Dutasteride in Enlarged Prostate Economic Assessment: A Retrospective Database Pooled Analysis of Early 5-alpha Reductase Inhibitor Use

Study Overview
=================
Brief Summary
-----------------
This retrospective study aims to assess the economic impact of early initiation of 5-alpha-reductase inhibitor (5ARI) therapy in patients with enlarged prostate (EP) receiving 5ARI and alpha-blocker (AB) combination therapy. Both the Integrated Health Care Information Solutions and PharMetrics databases will be utilized for this study (2000-2007).

Official Title
-----------------
Dutasteride in Enlarged Prostate Economic Assessment: A Retrospective Database Pooled Analysis of Early 5-alpha Reductase Inhibitor Use

Conditions
-----------------
Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Drug: 5ARI + AB


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male patients aged 50 years or older a medical claim of EP a prescription claim for a 5ARI and AB (provided both are within 180 days of index date) continuously eligible for 6 months prior to and at least 12 months after index prescription date. Exclusion Criteria: diagnosis of prostate or bladder cancer any prostate-related surgical procedure within 5 months of index date prescription claim for finasteride indicative of male pattern baldness 5ARI therapy initiated prior to initiating AB therapy

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Early 5ARI Initiation<br>Patients with EP receiving combination therapy (AB + 5ARI) with early initiation of 5ARI (within 30 days of initiation of AB) | Drug: 5ARI + AB<br>* 5ARI: Dutasteride or Finasteride AB: Doxazosin, Tamsulosin, Terazosin, or Alfuzosin<br>|
| Late 5ARI Initiation<br>Patients with EP receiving combination therapy (AB + 5ARI) with late initiation of 5ARI (more than 30 days but less than 6 months after initiation of AB) | Drug: 5ARI + AB<br>* 5ARI: Dutasteride or Finasteride AB: Doxazosin, Tamsulosin, Terazosin, or Alfuzosin<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Clinical Progression | Clinical progression was identified as the occurrence of acute urinary retention and/or surgery as identified by relevant Common Procedure Terminology (CPT) procedure codes and International Classification of Diseases (ICD)-9CM diagnosis codes. | Day 1 of a 1-day study | 
| Number of Participants With Acute Urinary Retention | Acute urinary retention was identified by relevant CPT procedure codes and ICD-9CM diagnosis codes. | Day 1 of a 1-day study | 
| Number of Participants Who Needed Prostate-Related Surgery | Prostate-related surgery was identified by relevant CPT procedure codes and ICD-9CM diagnosis codes. | Day 1 of a 1-day study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total BPH-related Costs | All costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx). | Day 1 of a 1-day study | 
| BPH-related Medical Costs | Medical costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx). | Day 1 of a 1-day study | 
| BPH-related Pharmacy Costs | Pharmacy costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx). | Day 1 of a 1-day study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Enlarged prostate, 5-alpha-reductase inhibitor, alpha-blocker, early, costs