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Coreg and HSRs-Updated Analysis

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ClinicalTrials.gov Identifier: NCT01316952
Recruitment Status : Completed
First Posted : March 16, 2011
Last Update Posted : April 15, 2015
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Hypersensitivity 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

Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: A Nested Case-control Study of the Association Between Coreg IR and Coreg CR and Hypersensitivity Reactions: Anaphylactic Reaction/Angioedema-Updated Analysis
Study Start Date : June 2010
Primary Completion Date : March 2011
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Anaphylaxis
U.S. FDA Resources

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01316952

Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01316952     History of Changes
Other Study ID Numbers: 114522
WEUSRTP4862 ( Other Identifier: GSK )
First Posted: March 16, 2011    Key Record Dates
Last Update Posted: April 15, 2015
Last Verified: April 2015

Keywords provided by GlaxoSmithKline:
hypersensitivity reactions
beta- blockers

Additional relevant MeSH terms:
Immune System Diseases
Adrenergic beta-Antagonists
Adrenergic Agents
Adrenergic Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists