Use of Beta-blockers and Risk of New Onset Diabetes

Completed

• Conditions: Hypertension
• Interventions: Drug: carvedilol; Drug: cardio selective betablocker

• Registration Number: NCT01587638
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Study First Submitted: 2011-04-14
• Status Verified: 2012-04
• Study First Submitted QC: 2012-04-26
• Last Update Submitted: 2012-04-26
• Study First Posted: 2012-04-30
• Last Update Posted: 2012-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12336

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hypertensive users of Beta blocker	carvedilol	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
Hypertensive users of Beta blocker	cardio selective betablocker	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

Primary Outcome Measures

Name	Time	Method
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