Coreg and HSRs-Updated Analysis

Study Overview
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Brief Summary
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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.

Official Title
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A Nested Case-control Study of the Association Between Coreg IR and Coreg CR and Hypersensitivity Reactions: Anaphylactic Reaction/Angioedema-Updated Analysis

Conditions
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Hypersensitivity

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: None
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LabRx database Oct. 1st 2004 to Sep. 30th 2009<br>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. | Drug: Carvedilol immediate release only<br>* All dosages of carvedilol immediate release<br>Drug: Carvedilol extended release only<br>* All dosages of carvedilol extended release<br>Drug: Long acting β-blockers<br>* All dosages of LA propranolol and SA metoprolol<br>Drug: Other α1/β-adrenergic antagonists<br>* i.e., labetalol. All dosages. Excluding carvedilol immediate release and carvedilol extended release.<br>Drug: Short acting Non-selective β-blockers and short acting β1-Selective agents<br>* All dosages of short acting non-selective β-Blockers (Carteolol, Levobunolol, Metipranolol, Nadolol, Penbutolol, Pindolol, Sotalol, Timolol) and short acting β1-Selective agents (Acebutolol, Atenolol, Betaxolol, Bisoprolol, Nebivolol)<br>Other: No β-blocker<br>* No β-blocker within the month prior to the index date<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypersensitivity reactions (anaphylactic reaction/ angioedema) |  | Hypersensitivity reactions among users in the LabRx database between Oct. 1st 2004 to Sep. 30th 2009 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carvedilol, propranolol, hypersensitivity reactions, beta- blockers, Coreg