Economic Impact of Switching From Metoprolol to Nebivolol for Hypertension Treatment

NCT01758263 | Unknown

• 1 other identifier: NEB-HE-200
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

This is a retrospective data analysis of patients with high blood pressure (hypertension) who took metoprolol for a minimum of 6 months who then switched to taking nebivolol for a minimum of 6 month to treat hypertension. These patients will be identified from a large medical claims database. This study tests the hypothesis (alternative, higher or lower) that average patient monthly health care administrative cost changes after switching from metoprolol to nebivolol.

Conditions

Hypertension

Keywords

Hypertension; Health Care Cost; Monthly health care cost

Outcome Measures

Primary Outcomes (1)

• Patient monthly health care cost

  The average per patient monthly health care cost for the pre-specified hypertensive target study population during the 6 months before and after switching from metoprolol to nebivolol

  6 months

Secondary Outcomes (3)

• Number of monthly out-patient visits

  6 months

• Monthly Emergency Room visits per patient

  6 months

• Monthly hospitalizations per patient

  6 months

Study Arms (1)

Metoprolol to Nebivolol

Patients with high blood pressure (hypertension) who were continuously treated with metoprolol for a minimum of 6 months prior to switching to nebivolol. Patients were then continuously treated with nebivolol for a minimum of 6 months.

Drug: Metoprolol; Drug: Nebivolol

Interventions

Metoprolol DRUG

Metoprolol, oral administration

Metoprolol to Nebivolol

Nebivolol DRUG

Nebivolol, oral administration

Metoprolol to Nebivolol

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

Patents treated for hypertension during the period of 2007-2011 in the United States.

You may qualify if:

• Be at least 18 years old at initiation of metoprolol (or first date on metoprolol treatment between 2007 and 2011)
• Had one or more inpatient or outpatient claims with a primary or non-primary diagnosis of hypertension (ICD-9-CM 401.xx-405.xx)
• Received nebivolol treatment continuously (defined as supply gap \<30 days) for at least 6 months after initiation
• Received metoprolol treatment continuously for at least 6 months prior to switching to (initiation of) nebivolol (defined as metoprolol was discontinued whereas a prescription for nebivolol was filled)
• Had at least 12 months of continuous enrollment (as verified using enrollment file): 6 month prior to nebivolol initiation and 6 months following nebivolol initiation.

Sponsors & Collaborators

• Forest Laboratories: lead

Study Sites (1)

Forest Investigative Site 0

Jersey City, New Jersey, 07311, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Metoprolol; Nebivolol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Ethanolamines; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Stephanie Chen, PhD

  Forest Laboratories

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: December 26, 2012
• First Posted: January 1, 2013
• Study Start: October 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: July 1, 2013
• Last Updated: January 1, 2013

Record last verified: 2012-12

Locations

US (1)