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1.
N Z Med J ; 137(1594): 62-68, 2024 May 03.
Artículo en Inglés | MEDLINE | ID: mdl-38696833

RESUMEN

AIMS: The kaupapa of the Caring for Australians and New Zealanders with Kidney Impairment (CARI) Clinical practice guidelines for management of chronic kidney disease for Maori in Aotearoa New Zealand is to provide whanau-centred and evidence-based recommendations to healthcare systems, healthcare providers and healthcare workers. The guidelines include screening, identification, management and system-level responses to chronic kidney disease (CKD) to deliver best practice care to Maori affected by CKD across community, primary and secondary services. METHODS: The guidelines are funded by the Ministry of Health - Manatu Hauora and are written by a panel of Maori and non-Maori clinicians and literacy experts across Aotearoa New Zealand from Kaupapa Maori organisations, general practice and nephrology units using standardised methods. The guidelines methodology included consultation with whanau Maori with lived experience of CKD and primary and secondary care practitioners. Additional guideline development would be required to inform management of CKD for non-Maori in Aotearoa New Zealand. RESULTS: The guidelines provide recommendations about equity, governance and accountability, cultural safety, case management, information systems, social determinants of equity and wellbeing and screening. CONCLUSIONS: Recommendations to health services for Maori with CKD are based on giving effect to Te Tiriti o Waitangi and best practice care to prevent CKD, delaying its progression, treating kidney failure through timely transplantation, delivering in community and providing high-quality symptom management.


Asunto(s)
Nativos de Hawái y Otras Islas del Pacífico , Insuficiencia Renal Crónica , Humanos , Servicios de Salud del Indígena/organización & administración , Pueblo Maorí , Nueva Zelanda , Guías de Práctica Clínica como Asunto , Insuficiencia Renal Crónica/terapia , Insuficiencia Renal Crónica/etnología , Insuficiencia Renal Crónica/diagnóstico
2.
Am J Pharm Educ ; 88(3): 100648, 2024 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-38220045

RESUMEN

The process of desegregation at Southern schools of pharmacy was long and arduous. Despite persistent protests, struggles, and lawsuits, many schools of pharmacy did not graduate their first Black students until the 1970s. The School of Pharmacy at the University of North Carolina at Chapel Hill unintentionally desegregated in 1962 when its first Black student, William Wicker, was inadvertently admitted. His personal story and those of his fellow pioneers in desegregation, Mona (Boston) Reddick and James Barnes, provide valuable context to Diversity, Equity, and Inclusion efforts. The historical proximity of desegregation affords the pharmacy profession only one or two generations of Black pharmacists trained during an era when Southern pharmacy education was broadly available. These stories personify the legacy of segregation, confront the ongoing impact of structural racism, and meaningfully inform conversations about Diversity, Equity, and Inclusion in pharmacy education.


Asunto(s)
Desegregación , Educación en Farmacia , Farmacia , Humanos , Hielo , Instituciones Académicas
3.
J Pharmacokinet Pharmacodyn ; 51(1): 39-63, 2024 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-37389744

RESUMEN

Mathematical modelling has become a key tool in pharmacological analysis, towards understanding dynamics of cell signalling and quantifying ligand-receptor interactions. Ordinary differential equation (ODE) models in receptor theory may be used to parameterise such interactions using timecourse data, but attention needs to be paid to the theoretical identifiability of the parameters of interest. Identifiability analysis is an often overlooked step in many bio-modelling works. In this paper we introduce structural identifiability analysis (SIA) to the field of receptor theory by applying three classical SIA methods (transfer function, Taylor Series and similarity transformation) to ligand-receptor binding models of biological importance (single ligand and Motulsky-Mahan competition binding at monomers, and a recently presented model of a single ligand binding at receptor dimers). New results are obtained which indicate the identifiable parameters for a single timecourse for Motulsky-Mahan binding and dimerised receptor binding. Importantly, we further consider combinations of experiments which may be performed to overcome issues of non-identifiability, to ensure the practical applicability of the work. The three SIA methods are demonstrated through a tutorial-style approach, using detailed calculations, which show the methods to be tractable for the low-dimensional ODE models.


