Use of Beta-blockers and Risk of New Onset Diabetes

NCT01587638 | Completed

• 1 other identifier: 111198
• Study Type: observational
• Target: 12,336
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertension

Keywords

new-onset diabetes; carvedilol; claims analysis; beta-blocker; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

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; Drug: cardio selective betablocker

Interventions

carvedilol DRUG

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

Also known as: carvedilol immediate-release (IR) and carvedilol controlled-release

Hypertensive users of Beta blocker

cardio selective betablocker DRUG

atenolol, metoprolol succinate, and metoprolol tartrate

Also known as: atenolol, metoprolol succinate, and metoprolol tartrate

Hypertensive users of Beta blocker

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This retrospective database study identified patients aged ≥18 years with at least one pharmacy claim for a beta-blocker of interest (carvedilol immediate-release \[IR\]/controlled-release \[CR\], atenolol, metoprolol succinate, or metoprolol tartrate) identified in the IMS LifeLink Health Plan Claims Database. Index date was the first chronologically occurring prescription for any beta-blocker during the enrollment period (July 1, 2000-December 31, 2007). Patients were identified if they were continuously eligible to receive healthcare services 6 months prior to and 3 months after the index date and at least 1 diagnosis of hypertension (ICD-9-CM: 401.xx-405.xx) during this time frame.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related Publications (1)

• Fonseca V, Sharma PP, Shah M, Deedwania P. Risk of new-onset diabetes mellitus associated with beta-blocker treatment for hypertension. Curr Med Res Opin. 2011 Apr;27(4):799-807. doi: 10.1185/03007995.2011.555477. Epub 2011 Feb 10.

  PMID: 21306286 RESULT

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus

Interventions

Carvedilol; Atenolol; Metoprolol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Phenoxypropanolamines

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2011
• First Posted: April 30, 2012
• Study Start: April 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: April 30, 2012

Record last verified: 2012-04