Economic Impact of Switching From Metoprolol to Nebivolol for Hypertension Treatment

Sponsor

Forest Laboratories (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01758263

Collaborator

(none)

3,000

Enrollment

Location

Duration (Months)

334.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: Metoprolol Drug: Nebivolol

Study Design

Study Type:

Observational

Anticipated Enrollment :

3000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Economic Impact of Switching From Metoprolol to Nebivolol for Hypertension Treatment: A Retrospective Database Analysis

Study Start Date :

Oct 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2012

Anticipated Study Completion Date :

Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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 Metoprolol, oral administration Drug: Nebivolol Nebivolol, oral administration

Arm

Intervention/Treatment

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

Metoprolol, oral administration

Drug: Nebivolol

Nebivolol, oral administration

Outcome Measures

Primary Outcome Measures

Patient monthly health care cost [6 months]
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

Secondary Outcome Measures

Number of monthly out-patient visits [6 months]
Estimate the average per patient monthly number of out-patient visits for the pre-specified hypertensive target study population during the 6 months before and after switching from metoprolol to nebivolol.
Monthly Emergency Room visits per patient [6 months]
Estimate of the average monthly number of Emergency Room (ER) visits per patient for the pre-specified hypertensive target study population during the 6 months before and after switching from metoprolol to nebivolol.
Monthly hospitalizations per patient [6 months]
Estimate of the average monthly number of hospitalizations per patient for the pre-specified hypertensive target study population during the 6 months before and after switching from metoprolol to nebivolol.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.