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Biomedical subjects

Julie Magno Zito

Publications and source records attributed to Julie Magno Zito.

16 recordsLinked to original sources

Effect of initial ziprasidone dose on treatment persistence in schizophrenia.

OBJECTIVE: To determine the relationship between ziprasidone initial dose and treatment persistence among patients diagnosed with schizophrenia. METHOD: Adult Medicaid recipients (N=1096) diagnosed with schizophrenia who had ziprasidone prescription claims between July 1, 2001 and September 30, 2003, were categorized by initial dose: low (20-60 mg per day, n=464), medium (61-119 mg per day, n=320) and high dose (120-160 mg per day, n=312). Treatment persistence up to 365 days was measured using refill patterns, allowing 15-day gaps between expected refill dates. Multivariate survival analysis explored the simultaneous impact of age, gender, race, previous hospitalization, and concomitant medication usage, in addition to initial dose of ziprasidone. Sensitivity analysis tested the robustness of results with different definitions for persistence and allowable gaps between refills. RESULTS: Discontinuation rates across the observation period (maximum, 12 months per individual) were lower for patients initiated with high-dose than low-dose ziprasidone (P=0.001). Other factors significantly associated with greater discontinuation of medication were monotherapy (versus combination therapy) and hospitalization within the 6 months prior to the index date of therapy. Black race was associated with greater discontinuation, although this was not consistent across sensitivity analyses. CONCLUSIONS: Patients with schizophrenia started on high doses of ziprasidone have lower discontinuation rates in a retrospective Medicaid database than patients started on low doses. These results were robust across various sensitivity analyses.

Adult↗

Anticonvulsant treatment for psychiatric and seizure indications among youths.

OBJECTIVE: This study compared the prevalence of anticonvulsant treatment for youths with a diagnosis of a psychiatric disorder to youths with a diagnosis of a seizure disorder. METHODS: Administrative claims from outpatient visits and prescriptions were organized for a data set of 258,472 youths who were younger than 18 years of age in a mid-Atlantic state Medicaid program and were continuously enrolled in 2000. Youths dispensed an anticonvulsant were grouped into the following ICD-9 diagnostic categories: a diagnosis of a psychiatric disorder without a seizure disorder, a diagnosis of a seizure disorder without a psychiatric disorder, and a diagnosis of both a psychiatric and a seizure disorder. Anticonvulsant use was analyzed for specific diagnostic classes by age, gender, race or ethnicity, and Medicaid eligibility categories. RESULTS: A total of 4,522 youths in the one-year data set received an anticonvulsant (1.75 percent): 3,061 had a psychiatric disorder only, 251 had a seizure disorder only, and 611 had both psychiatric and seizure disorders. Among anticonvulsant-treated youths with diagnosis information in their records (3,923 of 4,522 youths), 81 percent had a psychiatric diagnosis and 19 percent had a seizure disorder; 71 percent of those with a seizure disorder also had a psychiatric disorder. Anticonvulsant use for seizure control was proportionally greater for those younger than five years. By contrast, a vast majority of anticonvulsant users with a psychiatric diagnosis were between five and 17 years. Among anticonvulsant-treated youths with a psychiatric diagnosis, males were approximately twice as common as females. For youths with a seizure disorder, no difference was found for gender. Mood disorders and attention-deficit hyperactivity disorder were the major psychiatric diagnoses associated with anticonvulsant use. Valproic acid products were the most commonly dispensed type of anticonvulsant. CONCLUSIONS: Recent state Medicaid data reveal that youths who use anticonvulsants are far more likely to have a psychiatric diagnosis than a seizure diagnosis. Widespread off-label use of anticonvulsants for psychiatric disorders among youths warrants attention to ensure benefits and minimize risks.

Adolescent↗

Effect of Medicaid eligibility category on racial disparities in the use of psychotropic medications among youths.

