Use of Beta-blockers and Risk of New Onset Diabetes

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT01587638

Collaborator

(none)

12,336

Enrollment

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: carvedilol Drug: cardio selective betablocker

Study Design

Study Type:

Observational

Actual Enrollment :

12336 participants

Time Perspective:

Retrospective

Official Title:

Use of Beta-blockers and Risk of New Onset Diabetes

Study Start Date :

Apr 1, 2009

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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

Arm

Intervention/Treatment

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 Names:

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

Outcome Measures

Primary Outcome Measures

Rate of New Onset Diabetes (NOD) [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)]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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