Coreg and HSRs-Updated Analysis

Completed

• Conditions: Hypersensitivity
• Interventions: Drug: Carvedilol immediate release only; Drug: Carvedilol extended release only; Drug: Long acting β-blockers; Drug: Other α1/β-adrenergic antagonists; Drug: Short acting Non-selective β-blockers and short acting β1-Selective agents; Other: No β-blocker

• Registration Number: NCT01316952
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Study First Submitted: 2011-03-15
• Study First Submitted QC: 2011-03-15
• Study First Posted: 2011-03-16
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-14
• Last Update Posted: 2015-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• 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

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LabRx database Oct. 1st 2004 to Sep. 30th 2009	Carvedilol immediate release only	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.
LabRx database Oct. 1st 2004 to Sep. 30th 2009	No β-blocker	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.
LabRx database Oct. 1st 2004 to Sep. 30th 2009	Other α1/β-adrenergic antagonists	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.
LabRx database Oct. 1st 2004 to Sep. 30th 2009	Carvedilol extended release only	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.
LabRx database Oct. 1st 2004 to Sep. 30th 2009	Long acting β-blockers	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.
LabRx database Oct. 1st 2004 to Sep. 30th 2009	Short acting Non-selective β-blockers and short acting β1-Selective agents	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.

Primary Outcome Measures

Name	Time	Method
Hypersensitivity reactions (anaphylactic reaction/ angioedema)	Hypersensitivity reactions among users in the LabRx database between Oct. 1st 2004 to Sep. 30th 2009