OBJECTIVE: This study sought to determine the degree to which Medicaid eligibility categories modify disparities between black and white youths in the prevalence of psychotropic medication. METHODS: Computerized claims for 189,486 youths aged two to 19 years who were continuously enrolled in a mid-Atlantic state Medicaid program for the year 2000 were analyzed to determine population-based annual prevalence of psychotropic medication by race or ethnicity and by whether the youths were eligible for Medicaid for reasons of family income, disability, or foster care placement. Logistic regression was used to assess the interaction of eligibility category and race. RESULTS: The mean annual prevalence of psychotropic medication for the population was 9.9 percent. The prevalence was 2.17 times higher for white youths than for black youths (16.5 percent compared with 7.6 percent). However, within eligibility categories, the white-to-black disparity was 3.8 among youths who were eligible for Medicaid because their family income was below the federal poverty level and 3.2 for youths enrolled in the State Children's Health Insurance Program. CONCLUSIONS: Medicaid eligibility categories had a profound impact on the racial disparity associated with the prevalence of psychotropic medications for youths. Eligibility category should be taken into account when ascertaining the role of access, undertreatment, and culture in disparities in mental health treatment.

Adolescent↗

The ethical use of placebo in clinical trials involving children.

The authors reviewed various statements describing the ethical use of placebo-controls in clinical trials involving minors. Attention was focused upon the Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Populations, published by the American Academy of Pediatrics (AAP) (Kaufman et al. 1995). A brief review of certain key documents and a possible expansion of the guidelines are presented. Specifically, it is recommended that a review and update of guidelines for the use of placebo-controlled trials in children be undertaken by a working group comprised of stakeholders, including academic clinical and research professionals, bioethicists, consumers, members of key government agencies, and the pharmaceutical industry.

Child↗

Comparative prevalence of psychotropic medications among youths enrolled in the SCHIP and privately insured youths.

The one-year prevalence of use of psychotropic medications among youths enrolled in a Mid-Atlantic State Children's Insurance Program (SCHIP) in 1999 or 2000 was compared with the 1998-2000 prevalence findings for youths enrolled in four large multistate private medical insurance programs. Prevalence was significantly higher among youths enrolled in the SCHIP than among those with private insurance in all eight medication group comparisons. Unlike private insurance, the surveyed state SCHIP program did not require a copayment or have a restrictive formulary. These administrative differences may partly explain the comparatively higher rate of psychotropic use under the SCHIP.

Adolescent↗

Psychotropic practice patterns for youth: a 10-year perspective.

OBJECTIVE: To examine changes in the full spectrum of psychotropic medication treatment for youths from 1987 to 1996. METHODS: A population-based analysis of community treatment data on nearly 900,000 youths enrolled in 2 US health care systems included (1) computerized Medicaid data from 2 states (a midwestern state and a mid-Atlantic state) composed of outpatient prescription claims and enrollment records and (2) computerized prescription dispensing records from a group-model health maintenance organization. Ten 1-year cross-sectional data sets from 1987 through 1996 were analyzed. RESULTS: Total psychotropic medication prevalence for youths increased 2- to 3-fold and included most classes of medication. The rapid growth since 1991 of alpha-agonists, neuroleptics, and "mood stabilizer" anticonvulsants was particularly notable. The 1996 prevalence of any psychotropic medication among youths younger than 20 years was remarkably similar (5.9%-6.3%) across all 3 sites, with stimulants and antidepressants consistently ranked first and second. Medicaid rates almost always exceeded health maintenance organization rates by large margins, particularly for alpha-agonists, neuroleptics, "mood stabilizer" anticonvulsants, and lithium. Youths in health maintenance organizations had rates similar to Medicaid-insured youths for antidepressants and hypnotics. Over the decade, there was a proportional increase in females receiving stimulants and in males receiving antidepressants, particularly for the 10- to 14-year-old group. The prevalence ratios of whites to African Americans narrowed substantially in 1 Medicaid site. CONCLUSIONS: Youth psychotropic treatment utilization during the 1990s nearly reached adult utilization rates. Youth findings can be used to accurately assess the duration of treatment and unforeseen practice pattern changes, and to identify safety concerns.

Adolescent↗

Parental perceptions and satisfaction with stimulant medication for attention-deficit hyperactivity disorder.

