Coreg and HSRs-Updated Analysis

Hypersensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01316952
• Other study ID #: 114522
• Secondary ID: WEUSRTP4862
• Status: Completed
• Phase: N/A
• First received: March 15, 2011
• Last updated: April 14, 2015
• Start date: June 2010
• Est. completion date: March 2011

Study information

• Verified date: April 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: No Health Authority
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• At least one prescription claim for a ß-blocker during follow-up time available in the database.

• At least one month of enrollment in the healthcare plan

Exclusion Criteria:

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hypersensitivity

Intervention

Drug:
• Carvedilol immediate release only
All dosages of carvedilol immediate release
• Carvedilol extended release only
All dosages of carvedilol extended release
• Long acting ß-blockers
All dosages of LA propranolol and SA metoprolol
• Other a1/ß-adrenergic antagonists
i.e., labetalol. All dosages. Excluding carvedilol immediate release and carvedilol extended release.
• Short acting Non-selective ß-blockers and short acting ß1-Selective agents
All dosages of short acting non-selective ß-Blockers (Carteolol, Levobunolol, Metipranolol, Nadolol, Penbutolol, Pindolol, Sotalol, Timolol) and short acting ß1-Selective agents (Acebutolol, Atenolol, Betaxolol, Bisoprolol, Nebivolol)

Other:
• No ß-blocker
No ß-blocker within the month prior to the index date

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

References & Publications (1)

Koro CE, Sowell MD, Stender M. An assessment of the association between carvedilol exposure and severe hypersensitivity reactions, angioedema, and anaphylactic reactions: a retrospective nested case-control analysis. Clin Ther. 2012 Apr;34(4):870-7. doi: 10.1016/j.clinthera.2012.02.027. Epub 2012 Mar 22. — View Citation

Outcome

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