Coreg and HSRs-Updated Analysis

GlaxoSmithKline (GSK)

Status

Completed

Conditions

Hypersensitivity

Treatments

Drug: Carvedilol extended release only

Drug: Carvedilol immediate release only

Other: No β-blocker

Drug: Other α1/β-adrenergic antagonists

Drug: Long acting β-blockers

Drug: Short acting Non-selective β-blockers and short acting β1-Selective agents

Study type

Observational

Funder types

Industry

Identifiers

NCT01316952

114522

WEUSRTP4862 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

1 patient

Sex

All

Volunteers

No 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