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OBJECTIVE: To review the pharmacology and clinical data for brexpiprazole in schizophrenia and major depressive disorder (MDD). DATA SOURCES: An English-language literature search using PubMed and MEDLINE was performed using the term brexpiprazole. All articles containing human clinical trial data published up to September 2016 were evaluated for inclusion as well as information from the manufacturer's product labeling. STUDY SELECTION/DATA EXTRACTION: Phase 3 trials for brexpiprazole were evaluated. Key in vitro and animal data were incorporated into the pharmacology and pharmacokinetic sections where appropriate. DATA SYNTHESIS: Four phase 3 trials have evaluated the use of brexpiprazole as a primary therapy for schizophrenia or as an antidepressant adjunct for MDD. For its schizophrenia indication, brexpiprazole was studied in 2 placebo-controlled trials of approximately 1300 patients, with 4 mg of brexpiprazole consistently showing superiority over placebo. For MDD, brexpiprazole was compared with placebo as an adjunct to antidepressants in approximately 1000 patients who had failed trials of 1 to 3 prior antidepressants. The 2-mg and 3-mg dosages of brexpiprazole showed consistent superiority over placebo in the MDD trials. Common treatment emergent adverse effects included akathisia and weight gain. CONCLUSIONS: Brexpiprazole showed efficacy for the treatment of schizophrenia in the range of 2 to 4 mg/d and as an adjunct to antidepressant therapy in MDD when dosed at 2 to 3 mg/d. Advantages of this drug include once-daily dosing, good tolerability, and lack of effect on sexual function. Disadvantages include the lack of long-term safety data and potentially high cost.
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Antipsicóticos/uso terapêutico , Transtorno Depressivo Maior/tratamento farmacológico , Quinolonas/uso terapêutico , Esquizofrenia/tratamento farmacológico , Tiofenos/uso terapêutico , Antidepressivos/administração & dosagem , Antidepressivos/efeitos adversos , Antidepressivos/uso terapêutico , Antipsicóticos/administração & dosagem , Antipsicóticos/efeitos adversos , Antipsicóticos/farmacocinética , Ensaios Clínicos Fase III como Assunto , Transtorno Depressivo Maior/metabolismo , Quimioterapia Combinada , Humanos , Quinolonas/administração & dosagem , Quinolonas/efeitos adversos , Quinolonas/farmacocinética , Receptor 5-HT1A de Serotonina/metabolismo , Receptores de Dopamina D2/agonistas , Esquizofrenia/metabolismo , Tiofenos/administração & dosagem , Tiofenos/efeitos adversos , Tiofenos/farmacocinética , Aumento de Peso/efeitos dos fármacosRESUMO
OBJECTIVE: To outline an approach to help students achieve Entrustable Professional Activities (EPAs) entrustment during a sequence of Advanced Pharmacy Practice Experiences (APPEs) by implementing longitudinal monitoring and individualized intervention and remediation strategies. METHODS: Using the recommended EPAs within the core APPEs (Acute Care, Ambulatory Care, Community, Institutional), students were expected to achieve entrustment on all EPAs by graduation. A longitudinal monitoring approach, using an "EPA report card," was implemented to continuously identify students at risk of not meeting the EPA requirement of "Level 3" entrustment (perform with reactive supervision). Individualized interventions, including Proactive Outreach and In-Sequence Remediation were incorporated into the APPE core and elective sequence to help ensure all students were entrusted by end of APPEs without requiring further end of year remediation to graduate. RESULTS: For the graduating classes of 2023 and 2024, 12% (8/69) and 16% (12/75) students respectively were identified as at risk of not meeting EPA entrustment. Proactive Outreach, In-Sequence Remediation, or a combination of both strategies, were utilized to enhance learning and EPA performance. As a result, all students achieved "Level 3" entrustment on the deficient EPA(s) by the end of the APPE sequence. No student required further end of year remediation to graduate. CONCLUSION: Utilizing a multi-faceted strategy provided timely, real world practice opportunities to improve students' achievement of EPAs across the APPE curriculum and decreased the need for end of year remediation and potential graduation delays.