Asunto(s)
Modelos Biológicos , Modelos Teóricos , Ligandos , Transducción de Señal
5.
Am J Pharm Educ ; 87(7): 100075, 2023 07.
Artículo en Inglés | MEDLINE | ID: mdl-37380276

RESUMEN

OBJECTIVE: To examine the construct validity of cultural intelligence (CI) and evaluate faculty self-efficacy in developing cultural intelligence in Doctor of Pharmacy students. METHODS: A survey was developed based on a CI framework for pharmacy education consisting of four domains. Survey items were measured on a scale from 1-cannot do at all to 10-highly certain can do. Survey responses from faculty in the Doctor of Pharmacy program who completed ≥90% of the survey items were included. An exploratory factor analysis was conducted using principal components analysis with a varimax rotation and the Kaiser rule. Internal consistency reliability of each cultural intelligence construct was examined using Cronbach's alpha (α). RESULTS: Fifty-four Doctor of Pharmacy faculty members (83% response rate) completed the survey. The exploratory factor analysis revealed three CI constructs: (1) cultural awareness (α = 0.93), (2) cultural practice (α = 0.96), and (3) cultural desire (α = 0.89). Participants rated their CI teaching self-efficacy highest for cultural awareness (6.13 (1.93)), and lowest for cultural desire (3.90 (2.87)). CONCLUSION: Faculty play a critical role in the development of students; understanding CI teaching self-efficacy can inform faculty development strategies and curriculum improvements. Additional research is needed to identify related evidence-based methods for faculty development strategies utilizing the identified patterns and constructs.


Asunto(s)
Educación en Farmacia , Docentes de Farmacia , Humanos , Autoeficacia , Reproducibilidad de los Resultados , Inteligencia
6.
Res Social Adm Pharm ; 19(4): 622-627, 2023 04.
Artículo en Inglés | MEDLINE | ID: mdl-36621397

RESUMEN

BACKGROUND: A culturally intelligent pharmacy workforce is critical for addressing health disparities and ensuring that healthcare teams are equipped to support the medication needs of patients. Despite the critical role of preceptors in developing aspiring pharmacists, little is known about how they create or manage cross-cultural situations for students. OBJECTIVE: The objective of this study was to explore preceptor experiences teaching cultural intelligence within experiential pharmacy settings. METHODS: A convergent parallel mixed methods approach was used with a 10-item survey measuring preceptor teaching self-efficacy (measured from 0-cannot do at all to 10-highly certain can do) and interviews/focus groups to further understand cultural intelligence teaching experiences. Data were analyzed according to the 4 domains of the cultural intelligence framework (i.e., cultural awareness, cultural knowledge, cultural practice, and cultural desire). Survey data were analyzed descriptively and qualitative data were analyzed deductively. RESULTS: Participants (n = 24) were most confident Discussing factors underlying health and healthcare disparities (e.g., access, socioeconomic status, environment, racial/ethnic) (7.54 ± 2.04) and least confident in Understanding the importance of cultural desire in teaching students to be culturally intelligent healthcare practitioners (5.21 ± 2.72). All four cultural intelligence domains were identified in the qualitative data (n = 315 codes), with preceptors providing evidence of cultural awareness (n = 38, 12.1%), cultural knowledge (n = 54, 17.1%), cultural practice (n = 183 codes, 58.1%), and cultural desire (n = 40, 12.7%). Preceptors described various pedagogical strategies, such as case discussions, reflection, and simulation. CONCLUSIONS: Participants provided insight into pedagogical strategies for cultural intelligence that could promote student learning in experiential settings and help explicate curricular gaps. Further research regarding applicability of the cultural intelligence framework is needed, including application of these strategies and opportunities for preceptor development.


Asunto(s)
Educación en Farmacia , Farmacia , Estudiantes de Farmacia , Humanos , Preceptoría , Educación en Farmacia/métodos , Farmacéuticos , Encuestas y Cuestionarios
7.
Pharmacy (Basel) ; 10(5)2022 Sep 13.
Artículo en Inglés | MEDLINE | ID: mdl-36136846

RESUMEN

This article describes the design, implementation, and evaluation of five faculty development sessions focused on inclusive teaching strategies in pharmacy education. Inclusive strategies ensure that every student can clearly understand and engage in meaningful learning opportunities. Three sessions were implemented in fall 2020 and two in spring 2021. Sessions focused on experiential, didactic, and graduate education. A convergent parallel mixed methods evaluation was conducted using descriptive statistics and thematic analysis. Sessions were highly rated, and participants provided suggestions for curriculum improvement (e.g., creating resources, surveying students, and peer auditing syllabi for aspects of inclusiveness). Given the increasing emphasis on inclusion in pharmacy education, this work is timely for sharing strategies aimed at faculty development and teaching practices.

