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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01316952

Enrollment

Registered

2011-03-16

Start date

2010-06-30

Completion date

2011-03-31

Last updated

2015-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypersensitivity

Keywords

carvedilol, propranolol, hypersensitivity reactions, beta- blockers, Coreg

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.

Interventions

DRUGCarvedilol immediate release only

All dosages of carvedilol immediate release

DRUGCarvedilol extended release only

All dosages of carvedilol extended release

DRUGLong acting β-blockers

All dosages of LA propranolol and SA metoprolol

DRUGOther α1/β-adrenergic antagonists

i.e., labetalol. All dosages. Excluding carvedilol immediate release and carvedilol extended release.

DRUGShort 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)

OTHERNo β-blocker

No β-blocker within the month prior to the index date

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026