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This report describes a case of concomitant treatment of advanced diffuse large B-cell lymphoma with chemoimmunotherapy along with direct-acting antivirals for hepatitis C virus in a patient coinfected with HIV. The patient tolerated gemcitabine, dexamethasone, cisplatin, and rituximab and achieved sustained virologic response after treatment with ledipasvir/sofosbuvir.
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Antivirais/uso terapêutico , Coinfecção/tratamento farmacológico , Infecções por HIV/tratamento farmacológico , Hepatite C/tratamento farmacológico , Linfoma de Células B/tratamento farmacológico , Coinfecção/virologia , Quimioterapia Combinada , Hepacivirus/efeitos dos fármacos , Humanos , Linfoma de Células B/diagnóstico por imagem , Linfoma de Células B/virologia , Masculino , Pessoa de Meia-Idade , Resposta Viral Sustentada , Tomografia Computadorizada por Raios X , Resultado do TratamentoRESUMO
INTRODUCTION: Few qualitative studies have explored the attitude of prescribers towards the implementation of pharmacogenomic testing in the family medicine (FM) setting, and none among FM residents. The purpose of this study was to describe the level of engagement and interest in the implementation of pharmacogenomic education and testing in an FM clinic within a residency program. METHODS: A qualitative study utilizing semistructured interviews was conducted among prescribers within the FM clinic at The Brooklyn Hospital Center (TBHC). Voluntary prescribers included FM residents and attendings. No prescribers were excluded. Prior to the interview, informational sheets about pharmacogenomics were provided to standardize participant knowledge base. The research team created an interview guide of specific open-ended questions. Interviews were audio recorded and transcribed until a point of saturation was achieved. Transcripts of interviews served as data for analysis. Coding and analysis were performed to develop a hypothesis. No formal statistical analysis was required. RESULTS: Of the total 28 providers eligible for participation, 15 were recruited and interviewed (53% response rate). Based on analysis of interview data, four key conceptual concerns emerged regarding benefits and risks of testing, feasibility, accessibility, and modification of FM residency training curricula. CONCLUSION: Positive attitudes and perceptions provide support for pharmacogenomic education and testing to be incorporated into FM residency curricula. Addressing practical barriers, such as curricular education and training, will allow for expansion of such initiatives in the future.
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BACKGROUND: The use of adjunct, non-opioid agents is integral for pain control following total hip and knee arthroplasty. Literature comparing safety profiles of intravenous acetaminophen versus opioids is lacking. OBJECTIVE: To determine whether there is a difference in frequency and type of adverse effects between intravenous acetaminophen-treated and non-intravenous acetaminophen-treated patients. Primary safety endpoints included any adverse effect noted in the electronic medical record post-surgically. Secondary endpoints included changes in laboratory values, vital signs, and pain scores. METHODS: This is a retrospective, matched, cohort study with data collected from electronic medical records. Adverse effects were collected from progress notes, nursing notes, and post-operative notes. Mean pain score was measured by the 11-point visual analog scale over a 72-h period. RESULTS: A total of 609 patients who underwent a total hip or knee replacement were included. In all, 406 patients were treated with intravenous acetaminophen, and 203 patients received medication management without intravenous acetaminophen. More patients treated with intravenous acetaminophen experienced an adverse effect compared to patients who did not receive intravenous acetaminophen (91.63% versus 84.73%; p = 0.012). Mean cumulative acetaminophen exposure was similar in the intravenous acetaminophen group (7704.89 ± 2558.6 versus 7260.1 ± 3016.09 mg; p = 0.07). Mean opioid use was similar in the intravenous acetaminophen group as compared to the non-intravenous acetaminophen group (209.61 ± 555.09 versus 163.89 ± 232.44 mg; p = 0.152). Significantly higher mean pain scores were found in the intravenous acetaminophen group during the 72-h post-surgery period as compared with non-intravenous acetaminophen-treated patients. CONCLUSION: The increased utilization of intravenous acetaminophen in multimodal pain management did not result in an improved safety or tolerability profile or reduced opioid utilization in orthopedic patients.