8.
Am J Health Syst Pharm ; 79(5): 351-358, 2022 02 18.
Artículo en Inglés | MEDLINE | ID: mdl-34369967

RESUMEN

PURPOSE: To describe an approach to diversity, equity, and inclusion (DEI) strategy development at a school of pharmacy aimed at stakeholder investment and infrastructure that can address systemic challenges in various healthcare settings. SUMMARY: The UNC Eshelman School of Pharmacy utilized an organizational approach focused on infrastructure to produce a diverse and inclusive school community. The Office of Organizational Diversity and Inclusion (ODI) established vision and mission statements to represent the school's commitment and conducted a comprehensive environmental scan to compose a shared vision. Students, faculty, staff, and alumni participated in a series of retreats, symposiums, and focus groups to identify opportunities to cultivate a diverse and inclusive school community. A working group comprised of key leaders in the school developed and launched a 3-year DEI Strategic Plan along with initiatives and metrics for year 1. The plan's 3 priorities were (1) to recruit and retain diverse talent, (2) to prepare culturally intelligent professionals, and (3) to build an inclusive community. The ODI collaborated with internal and external stakeholders, which included students, faculty, staff, postdocs, alumni, and partners from health systems, industry, and other institutions and organizations, to initiate, implement, and monitor progress through an organizational approach to establish accountability and greater commitment. CONCLUSION: An organizational approach to DEI strategy through stakeholder engagement and infrastructure increased commitment and shared ownership among members of the school community. Applications in an organizational approach can be adapted to multiple healthcare settings to contribute to the cultural transformation necessary to develop a diverse and inclusive healthcare workforce.


Asunto(s)
Servicios Farmacéuticos , Farmacia , Docentes , Personal de Salud , Humanos
9.
Am J Pharm Educ ; 85(9): 8580, 2021 10.
Artículo en Inglés | MEDLINE | ID: mdl-34301553

RESUMEN

Objective. Pharmacists must be equipped with the knowledge, skills, and attitudes necessary to provide culturally intelligent and patient-centered care; however, most are not trained to do so. In order to prepare culturally intelligent pharmacists, standards and curricula for cultural intelligence must be defined and implemented within pharmacy education. The objective of this study was to create a cultural intelligence framework (CIF) for pharmacy education and determine its alignment with Doctor of Pharmacy (PharmD) training.Methods. An extensive literature analysis on current methods of cultural intelligence education was used to construct a CIF, which integrates leading models of cultural intelligence in health care education with Bloom's Taxonomy. Five student focus groups were conducted to explore and map their cultural experiences to the CIF. All focus groups were recorded, transcribed, deidentified and deductively coded using the CIF.Results. The four CIF domains (awareness, knowledge, practice, desire) were observed in all five focus groups; however, not every participant expressed each domain when sharing their experiences. Most students expressed cultural awareness, knowledge, and desire, however, only a few students discussed cultural practice. Participant comments regarding their experiences differed by race and year in the curriculum.Conclusion. This study was a first step toward understanding cultural intelligence education and experiences in pharmacy. The CIF represents an evidence-based approach to cultural intelligence training that can help prepare pharmacy learners to be socially responsible health care practitioners.


