Coreg and HSRs-Updated Analysis

NCT01316952 | Completed

• 2 other identifiers: 114522WEUSRTP4862
• Study Type: observational
• Target: 1
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypersensitivity

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Hypersensitivity reactions (anaphylactic reaction/ angioedema)

  Hypersensitivity reactions among users in the LabRx database between Oct. 1st 2004 to Sep. 30th 2009

Study Arms (1)

LabRx database Oct. 1st 2004 to Sep. 30th 2009

The study cohort from which cases and controls are drawn is all subjects in the LabRx database between Oct. 1st 2004 to Sep. 30th 2009.

Drug: Carvedilol immediate release only; Drug: Carvedilol extended release only; Drug: Long acting β-blockers; Drug: Other α1/β-adrenergic antagonists; Drug: Short acting Non-selective β-blockers and short acting β1-Selective agents; Other: No β-blocker

Interventions

Carvedilol immediate release only DRUG

All dosages of carvedilol immediate release

LabRx database Oct. 1st 2004 to Sep. 30th 2009

Carvedilol extended release only DRUG

All dosages of carvedilol extended release

LabRx database Oct. 1st 2004 to Sep. 30th 2009

Long acting β-blockers DRUG

All dosages of LA propranolol and SA metoprolol

LabRx database Oct. 1st 2004 to Sep. 30th 2009

Other α1/β-adrenergic antagonists DRUG

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

LabRx database Oct. 1st 2004 to Sep. 30th 2009

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

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)

LabRx database Oct. 1st 2004 to Sep. 30th 2009

No β-blocker OTHER

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

LabRx database Oct. 1st 2004 to Sep. 30th 2009

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Derived from the LabRx database from Oct. 1st 2004 to Sep. 30th 2009. The LabRx Database (referred to in publications as the "i3 InVision Data Mart") is provided by Ingenix Pharmaceutical Services, Inc. It is a comprehensive, de-identified U.S. healthcare claims database that contains the aggregated health claims experience of the covered lives managed by United Healthcare. It contains only those covered lives for which there exists a combined benefit structure including medical and prescription coverage. Overall, it is representative of the non-elderly, insurance-carrying population in the U.S., but it also contains information on several hundred thousand Managed Medicaid and Medicare Advantage members. It contains inpatient, outpatient and pharmacy claims, lab results and enrolment information on over 30.5 million lives from October 2004 through September 2009.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related 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.

  PMID: 22444788 BACKGROUND

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2011
• First Posted: March 16, 2011
• Study Start: June 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: April 15, 2015

Record last verified: 2015-04