Use of Beta-blockers and Risk of New Onset Diabetes
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: carvedilol (Drug); cardio selective betablocker (Drug)
Phase: N/A
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
Official title: Use of Beta-blockers and Risk of New Onset Diabetes
Study design: Time Perspective: Retrospective
Primary outcome: Rate of New Onset Diabetes (NOD)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: April 2009
Last updated: April 26, 2012
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