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Use of Beta-blockers and Risk of New Onset Diabetes

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ClinicalTrials.gov Identifier: NCT01587638
Recruitment Status : Completed
First Posted : April 30, 2012
Last Update Posted : April 30, 2012
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment
Hypertension Drug: carvedilol Drug: cardio selective betablocker

Study Design
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Study Type : Observational
Actual Enrollment : 12336 participants
Time Perspective: Retrospective
Official Title: Use of Beta-blockers and Risk of New Onset Diabetes
Study Start Date : April 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

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Groups and Cohorts
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Group/Cohort Intervention/treatment
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
 Drug: carvedilol
carvedilol immediate-release (IR) and carvedilol controlled-release (CR)
Other Name: carvedilol immediate-release (IR) and carvedilol controlled-release

Drug: cardio selective betablocker
atenolol, metoprolol succinate, and metoprolol tartrate
Other Names:
  • atenolol
  • metoprolol succinate
  • and metoprolol tartrate


Outcome Measures
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Primary Outcome Measures :
  1. Rate of New Onset Diabetes (NOD) [ Time Frame: From index event (BB prescription) to NOD outcome event (DM diagnosis or antidiabetic Rx) during the effective dates of the database (up to 7 years) ]
    Rate of NOD per 100 person years. NOD was defined as at least two medical claims with a Diabetes Mellitus diagnosis (ICD-9-CM: 250.xx) or a prescription fill of an antidiabetic medication


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This retrospective database study identified patients aged ≥18 years with at least one pharmacy claim for a beta-blocker of interest (carvedilol immediate-release [IR]/controlled-release [CR], atenolol, metoprolol succinate, or metoprolol tartrate) identified in the IMS LifeLink Health Plan Claims Database. Index date was the first chronologically occurring prescription for any beta-blocker during the enrollment period (July 1, 2000-December 31, 2007). Patients were identified if they were continuously eligible to receive healthcare services 6 months prior to and 3 months after the index date and at least 1 diagnosis of hypertension (ICD-9-CM: 401.xx-405.xx) during this time frame.
Criteria

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
Contacts and Locations
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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): NCT01587638


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

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01587638     History of Changes
Other Study ID Numbers: 111198
First Posted: April 30, 2012    Key Record Dates
Last Update Posted: April 30, 2012
Last Verified: April 2012
Keywords provided by GlaxoSmithKline:
new-onset diabetes
carvedilol
claims analysis
beta-blocker
Diabetes Mellitus
Additional relevant MeSH terms:
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Atenolol
Hypertension
Vascular Diseases
Cardiovascular Diseases
Metoprolol
Carvedilol
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antioxidants
Protective Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists