Coreg and HSRs-Updated Analysis

April 14, 2015 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
All dosages of carvedilol immediate release
Drug: Carvedilol extended release only
All dosages of carvedilol extended release
Drug: Long acting β-blockers
All dosages of LA propranolol and SA metoprolol
Drug: Other α1/β-adrenergic antagonists
i.e., labetalol. All dosages. Excluding carvedilol immediate release and carvedilol extended release.
Drug: Short 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)
Other: No β-blocker
No β-blocker within the month prior to the index date

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

March 15, 2011

First Submitted That Met QC Criteria

March 15, 2011

First Posted (Estimate)

March 16, 2011

Study Record Updates

Last Update Posted (Estimate)

April 15, 2015

Last Update Submitted That Met QC Criteria

April 14, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 114522
  • WEUSRTP4862 (Other Identifier: GSK)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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