Coreg and HSRs-Updated Analysis

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01316952
First received: March 15, 2011
Last updated: July 26, 2011
Last verified: July 2011
  Purpose

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 Intervention
Other Anaphylactic Shock
Hypersensitivity
Angioneurotic Edema
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
Study Design: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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

Enrollment: 0
Study Start Date: June 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01316952

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01316952     History of Changes
Other Study ID Numbers: 114522, WEUSRTP4862
Study First Received: March 15, 2011
Last Updated: July 26, 2011
Health Authority: United States: No Health Authority

Keywords provided by GlaxoSmithKline:
Coreg
carvedilol
propranolol
beta- blockers
hypersensitivity reactions

Additional relevant MeSH terms:
Anaphylaxis
Angioedema
Edema
Hypersensitivity
Shock
Hypersensitivity, Immediate
Immune System Diseases
Vascular Diseases
Cardiovascular Diseases
Urticaria
Skin Diseases, Vascular
Skin Diseases
Signs and Symptoms
Pathologic Processes
Adrenergic Agents
Carvedilol
Adrenergic Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Adrenergic beta-Antagonists
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists

ClinicalTrials.gov processed this record on July 22, 2014