Asunto(s)
Educación en Farmacia , Farmacia , Estudiantes de Farmacia , Competencia Cultural , Curriculum , Humanos , Inteligencia
10.
Front Med (Lausanne) ; 7: 553, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-33015103

RESUMEN

Clinical and experimental data suggest that pathogenesis in anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis is driven by ANCA-mediated activation of neutrophils and monocytes. While the role of neutrophils has been extensively investigated, the function of monocytes remains relatively understudied. We have previously demonstrated that stimulation of monocytes with anti-myeloperoxidase (MPO), but not anti-proteinase-3 (PR3), antibodies results in production of the pro-inflammatory cytokine IL-1ß. Changes in cellular metabolism, particularly a switch to glycolysis, have recently been linked to activation of immune cells and production of IL-1ß. Therefore, we investigated the metabolic profile of monocytes following ANCA stimulation. We found a significant increase in glucose uptake in anti-MPO stimulated monocytes. Interestingly, both anti-MPO and anti-PR3 stimulation resulted in an immediate increase in glycolysis, measured by Seahorse extracellular flux analysis. However, this increase in glycolysis was sustained (for up to 4 h) in anti-MPO- but not anti-PR3-treated cells. In addition, only anti-MPO-treated cells exhibited increased oxidative phosphorylation, a metabolic response that correlated with IL-1ß production. These data indicate that monocyte metabolism is altered by ANCA, with divergent responses to anti-MPO and anti-PR3 antibodies. These metabolic changes may underlie pathologic immune activation in ANCA associated vasculitis, as well as potentially contributing to the differing clinical phenotype between PR3- and MPO-ANCA positive patients. These metabolic pathways may therefore be potential targets for therapeutic intervention.

11.
Bull Math Biol ; 81(9): 3542-3574, 2019 09.
Artículo en Inglés | MEDLINE | ID: mdl-29349610

RESUMEN

Evidence suggests that many G protein-coupled receptors (GPCRs) are bound together forming dimers. The implications of dimerisation for cellular signalling outcomes, and ultimately drug discovery and therapeutics, remain unclear. Consideration of ligand binding and signalling via receptor dimers is therefore required as an addition to classical receptor theory, which is largely built on assumptions of monomeric receptors. A key factor in developing theoretical models of dimer signalling is cooperativity across the dimer, whereby binding of a ligand to one protomer affects the binding of a ligand to the other protomer. Here, we present and analyse linear models for one-ligand and two-ligand binding dynamics at homodimerised receptors, as an essential building block in the development of dimerised receptor theory. For systems at equilibrium, we compute analytical solutions for total bound labelled ligand and derive conditions on the cooperativity factors under which multiphasic log dose-response curves are expected. This could help explain data extracted from pharmacological experiments that do not fit to the standard Hill curves that are often used in this type of analysis. For the time-dependent problems, we also obtain analytical solutions. For the single-ligand case, the construction of the analytical solution is straightforward; it is bi-exponential in time, sharing a similar structure to the well-known monomeric competition dynamics of Motulsky-Mahan. We suggest that this model is therefore practically usable by the pharmacologist towards developing insights into the potential dynamics and consequences of dimerised receptors.


Asunto(s)
Modelos Biológicos , Receptores Acoplados a Proteínas G/química , Receptores Acoplados a Proteínas G/metabolismo , Animales , Unión Competitiva , Simulación por Computador , Relación Dosis-Respuesta a Droga , Descubrimiento de Drogas , Humanos , Ligandos , Modelos Lineales , Conceptos Matemáticos , Multimerización de Proteína , Estructura Cuaternaria de Proteína , Transducción de Señal
13.
Health Promot Pract ; 19(1): 23-30, 2018 01.
Artículo en Inglés | MEDLINE | ID: mdl-27913658

RESUMEN

Addressing the social determinants of health (SDOH) that influence teen pregnancy is paramount to eliminating disparities and achieving health equity. Expanding prevention efforts from purely individual behavior change to improving the social, political, economic, and built environments in which people live, learn, work, and play may better equip vulnerable youth to adopt and sustain healthy decisions. In 2010, the Centers for Disease Control and Prevention in partnership with the Office of Adolescent Health funded state- and community-based organizations to develop and implement the Teen Pregnancy Prevention Community-Wide Initiative. This effort approached teen pregnancy from an SDOH perspective, by identifying contextual factors that influence teen pregnancy and other adverse sexual health outcomes among vulnerable youth. Strategies included, but were not limited to, conducting a root cause analysis and establishing nontraditional partnerships to address determinants identified by community members. This article describes the value of an SDOH approach for achieving health equity, explains the integration of such an approach into community-level teen pregnancy prevention activities, and highlights two project partners' efforts to establish and nurture nontraditional partnerships to address specific SDOH.


