Publications by authors named "Layton J"

Introduction: The clinical landscape for the treatment of patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) is rapidly evolving. As part of the FOUNTAIN platform (NCT05526157; EUPAS48148), we described and compared cohorts of adult patients with CKD and T2D initiating a sodium-glucose cotransporter 2 inhibitor (SGLT2i) before the launch of finerenone in Europe, Japan, and the United States (US).

Methods: This was a multinational, multi-cohort study of patients with T2D in five data sources: the Danish National Health Registers (DNHR) (Denmark), PHARMO Data Network (The Netherlands), Valencia Health System Integrated Database (VID) (Spain), Japan Chronic Kidney Disease Database Extension (J-CKD-DB-Ex) (Japan), and Optum's de-identified Clinformatics Data Mart Database (CDM) (US).

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  • * A quality improvement project aimed at using academic detailing (AD) was conducted to educate primary care providers on screening, referral, and treatment for opioid use disorder, alongside available community resources.
  • * While the project did not lead to increased screening or prescribing practices for opioid use disorder, it successfully improved providers' knowledge of local resources, revealing time constraints as a key barrier to implementing such services.
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  • The study investigates Alzheimer's disease-related psychosis (ADP) in older adults, focusing on demographic and clinical differences between those treated with antipsychotics and those who are not.
  • Researchers analyzed data from over 145,000 ADP patients, comparing health outcomes related to falls, fractures, seizures, and mortality between the two groups.
  • Findings reveal that antipsychotic users had more baseline health issues and higher rates of falls, fractures, and mortality compared to nonusers, indicating a significant impact of antipsychotic treatment on health outcomes in ADP patients.
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Background: Real-world evidence (RWE) plays a key role in regulatory and healthcare decision-making, but the potentially fragmentated nature of generated evidence may limit its utility for clinical decision-making. Heterogeneity and a lack of reproducibility in RWE resulting from inconsistent application of methodologies across data sources should be minimized through harmonization.

Methods: This paper's aim is to describe and reflect upon a multidisciplinary research platform (FOUNTAIN; FinerenOne mUlti-database NeTwork for evidence generAtIoN) with coordinated studies using diverse RWE generation approaches and explore the platform's strengths and limitations.

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Marine science is widely recognized as one of the least diverse fields within geoscience. Despite substantial investments in diversity initiatives and resources aimed at engaging underserved communities, the representation and recognition of Black individuals in marine science remain limited. This lack of representation highlights a broader issue: a shortage of professionals who are attuned to the pressing issues within Black communities.

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Background: COVID-19 vaccines are authorized for use in children in the United States; real-world assessment of vaccine effectiveness in children is needed. This study's objective was to estimate the effectiveness of receiving a complete primary series of monovalent BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine in US children.

Methods: This cohort study identified children aged 5-17 years vaccinated with BNT162b2 matched with unvaccinated children.

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Background: People experiencing homelessness are at increased risk of infectious disease transmission due to congregate living conditions, barriers to healthcare, and excess burden of underlying chronic disease.

Objectives: We are a multisectoral community-academic partnership working to address the intersecting crises of homelessness and health disparities in Tippecanoe County, Indiana. We offer key recommendations for infectious disease preparedness and risk mitigation for homeless populations based on our ongoing community-based participatory research and lessons learned through COVID-19 response and Monkeypox preparations.

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Introduction: Influenza infections contribute to excess healthcare utilization, morbidity, and mortality in individuals with glomerular disease (GD); however, influenza vaccination may not yield protective immune responses in this high-risk patient population. The objective of the present study was to describe influenza vaccine administration from 2010 to 2019 and explore the effectiveness of influenza vaccination in patients with GD.

Methods: We conducted an observational cohort study using healthcare claims for seasonal influenza vaccination (exposure) as well as influenza and influenza-like illness (outcomes) from commercially insured children and adults <65 years of age with primary GD in the Merative MarketScan Research Databases.

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Background: Monovalent booster/additional doses of COVID-19 vaccines were first authorized in August 2021 in the United States. We evaluated the real-world effectiveness of receipt of a monovalent booster/additional dose of COVID-19 vaccine compared with receiving a primary vaccine series without a booster/additional dose.

Methods: Cohorts of individuals receiving a COVID-19 booster/additional dose after receipt of a complete primary vaccine series were identified in 2 administrative insurance claims databases (Optum, CVS Health) supplemented with state immunization information system data between August 2021 and March 2022.

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Lu-PSMA-617 and Lu-PSMA I&T (collectively termed Lu-PSMA) are currently being used for the treatment of selected metastatic castration-resistant prostate cancer (mCRPC) patients with PSMA PET-positive disease, but biomarkers for these agents remain incompletely understood. Pretreatment circulating tumor DNA (ctDNA) samples were collected from 44 mCRPC patients receiving Lu-PSMA treatment. Prostate-specific antigen responders and nonresponders were assessed relative to the ctDNA findings at baseline.

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Introduction: Intravenous immunoglobulin (IVIG) is recommended as first-line therapy for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), an immune-mediated neuropathy. The clinical profile of patients with CIDP newly initiating IVIG is poorly characterized. This claims-based cohort study describes characteristics of US patients with CIDP initiating IVIG treatment.

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Introduction: Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is a rare progressive or relapsing inflammatory disease. Intravenous immunoglobulin (IVIG) is recommended as a first-line therapy. The aim of this study was to describe real-world treatment patterns and outcomes of patients with CIDP in the Define initiating IVIG treatment.

