A Nested Case-control Study of the Association Between Coreg IR and Coreg CR and Hypersensitivity Reactions: Anaphylactic Reaction/Angioedema-Updated Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 主要终点
- Hypersensitivity reactions (anaphylactic reaction/ angioedema)
研究概览
简要总结
A cluster of reports of hypersensitivity reactions among patients who switched from carvedilol (immediate release formulation, referred to hereafter as carvedilol) to carvedilol extended release was received during the initial post-launch period of carvedilol extended release. In follow up to this observation, product labeling for both agents was updated and a nested case control study was subsequently conducted to examine the risk of serious hypersensitivity reactions i.e. anaphylactic reaction and/or angioedema among patients who used carvedilol extended release compared to carvedilol and separately compared to other long acting beta(β)-blockers. This proposed analysis is an update to the previously conducted analysis using the same database, LabRx, now containing 2 additional years of data, which should provide a larger number of carvedilol extended release exposed subjects.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least one prescription claim for a β-blocker during follow-up time available in the database.
- •At least one month of enrollment in the healthcare plan
排除标准
- 未提供
研究组 & 干预措施
LabRx database Oct. 1st 2004 to Sep. 30th 2009
The study cohort from which cases and controls are drawn is all subjects in the LabRx database between Oct. 1st 2004 to Sep. 30th 2009.
干预措施: Carvedilol immediate release only (Drug)
LabRx database Oct. 1st 2004 to Sep. 30th 2009
The study cohort from which cases and controls are drawn is all subjects in the LabRx database between Oct. 1st 2004 to Sep. 30th 2009.
干预措施: Carvedilol extended release only (Drug)
LabRx database Oct. 1st 2004 to Sep. 30th 2009
The study cohort from which cases and controls are drawn is all subjects in the LabRx database between Oct. 1st 2004 to Sep. 30th 2009.
干预措施: Long acting β-blockers (Drug)
LabRx database Oct. 1st 2004 to Sep. 30th 2009
The study cohort from which cases and controls are drawn is all subjects in the LabRx database between Oct. 1st 2004 to Sep. 30th 2009.
干预措施: Other α1/β-adrenergic antagonists (Drug)
LabRx database Oct. 1st 2004 to Sep. 30th 2009
The study cohort from which cases and controls are drawn is all subjects in the LabRx database between Oct. 1st 2004 to Sep. 30th 2009.
干预措施: Short acting Non-selective β-blockers and short acting β1-Selective agents (Drug)
LabRx database Oct. 1st 2004 to Sep. 30th 2009
The study cohort from which cases and controls are drawn is all subjects in the LabRx database between Oct. 1st 2004 to Sep. 30th 2009.
干预措施: No β-blocker (Other)
结局指标
主要结局
Hypersensitivity reactions (anaphylactic reaction/ angioedema)
时间窗: Hypersensitivity reactions among users in the LabRx database between Oct. 1st 2004 to Sep. 30th 2009
次要结局
未报告次要终点