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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

Page last updated: August 23, 2015

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