCVD (death from coronary heart disease, nonfatal myocardial infarction, and fatal or nonfatal ischemic stroke) in the total sample, in race- and sex-specific subgroups, and in those with and without clinical ASCVD risk factors at baseline. Model discrimination was assessed with the Harrell C statistic; model calibration, with Greenwood-Nam-D'Agostino statistics. Results:The study population of 4893 participants included 2205 men (45.1%) and 2688 women (54.9%) with a mean (SD) age at baseline of 24.8 (3.6) years; 2483 (50.7%) were black; and 427 (8.7%) had at least 1 clinical ASCVD risk factor (hypertension, hyperlipidemia, or diabetes types 1 and 2). Among these participants, 64 premature ASCVD events occurred in women and 99 in men. The HHS showed moderate discrimination for ASCVD risk assessment in this diverse population of mostly healthy young adults (C statistic, 0.71; 95% CI, 0.66-0.76); it performed better in men (C statistic, 0.74; 95% CI, 0.68-0.79) than in women (C statistic, 0.69; 95% CI, 0.62-0.75); in white (C statistic, 0.77; 95% CI, 0.71-0.84) than in black (C statistic, 0.66; 95% CI, 0.60-0.72) participants; and in those without (C statistic, 0.71; 95% CI, 0.66-0.76) vs with (C statistic, 0.64; 95% CI, 0.55-0.73) clinical risk factors at baseline. The HHS was adequately calibrated overall and within each subgroup. Conclusions and Relevance:The HHS, when measured in younger persons without ASCVD risk factors, performs moderately well in assessing risk for ASCVD events by early middle age. Its reliance on self-reported, modifiable lifestyle factors makes it an attractive tool for risk assessment and counseling for early ASCVD prevention.

Dataset Information

ADHD drugs and serious cardiovascular events in children and young adults.

Publications

ADHD drugs and serious cardiovascular events in children and young adults.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets