The Current Landscape of Cobenfy (KarXT): Patient Characteristics, Treatment Patterns, and Healthcare Resource Utilization
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 6,876
- 试验地点
- 1
- 主要终点
- Number of participants with gastrointestinal adverse events
研究概览
简要总结
This study uses existing health records and insurance claims data to understand how adults in the United States are treated with KarXT, a medication for schizophrenia. It will describe who receives KarXT, how it is used in real-world practice, and how often healthcare services such as hospital visits are used. It will also explore information recorded by clinicians about schizophrenia symptoms
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants in the Veradigm EHR/claims-linked database with evidence of treatment with KarXT on or after September 24, 2024
- •Earliest KarXT treatment date = index date
- •Aged 18 years or older on index date
排除标准
- •Not applicable
研究组 & 干预措施
Adults treated with KarXT
Adults aged ≥18 years in the United States with at least one prescription for KarXT on or after September 24, 2024 identified in linked electronic health record and claims data.
干预措施: KarXT (xanomeline and trospium) (Drug)
结局指标
主要结局
Number of participants with gastrointestinal adverse events
时间窗: Baseline and up to 6 months
Number of all-cause and schizophrenia-related healthcare encounters per participant
时间窗: Baseline and up to 6 months
Number of inpatient admissions, emergency room visits, urgent care visits, and outpatient visits identified from claims and EHR data. Schizophrenia-related encounters are defined as those with a primary diagnosis of schizophrenia using ICD-10-CM codes.
Number of participants adherent to KarXT (proportion of days covered ≥80%)
时间窗: Baseline and up to 6 months
Adherence measured using proportion of days covered (PDC), defined as total days of KarXT supply divided by total number of days in the follow-up period. Participants with PDC ≥80% are classified as adherent. Reported as number and percentage of participants meeting adherence criteria.
Time to discontinuation of KarXT
时间窗: Baseline and up to 6 months
Time from index date (first KarXT prescription) to discontinuation, defined as a gap of ≥45 consecutive days without KarXT supply.
KarXT initial dose (index dose)
时间窗: Baseline
Distribution of index dose (50 mg/20 mg, 100 mg/20 mg, 125 mg/30 mg, or starter pack)
Number of of participants with dose increases or decreases
时间窗: Baseline and up to 6 months
Number of participants using concomitant antipsychotic and anticholinergic medications
时间窗: Baseline and up to 6 months
Number of participants with comorbidities
时间窗: Baseline and up to 6 months
Number of participants with documented schizophrenia symptoms
时间窗: Baseline and up to 6 months
Presence of positive and negative schizophrenia symptoms identified using natural language processing (NLP) of unstructured clinical notes, including hallucinations, delusions, disorganized thought, amotivation, avolition, anhedonia, asociality, alogia, and blunted affect.
次要结局
未报告次要终点