Use of Beta-blockers and Risk of New Onset Diabetes

GlaxoSmithKline12,336 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

12,336

Conditions

Hypertension

Interventions

carvedilolDRUG

carvedilol immediate-release (IR) and carvedilol controlled-release (CR)

cardio selective betablockerDRUG

atenolol, metoprolol succinate, and metoprolol tartrate

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Rate of New Onset Diabetes (NOD)

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

Time frame: 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)

Data from ClinicalTrials.gov

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