Overview

Coreg and HSRs-Updated Analysis

Status:
Completed

Trial end date:
2011-03-01

Target enrollment:
0

Participant gender:
All

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.

Accepts Healthy Volunteers?

Details

Lead Sponsor:

GlaxoSmithKline

Treatments:

Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-Antagonists
Carvedilol
Propranolol

Criteria

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