Stroke Risk Among Users of Typical vs. Atypical Antipsychotics Stratified by Broad Age Group, a Post-authorization Safety Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,234,412
- 试验地点
- 1
- 主要终点
- Number of Participants with Stroke as a Principal Inpatient Diagnosis
研究概览
简要总结
The purpose of this study is to extend the recent Food and Drug Administration (FDA) Sentinel tabulations regarding stroke risk among new users of typical and atypical antipsychotics to participants who were aged 18-64 years and did not have dementia to participants aged 65 years and older regardless of dementia status.
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
- •For entry event of an initial drug exposure:
- •First exposure to the particular drug(s) in the past 183 days (index date)
- •Had at least 183 days of continuous observation time prior to index
- •Exactly 0 condition occurrences of 'Cancer' any time in the 183 days before or on the index date
- •Exactly 0 condition occurrences of 'Stroke' any time in the 183 days before or on the index date
- •Exactly 0 exposures to any other typical or atypical antipsychotics any time in the 183 days before or on the index date
排除标准
- 未提供
研究组 & 干预措施
Target Cohort 1
Participants will be analyzed for stroke-risk who are new users of typical antipsychotics aged 18 to 64 years without a recent dementia diagnosis.
干预措施: Typical Antipsychotics (Drug)
Target Cohort 2
Participants will be analyzed for stroke-risk who are new users of haloperidol aged 18 to 64 years without a recent dementia diagnosis.
干预措施: Haloperidol (Drug)
Target Cohort 3
Participants will be analyzed for stroke-risk who are new users of typical antipsychotics aged greater than or equal to (>=) 65 years.
干预措施: Typical Antipsychotics (Drug)
Target Cohort 4
Participants will be analyzed for stroke-risk who are new users of haloperidol aged >= 65 year.
干预措施: Haloperidol (Drug)
Target Cohort 5
Participants will be analyzed for stroke-risk who are new users of typical antipsychotics aged 18 to 64 years.
干预措施: Typical Antipsychotics (Drug)
Target Cohort 6
Participants will be analyzed for stroke-risk who are new users of haloperidol aged 18 to 64 years.
干预措施: Haloperidol (Drug)
Comparator Cohort 7
Participants will be analyzed for stroke-risk who are new users of atypical antipsychotics aged 18-64 years without a recent dementia diagnosis.
干预措施: Atypical Antipsychotics (Drug)
Comparator Cohort 8
Participants will be analyzed for stroke-risk who are new users of atypical antipsychotics aged >= 65 years.
干预措施: Atypical Antipsychotics (Drug)
Comparator Cohort 9
Participants will be analyzed for stroke-risk who are new users of atypical antipsychotics aged 18-64 years.
干预措施: Atypical Antipsychotics (Drug)
结局指标
主要结局
Number of Participants with Stroke as a Principal Inpatient Diagnosis
时间窗: Up to 16 years (from 01-January-2002 through 31-December-2017)
Number of participants with stroke in each target cohort versus comparator cohort (aged 65 years and older) per person years at risk will be reported. It is defined defined by the presence of the relevant ICD codes (ICD-9 or ICD-10 according to date) in the inpatient setting as the primary diagnoses.
次要结局
- Number of Participants at Stroke Risk when Compared Among New Users of Typical Antipsychotics/Haloperidol versus Atypical Antipsychotics(Up to 16 years (from 01-January-2002 through 31-December-2017))