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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
History of Changes
  Purpose

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 Intervention
Hypertension
 Drug: carvedilol
Drug: cardio selective betablocker

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Use of Beta-blockers and Risk of New Onset Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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


Enrollment: 12336
Study Start Date: April 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01587638

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

Publications:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01587638     History of Changes
Other Study ID Numbers: 111198
Study First Received: April 14, 2011
Last Updated: April 26, 2012
Health Authority: United States: No Health Authority

Keywords provided by GlaxoSmithKline:
new-onset diabetes
carvedilol
claims analysis
beta-blocker
Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Adrenergic beta-Antagonists
Atenolol
Metoprolol
Metoprolol succinate
Carvedilol
Adrenergic beta-1 Receptor Antagonists
Adrenergic Antagonists
Adrenergic Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists

ClinicalTrials.gov processed this record on May 16, 2013