Economic Impact of Switching From Metoprolol to Nebivolol for Hypertension Treatment

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

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.

Study Overview

• Status: Unknown
• Conditions: Hypertension
• Intervention / Treatment: Drug: Metoprolol; Drug: Nebivolol

• Study Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Jersey City, New Jersey, United States, 07311
      • Forest Investigative Site 0

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of monthly out-patient visits	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.	6 months
Monthly Emergency Room visits per patient	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.	6 months
Monthly hospitalizations per patient	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.	6 months

Collaborators and Investigators

• Sponsor: Forest Laboratories
• Investigators: Study Director: Stephanie Chen, PhD, Forest Laboratories

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): July 1, 2013

Study Registration Dates

• First Submitted: December 26, 2012
• First Submitted That Met QC Criteria: December 26, 2012
• First Posted (Estimate): January 1, 2013

Study Record Updates

• Last Update Posted (Estimate): January 1, 2013
• Last Update Submitted That Met QC Criteria: December 26, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Hypertension; Health Care Cost; Monthly health care cost
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agonists; Adrenergic beta-Agonists; Sympatholytics; Adrenergic beta-1 Receptor Antagonists; Adrenergic beta-1 Receptor Agonists; Nebivolol; Metoprolol
• Other Study ID Numbers: NEB-HE-200