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Article Synopsis
  • African American men are diagnosed with and die from prostate cancer at higher rates than Caucasian men, and genetic differences, specifically higher rates of CDK12 somatic mutations, may contribute to this disparity.
  • A study analyzing ctDNA in metastatic castration-resistant prostate cancer (mCRPC) between these two groups found that African American men exhibited significantly more pathogenic mutations and frameshift mutations after treatment with abiraterone and/or enzalutamide.
  • The results suggest that the genetic differences observed in African American men could have implications for targeted treatments and personalized medicine in managing prostate cancer.
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Background: Accumulating evidence suggests that toxoplasmosis in immunocompetent hosts can be severe and life-threatening.

Methods: We performed a systematic review of severe toxoplasmosis cases in immunocompetent patients to gain insight into the epidemiology, clinical characteristics, radiological findings, and outcomes of these cases. We classified severe toxoplasmosis as cases with the symptomatic involvement of target organs (the lungs, central nervous system (CNS), and heart), disseminated disease, prolonged disease (>3 months), or a fatal outcome.

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Background: Bipolar androgen therapy (BAT) is a novel therapy known to be effective in a subset of men with metastatic castrate resistant prostate cancer (mCRPC). A better understanding of responders and nonresponders to BAT would be useful to clinicians considering BAT therapy for patients. Herein we analyze clinical and genetic factors in responders/nonresponders to better refine our understanding regarding which patients benefit from this innovative therapy.

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Introduction: At the time of dapagliflozin's approval in Europe (2012) to treat patients with type 2 diabetes mellitus, concerns regarding acute liver injury and severe complications of urinary tract infection (sUTI) led to two post-authorization safety (PAS) studies of these outcomes to monitor the safety of dapagliflozin in real-world use.

Objective: To investigate the incidence of hospitalization for acute liver injury (hALI) or sUTI (pyelonephritis or urosepsis) among patients initiating dapagliflozin compared with other glucose-lowering drugs (GLDs).

Methods: These two noninterventional cohort studies identified initiators of dapagliflozin and comparator GLDs in November 2012-February 2019 using data from three longitudinal, population-based data sources: Clinical Practice Research Datalink (UK), the HealthCore Integrated Research Database (USA), and the Medicare database (USA).

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Introduction: Dapagliflozin is a sodium-glucose cotransporter 2 inhibitor approved to treat type 2 diabetes mellitus (T2DM), among other conditions. When dapagliflozin was approved in Europe for treating T2DM (2012), potential safety concerns regarding its effect on kidney function resulted in this post-authorization safety study to assess hospitalization for acute kidney injury (hAKI) among dapagliflozin initiators in a real-world setting.

Objective: The aim of this study was to evaluate the incidence of hAKI in adults with T2DM initiating dapagliflozin compared with other glucose-lowering drugs (GLDs).

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Introduction: Pimavanserin is approved in the USA to treat hallucinations and delusions associated with Parkinson's disease psychosis (PDP).

Objectives: We evaluated mortality in patients with PDP after initiation of pimavanserin or comparator atypical antipsychotics, overall, over time, and across subgroups.

Methods: A cohort of patients aged ≥65 years in the USA with PDP newly initiating pimavanserin or a comparator atypical antipsychotic (clozapine, quetiapine, risperidone, olanzapine, aripiprazole, brexpiprazole) was identified in 2016-2019 Medicare claims data.

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Background: The results of rehabilitation trials are often not fully attained when the intervention is implemented beyond the initial trial. One of the key reasons is that a patients' ability and/or capacity to take part in their own healthcare is not considered in the trial design yet has significant impact on the outcomes during the implementation phase.

Body Of Text: We propose a shift from a therapist-focus to patient-focus in trial design, through addressing patient engagement as a core consideration in trials.

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Background: Prostate cancer (PC) rarely metastasizes to the central nervous system (CNS). In this retrospective single-institution study at a tertiary cancer center, we aimed to evaluate the clinical and genetic characteristics of advanced PC patients with CNS metastases.

Patients And Methods: Between January 2010 and March 2020, 12 out of 579 patients with extracranial metastatic PC were identified to have CNS metastases based on imaging, including six patients with brain metastases (BMs), five patients with dural metastases, and one unknown.

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Background: Black men are at higher risk for prostate cancer death. Previous studies showed a benefit of different therapies, including immune-based therapy, for Black men with metastatic prostate cancer. We sought to explore the efficacy of the PD-L1 inhibitor avelumab in Black men with metastatic castrate-resistant prostate cancer (mCRPC) progressing after abiraterone or enzalutamide.

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Background: Little is known about the incidence of clinical events and treatment patterns among older adults with dementia-related psychosis. Given that dementia-related psychosis comprises various dementia types, this study describes the incidence of clinical events and treatment patterns by dementia type after patients with dementia are diagnosed with psychosis.

Methods: Adults aged ≥ 65 years with dementia and newly diagnosed with psychosis were identified in US Medicare claims during 2013-2018.

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Treatment options for men with metastatic castration-resistant prostate cancer are rapidly changing. In addition to novel anti-androgens and taxane-based chemotherapy, radiopharmaceuticals are having an increasing role. Although calcium-mimetic theranostics have been in use for years, newer approaches use molecularly targeted radiation therapy by conjugating isotopes to prostate-specific membrane antigen (PSMA) and in so doing directly target prostate cancer cells; Lutetium-PSMA-617 is perhaps the best-known member of this new class.

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Purpose: Human epidermal growth factor receptor 2 (HER2)-targeted therapies improve survival for patients with HER2-positive breast cancer but carry risks of hematologic, cardiopulmonary, gastro-hepatobiliary, and other adverse events (AEs). In this review, we describe published AE incidences for HER2-targeted therapies for metastatic breast cancer (mBC).

Methods: We searched PubMed and Embase to identify studies on HER2-targeted therapies in HER2-positive mBC, reporting on AEs of special interest, and published between January 1, 2009, and February 6, 2020.

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