Use of Beta-blockers and Risk of New Onset Diabetes

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Hypertension

Treatments: Drug: carvedilol; Drug: cardio selective betablocker

Study type: Observational

Funder types: Industry

Identifiers

NCT01587638

111198

Details and patient eligibility

About

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.

Enrollment: 12,336 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

12,336 participants in 1 patient group

Hypertensive users of Beta blocker

Description:

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

Treatment:

Drug: cardio selective betablocker

Drug: carvedilol