Few reports have documented parental perceptions of stimulants for attention-deficit hyperactivity disorder (ADHD), despite the recent increased use of stimulants among youths. Of 302 parents recruited from six pediatric primary care clinics, 84% completed a survey of their knowledge, attitudes, and satisfaction with the medication their child was taking for ADHD. Two thirds of the parents believed that sugar and diet affect hyperactivity. Although few parents believed that stimulants could lead to drug abuse, 55% initially were hesitant to use medication on the basis of information in the lay press, and 38% believed that too many children receive medication for ADHD. Parents were more satisfied with the behavioral and academic improvement relative to improvement in their child's self-esteem. Attitudes were positively correlated with satisfaction and were more positive among white than nonwhite parents. The findings highlight parental misconceptions and reservations about ADHD medication treatment that require clarification as to whether race/ethnicity, income, and social status influence their views and use of treatments.

Adolescent↗

Concomitant psychotropic medication for youths.

OBJECTIVE: This study reviewed the clinical research and practice literature relating to the prevalence and patterns of concomitant psychotropic medication given to youths with emotional and behavioral disorders. METHOD: A MEDLINE search from 1996 through spring 2002, including a review of references from relevant published articles and reports, was undertaken to identify available information on concomitant psychotropic medication for youths. RESULTS: The data supporting concomitant psychotropic medication for youths are almost exclusively based on case reports and small-scale, nonblind assessments. In the mid-1990s, over 20% of outpatient youths treated in community mental health centers and over 40% of youths treated in inpatient psychiatric facilities were given concomitant psychotropic medication. The rate has since increased. Psychiatrists more than primary care physicians prescribe concomitant psychotropic medication, and they show great variability in their prescribing habits. Youths with aggressive behavior, male gender, severe emotional illness, and disabling social maladjustment are most likely to receive concomitant psychotropic medication. CONCLUSIONS: Substantive systematic evidence is needed to clarify this increasingly common, inadequately researched child psychopharmacologic practice.

Adolescent↗

Antipsychotic dosing and concurrent psychotropic treatments for Medicaid-insured individuals with schizophrenia.

Antipsychotic medications have been first line treatment for schizophrenia for half a century, yet few studies have assessed outpatient maintenance treatment in large populations. This article describes oral antipsychotic dosing patterns and psychotropic treatments using computerized Medicaid claims data for individuals who were diagnosed with schizophrenia and received treatment on an outpatient basis during 1991. The findings show that the mean daily oral antipsychotic dose was 729 +/- 586 chlorpromazine equivalents (CPZ-EQ) for high-potency agents and 304 +/- 328 CPZ-EQ for low-potency agents. Males, younger individuals, and African-Americans received larger mean daily doses of high-potency agents, ranging from 747 to 800 CPZ-EQ. Antiparkinsonian agents were prescribed for over 90 percent of the outpatient antipsychotic treatment exposure. In summary, young adults, males, and African-Americans were given high-potency antipsychotic medications at outpatient maintenance doses that exceeded the maximum recommended levels, despite well-established evidence that high-dose treatment offers no additional benefit. Likewise, concurrent antiparkinsonian treatment exceeded the 1990 World Health Organization recommendations.

Adolescent↗

Rising prevalence of antidepressants among US youths.

OBJECTIVE: To examine changes in antidepressant (ATD) prevalence and the sociodemographic and clinical correlates of ATD use among youths who are treated in community practice settings. METHODS: A retrospective study was undertaken using large data sets from 3 US sites. Outpatient prescription and clinical service records of youths who were aged 2 to 19 and enrolled in Midwestern Medicaid (MWM) and mid-Atlantic Medicaid (MAM) state programs and a group-model health maintenance organization (HMO) were organized into seven 1-year cross-sectional data sets from 1988 through 1994 to evaluate ATD utilization patterns. RESULTS: In 1994, ATD prevalence per 1000 youths was 19.10 (MWM), 17.78 (MAM), and 12.85 (HMO), which represented a consistent increase in prevalence from 1988-1994: 2.9-fold (MWM), 4.6-fold (MAM), and 3.6-fold (HMO). Despite the rapidly expanding use of selective serotonin reuptake inhibitors prescribed mainly for depression, more than half of ATD use in 1994 was still attributable to tricyclic antidepressants prescribed mainly for attention-deficit/hyperactivity disorder. ATD prevalence was generally predominant among 10- to 14-year-old boys and among 15- to 19-year-old girls. In the Medicaid populations, 42% (MAM) and 72% (MWM) of ATD-treated youths had primary care services, whereas the bulk of the remainder had psychiatric services. Attention-deficit/hyperactivity disorder followed by depression led the physician-reported primary care diagnoses associated with ATD use, whereas that diagnostic rank order was reversed for youths who received psychiatric services. CONCLUSIONS: ATD treatments among youths substantially increased in the 1990s. This was generated primarily by primary care providers, and thus evaluations of the outcome of ATD treatment need to target primary care in addition to psychiatric providers. Longitudinal study designs are needed to evaluate the use of ATDs in youths in regard to the duration of treatment, combination medications, and the reasons for treatment.

