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Shaw M.,Shire Pharmaceuticals Ltd. | Hodgkins P.,Shire Development LLC | Caci H.,Nice University Hospital Center | Young S.,Kings College London | And 3 more authors.
BMC Medicine | Year: 2012

Background: In childhood, attention deficit/hyperactivity disorder (ADHD) is characterized by age-inappropriate levels of inattentiveness/disorganization, hyperactivity/impulsiveness, or a combination thereof. Although the criteria for ADHD are well defined, the long-term consequences in adults and children need to be more comprehensively understood and quantified. We conducted a systematic review evaluating the long-term outcomes (defined as 2 years or more) of ADHD with the goal of identifying long-term outcomes and the impact that any treatment (pharmacological, non-pharmacological, or multimodal) has on ADHD long-term outcomes.Methods: Studies were identified using predefined search criteria and 12 databases. Studies included were peer-reviewed, primary studies of ADHD long-term outcomes published between January 1980 to December 2010. Inclusion was agreed on by two independent researchers on review of abstracts or full text. Published statistical comparison of outcome results were summarized as poorer than, similar to, or improved versus comparators, and quantified as percentage comparisons of these categories.Results: Outcomes from 351 studies were grouped into 9 major categories: academic, antisocial behavior, driving, non-medicinal drug use/addictive behavior, obesity, occupation, services use, self-esteem, and social function outcomes. The following broad trends emerged: (1) without treatment, people with ADHD had poorer long-term outcomes in all categories compared with people without ADHD, and (2) treatment for ADHD improved long-term outcomes compared with untreated ADHD, although not usually to normal levels. Only English-language papers were searched and databases may have omitted relevant studies.Conclusions: This systematic review provides a synthesis of studies of ADHD long-term outcomes. Current treatments may reduce the negative impact that untreated ADHD has on life functioning, but does not usually 'normalize' the recipients. © 2012 Shaw et al; licensee BioMed Central Ltd.

Devlen J.,Icon PLC Inc. | Beusterien K.,Outcomes Research Strategies in Health LLC | Yen L.,Shire Development LLC | Ahmed A.,Beth Israel Deaconess Medical Center | And 2 more authors.
Inflammatory Bowel Diseases | Year: 2014

Background: The aim of this study was to describe the impacts of inflammatory bowel disease (IBD) from the patients' perspective and to inform the development of a conceptual model. Methods: Focus groups and one-on-one interviews were undertaken in adult patients with IBD. Transcripts from the focus groups and interviews were analyzed to identify themes and links between themes, assisted by qualitative data software MaxQDA. Themes from the qualitative research were supplemented with those reported in the literature and concepts included in IBD-specific patient-reported outcome measures. Results: Twenty-seven patients participated. Key physical symptoms included pain, bowel-related symptoms such as frequency, urgency, incontinence, diarrhea, passing blood, and systemic symptoms such as weight loss and fatigue. Participants described continuing and variable symptom experiences. IBD symptoms caused immediate disruption of activities but also had ongoing impacts on daily activities, including dietary restrictions, lifestyle changes, and maintaining close proximity to a toilet. More distal impacts included interference with work, school, parenting, social and leisure activities, relationships, and psychological well-being. The inconvenience of rectal medications, refrigerated biologics, and medication refills emerged as novel burdens not identified in existing patient-reported outcome measures. Conclusions: IBD symptoms cause immediate disruption in activities, but patients may continue to experience some symptoms on a chronic basis. The conceptual model presented here may be useful for identifying target concepts for measurement in future studies in IBD. Copyright © 2014 Crohn's & Colitis Foundation of America, Inc.

Quinn P.O.,National Center for Girls and Women With | Madhoo M.,Shire Development LLC
Primary Care Companion to the Journal of Clinical Psychiatry | Year: 2014

Objective: To describe the clinical presentation of attention-deficit/hyperactivity disorder (ADHD) in women and girls and factors influencing proper diagnosis and treatment. Data Sources: A PubMed search was conducted in April 9, 2012 for English-language publications from the previous 10 years. Search terms included attention deficit hyperactivity disorder, attention deficit/hyperactivity disorder, ADHD, and AD/HD combined with gender, girls, females, women, continuity, discontinuity, gap, treatment, untreated, and lack of treatment. Study Selection/Data Extraction: A total of 41 articles were reviewed for relevance. Reference lists from relevant articles were reviewed for additional publications; sources known to the authors were also included. Results: Attitudes about ADHD among individuals with ADHD and knowledgeable informants (families, teachers, colleagues) vary on the basis of the diagnosed individual's gender. The ADHD prevalence rates are higher among boys than girls. A low index of clinical suspicion exists for girls; their presentation is considered "subthreshold" because inattentiveness is more prominent than hyperactivity/impulsivity. Females with ADHD may develop better coping strategies than males to mask their symptoms. Lastly, anxiety and depression, common comorbidities in female patients with ADHD, can lead to missed or misdiagnosis. If not properly diagnosed and treated, girls with ADHD experience the same negative consequences as boys, including poor academic performance and behavioral problems. Unique issues related to hormonal effects on ADHD expression and treatment response are also experienced by women and girls. Conclusions: Accurate ADHD diagnosis in women and girls requires establishing a symptom history and an understanding of its gender-specific presentation. Coexisting anxiety and depression are prominent in female patients with ADHD; satisfactory academic achievement should not rule out an ADHD diagnosis. © 2014 Physicians Postgraduate Press, Inc.

