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Use of Beta-blockers and Risk of New Onset Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01587638
First received: April 14, 2011
Last updated: April 26, 2012
Last verified: April 2012

April 14, 2011
April 26, 2012
April 2009
December 2009   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: Yes ]
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
Same as current
Complete list of historical versions of study NCT01587638 on ClinicalTrials.gov Archive Site
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Use of Beta-blockers and Risk of New Onset Diabetes
Use of Beta-blockers and Risk of New Onset Diabetes

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.

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Observational
Time Perspective: Retrospective
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Non-Probability Sample

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.

Hypertension
  • 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
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
Interventions:
  • Drug: carvedilol
  • Drug: cardio selective betablocker
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12336
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT01587638
111198
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GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP