Use of Beta-blockers and Risk of New Onset Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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Use of Beta-blockers and Risk of New Onset Diabetes

Conditions
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Hypertension

Intervention / Treatment
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* Drug: carvedilol
* Drug: cardio selective betablocker


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hypertensive users of Beta blocker<br>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<br>* carvedilol immediate-release (IR) and carvedilol controlled-release (CR)<br>* Other names: carvedilol immediate-release (IR) and carvedilol controlled-release;Drug: cardio selective betablocker<br>* atenolol, metoprolol succinate, and metoprolol tartrate<br>* Other names: and metoprolol tartrate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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new-onset diabetes, carvedilol, claims analysis, beta-blocker, Diabetes Mellitus