Adjustment Disorders↗

Treatment-emergent adverse events from selective serotonin reuptake inhibitors by age group: children versus adolescents.

OBJECTIVE: The aim of this study was to report the frequency of common treatment-emergent adverse events (AEs) from selective serotonin reuptake inhibitors (SSRIs) in children, adolescents, and adults. METHOD: AE data were obtained from all published double-blind, placebo-controlled SSRI studies of children and adolescents that separated AE findings by age group. The AE findings were pooled for purposes of age-group comparisons. Double-blind, placebo-controlled SSRI studies of adolescents (n = 2) and of adults identified in systematically identified trials (n = 22) were assessed to compare patterns and rates across the age span. Other reports, primarily from the published SSRI literature, were added to clarify the findings presented. RESULTS: Activation and vomiting SSRI AEs were 2- to 3-fold more prevalent in children than in adolescents, and their rate was lowest in adults. Somnolence as a SSRI AE was uncommon in children; its rate increased with advancing age. Insomnia and nausea were common SSRI AEs across the age span. Activation AEs were a frequent reason for discontinuation from SSRI clinical trials in preadolescents, whereas somnolence, nausea, and insomnia AEs were the most common reasons for trial discontinuations in adults. CONCLUSIONS: Children are particularly vulnerable to specific AEs from certain medications, such as SSRIs. It is likely that the level of children's biological immaturity explains part of this phenomenon.

Adolescent↗

Antidepressant use in children and adolescents in Germany.

OBJECTIVE: The expanded use of antidepressants in youth has been the subject of numerous studies and some concerns in recent years. This study describes prescription patterns of antidepressants (ATD) for youths in Germany for the years 2000-2003 and includes prescription use of St. John's Wort. METHODS: Prescription data from a health insurance organization with 1.4 million members per year across Germany, of whom approximately 280,000 were under 20 years of age, were accessed. Total age- and gender-specific ATD yearly utilization rates were computed. Prevalence was defined as the dispensing of 1 or more prescriptions for an ATD per calendar year per 1000 continuously enrolled youth. RESULTS: ATD prevalence was 3.43 per 1000 (95% Confidence Interval [CI], 3.21-3.65) in 2000 and 3.74 per 1000 (3.25-3.97) in 2003. St John's Wort products, which are approved for antidepressant use by the German drug agency, and tricyclic antidepressants (TCAs), accounted for more than 80% of antidepressant use. Although selective serotonin reuptake inhibitors (SSRIs) represented only 15% of antidepressant use, there was a doubling of its use over the 4-year period. Adolescent girls (age, 15-19 years) had utilization rates ranging from 11.44 to 13.82 per 1000, and accounted for most ATD use. Overall, females were twice as likely as males to get an antidepressant. Among users, there were low rates of multiple medication use (5.6% used more than one class of ATD, and 6.7% more than one drug). CONCLUSIONS: Prescription patterns in Germany reveal predominate use of St. John's Wort and TCAs, which contrasts sharply with U.S. patterns, wherein SSRIs predominate. Also, in the United States, unlike Germany, 5-9- and 10-14 year olds receive sizable proportions of ATDs. Labeling status (only herbal hypericum preparations and TCAs are labeled for the treatment of depression in children and adolescents in Germany) and cost restrictions appear to influence the prescribing pattern of doctors in Germany. Recent treatment recommendations of national and international regulatory agencies need to take into account the different national situations.

Adolescent↗