Asunto(s)
Embarazo en Adolescencia/prevención & control , Determinantes Sociales de la Salud , Adolescente , Toma de Decisiones , Femenino , Promoción de la Salud/métodos , Disparidades en el Estado de Salud , Humanos , Embarazo , Embarazo en Adolescencia/estadística & datos numéricos , Estados Unidos , Adulto Joven
14.
Am J Pharm Educ ; 81(8): S13, 2017 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-29200461

RESUMEN

The 2015-2017 American Association of Colleges of Pharmacy (AACP) Special Taskforce on Diversifying our Investment in Human Capital was appointed for a two-year term, due to the rigors and complexities of its charges. This report serves as a white paper for academic pharmacy on diversifying our investment in human capital. The Taskforce developed and recommended a representation statement that was adapted and adopted by the AACP House of Delegates at the 2016 AACP Annual Meeting. In addition, the Taskforce developed a diversity statement for the Association that was adopted by the AACP Board of Directors in 2017. The Taskforce also provides recommendations to AACP and to academic pharmacy in this white paper.


Asunto(s)
Educación en Farmacia , Facultades de Farmacia , Sociedades Farmacéuticas , Comités Consultivos , Humanos , Estados Unidos
15.
Am J Pharm Educ ; 81(7): 5961, 2017 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-29109561

RESUMEN

Objective. To review and categorize published educational research concerning diversity within colleges and schools of pharmacy. Methods. The Three Models of Organizational Diversity Capabilities in Higher Education framework was used to guide the review efforts. Of the 593 documents retrieved, 11 met the inclusion criteria for review. Each included article was individually reviewed and coded according to the framework. Results. The reviewed articles were primarily influenced by contemporary drivers of change (eg, shifting demographics in the United States), focused on enhancing the compositional diversity of colleges and schools of pharmacy, examined the experiences of underrepresented groups, and suggested process improvement recommendations. Conclusion. There is limited published educational research concerning diversity within schools and colleges of pharmacy. Contemporary drivers of change are influencing this research, but more attention must be given to the focus of the research, individuals targeted, and recommendations suggested.


Asunto(s)
Curriculum/normas , Educación en Farmacia/normas , Publicaciones/normas , Facultades de Farmacia/normas , Humanos , Estudiantes de Farmacia
16.
J Atten Disord ; 21(2): 110-119, 2017 01.
Artículo en Inglés | MEDLINE | ID: mdl-24071772

RESUMEN

OBJECTIVE: To examine efficacy and safety of adjunctive guanfacine extended release (GXR) on morning and evening ADHD symptoms using the Conners' Global Index-Parent (CGI-P) and Before-School Functioning Questionnaire (BSFQ). METHOD: Participants 6 to 17 years with ADHD ( N = 461) and suboptimal psychostimulant response were maintained on current psychostimulants and randomized to dose-optimized GXR (≤4 mg/d) in the morning (GXR AM) or evening (GXR PM), or placebo. RESULTS: CGI-P scores improved with GXR (morning assessment, GXR AM, placebo-adjusted least squares [LS] mean = -1.7, GXR PM = -2.6; evening assessment, GXR AM = -2.4, GXR PM = -3.0; all ps < .01). Parent-rated BSFQ scores reflected improved morning functioning with GXR (GXR AM, placebo-adjusted LS mean = -5.1; GXR PM = -4.7; both ps < .01). Most adverse events were mild or moderate. CONCLUSION: Adjunctive GXR AM or GXR PM was associated with improvements in morning and evening ADHD symptoms in children and adolescents.


