NCT01316952

Coreg and HSRs-Updated Analysis

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Hypersensitivity

Interventions

Type	Name	Description
DRUG	Carvedilol immediate release only	All dosages of carvedilol immediate release
DRUG	Carvedilol extended release only	All dosages of carvedilol extended release
DRUG	Long acting β-blockers	All dosages of LA propranolol and SA metoprolol
DRUG	Other α1/β-adrenergic antagonists	i.e., labetalol. All dosages. Excluding carvedilol immediate release and carvedilol extended release.
DRUG	Short acting Non-selective β-blockers and short acting β1-Selective agents	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)
OTHER	No β-blocker	No β-blocker within the month prior to the index date

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2011-03-16
• Last updated: 2015-04-15