Lindenmayer J.-P.,New York University | Nasrallah H.,University of Cincinnati | Pucci M.,Science Scientific Communications and Information | James S.,Shire Development LLC | Citrome L.,New York Medical College
Schizophrenia Research | Year: 2013

Background: Primary negative symptoms of schizophrenia (NSS) contribute heavily to functional disability and treatment of these symptoms continues to be a major unmet need even when the positive (psychotic) symptoms are controlled. The modified dopamine (DA) hypothesis posits that positive symptoms are associated with increased DA activity in the mesolimbic tract whereas NSS and cognitive symptoms are associated with decreased DA activity in the mesocortical (frontal) region. Several studies have reported improvement in NSS with DA agonist use, but with varying degrees of risk for triggering psychotic symptoms, especially in the absence of concurrent antipsychotic drug treatment. This article aims to examine older and newer evidence suggesting that psychostimulants may have a potential therapeutic role in the treatment of NSS together with a thorough review of the potential risks and benefits of psychostimulant administration in individuals with schizophrenia. Methods: A systematic search of relevant literature using electronic databases, reference lists, and data presented at recent meetings was conducted. Results: Improvement of NSS after psychostimulant administration is reviewed both in challenge and treatment paradigms with various agents such as methylphenidate, amphetamine, and modafinil or armodafinil. The literature points to evidence that, used adjunctively, DA agonists may improve NSS without worsening of positive symptoms in selected patients who are stable and treated with effective antipsychotic medications. Several areas of inadequate study and limitations are identified including small study samples, single-site trials, varying rigor of bias control, the dose and the duration of adjunctive psychostimulant administration, and the potential for development of tolerance. Conclusion: Large, controlled clinical trials to further characterize effects of psychostimulants on NSS in carefully selected patients are warranted. © 2013 Elsevier B.V.

Lasser R.A.,Shire Development LLC | Dirks B.,Shire Development LLC | Nasrallah H.,University of Cincinnati | Kirsch C.,Shire Development LLC | And 4 more authors.
Neuropsychopharmacology | Year: 2013

Negative symptoms of schizophrenia (NSS), related to hypodopaminergic activity in the mesocortical pathway and prefrontal cortex, are predictive of poor outcomes and have no effective treatment. Use of dopamine-enhancing drugs (eg, psychostimulants) has been limited by potential adverse effects. This multicenter study examined lisdexamfetamine dimesylate (LDX), a d-amphetamine prodrug, as adjunctive therapy to antipsychotics in adults with clinically stable schizophrenia and predominant NSS. Outpatients with stable schizophrenia, predominant NSS, limited positive symptoms, and maintained on stable atypical antipsychotic therapy underwent a 3-week screening, 10-week open-label adjunctive LDX (20-70 mg/day), and 4-week, double-blind, randomized, placebo-controlled withdrawal. Efficacy measures included a modified Scale for the Assessment of Negative Symptoms (SANS-18) and Positive and Negative Syndrome Scale (PANSS) total and subscale scores. Ninety-two participants received open-label LDX; 69 received double-blind therapy with placebo (n=35) or LDX (n=34). At week 10 (last observation carried forward; last open-label visit), mean (95% confidence interval) change in SANS-18 scores was -12.9 (-15.0, -10.8; P<0.0001). At week 10, 52.9% of participants demonstrated a minimum of 20% reduction from baseline in SANS-18 score. Open-label LDX was also associated with significant improvement in PANSS total and subscale scores. During the double-blind/randomized-withdrawal phase, no significant differences (change from randomization baseline) were found between placebo and LDX in SANS-18 or PANSS subscale scores. In adults with clinically stable schizophrenia, open-label LDX appeared to be associated with significant improvements in negative symptoms without positive symptom worsening. Abrupt LDX discontinuation was not associated with positive or negative symptom worsening. Confirmation with larger controlled trials is warranted. © 2013 American College of Neuropsychopharmacology. All rights reserved.

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