Asunto(s)
Agonistas de Receptores Adrenérgicos alfa 2/administración & dosificación , Trastorno por Déficit de Atención con Hiperactividad/tratamiento farmacológico , Estimulantes del Sistema Nervioso Central/administración & dosificación , Guanfacina/administración & dosificación , Adolescente , Agonistas de Receptores Adrenérgicos alfa 2/efectos adversos , Anfetamina/administración & dosificación , Anfetamina/efectos adversos , Análisis de Varianza , Estimulantes del Sistema Nervioso Central/efectos adversos , Niño , Preparaciones de Acción Retardada , Relación Dosis-Respuesta a Droga , Método Doble Ciego , Esquema de Medicación , Quimioterapia Combinada , Femenino , Guanfacina/efectos adversos , Humanos , Masculino , Metilfenidato/administración & dosificación , Metilfenidato/efectos adversos , Padres , Instituciones Académicas , Resultado del Tratamiento
17.
Am J Pharm Educ ; 80(7): S6, 2016 Sep 25.
Artículo en Inglés | MEDLINE | ID: mdl-27756938

RESUMEN

The 2015-2017 AACP Special Taskforce on Diversifying our Investment in Human Capital was appointed for a two-year term, therefore the interim update from the Taskforce. A full report will be provided in 2017 in the form of a white paper for academic pharmacy on diversifying our investment in human capital.


Asunto(s)
Educación en Farmacia , Sociedades Farmacéuticas , Comités Consultivos , Estados Unidos
18.
Int J Med Educ ; 7: 1-5, 2016 Jan 03.
Artículo en Inglés | MEDLINE | ID: mdl-26724917

RESUMEN

OBJECTIVE: This study explored new models of diversity for health professions education that incorporate multiple attributes and examined differences in diversity based on urbanicity, geographic region, and institutional structure. METHODS: Simpson's Diversity Index was used to develop race, gender, and interprofessional diversity indices for health professions schools in the United States (N = 318). Sullivan's extension was used to develop a composite diversity index that incorporated multiple individual attributes for each school. Pearson's r was used to investigate correlations between continuous variables. ANOVA and independent t-tests were used to compare groups based on urbanicity, geographic region, and Basic Carnegie Classification. RESULTS: Mean (SD) for race, gender, and interprofessional diversity indices were 0.36(0.17), 0.45(0.07), and 0.22(0.27) respectively. All correlations between the three indices were weak. The composite diversity index for this sample was 0.34(0.13). Significant differences in diversity were found between institutions based on urbanicity, Basic Carnegie Classification, and geographic region. CONCLUSIONS: Multidimensional models provide support for expanding measures of diversity to include multiple characteristics and attributes. The approach demonstrated in this study enables institutions to complement and extend traditional measures of diversity as a means of providing evidence for decision-making and progress towards institutional initiatives.


Asunto(s)
Diversidad Cultural , Empleos en Salud/educación , Modelos Teóricos , Escuelas para Profesionales de Salud/estadística & datos numéricos , Femenino , Humanos , Masculino , Grupos Raciales/estadística & datos numéricos , Distribución por Sexo , Estudiantes/estadística & datos numéricos , Estados Unidos
19.
J Am Acad Child Adolesc Psychiatry ; 53(10): 1092-101, 2014 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-25245353

RESUMEN

OBJECTIVE: In this post hoc analysis, we assessed whether guanfacine extended-release (GXR) adjunctive to a psychostimulant resulted in greater response and remission rates than placebo + psychostimulant in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). METHOD: In this 9-week, double-blind, placebo-controlled dose-optimization study, participants (N = 461) aged 6 to 17 years with suboptimal response to psychostimulants were randomized to GXR on awakening (AM) + psychostimulant, GXR at bedtime (PM) + psychostimulant, or placebo + psychostimulant. RESULTS: At the final on-treatment assessment, more participants in both GXR + psychostimulant groups versus the placebo + psychostimulant group achieved response as assessed by 2 criteria: reduction from baseline in ADHD Rating Scale IV (ADHD-RS-IV) total score (1) ≥40% (GXR AM + psychostimulant = 69.8%, GXR PM + psychostimulant = 70.3%, versus placebo + psychostimulant = 57.9%; p = .032 and p = .026, respectively), or (2) ≥50% (63.1%, 64.9%, versus 43.4%; p <.001 for both). Results were similar for symptomatic remission (ADHD-RS-IV total score ≤18; 61.1%, 62.2%, versus 46.1%; p = .010 and p = .005, respectively) and syndromal remission (symptomatic remission plus Clinical Global Impressions of Severity of Illness score ≤2). The most common treatment-emergent adverse events in participants receiving GXR + psychostimulant were headache (21.2%) and somnolence (13.6%). CONCLUSION: GXR + psychostimulant treatment resulted in a greater percentage of participants meeting stringent criteria for response and remission compared with placebo + psychostimulant. The adverse event profile of adjunctive therapy was consistent with known effects of either treatment alone. Clinical trial registration information-Efficacy and Safety of SPD503 in Combination With Psychostimulants; http://clinicaltrials.gov/; NCT00734578.


