Use of Beta-blockers and Risk of New Onset Diabetes

NCT ID: NCT01587638

Last Updated: 2012-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12336 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-12-31

Brief Summary

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This study used an observational, retrospective cohort design to compare the presence and timing of new-onset diabetes (NOD) between hypertensive patients initiating therapy with carvedilol immediate-release (IR) and carvedilol controlled-release (CR) vs the following cardioselective beta blockers (BBs): atenolol, metoprolol succinate, and metoprolol tartrate (referred to hereafter as 'other BB').

The aim of the study was to investigate the likelihood of developing NOD among hypertensive patients initiating carvedilol therapy vs other BB therapy in a real world setting derived from data contained in a large United States (US) managed care database.

Detailed Description

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Conditions

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Hypertension

Keywords

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new-onset diabetes carvedilol claims analysis beta-blocker Diabetes Mellitus

Study Design

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Study Time Perspective

RETROSPECTIVE

Study Groups

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Hypertensive users of Beta blocker

Patients aged ≥18 years and at least 1 diagnosis of hypertension (ICD-9-CM: 401.xx-405.xx) during this time frame in a US Managed care population

carvedilol

Intervention Type DRUG

carvedilol immediate-release (IR) and carvedilol controlled-release (CR)

cardio selective betablocker

Intervention Type DRUG

atenolol, metoprolol succinate, and metoprolol tartrate

Interventions

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carvedilol

carvedilol immediate-release (IR) and carvedilol controlled-release (CR)

Intervention Type DRUG

cardio selective betablocker

atenolol, metoprolol succinate, and metoprolol tartrate

Intervention Type DRUG

Other Intervention Names

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carvedilol immediate-release (IR) and carvedilol controlled-release atenolol metoprolol succinate and metoprolol tartrate

Eligibility Criteria

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Inclusion Criteria

* Enrollment in a plan captured in the IMS LifeLink Health Plan Claims Database between July 1, 2000 and December 31, 2007
* aged ≥18 years
* at least one pharmacy claim for a beta-blocker of interest (carvedilol immediate-release \[IR\]/controlled-release \[CR\], atenolol, metoprolol succinate, or metoprolol tartrate)
* Index date was the first chronologically occurring prescription for any beta-blocker during the enrollment period
* Continuously eligible to receive healthcare services 6 months prior to and 3 months after the index date
* at least 1 diagnosis of hypertension (International Classification of Disease, 9th Revision, Clinical Modification (ICD-9-CM): 401.xx-405.xx) during this time frame.

Exclusion Criteria

* Diagnosis of diabetes mellitus (ICD-9-CM: 250.xx) and/or a prescription for antidiabetic therapy in the 6 months prior to and/or 3 months after the index date
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

References

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Fonseca V, Sharma PP, Shah M, Deedwania P. Risk of new-onset diabetes mellitus associated with beta-blocker treatment for hypertension. Curr Med Res Opin. 2011 Apr;27(4):799-807. doi: 10.1185/03007995.2011.555477. Epub 2011 Feb 10.

Reference Type RESULT
PMID: 21306286 (View on PubMed)

Other Identifiers

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111198

Identifier Type: -

Identifier Source: org_study_id