Asunto(s)
Agonistas de Receptores Adrenérgicos alfa 2/farmacología , Trastorno por Déficit de Atención con Hiperactividad/tratamiento farmacológico , Estimulantes del Sistema Nervioso Central/uso terapéutico , Guanfacina/farmacología , Adolescente , Agonistas de Receptores Adrenérgicos alfa 2/administración & dosificación , Agonistas de Receptores Adrenérgicos alfa 2/efectos adversos , Niño , Quimioterapia Combinada , Femenino , Guanfacina/administración & dosificación , Guanfacina/efectos adversos , Humanos , Masculino , Resultado del Tratamiento
20.
J Child Adolesc Psychopharmacol ; 24(5): 245-52, 2014 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-24945085

RESUMEN

OBJECTIVE: The purpose of this study was to assess the effect of guanfacine extended release (GXR) adjunctive to a psychostimulant on oppositional symptoms in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). METHODS: A multicenter, double-blind, placebo-controlled dose-optimization study of GXR (1-4 mg/d) or placebo administered morning (a.m.) or evening (p.m.) adjunctive to psychostimulant was conducted in subjects ages 6-17 with suboptimal response to psychostimulant alone. Suboptimal response was defined as treatment with a stable dose of psychostimulant for ≥4 weeks with ADHD Rating Scale IV total score ≥24 and Clinical Global Impressions-Severity of Illness score ≥3, as well as investigator opinion. Primary efficacy and safety results have been reported previously. Secondary efficacy measures included the oppositional subscale of the Conners' Parent Rating Scale-Revised: Long Form (CPRS-R:L); these are reported herein. RESULTS: Significant reductions from baseline to the final on-treatment assessment on the oppositional subscale of the CPRS-R:L were seen with GXR plus psychostimulant compared with placebo plus psychostimulant, both in the overall study population (placebo-adjusted least squares [LS] mean change from baseline to the final on-treatment assessment: GXR a.m.+psychostimulant, -2.4, p=0.001; GXR p.m.+psychostimulant, -2.2, p=0.003) as well as in the subgroup of subjects with significant baseline oppositional symptoms (GXR a.m.+psychostimulant, -3.6, p=0.001; GXR p.m.+psychostimulant, -2.7, p=0.013). Treatment-emergent adverse events were reported by 77.3%, 76.3%, and 63.4% of subjects in the GXR a.m., GXR p.m., and placebo groups, respectively, in the overall study population. CONCLUSIONS: GXR adjunctive to a psychostimulant significantly reduced oppositional symptoms compared with placebo plus a psychostimulant in subjects with ADHD and a suboptimal response to psychostimulant alone.


Asunto(s)
Trastorno por Déficit de Atención con Hiperactividad/tratamiento farmacológico , Déficit de la Atención y Trastornos de Conducta Disruptiva/tratamiento farmacológico , Estimulantes del Sistema Nervioso Central/uso terapéutico , Guanfacina/uso terapéutico , Adolescente , Agonistas de Receptores Adrenérgicos alfa 2/administración & dosificación , Agonistas de Receptores Adrenérgicos alfa 2/uso terapéutico , Trastorno por Déficit de Atención con Hiperactividad/complicaciones , Trastorno por Déficit de Atención con Hiperactividad/fisiopatología , Déficit de la Atención y Trastornos de Conducta Disruptiva/complicaciones , Déficit de la Atención y Trastornos de Conducta Disruptiva/fisiopatología , Estimulantes del Sistema Nervioso Central/administración & dosificación , Niño , Preparaciones de Acción Retardada , Relación Dosis-Respuesta a Droga , Método Doble Ciego , Esquema de Medicación , Quimioterapia Combinada , Femenino , Guanfacina/administración & dosificación , Humanos , Masculino , Escalas de Valoración Psiquiátrica , Índice de Severidad de la Enfermedad
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